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Investment trend
Jingtai Technology and Parthenon Therapeutics entered into antibody drug discovery cooperation
9On October 4, Jingtai Technology announced a cooperation with Parthenon Therapeutics, a company focused on tumor microenvironment reconstruction, to jointly develop antibody drugs for solid tumors。
Under the partnership, Jingtai will license its XupremAb to Parthenon Therapeutics®Antibody discovery platform。The platform includes a series of "experiment +AI" technology solutions that can be used to discover antibody drugs with better efficacy and developability。Parthenon Therapeutics and Jingtai will use XupremAb®A variety of discovery methods, in-depth analysis of the immune set library, the generation of a large integrated database, and then the algorithm of Jingtai technology to dig out excellent candidate antibody molecules。
(Information source: Medicine Wisdom News)
Zenex Bio has announced a partnership agreement with Bristol-Myers Squibb
9Today, Zenos Bio announced that it has entered into a partnership agreement with Bristol-Myers Squibb to acquire the rights of Zenos Bio's CD19 antibody Obexelimab in Japan, South Korea, Taiwan, Singapore, Hong Kong, China and Australia。Under the agreement, Bristol-Myers Squibb will pay an upfront payment of $50 million, as well as certain sales milestones and a percentage of sales。In addition, Bristol-Myers Squibb will make an equity investment in Zenos。
It is understood that Obexelimab is an antibody engineered CD19 antibody, which is the first pipeline of Zenex Bio, in addition to TNF-α antibody, CTLA4-Ig fusion protein, IGF-1R antibody and other drugs under development。Xencor is a pioneer in the field of antibody engineering, and Obexelimab increases the affinity of Fc gamma RIIb by 400 times through Fc modification, which more effectively exerts the effect of inhibiting B cells to treat autoimmune diseases。
Previously, on December 22, 2022, Zenaz Bio was in Clinicaltrials.Obexelimab is registered on gov for Phase 3 clinical use for the treatment of IGG4-related disorders。The Phase III trial is planned to enroll 200 patients with IgG4-RD and is expected to be initially completed in 2025。
(Information source: ZhitongFinance)
Biotech company Twist Bioscience announced a new drug development agreement with Ono Pharmaceutical
8Biotechnology company Twist Bioscience Corporation announced a partnership with Ono Pharmaceutical Co.,Ltd.Enter into a new drug discovery agreement to jointly discover and develop novel antibodies to treat autoimmune diseases。Under the terms of the agreement, Twist will conduct research activities using the Twist Biopharma Solutions Library of Libraries to discover novel antibodies against targets identified by the Ono。Twist will receive research fees, success-based clinical and regulatory milestones, and royalties from product sales。
Emily M.Leproust"Ono has a strong and proven track record of developing candidate antibodies in areas of need, including the development of Opdivo, the anti-PD-1 antibody, which has made a huge impact on patients and researchers。”.D., CEO and co-founder of Twist Bioscience。"This collaboration combines our antibody discovery expertise with Ono's experience in drug development and has the potential to lead to future breakthrough treatment options for patients with autoimmune diseases.。”
Under the terms of the agreement, Twist will use the Twist Biopharma Solutions Library of Libraries to conduct research activities to discover novel antibodies against targets identified by Ono。Twist's library is an extensive collection of synthetic antibody libraries based on naturally occurring sequences that leverage innovative structural and exploitability features to cover a wide range of drug targets。Twist will receive research fees, success-based clinical and regulatory milestones, and royalties from product sales。As part of the strategic collaboration, Ono will also leverage the scientific expertise of the biopharmaceutical Solutions team and Twist's advanced project management services to evaluate new targets and conduct comprehensive discovery activities。Ono will be in charge of development,
"We are actively working to create biologics such as antibodies to address unmet medical needs for a variety of diseases, including autoimmune disorders.。"We are very excited to be working with Twist at this time in the field of autoimmune diseases and are confident that their expertise in antibody discovery and impressively diverse and highly specific antibody library will bring us potentially functional antibodies.。Ono Senior Executive Officer/Executive Director of Discovery and Research。"We are confident that this new collaboration will enhance our biologics drug discovery efforts and bring innovative medicines to patients as quickly as possible.。”
(Source: businesswire)
Capital competition
Biopharmaceutical company Cellectar Biosciences announced the acquisition of approximately 1.$0.3 billion in private financing
9On October 5, biopharmaceutical company Cellectar Biosciences, Inc.Announced that it has entered into a securities purchase agreement with certain institutional investors for a private placement financing that is expected to generate up to 1.Total proceeds of $02.9 billion, including initial funding of $24.5 million, are priced at the closing price of the Company's common stock on September 1, 2023 at $1.00 per share.82美元。The round was led by Rosalind Advisors, with participation from AIGH Capital, ADAR1, Second Line, Nantahala Capital, AuGC and other new and existing institutional investors。
CellectarJames Caruso, President and Chief Executive Officer, said: "Current and new investor funding is up to 1.The $02.9 billion in financing reflects the significant value of our leading assets, Ipofoine and R&D pipelines。"With the initial $24.5 million, we are able to fully fund all corporate activities by completing key trials and expecting to report top-line data later this year.。The additional financing is fully funded in part through the potential accelerated approval and subsequent commercialization of iopofosin。”
By value 1.Under the $02.9 billion Securities Purchase Agreement, Cellectar will issue to the purchasers (i) an aggregate of $24.5 million of the Company's Series E-1 Preferred Stock, and (ii) two tranches of exercisable warrants, as follows:
AThe aggregate exercise price of some of the warrants will be approximately $44.1 million and the Series E-3 preferred stock can be exercised prior to September 6, 2026 or 10 days after the Company releases top-line data for WM CLOVER-WaM key data。Trial;The Class B warrants, which have a aggregate exercise price of approximately $34.3 million, can be exercised prior to September 6, 2028 or 10 days after the Company discloses that it has received written approval from the Board of Directors。FDA's New Drug Application for iopofosin I 131。
EThe Series preferred stock will be issued at a price of $20,000 per share。Conversion of Series E Preferred Stock into common stock of the Company is subject to approval by the shareholders of the Company。The conversion price of the Series E-1 Preferred Stock is 1 per common share.At $82, the conversion price of the Series E-3 Preferred stock is 3 per share of common stock.At $185, the conversion price of the Series E-4 Preferred Stock is 4 per share of common stock.7775美元。The shares of common stock, in any event, will be appropriately adjusted in the event of any stock dividend, stock split, merger or other similar recapitalization。
Oppenheimer&Co.Inc.Acting as the sole placing agent for the private placement。
The securities to be issued in connection with PIPE are being issued in a private placement pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended, and Regulation D enacted thereunder,And has not been registered under the Securities Act of 1933, as amended or the applicable state securities laws,May not be issued or sold in the United States,Unless exempted in accordance with a valid registration statement or applicable registration requirements。Cellectar has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the Series E Preferred Stock underlying common stock。
The U.S. Food and Drug Administration has granted iopofosine, Cellectar's primary asset.,This is a small molecule called PDC,The aim is to provide targeted delivery of iodine-131 (radioisotope) to patients with Warburg macroglobulinemia who have previously received two or more treatment regimens,And fast track designation。Recurrent (or refractory) multiple myeloma and recurrent (or refractory) diffuse large B-cell lymphoma (DLBCL)。
(Source: globenewswire)
Market situation
The ophthalmic drug market started late with large demand, and innovative drug companies competed to lay out the "blue ocean" of low concentration atropine.
The ophthalmic pharmaceutical company Zhaoke has made further progress in the commercialization of ophthalmology。The recently announced 2023 interim results report disclosed that Zhaoke Ophthalmology recorded a significant sales income for the first time with a total revenue of 11.3 million yuan。Zhaoke's sales revenue comes from both traditional hospitals and digital and physical channels。In addition, the company received an upfront payment of $5.4 million from a distribution and supply agreement with commercialized NVK002 in Korea。
Recently, Li Xiaoyi, chairman of the Board of directors, executive director and chief executive officer of Zhaoke Ophthalmology, introduced that the main market for ophthalmic treatment is in the field of surgery and medical devices, while the eye surface drug market is small。Previously, the eye surface drug market was mainly limited to the field of antibiotics, and dry eye, myopia, presbyopia and other major ocular surface diseases, although the demand is huge, but few treatment drugs。Among domestic pharmaceutical companies, Xingqi Ophthalmology laid out the ophthalmic drug market earlier, in recent years, Zhaoke Ophthalmology, OKvision and other innovative enterprises have entered the market, emphasizing the huge potential for the development of ophthalmic drugs。
In the eye drug market,Myopia treatment drugs have become a track of concern,"Comprehensive prevention and control of children and adolescents myopia implementation plan" proposed: by 2023,The myopia rate of 6-year-old children should be controlled at about 3%,The myopia rate of primary school students, middle school students and high school students is controlled below 38%, 60% and 70%, respectively,Earlier, the National Health Commission issued the "Children and adolescents myopia prevention and control appropriate technical guidelines" pointed out,Atropine at low concentrations is the only recommended anticholinergic,The demand and market size of atropine with low concentration can be seen。
However, it is understood that at present, there is no low concentration atropine for the prevention and control of myopia in children and adolescents in China has been approved for listing, but in April this year, the application for listing atropine sulfate eye drops (SQ-729) of Xingqi Eye medicine was accepted by the Food and Drug Administration to delay the progress of myopia in children。At present, the layout of Zhaoke ophthalmology is also progressing rapidly。On August 9, Zhao Ke Ophthalmology announced that the NVK002 trial of atropine eye drops used to treat myopia in China was progressing smoothly, and the last patient of "small CHAMP" was completed on August 3。In addition, the domestic research and development of low-concentration atropine eye drops and entered the phase III clinical trials of enterprises are OKvision, Hengrui Medicine and so on。
However, while there is great development potential in the ophthalmic drug market, the capital winter faced by the current pharmaceutical industry is also a problem that innovative pharmaceutical companies have to face。对此,Li Xiaoyi said,How long the capital winter will last remains unknown,Zhaoke Ophthalmology as a listed company is still in the main stage of research and development,There is no significant product sales revenue yet,So make sure you don't have to refinance,Ability to move R&D projects and commercialization forward,Until commercialization brings sufficient cash flow,Make the company enter the virtuous circle earlier。
In commercialization,Zhaoke Ophthalmology also promotes online and offline channel layout,Zhaoke Ophthalmology chief business officer and chief financial officer Feng Xinyan introduced,Mega focuses on strategic cooperation with private hospital groups and optometry centers,Use partners' existing channels to promote;And online channels,Zhaoke Eye pays attention to brand and relationship building,Created a public account,Strengthen relationships with the physician community,At the same time, it aims at the consumption attributes of the ophthalmic market,Use online social networking platforms,Popular science education for the public。
Ophthalmic drugs have a large market demand and a late start
In the domestic eye treatment market segments,The field of ophthalmic medicine started late,About ophthalmic drug market development,Li Xiaoyi introduced,Traditionally speaking,The main ophthalmic market is primarily in the field of surgery,Such as cataract surgery, laser correction and so on,The profit of private eye hospitals in China mainly comes from surgery.In addition,Ophthalmic medical devices are also one of the major markets for ophthalmology,Such as artificial lens, ok mirror and other fields。The scale of ophthalmic drug market is relatively small, among which, the fundus drug market has sprung up in recent years, while the scale of ocular surface drug market is still small。
Specifically speaking,Li Xiaoyi pointed out,此前,The ocular surface drug market is mainly confined to the field of anti-allergy, anti-viral, anti-fungal antibiotics,Many major ocular surface diseases have no treatment in China,Cyclosporins for dry eye, for example, have only recently emerged,In China, they were treated with artificial tears,The action is mainly physical,No pharmacological effect;In the field of myopia prevention and control,At present, there are no drugs on the market in the world,And laser correction, OK mirror and other aspects of myopia prevention and control related market is very large,But the drug market is small;In addition,In the field of presbyopia,At present, there are no relevant ocular surface drugs introduced in China,The disease is mainly resolved by instruments or surgery,To wear reading glasses mainly,Or with cataract surgery。
Zhaoke Ophthalmology performance announcement introduced that the number of patients with eye diseases in China is the largest in the world, the patient group is rapidly expanding, and the medical gap is huge。According to the data, the ophthalmic drug market is expected to reach about $11 billion by 2027。
"This is a market with rigid demand, the market demand is relatively clear, there is no need to recreate the demand.。Ophthalmology market is very large, as far as the eye surface market is concerned, it can be imagined that the market size in the future may be dozens or even hundreds of times larger than the current。"Li Xiaoyi thought。
The competitive landscape of ophthalmic drug market,There are industry insiders,In terms of the traditional ophthalmic market,In China, there are professional multinational ophthalmological enterprises such as Alcon and Allergan,But these multinationals are in the domestic market,Less emphasis on ophthalmic medicine,Allergan, for example, focuses more on the field of medical beauty,Alcon mainly focuses on the field of ophthalmic instruments,Among multinational pharmaceutical companies, only Japan's Santen Pharmaceutical has a presence in China for ophthalmic drugs,But the scale is still limited。
In contrast, the ophthalmic product line of domestic pharmaceutical companies is relatively rich。Li Xiaoyi introduced that in the domestic pharmaceutical company Zhongxing Qi ophthalmic medicine layout earlier, Qilu Pharmaceutical, Broad pharmaceutical industry and other large pharmaceutical companies in the previous layout, and in recent years, Zhaoke Ophthalmology, OKvision and other innovative enterprises have entered the market, focusing on the huge potential for the development of ophthalmic drugs。"In the field of ophthalmic drugs, there is still a chance to become the leader of the track, because the track has just started, everyone is almost on the same starting line, and the gap between each other is not large.。”
Compared to other drugs,There are some differences in the ophthalmic drug market,About the commercial aspects and differences and targeted layout,Feng Xinyan pointed out,In the field of eye treatment services,首先,Except for public hospitals,Private hospital groups are an important channel,Cooperation and coverage are needed,For example, Zhaoke Ophthalmology in the B round of financing,Aier Group is the strategic shareholder,He was also a cornerstone investor in the IPO。Secondly, in the offline business form, the optometry center is also strongly related to ophthalmic drug companies, so in early August 2023, Zhaoke Ophthalmology reached a strategic cooperation with Aibo Medical。
"For example, for children,In the ok mirror track of myopia treatment,Optometry centers play a very important role in the industry,Head optometry centers such as Aibo Medical and Opkang Vision have a large customer base,This is also the target population for the treatment of myopia with low concentration atropine eye drops,因此,We chose to cooperate with Aibo Medical,Be able to leverage its existing channels。"Feng Xinyan analysis said。
In addition to offline channels, online channels also play an important role。Feng Xinyan also said that online channels not only reflect the online sale of drugs, but also play a role in brand building, such as Zhaoke Ophthalmology created a public number for doctors, through the online content platform to enhance the trust between doctors。
In addition to the B-end channel, Feng Xinyan also pointed out that the ophthalmic treatment field has a stronger consumer attribute, for example, in the selection of children's myopia eye drugs, although atropine eye drops require a doctor to prescribe, but parents will also carefully study the product attributes, the product will also form a reputation in the parent group, the same is true in the field of presbyopia drugs。"Therefore, before the launch of our main products, we have been using online social platforms to educate the public, so that the public can pay attention to related diseases and understand public demands.。”
Layout atropine eye drops Blue Ocean market
The number of myopia in China is on the rise, the National Health Commission data show that the overall myopia rate of children and adolescents in 2022 is 53.6%。In the "Appropriate Technical Guidelines for the Prevention and Control of Myopia in Children and Adolescents" issued by the National Health Commission, low-concentration atropine is the only recommended anticholinergic drug。
At present, no low-concentration atropine has been approved for the prevention and control of myopia in children and adolescents in China, and it is mainly sold in the form of hospital preparations in recent years。At present, the low-concentration atropine eye drops developed by many domestic enterprises have entered phase III clinical trials。"Zhaoke Ophthalmology is in the first echelon of domestic research and development progress。"Mr Feng said。
Among the enterprises in the layout of research and development, Xingqi Eye Medicine is the first enterprise in China to start low-concentration atropine eye drops test。In April 2023, Xingqi Eye Medicine issued an announcement, the company 0.01% low concentration atropine sulfate eye drops domestic marketing authorization application accepted。
Except for the Shinzie eye medicine,Mega Eye's US partner Vyluma was previously announced,The New Drug Application (NDA) for NVK002 has been accepted by the U.S. Food and Drug Administration (FDA),The NVK002 Prescription Drug User Pay Act (PDUFA) approval date is January 31, 2024。At the same time, the NVK002 trial in China is progressing smoothly, and the Phase III bridging clinical trial has completed the last visit of the last patient on August 3, 2023。In addition, Mega is conducting a two-year CHAMP trial in China for NVK002, achieving good patient compliance and making the trial period more than half smooth。
It is understood,In addition to the first echelon of Xingqi ophthalmology and mega ophthalmology,The low-concentration atropine eye drops independently developed by Hengrui Medicine was registered for phase III clinical trials in September 2021,The treatment period was 144 weeks,Multiple clinical endpoints, including the primary endpoint, were set at weeks 96 and 48,At present, patients have been enrolled。It is expected that Hengrui Medicine may complete clinical patient selection in Q2 to Q3 2024。
此外,Okvision adopts a double chamber device of compound solution + freeze-dried powder,To solve the problem of long-term storage stability of low concentration atropine sulfate eye drops,Also completed Phase III international multi-center clinical patient enrollment in June this year (completed Chinese enrollment in February),Because it's a global clinical trial,Design 3+1 study cycle。
Previously, there were a number of Internet hospitals to halt the online sale of atropine eye drops, for atropine eye drops standardized sales, Li Xiaoyi said that the current demand for low concentration atropine eye drops is very large, but it is still sold as a hospital preparation。Hospital preparations compared with regular drugs in the supervision and other aspects of the difference, so there are a variety of problems, such as to solve these problems, need to really through the State drug Administration approved the listing of drugs, so that through large-scale clinical testing proved safe and effective atropine eye drops, can really be provided to the public through pharmaceutical sales channels。
When there is great development potential in the ophthalmic drug market, enterprises are competing for layout,The pharmaceutical industry's capital winter continues,It also brings challenges to the research and development and commercialization of Zhaoke Ophthalmology,对此,Li Xiaoyi said,How long the capital winter will last remains unknown,Zhaoke Ophthalmology as a listed company is still in the main stage of research and development,There is no significant product sales revenue yet,Still relies heavily on funds raised before and after the listing,To promote project research and development and other work。
"So we have to think about how we can survive on our own, and right now for us, it's all about making sure that we can carry out all the R&D projects without having to refinance, and then commercializing them successfully, until commercialization can provide enough cash flow to get the company into a virtuous cycle earlier.。Li Xiaoyi pointed out。
From a research and development perspective,Li Xiaoyi thought,Rhythm is very important these days,Focus on some recent products,Zhaoke Ophthalmology currently focuses on 5 products,These 5 products have completed phase III clinical trials and are ready for approval,Or in phase III clinical trials,The Company's current resources are sufficient to support the successful completion of development and commercialization of these products。
At the same time, in terms of commercialization, Li Xiaoyi said that Zhaoke Ophthalmology hopes to make preparations for commercialization first, and once the product is approved for listing, it can cover important channels at the fastest speed。
According to the company's results announcement, as at 30 June 2023, the total value of cash and cash equivalents of the Company was approximately 16.$7.5 billion to support resources needed for clinical and research and development programs;Gross profit margin is approximately 89.8%;Research and development expenditure is about 2.0.5 billion yuan, reflecting the progress of the company's research and development projects and its clinical stage;Sales and distribution expenses were approximately 0.2.3 billion yuan;The general and administrative expenses are approximately 0.43亿元。The results announcement believes that the above figures are in line with the latest development stage of the company's various projects, as well as the company's overall strategy from a pure research and development company to a dual track of research and development and commercialization。
(Information source: 21 Economic network)

Market analysis
Why China's innovative drugs are just waking up
If China's innovative drugs want to succeed globally, what preparations need to be made?There may be no right answer。After all, different people have different perceptions。
But one thing is for sure,At least a group of awakening people should lead China's innovative medicine to continue to move forward。And this is what continues to happen in China's innovative drug industry
It is not difficult to find that China's innovative drug industry has gone through many metamorphoses。
The first stage, from the end of the last century to 2009, the green forest period。At that time, angel investors were mostly non-professional investors, and with the support of some far-sighted governments, pioneers such as Beida Medicine and Microcore biology were born.
The second stage is the start-up period from 2010 to 2014。Forward-thinking returnees are returning home, and domestic investors are starting to raise their stakes。Driven by the fast follow strategy, Baekje and Junshi creatures took the stage;
The third stage is the period of events from 2015 to the present。Pharmaceutical companies have begun to deeply feel that innovation is the source of development, and have begun to look to the world and seek internationalization。As a result, new forces such as legendary creatures have emerged。
China's innovative drug industry has been changing the landscape, which is the "awakening" of the innovative force.。The next wave of innovation is coming, and China's innovative drug industry will also move towards the fourth stage。
At this stage, two categories of "global new" forces will emerge。One is from the basic scientific research to the transformation of new drugs;The other type is the enterprise that starts from the technical bottleneck and leads the global development with a breakthrough attitude, such as the cell therapy industry。The innovation and internationalization of these pharmaceutical companies are destined to be more magnificent。
Awakening before, subversion after。When the domestic pharmaceutical companies continue to evolve, the entire industry continues to rise, based on the world, from behind to parallel, and then to overtake。
01From behind to neck and neck
Five years ago, the last time the passion of Chinese medicine was ignited。
2018On December 17, a piece of news strongly ignited the investment confidence in the field of domestic innovative drugs: the first domestic PD-1 monoclonal antibody was approved for listing。
PD-1Monoclonal antibody is a rare star anticancer product。Domestic PD-1 can be regarded as the starting point of the take-off of China's pharmaceutical industry: before this, the domestic generic drugs are mainly, innovative drugs are almost all imported, and the cost of innovative drugs for patients is high;Since then, innovative drug types have emerged in endlessly and flourished, and China and the world have almost equalized or even caught up with the progress of new drug listing。
The essential reason for achieving this breakthrough is the result of the accumulation and convergence of domestic pharmaceutical innovation forces in the past few decades。
2014In June, the world's first PD-1, the "Odivo" produced by Bristol-Myers Squibb in the United States was approved for listing in Japan, causing a sensation around the world。PD-1 at that time was known as the "universal anti-cancer drug", different from the previous anti-cancer drugs dedicated to killing cancer cells, PD-1 strengthens the body's own immune cells, and theoretically has a certain inhibitory effect on all cancers。
After the "Odivo" came on the market, a rival product soon appeared: the United States Merck Company's "Creda"。This is also a type of PD-1, but because of its different molecular structure, "Corida" is better than "Odivo" in the treatment of some tumors。In just a few years, Merck's "Corida" has surpassed sales。In 2023, "Kerida" has firmly secured the throne of global drug sales champion。
This incident has given China's innovative drug companies a great inspiration: as long as the direction is correct, the latter can also create miracles。
When foreign PD-1 competition for the situation, the internal power of Chinese enterprises is also gradually condensed。During the 13th Five-Year Plan period, biological drugs were listed as the key development of innovative drug categories in China's industry, and a series of policies such as national major new drug creation encouraged pharmaceutical companies to invest in research and development, and funds quickly tilted to biopharmaceuticals, and domestic innovative drug companies mushroomed quickly。PD-1 is one of them。
Before the approval of domestic PD-1, the price of "Odivo" and "Keruida" in the Chinese market is amazing, and the annual cost is more than 500,000 yuan, which is exactly the same as the operation of foreign pharmaceutical companies to control high-end drug prices in the past few decades。
However, after 2019, domestic PD-1 has been approved for market, and the efficacy is comparable to the two imported drugs, and the drug choice for domestic patients has greatly increased。In the past five years, there have been more than 10 kinds of domestic PD-1, most of which entered the medical insurance through price negotiations with the medical insurance department。
The current annual treatment cost of domestic PD-1 has dropped to less than 40,000 yuan, and it can also enjoy nearly 70% of medical insurance reimbursement。This has an obvious impact on imported drugs such as K and O drugs。Although the price of these drugs is still strong, at present, patients are basically preferential by donating drugs: the treatment cost of K drug is more than 500,000 yuan in the early years of the market, and now the actual annual cost of treating some cancer types is only about 70,000 yuan。
Domestic innovative drugs have promoted the unprecedented prosperity of the PD-1 market, benefiting not only patients, but also participants。That's the beauty of the market。
Research and development requires technical confidence, decision-making requires passion and faith。China can appear PD-1 everywhere flowering scene, on the one hand, from 2012, the internal introduction and external outreach, open the door to continue to accumulate cutting-edge technologies from the world;On the other hand, policy support, technology, investors can see the booming market opportunities, have expectations for the future, is a deeper reason。
It can be seen that since the emergence of a large number of domestic PD-1 drugs, China has become an internationally recognized emerging innovative drug market that can match the US market。Many domestic innovative drugs, including PD-1, have carried out clinical trials and been approved for listing in the United States, representing China's scientific and technological strength to the world。
02New key nodes and new opportunities
PD-1It is a prominent representative of China's biomedicine industry。China's pharmaceutical innovation started significantly later than foreign countries, and failed to catch up with the world's first wave of innovative drug research and development at the beginning of this century。但After 2010, some segments not only achieved parity with the world's giants, but even triggered competition concerns from multinational pharmaceutical companies, and in fact completed the performance of industry breakthroughs。
It can be said that in the second wave of innovative drugs, Chinese companies are not weak。
According to statistics, as of July this year, a total of 130 innovative drugs and 217 innovative medical devices have been approved in China, and the innovation momentum of China's pharmaceutical industry is becoming stronger and stronger。
More advanced treatments are emerging,Such as in the current more popular ADC field,In 2021, Vedicetuzumab for injection from Rongchang Bio was approved for market;The 2022 Colombotai ADC variety is not yet available,On the authorization fee of 10 billion yuan to get the investment of multinational Merck;April of this year,The EIC TROP2 ADC is also licensed to Pyramid Biopharmaceuticals in the United States。
ADCAs a representative of a class of innovative drugs, Chinese companies have basically achieved and run with multinational giants。In more cutting-edge fields, domestic innovative varieties are more likely to surpass。
In the third wave represented by CGT, Chinese enterprises rushed to the front row of the world。2022At the end of February, Legendary Bio's Sidagiorense was approved by the FDA for listing in the United States, representing China's CAR T officially entering the US market, which is the world's largest new drug。In the first half of this year, sales of this BCMA CAR-T from Legendary Biology reached 1.$1.7 billion, an increase of 388%, has become a first-line CAR-T product in the United States。
At present, there are already two CAR-T products on the market in China, respectively, Fosun Kat's "Yikaida" and Yaoming Juno's "Binorda".。New CAR-T therapies are still emerging。In July this year, the third domestic CAR-T therapy jointly developed by Xinda Biology and Reindeer Biology was approved for listing, and it was determined to be 116.60,000 yuan per injection, lower than the previous two CAR-T models。
Regulators speed up the market evaluation of innovative drugs, making CAR-T product prices have loosened, which is similar to the competitive landscape of PD-1。Once monopolized by foreign pharmaceutical giants, with the increase of Chinese entrants, "god medicine" is getting closer and closer to patients, which on the one hand shows that the development of China's biomedical technology is unstoppable, and on the other hand, it also continuously confirms the objective law of the industry from high-end rare to accessible to everyone。
Without the concerted efforts of industry players, the promise of CAR-T would not have been discovered so quickly;Without policy and industry responses, CAR-T is unlikely to benefit more patients quickly。
According to incomplete statistics, there are at least 5 CAR T models that are currently undergoing confirmatory clinical trials, among which BCMA CAR-T from Legendary Biology and CLDN18 from Keji Pharmaceutical.2 CAR-T, CD19 CAR-T of syngeneic biology has been declared for market;CAR-T products such as CD19 and CD19/BCMA dual targets from Hengrun Dashen are expected to enter the NDA stage soon。
The introduction of a new technology will surely go through the process of breaking through the technical bottleneck, the emergence of competitive products, the measurement of advantages, the survival of the fittest and so on, and the whole industry will continue to deepen the cognition of new technology, the evaluation of the track will be more rational, the risk will have a deeper understanding, and the technology will reflect greater value to the society。
This process requires sufficient time and patience from society, policies, and funds。In particular, in the field of innovative drugs, the industry generally recognizes the "double ten law" (that is, the average time to develop a new drug is ten years, and the cost of one billion dollars), which has illustrated the twists and turns of the development of innovative drugs。
The field of cell and gene therapy represented by CAR-T must be the crown jewel of future biomedicine。At the national level, the Opinions on Further Optimizing the Foreign Investment Environment and Increasing Efforts to attract Foreign Investment issued by The State Council on August 13 clearly pointed out that foreign-invested enterprises are encouraged to carry out clinical trials of overseas listed cell and gene therapy drugs in China according to law。
The cell and gene therapy industry is now in the introductory phase。Only when the environment facing enterprises is more and more tolerant, sustainable innovation can become the common goal of the whole industry, and Chinese pharmaceutical companies will no longer be far away among the world's top pharmaceutical companies。
The biomedical industry is full of resilience, and after experiencing the test of the epidemic, the whole industry has become mature and pragmatic。Enterprises that are looking forward to running on this track will usher in a new round of rapid development of innovative drugs in China。
(Source: Amino Watch)

Operation management
The Art of Upward: What are the driving forces of Cancer Early screening companies?
The classic book The Structure of Scientific Revolutions argues that each era has a dominant paradigm in science。
In the early screening industry, in the early stage of rapid technological development, how to build a new generation of products, reduce the application threshold, and open up the commercialization path is a challenge that the industry needs to solve jointly。Winners will inevitably become the "paradigm" that affects the development of the entire industry.。
So, in such an era, what is the "paradigm" of the early screening industry?As industry observers, we try to answer these questions by thinking from the experiences and insights of front-line players。
One observation sample is Nuo Hui Health。The word "red" can accurately describe the past two years of Nuohui, 2021 is still just one of the unknown 18A enterprises, 2023 has become one of the few biotechnology enterprises that rely on product profits。
It's like a 100-meter race in which the runner who was left behind suddenly speeds up and overtakes everyone。Today, Nuo Hui's sprint continues。
9On October 2, Novo released baseline clinical data showing that the consistency of urine sampling and cervical sampling was very high。This indicates that the first urine cervical cancer HPV screening product is expected to be listed in 2027, becoming a new growth driver for the company。
So, what does the constant acceleration tell us?
01, initial intention, patience and determination
In the process of human and natural development, there exists the "lotus law" objectively.。One of its main points is that he who travels a hundred miles is half ninety。What a person fights to the end is not luck and wisdom, the most important is perseverance。
The inspiration of lotus law to the early screening industry is very realistic and operational。Because of the characteristics of early screening slow work out of fine work, it requires that the enterprise's original heart, patience and determination are indispensable。
For a "certified" early screening product, responsible test data is the touchstone of product detection ability, and it is also the cornerstone of obtaining the trust of clinicians and users。
This means that the product must go through four stages of "underlying technology development - retrospective research - large-scale prospective research - industrialization landing"。
Each stage is challenging, especially for large-scale prospective studies。This point can be seen through the palace evidence clear。
Due to the need to observe a sufficient number of positive samples, large-scale, prospective studies need to ensure a large enough number of participants:
Based on calculation, a total of 1.With 670,000 subjects, this is also the largest prospective cancer screening registration clinical trial in China so far。
In order to ensure that the samples of enrolled subjects really meet the real world standards, Gong Zhengqing set five centers in Beijing, Henan, Sichuan, Zhejiang and Hunan to be carried out simultaneously。
The number of clinical scale is large, multi-center parallel, and the clinical cycle and difficulty are undoubtedly increased sharply。
More importantly, the enrollment of subjects is only the beginning, the clinical success depends on the final data analysis, therefore, Miyazaki will enter the second stage: a three-year follow-up study。
This is also why, Miyazaki's product development started in 2017, but is currently only half successful, and the real market needs to wait until 2027。
For the development of an early screening product, "ten years of grinding a sword" is the norm。From the perspective of the industry, the lotus law means that the competitive landscape is good。But many factors, such as the clamor of capital and impatience of enterprises, have led to few executors。
Now, the example of Nuo Hui may be able to make the market calm down and rethink the development of the company。
02Ideas are more important than products
Nuohui's success is not limited to the ability to calm down to do product research and development。In fact, the development of early screening enterprises, business ideas are more important than products。
The business idea of Nuohui is mainly reflected in two levels, one is the selection strategy, the other is the commercialization strategy。Only by understanding its strategy as a whole can we gain insight into the secret of the growth of the early-screening industry。
At the selection level, although there are many indications that can be "early screening", as a difference from the existence of "diagnosis", which indications are suitable for early screening is quite worth thinking about。
For faster-progressing or slower-progressing cancers that are less lethal, the clinical benefits of early screening are relatively limited and market demand is limited。This requires a clear idea to start the business initiative。Nuo Hui healthy Miyaqing, is a good sample to observe。
First of all, screening for Miyazaki can bring clinical benefits。Although cervical cancer is characterized by a high incidence, it progresses slowly, taking decades from precancerous lesions to eventually develop into cancer。Therefore, "early screening" can not only reduce mortality, but also reduce the incidence, which is of great social value。This is also the core basis for the establishment of the commercial logic of cervical cancer early screening products。
Secondly, compared with clinical screening methods, Gong Zhengqing has significant differences。As the first painless and non-invasive cervical cancer HPV screening product based on urine samples, it has obvious advantages in terms of compliance and accessibility。
This also makes it a powerful complement to existing cervical cancer screening。On the one hand, the simple and fast non-invasive way allows more women to avoid the trouble of going to the hospital;On the other hand, testing is not limited by location or time, and can reach areas with poor medical resources。
Previously, the Health Commission set the screening rate of cervical cancer in women of the right age to reach more than 70% by 2030, but as shown in the figure below, limited by medical resources and other factors, China's cervical cancer screening to achieve the expected goal, self-sampling method is indispensable。
This also means that the compliance and accessibility advantages of Gong Zhengqing have foreshadowed its subsequent volume。It can be seen that the selection strategy is crucial。
The selection determines whether the early-screening logic is established, and the commercialization corresponds to the growth ceiling of the product。If the early screening products are limited to B-end channels such as hospitals, the ceiling can be seen at a glance。After all, at the B end, the voice of the hospital and other channels is more powerful;And only focusing on consumer medical channels is tantamount to water without a source。
And Nuohui is the perfect combination of the two。First of all, from the clinical channels, to carry out continuous education to consumers;Secondly, consumers who have completed education through clinical channels can bring follow-up and continuous re-purchase needs, thus forming a "pool" of the company's medical consumption.。With the expansion and widening of clinical channels, the consumption pool is also increasing, and finally forming a positive feedback。
This does not mean that Nuohui's commercialization path is the best solution for China's early screening industry, but at least, its current performance growth trajectory has told the market that this is a strategy worth paying attention to。
To some extent, the "thinking" of a business determines how it moves toward its goals。Ideas can iron out the fluctuations brought about by the industry cycle, and also determine the ceiling of the long-term development of an enterprise。With the growth of Nuohui, its deep cultivation of ideas in the early screening industry is also more worthy of other companies to think about。
03The ultimate efficiency pursuit
The innovation industry is also a creative industry, that is, to make better products at lower costs。Cost control, is to create the underlying ability of the company, is the physical law of manufacturing, it determines everything。Nuohui also relies on the continuous reduction of total cost strategy to achieve the goal of taking the lead in profitable landing。
Because it has a large number of C-end businesses, how to "integrate" it and bring significant scale effect is the top priority。To this end, Nuohui carried out extensive exploration, and finally made the average transportation cost significantly reduced through "merger signing" and other ways。
In terms of process, Nuohui changes the way of individual full responsibility system to the way of assembly line, which also makes it improve the detection efficiency while ensuring the quality of detection。According to the company, through this way, the per capita processing capacity of Nuohui has increased by 60%, and the human efficiency has been greatly improved。
Of course, improving human efficiency depends not only on processes, but also on technology。At present, Nuohui adopts a semi-automated way to replace part of the manual with machines, including automated pipetting, which also makes the number of company personnel increased by 87% year-on-year, and the amount of detection increased by 354%。
For most manufacturing, manufacturing efficiency leadership is enough to bring significant cost advantages, but not in the genetic testing industry。After all, consumables, as high-priced products in the genetic testing industry, have a direct impact on the overall profit margin。
Based on this, in addition to improving efficiency, Nuohui also further controlled costs through measures such as reducing procurement prices, including vertical supply chain integration。
For example, pipette consumables "gun heads"。As a consumable that each sample needs to be used independently, the purchase cost of Nuohui's "gun head" was 8 cents at the beginning, and through supply chain management, the cost was reduced by 10%。
For a business that measures millions of dollars annually, such cost reductions are obvious。It can be seen that through the optimization of raw material prices, Nuohui's overall procurement cost decreased by 3%。
Not only that, Nuohui's pursuit of efficiency is not limited to management, but also to integration - to do more things by themselves。
It is understood that Nuohui has established a wholly-owned subsidiary Xinhui Biology to focus on the research and development of core raw materials。This means that Nuohui can not only be self-sufficient in core raw materials in the future, but also can sell to earn money from core consumables。
From these aspects, Nuohui Health can be described as a practitioner of the "lean" concept。
The extreme control of the process and supply chain is the foundation for Nuohui to become the earliest ashore in the early screening industry, and also brings a new development paradigm reference for the entire industry。
Looking back at the development track of Nuohui, it is not difficult to find that the driving force of early screening enterprises is multi-dimensional。
To become a successful "paradigm" requires not only technical proficiency, but also patience。This is only the basis for success, and the understanding of the industry determines how far the enterprise can eventually go。
More importantly, in the continuous exploration of enterprises, the opponent is not only the new and old early screening enterprises, but also the past。
(Source: Amino Watch)

Science and technology research and development
Successful Phase III study of Roche Aletinib in the treatment of ALK-positive early NSCLC
9Roche today announced that the Phase III Aletinib ALINA study in ALK-positive early non-small cell lung cancer (NSCLC) met its primary endpoint of disease-free survival (DFS) in a preset interim analysis。Aletinib is the first and only ALK inhibitor demonstrated in a Phase III trial to reduce the risk of disease recurrence or death in patients with ALK-positive early stage NSCLC。
The results showed that aletinib adjuvant treatment of completely resected patients with stage IB (tumor ≥4cm) to stage IIIA ALK-positive NSCLC reduced the risk of disease recurrence and death compared with platinum-based chemotherapy。
Overall survival (OS) data were not yet mature at the time of this analysis。No unexpected safety results were observed。The results of the ALINA study will be presented at an upcoming medical conference and presented to global regulatory agencies, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).。
"Aletinib has transformed treatment outcomes for patients with advanced ALK-positive NSCLC, and now these robust results demonstrate for the first time that this drug can also play a critical role in early stage disease, where there is a large unmet need.。Levi Garraway, MD, Roche's chief medical officer and head of global product development, said: "If approved, Aletinib has the potential to treat cancer before it spreads, thereby increasing the chances of a cure, which is our ultimate goal at Roche。We look forward to sharing this data with regulators and hopefully bringing benefits to patients as soon as possible.。”
Currently, about half of patients with early-stage lung cancer (45% to 76%, depending on the stage of the disease) experience a recurrence of their cancer after surgery despite receiving adjuvant chemotherapy。Recent innovative therapies, including immunotherapy, have improved the prognosis for some patients with early-stage NSCLC;However, there are currently no approved ALK inhibitors for early-stage ALK-positive disease。About 5% of NSCLC patients are ALK-positive。
(Information source: Medical Cube)
For children with refractory SLE, Rongchang Biotecitacept clinical subjects are extended to 5 years of age and above
9Rongchang Bio announced that the supplemental application for the Phase 1 clinical study of Taitacept (RC18) for pediatric patients with systemic lupus erythematosus was approved by the China National Drug Administration (NMPA), and the age range of subjects was expanded from 12 to 17 years old to 5 years old and above。
Systemic lupus erythematosus (cSLE) in children is an autoimmune disease that affects multiple systems and organs, especially SLE patients who develop SLE before the age of 18。Compared with adult SLE, children often have more rapid onset, more severe disease, more migratory disease course, and more severe kidney and nervous system involvement, and need better treatment options with fewer side effects。
Taitacept is a BLyS/APRIL dual-target fusion protein innovative drug independently developed by Rongchang Biology,It can inhibit the overexpression of both BLyS and APRIL cytokines simultaneously,The "two-pronged approach" prevents abnormal differentiation and maturation of B cells,So as to treat a variety of immune diseases mediated by B cells。In March 2021, the first indication for Taitacept received conditional approval from NMPA for the treatment of systemic lupus Erythematosus (SLE).。
According to the Rong Chang Bio press release,The current approval of Taitacept is in a multicenter, multiple-dose, single-arm, open clinical study in patients with active systemic lupus erythematosus aged 5 to 17 years receiving standard care,To evaluate the pharmacokinetic characteristics, efficacy and safety of multiple administration of titacercept in Chinese patients with cSLE。In this study, children aged 5 to 17 years were divided into 2 cohorts (12 to 17 years and 5 to 11 years) according to age, and Rongchang Biology is conducting a clinical trial in cohort 1 (12 to 17 years)。
The study was first approved in April 2022,Rongchang Biology then submitted a supplementary application,Includes sufficient non-clinical and clinical safety data,The evaluation was approved by the Center for Drug Evaluation (CDE) of the China State Drug Administration,Titacept may be used in clinical studies in patients over 5 years of age with cSLE。
According to the Expert Consensus on the Clinical Diagnosis and Treatment of Systemic Lupus Erythematosus in Children published in 2022, patients with cSLE can be treated with biologics such as Taitacept。In May of the same year, clinical data from an own before-and-after controlled trial of the safety and efficacy of titacept in patients with refractory cSLE were published in Lupus。This is the first report of Titacept at home and abroad based on cSLE real world clinical study data。The study concluded that Taitacept combined with standard treatment significantly improved the SRI-4 (SLE responder Index 4) response rate in patients with cSLE, reduced glucocorticoid dose in refractory cSLE, and also showed efficacy in lupus nephritis。
(Information source: Medical Guanlan)
GenmabTIVDAK announced with Seagen®The primary endpoint of improving overall survival in patients with recurrent or metastatic cervical cancer was achieved
9On Friday, biotechnology companies Genmab A/S and Seagen Inc.Announced the Phase 3 innovaTV 301 global trial receiving TIVDAK in patients with recurrent or metastatic cervical cancer who have disease progression during or after first-line treatment®People treated (tisotumab vedotin-tftv) met the primary endpoint of overall survival (OS) compared to chemotherapy alone。The Independent Data Monitoring Board determined that OS crossed the pre-specified efficacy boundary in the interim analysis。Key secondary endpoints for progression-free survival and objective response rate assessed by the investigators also showed statistical significance。The safety profile of TIVDAK in innovaTV 301 was consistent with what is known about TIVDAK in U.S. prescribing information, and no new safety signals were observed。
innovaTV 301/ENGOT cx-12/GOG 3057The results (a global, randomized, open-label Phase 3 trial) complement the previous innovaTV 204 results and set the stage for accelerated approval of TIVDAK in the United States。Following discussions with regulators, the innovaTV 301 results are intended to serve as a key confirmatory trial for accelerated approval in the United States and to support global regulatory applications。The innovaTV 301 China outreach study has been launched and continues to enroll patients in collaboration with Zai Lab Limited。
"TIVDAK is the only U.S. Food and Drug Administration-approved therapy for second-line recurrent or metastatic cervical cancer, regardless of biomarker status, tumor histology and prior treatment," said Roger Dansey, MD, president of Research and development and chief medical officer of the company。西根。"Demonstrating the survival benefit through the innovaTV 301 results is an important milestone in our efforts to ensure that more adults with advanced cervical cancer have access to approved treatment options.。”
"For patients with advanced cervical cancer whose disease progresses after first-line treatment, options are limited, so treatment options with novel mechanisms of action are needed, especially those with proven survival benefits," said Dr. Jan van de Winkel。CEO of Genmab。"These results offer hope for patients with recurrent or metastatic cervical cancer。”
innovaTV 301 3The results of the Phase I clinical trial will be presented to an upcoming medical congress and discussed with regulatory agencies。
(Source: Arterial Network)
Merck Class 1 new drug was clinically approved in China for pulmonary hypertension
9On October 4, CDE official website showed that the application for clinical trial of sotatercept, a Class 1 new drug for injection, submitted by Merck in China has been granted clinical implied approval for the treatment of pulmonary hypertension。
Pulmonary hypertension is a rare, rapidly progressive, and ultimately life-threatening condition characterized by constriction of the small pulmonary arteries and elevated blood pressure in the pulmonary circulation that can cause a significant increase in cardiac load, leading to physical activity restriction, heart failure, and shortened life expectancy, with a five-year mortality rate of 43%。
sotaterceptIt is a potential "first-in-class" ActRIIA receptor fusion protein,ActRIIA's modified outer cell domain can be fused with the Fc end of the antibody,Blocking the activin from binding to receptors on the cell membrane,Thereby reducing activin-mediated signaling。
2021In September, Merck completed its acquisition of Acceleron to acquire sotatercept, an innovative treatment in development。Previously, Merck submitted a biologics license application to the U.S. Food and Drug Administration (FDA) for sotatercept, which has also been granted "rare disease drug" and breakthrough therapy designation by the FDA。
(Source: Beijing News)
RNAEdit therapy to submit clinical trial application
Wave Life Sciences 9Announced the filing of the first clinical trial application (CTA) of its investigational therapy WVE-006 for the treatment of alpha-1 antitrypsin deficiency (AATD)。WVE-006 is a potential "first-in-class" GalNAc conjugated RNA editing oligonucleotide,Designed to correct single base mutations in mRNA encoded by the SERPINA1Z allele,This allows the functional wild-type alpha-1 antitrypsin (AAT) to recover and circulate。According to the press release, WVE-006 is the first RNA editing therapy to enter clinical development。
Oligonucleotides are short strands of DNA or RNA that have the potential to reduce, restore, or regulate RNA through different mechanisms。Because oligonucleotides are able to target an extremely wide range of genomic sequences, they have the potential to be developed as therapies for many different disease areas, including targets that were previously considered difficult to develop through small molecules or biological products。According to the press release, Wave's proprietary PRISM platform is capable of providing three RNA-targeting modes (editing, splicing, silencing, including siRNA and antisense oligonucleotides)。These different RNA-targeting modes incorporate innovative chemical techniques, including chemically modified mainchains using phosphoryl guanidine (PN) and stereochemical control, to optimize the pharmacologic properties of oligonucleotide therapy。
AATDIt is a genetic disease that can affect lung and liver function. Due to the lack of α-1 antitrypsin with normal function, newborns may develop hepatitis syndrome, adults may develop liver fibrosis, and even develop cirrhosis and hepatocellular carcinoma。The main pathological feature of the disease is the accumulation of mutant AAT proteins, which damage the liver and lungs。About 200,000 patients in Europe and the United States have Z mutations in both alleles, known as PiZZ genotypes。Currently, the only treatment option for AATD lung disease is through weekly intravenous infusion to deliver the AAT protein。There is no treatment for AATD except liver transplantation。
WVE-006Oligonucleotide therapy for potentially "first-in-class" AATD, chemically modified by PN and coupled by GalNAc, is being developed to modify the transcript of the mutated SERPINA1 gene to improve the liver and lung symptoms of this disease。
In December, Wave entered into a strategic partnership with GSK to leverage Wave's multimodal RNA platform to advance RNA drugs, including WVE-006。Wave got 1.$700 million in advances and research funding。In addition, for WVE-006, Wave is eligible for up to 2.$2.5 billion in development and go-to-market milestones。
The current clinical development program for WVE-006, which includes healthy volunteers as well as individuals with homozygous PiZZ mutations with AATD, aims to provide an effective proof-of-mechanism pathway by restoring wild-type AAT proteins in serum。Wave expects to begin dosing healthy volunteers in the fourth quarter of 2023 and provide mechanovalidation data for individuals with AATD in 2024。
(Source: Wuxi Apptec)

Launch of new drug
Domestic listing
China Antibody Pharmaceutical anti-CD22 monoclonal antibody listing application accepted
9On October 5, the latest announcement on the official website of CDE, China Antibody Pharmaceutical branch company Xylomin Biological submitted a new drug listing application for Sucilizumab injection and was accepted。Public information shows that suciraslimab (SM03, suciraslimab) is an anti-CD22 monoclonal antibody developed by China Antibody Pharmaceutical, and has submitted a marketing application for the treatment of rheumatoid arthritis in August this year。
Rheumatoid arthritis (RA) is a chronic autoimmune disease, mainly characterized by aggressive arthritis. The initial joint manifestations are morning stiffness, swelling, pain, etc., and finally joint deformity and loss of normal joint function may occur, seriously affecting the quality of life of patients。Although existing therapies have played an important role in alleviating the disease of patients, from the mechanism of action, most of these therapies lead to the depletion or death of B cells, which has some side effects on the body's own immune system。The weakening of the immune system generally leads to the occurrence of other debilitating diseases, and has long-term risks for patients with autoimmune diseases that require long-term medication。
CD22It is a type 1 transmembrane sialoglycoprotein in the immunoglobulin superfamily, which is mainly expressed in B cells and acts as a suppressor of B cell receptor signaling。Sucilizumab is a recombinant human/mouse chimeric monoclonal antibody that specifically targets the extracellular domain of CD22。According to the public information of China Antibody Pharmaceutical, compared with the existing standard therapy for rheumatoid arthritis, the core advantage of Sucilizumab is its novel and unique mechanism of action: it suppresses the B-cell-related immune response by changing the binding mode of CD22 and recruiting related inhibitory molecules。Because it does not damage B cells, the drug does not affect the normal role of B cells in the immune system。This mechanism of action can ensure that sucilizumab has a significant advantage in terms of safety while being effective, which is the core concern of patients with autoimmune diseases on long-term medication。
In April of this year, Sucilizumab completed unblinding and preliminary statistical analysis in a randomized, multicenter, double-blind, placebo-controlled Phase 3 clinical study and achieved the primary endpoint。The trial was designed to evaluate the clinical efficacy and safety of sucilizumab in combination with methotrexate (MTX) in patients with moderate-to-severe, active rheumatoid arthritis。The primary endpoint of the trial was the percentage of patients who achieved an ACR20 response at week 24。ACR20 is a composite measure used by the American College of Rheumatology to assess improvement in rheumatoid arthritis,Defined as compared to the patient's own baseline,At least 20% improvement in the number of joint pain and joint swelling,And three of the other five measures also showed at least a 20 percent improvement,Includes three visual rating scales (VAS,That is, the doctor's overall assessment of disease activity, the patient's overall assessment of disease activity, the patient's assessment of pain status),The patient's health assessment questionnaire (HAQ-DI) and laboratory-tested levels of acute phase reactants (ESR or C-reactive protein)。
3Phase I clinical trial results showed that compared with placebo, sucilizumab combined with methotrexate can effectively reduce disease activity and alleviate symptoms of RA disease in patients with active RA。
China Antibody pharmaceutical has said in the announcement,The company will accelerate efforts to commercialize Sucilimab,At the same time, the clinical study of this product in other immune diseases is also being closely advanced,And is planning to file an IND for mild cognitive impairment (MCI) or Alzheimer's disease,To further expand the potential use of Sucilimab。
(Source: Biologics Circle)
Beigene anti-PD-1 monoclonal antibody new indication application accepted
8On October 30, the latest announcement on the CDE official website said that Beigene submitted a new indication listing application for anti-PD-1 monoclonal antibody tirellizumab injection and was accepted。Public information shows that this is the 13th indication of the product submitted in China marketing authorization application, the drug has been approved in China 11 indications, and another indication of the application is under review。
Tirellizumab (trade name: Biotron) is a humanized IgG4 anti-programmed death receptor-1 (PD-1) monoclonal antibody designed to minimize binding to the FC-γ receptor in macrophages and help human immune cells detect and fight tumors。Preclinical data suggest that binding of the FC-γ receptor in macrophages activates antiboy-dependent cell-mediated killer T cells, thereby reducing the antitumor activity of anti-PD-1 antibodies。At present, the global clinical development program of Tirellizumab has conducted more than 20 registered-related trials in more than 30 countries and regions, enrolling more than 1.20,000 patients。
In China, Tirellizumab has been approved for 11 indications, including non-small cell lung cancer (NSCLC), transtypical Hodgkin lymphoma, urothelial carcinoma, hepatocellular carcinoma, esophageal squamous cell carcinoma (ESCC), nasopharyngeal carcinoma, and gastric or gastroesophageal junction (G/GEJ) adenocarcinoma。These include two new indications approved in China this year for combination chemotherapy for the first-line treatment of unresectable locally advanced, relapsed or metastatic ESCC, and for the first-line treatment of patients with advanced or metastatic gastric or gastroesophageal junction adenocarcinoma with high PD-L1 expression。In addition, the marketing application of the product for first-line unresectable or metastatic hepatocellular carcinoma (HCC) is currently under review。
According to Beigene's financial results for the second quarter of 2023 released on August 2, the expected milestone for Tirellizumab is the filing of registration for the first-line treatment of extensive stage small cell lung cancer in China。Small cell lung cancer (SCLC) is the most aggressive subtype of lung cancer, accounting for about 15%-20% of all lung cancer cases, with rapid progression, early metastasis, poor prognosis and other characteristics。SCLC can be divided into limited-stage (LS-SCLC) and extensive stage (ES-SCLC).。Most patients have been diagnosed with ES-SCLC at the time of treatment, with a median survival of less than 1 year and a 2-year survival rate of less than 10%, which is still a major unsolved clinical problem。
In May, Beigene announced that RATIONALE-312, a Phase 3 clinical trial of Tirellizumab in combination with chemotherapy in untreated patients with ES-SCLC, met its primary endpoint。This was A randomized, double-blind, placebo-controlled, multicenter phase 3 trial comparing the efficacy of tirellizumab in combination with chemotherapy (group A) versus placebo in combination with chemotherapy (group B) as first-line treatment for untreated patients with ES-SCLC。The primary endpoint was overall survival (OS), and secondary endpoints included objective response rate, duration of response (as per RECIST v1).1 edition) and progression-free survival。The results showed that the combination therapy showed superior OS efficacy compared with chemotherapy in untreated ES-SCLC patients。No new safety warnings were found。In a press release, Beigene said it would orally report RATIONALE-312 trial results at the 2023 World Congress on Lung Cancer in September。
(Information source: Medical Guanlan)
Zhengda Tianqingshakubatrol valsartan sodium tablets approved for market
9On October 1, the Sakubactril valsartan sodium tablet was approved by the State Food and Drug Administration, which is the third approved Sakubactril valsartan generic drug in China。
Valsartan was originally developed by Novartis,Sacubatrol valsartan sodium tablets contain sacubatrol, an enkephalase inhibitor, and valsartan, an angiotensin receptor antagonist,Enkephalase was inhibited by LBQ657, an active metabolite of the prodrug xacubactril,Angiotensin II type 1 receptor is also blocked by valsartan,It plays the role of vasodilating, preventing and reversing cardiovascular remodeling and sodium excretion。
Sacubactril valsartan was first approved for sale in the United States in July 2015 under the brand name Entresto。As of today, approved indications for Entresto include: 1) heart failure with reduced ejection fraction;2) Heart failure;3) Ejection fraction retention in heart failure。In addition, Sakubactril valsartan has also been approved for essential hypertension indications in China。
According to Novartis' financial report, Entresto's global sales reached 29 percent in the first half of 2023.$1.5 billion, up 31 percent from a year earlier。
Last month, two generic versions of Sakubactril valsartan were approved on the same day, from Fang Sheng Pharmaceutical and Stone Pharmaceutical Group。
(Information source: Medical Cube)
The HER2-targeted therapy "Magituximab" was approved for the treatment of breast cancer
9On January 1, the latest announcement on NMPA's official website said that the magituximab injection declared by Zaiding Pharmaceutical has been approved for listing in China。Public information display,margetuximab is a FC-optimized monoclonal antibody against HER2 introduced from MacroGenics,The approved indication is for third-line and above treatment in patients with metastatic HER2-positive breast cancer。
In breast cancer patients, many patients will overexpress human epidermal growth factor receptor 2 (HER2), HER2 protein will promote the growth of cancer cells, seriously affecting the treatment and prognosis of patients。More than 25% of women with metastatic HER2-positive breast cancer develop brain metastases。
Magituximab is a FC-optimized monoclonal antibody against human epidermal growth factor receptor 2 (HER2) developed by MacroGenics。In November 2018, Zai Ding Pharmaceutical and MacroGenics reached an agreement of up to 1.65亿美元的合作,获得了后者开发的三款免疫肿瘤药物在大中华区(包括中国大陆、香港、澳门和台湾地区)的开发及商业化独家授权,马吉妥昔单抗就是其中之一。
Public data show that magituximab can reduce HER2 extracellular shedding and antibody-mediated cytotoxic killing effect (ADCC).。In addition, MacroGenics engineered magituximab through its Fc optimization technology to enhance immune system engagement。In vitro data showed that the optimized Fc domain increased affinity for the activated Fc receptor FCGR3A (CD16A) and decreased affinity for the inhibited Fc receptor FCGR2B (CD32B), and these changes enhanced the ADCC effect and the activation of NK cells。
According to an earlier press release from Zaiding, the drug has been approved in China for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more anti-HER2 treatment regiments, at least one of which is for metastatic breast cancer。
Data from a global Phase 3 clinical study called SOPHIA showed that combined chemotherapy with magituximab significantly reduced the risk of disease progression or death in patients compared with trastuzumab combined chemotherapy, with statistical significance (HR=0.76), the median progression-free survival (mPFS) of the two groups was 5.Eight months and four.9个月。In terms of objective response rate, the margituximab combined chemotherapy group was 22%, also higher than the control group's 16%。Based on this research, the FDA has approved the marketing application for magituximab in 2020。
2021In October, Zaiding announced that the bridging study of magituximab for the treatment of advanced HER2-positive breast cancer in Greater China met the primary study endpoint。In November 2022, at the Clinical Oncology Society of China (CSCO) Breast Cancer session, researchers reported data from the magituximab SOPHIA China Bridge study。The data showed that the median PFS in the magituximab group as assessed by independent center imaging was 5.At 5 months, the trastuzumab group was 4.1 month, HR is 0.69;In the tyrosine kinase inhibitor (TKI) subgroup, magituximab combined with chemotherapy also showed a tendency to prolong PFS;Objective response rate in the magituximab group (ORR, 25.5%vs12.5%) and clinical benefit rate (CBR, 32.7%vs14.3%) are better;At the same time, the safety of the two groups of patients was comparable。
Overall, the results of the SOPHIA China Bridge study showed that magituximab was effective and well tolerated in the Chinese population, consistent with the efficacy of the SOPHIA study in the global population。
(Information source: Medical Guanlan)
Eli Lilly Abexili tablets approved for new indication in China
9月1日,Lilly announced that Abesili has been approved by the National Food and Drug Administration for an expanded indication,Combined endocrine therapy (tamoxifen or aromatase inhibitors) is used as an adjunctive therapy in adult patients with early breast cancer who are hormone receptor (HR) positive, human epidermal growth factor 2 (HER2) negative, lymph node positive, and at high risk of recurrence。
Abesili tablet was approved for early breast cancer indication in December 2021 and is the first and only CDK4/6 inhibitor approved for early high-risk patients in China。This expanded indication marks the further expansion of the population suitable for abesili tablets combined with endocrine therapy regimen, and will benefit more patients with HR+ and HER2- high-risk early breast cancer。
The approval of this expanded indication is based on four years of data from the global multicenter Phase III monarchE study。A total of 5637 patients were enrolled in the study, of whom 501 were Chinese patients。Recent results show that patients at high risk for early breast cancer who received endocrine therapy combined with abesilide for 2 years after surgery showed clinically significant improvements and sustained benefits in invasive disease-free survival (IDFS) and distant relapse-free survival (DRFS) compared to endocrine therapy alone。The safety profile observed in Chinese patients with early-stage breast cancer is consistent with the global population, and the safety profile is consistent with that observed in Chinese clinical studies of advanced breast cancer。
(Information source: Medical Cube)
Astrazeneca's neurofibromatosis treatment, Coxeo®Listing in China
9Astrazeneca launches its first innovative drug in the field of neurofibromatosis®(Koselugo, generic name: Smeitinib hydrosulfate capsule) is officially marketed to children 3 years of age and older with neurofibromatosis type I (NF1) with symptomatic, inoperable plexiform neurofibroma (PN)。
Neurofibromatosis (NF) is an autosomal dominant disorder, with NF1 accounting for about 98% of the three major subtypes。There is no epidemiological data on NF1 in China, and the estimated incidence is 5/1,000,000。About 30% to 50% of NF1 patients develop plexiform neurofibroma (NF1-PN).。As a chronic syndrome involving multiple systems in the whole body, NF1-PN can cause disfigurement, pain, dysfunction, lifelong cognitive impairment, etc. [6-10]. Compared with the general population, NF1-PN has a 13% risk of malignant tumor and heart disease, and its survival time is reduced by 15 years on average。
Before the advent of Smeitinib, the main treatment options for NF1 included surgical resection and plastic surgery, but 90% of NF1-PN could not be surgically treated or completely resected, and the recurrence rate was high。
Li Qingfeng, vice president of the Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine and director of plastic surgery Department, said: "Neurofibromatosis type I involves multiple systems throughout the body and can lead to pain, disability, cognitive dysfunction and malignant transformation。We are very pleased to see the official application of Smetinib in the clinic, as China's first approved treatment in the field of NF1, Smetinib is expected to help more children usher in a better life。”
Wang Fang, director of Shenzhen Bubble Home Neurofibromatosis Care Center, said: "As a rare, progressive genetic disease, NF1 has brought a heavy physical and mental burden to patients and their families due to repeated attacks and serious complications。With the help of innovative medicines, people with NF1 can control disease progression and return to their normal lives with their caregivers as soon as possible。”
Executive Vice President, Astrazeneca Worldwide,Lei Wang, President of International Business and China, said: "We have deep insight and understanding of the difficulties faced by NF1 patients and the rare disease community in China,We are also very proud to bring the first drug treatment to children with NF1 in China,To help patients achieve a life of hope, quality and dignity。With its leading scientific innovation strength and forward-looking layout in the field of rare diseases, Astrazeneca will continue to accelerate the introduction of innovative medicines for rare diseases, work with partners to promote access to medicines, support the construction of a sound rare disease diagnosis and treatment ecosystem, and benefit rare disease patients in China。”
To date, Simetinib has been approved in the United States, the European Union, Japan and other countries for the treatment of pediatric neurofibromatosis type I with symptomatic, inoperable plexiform neurofibroma。
About Neurofibromatosis Type I (NF1)
NF1It is a multisystem genetic disorder caused by the NF1 gene or genetic mutation, with a variety of symptoms, including the formation of neurofibromas and pigmentation (milk coffee spots) on the outside or inside of the skin。Of these, 30-50% of NF1 patients will be accompanied by plexiform neurofibroma。Plexiform neurofibroma (PN) can cause disfigurement, pain, motor and respiratory dysfunction, impaired vision, and bladder or intestinal dysfunction。Plexiform neurofibromas occur more often in early childhood, vary in severity, and can reduce life expectancy by up to 15 years。
About Smitinib
Smetinib is the first and only drug therapy approved by the National Medical Products Administration for the treatment of pediatric patients with neurofibromatosis type I (NF1) aged 3 years and older with symptomatic, inoperable plexiform neurofibromatosis (PN) 18,Blocks specific enzymes involved in promoting cell growth (MEK1 and MEK2)。In NF1, these enzymes are overactive, causing plexiform neurofibromas to grow in an uncontrolled manner。By blocking a specific enzyme, simetinib slows the condition。Smitinib has been approved in the United States, the European Union, Japan, China, and has been recognized as an "orphan drug" in several countries and regions around the world.。
About Astrazeneca
Astrazeneca (LSE/STO/Nasdaq:AZN) is a science-based global biopharmaceutical company,Focus on research and development, production and marketing of prescription drugs,The focus is on oncology, biopharmaceuticals including cardiovascular, renal and metabolic, respiratory and immune, vaccines and infections, and rare diseases。With its global headquarters in Cambridge, UK, Astrazeneca operates in more than 100 countries and delivers innovative medicines to millions of patients around the world。
Astrazeneca China
Since Astrazeneca entered China in 1993, it has focused on the most urgent treatment areas for Chinese patients, including oncology, cardiovascular, renal, metabolic, respiratory, digestive, rare diseases, vaccine antibodies and autoimmunity, and has brought nearly 40 innovative medicines to China。Astrazeneca's China headquarters and Global R&D China Center are located in Shanghai, and Astrazeneca has established global production and supply bases in Wuxi, Taizhou and Qingdao, respectively, and has shipped high-quality medicines to about 80 global markets。In recent years, the company has set up regional headquarters in Beijing, Guangzhou, Hangzhou, Chengdu and Qingdao。Astrazeneca is also working with partners,Through the creation of an innovation "troika" including China Smart Health Innovation Center (CCiC), International Life Sciences Innovation Park (iCampus), Astrazeneca CICC Medical Industry Fund,Build a diversified international innovative health ecosystem,Jointly promote the regional economy and the long-term development of the large health industry。Today, China has become Astrazeneca's second largest market in the world。
(Credit: PR Newswire)
The marketing application for Novo Nordisk's long-acting therapy for hemophilia A is to be included in the priority review
9月1日,China State Drug Administration Drug Evaluation Center (CDE) official website,Novo Nordisk's new drug marketing application for turoctocog alfa pegol for injection is intended for priority review,Intended for adults and children with hemophilia A (congenital coagulation factor VIII deficiency) : on-demand treatment and control of bleeding events;Perioperative management;Routine preventive treatment to prevent or reduce the occurrence of bleeding events。Public information shows that this is A long-acting recombinant clotting factor VIII (FVIII), which has been approved in the United States for the preventive treatment and acute treatment of adults and children with hemophilia A。
Hemophilia A is a rare hereditary bleeding disorder caused by the lack of coagulation factor VIII. Repeated bleeding and its associated complications are the main clinical manifestations。If repeated bleeding is not treated in time, it can lead to joint deformity or false tumor formation, which can be life-threatening in severe cases。At present, the main treatment for hemophilia A is regular infusions of coagulation factor VIII, but frequent infusions bring great inconvenience to patients' lives。Prolonging the half-life of clotting factors through chemical modification can help hemophilia patients reduce the number of transfusions and reduce their treatment burden。
Peturol thrombinα (N8-GP) for injection is a coagulation factor whose half-life is significantly prolonged after modification with polyethylene glycol (PEG)。It is based on the recombinant FVIII protein turoctocog alfa (trade name: Novoeight) developed by Novo Nordisk,PEG with a molecular weight of about 40kDa was modified on the B domain of turoctocog alfa,Which increases the half-life。Compared to non-modified FVIII products, Peturol thrombinalfa for injection has an extended half-life of 1 in adults/adolescents.6 times longer half-life in children.9倍。
2019In February, the FDA approved Peturol thrombin-alpha for injection for the prophylactic and acute treatment of adults and children with hemophilia A (trade name: Esperoct).。The approval is based on the results of A clinical trial involving 270 hemophilia A patients。The data showed that prophylactic injection of Peturol with thrombinin-alpha (50 IU/kg) every 4 days was able to maintain the annual bleeding rate to 1.Low level of 18 times。The results of the trial also show that the product can be used as an effective acute therapy for the treatment and control of bleeding, as well as an effective means of perioperative bleeding control。At the same time, Peturol thrombin alpha for injection also demonstrated good safety and tolerability。
The researchers also studied hemophilia A patients who used Peturol thrombin-alpha for injection to see how satisfied they were after switching to the product and comparing it to previous treatment。The results showed that compared with the previous treatment, patients were more satisfied after using Peturol injectable thrombinin-alpha, mainly because of the reduced frequency of infusion, easy storage, better hemostatic effect, and improved quality of life。In conclusion, patients with hemophilia A may benefit from treatment with peturol thrombin alpha for injection。
In China,According to the drug clinical trial registration and information publicity platform,Novo Nordisk has completed A Phase 3, multicenter, open trial (pathfinder10) evaluating the efficacy, safety and pharmacokinetics of Peturol thrombin-alpha for injection in the treatment and prevention of bleeding events in treated patients with hemophilia A in China.。The primary endpoint of the trial was the number of bleeding events, and the principal investigator was Professor Yang Renchi, Hospital of Hematology, Chinese Academy of Medical Sciences。
(Information source: Medical Guanlan)
Global listing
Menarini Group announces ELZONRIS®(Tagraxofusp) is recognized by the Japanese Ministry of Health, Labour and Welfare as a rare drug for dendritic cell tumors
8Today, Menarini Group (" Menarini "), a leading international pharmaceutical and diagnostic company, and Stemline Therapeutics,Inc., a wholly owned subsidiary of Menarini Group.(" Stemline ") announced Nippon Shinyaku Co, Stemline's development partner in Japan.Nippon Shinyaku (Nippon Shinyaku) has been approved by the Japanese Ministry of Health, Labour and Welfare (MHLW) as a rare drug for Tagraxofusp for the treatment of blastocytic dendritic cell tumor (BPDCN)。
BPDCNIt is an aggressive rare hematologic malignancy with a historically poor clinical prognosis。ELZONRIS of Stemline®Tagraxofusp is the only approved treatment for BPDCN patients in the United States and Europe, and the first and only approved CD123-targeted therapy。
Japan's Health Ministry has designated rare drugs for the treatment of less than 50,000 patients, whose medical needs are also particularly high。The designation of rare drugs could reduce the time required for regulatory approval in Japan by several months, allowing patients to access treatment more quickly。
In Japan, Tagraxofusp is being developed by Nippon Shinyaku and is currently undergoing phase 1/2 clinical trials。In March 2021, Stemline and Nippon Shinyaku entered into an exclusive licensing agreement for the development and commercialization of Tagraxofusp in Japan, including co-ownership of promotional opportunities。
Elcin Barker Ergun, Chief Executive Officer of the Menarini Group, said: "The decision by the Japanese Ministry of Health and Welfare to designate rare drugs recognizes the potential positive impact that Tagraxofusp can have on BPDCN patients in Japan, a patient population that currently has limited treatment options。"This achievement by our partner Nippon Shinyaku advances our commitment to bring transformative new treatment options to patients with hard-to-treat cancers and to bring innovative medicines to the global public."。
Blastocytoid dendritic cell tumor (BPDCN), formerly known as blastocytic NK cell lymphoma, is an aggressive hematological malignancy that usually has skin manifestations and has a historically poor prognosis。BPDCN is usually present in the bone marrow and/or skin, and may also involve lymph nodes and internal organs。BPDCN cells are precursors of plasmacytoid dendritic cells (pDC)。The diagnosis of BPDCN is based on immunophenotypic diagnostic triplets of CD123, CD4, and CD56, as well as other markers。The World Health Organization (WHO) named the disease "BPDCN" in 2008;Previous names include lymphocytic NK cell lymphoma and agranular CD4+/CD56+ hemocytic tumors。
About the Menarini Group
The Menarini Group is a leading international pharmaceutical and diagnostic company with a turnover of more than $4.4 billion and more than 17,000 employees。Menarini focuses on therapeutic areas of unmet need, with products including cardiology, oncology, pneumoniology, gastroenterology, infectious diseases, diabetes, inflammation and analgesia。Menarini has 18 production sites and 9 research and development centers and its products are sold in 140 countries around the world。
About Stemline Therapeutics Inc.
Stemline Therapeutics,Inc.Stemline (" STEMLINE "), a wholly owned subsidiary of the Menarini Group, is focused on the development and commercialization of novel oncology therapeutics。Stemline will be based in the United States on ORSERDU®(Elacestrant) to be commercialized,This is an oral endocrine drug,Indicated for the treatment of advanced or metastatic cancer in postmenopausal women or adult men with disease progression following at least one endocrine therapy, estrogen receptor (ER) positive, human epidermal growth factor receptor 2 (HER2) negative, ESR1 mutation。Stemline will also settle for ELZONRIS®(Tagraxofusp-erzs) for commercialization,This is a new type of targeted therapy for CD123,For use in blastocytoid dendritic cell tumors (BPDCN) in the United States and Europe,An aggressive form of cancer),It is the only BPDCN treatment approved to date in the United States and the European Union。Stemline will also launch NEXPOVIO in Europe®Commercialized, this is an XPO1 inhibitor for the treatment of multiple myeloma。Stemline also has an extensive clinical pipeline of small molecules and biologics for various stages of development in a variety of solid cancers and blood cancers。
About Nippon Shinyaku
Our mission is to help people live healthier, happier lives。By creating unique medicines that bring hope to patients and families struggling with disease, we aim to be an organization trusted by the community。
(Credit: PR Newswire)
Astrazeneca (AZN.The ADC jointly developed by US) and Daiichi Sankyo was recognized as a breakthrough therapy
9On Monday, Astrazeneca (AZN).US) and Daiichi Sankyo announced that its Antibody Coupling drug (ADC)Enhertu has been granted two Breakthrough Therapy designations (BTDS) by the US FDA.,For the treatment of adult patients with unresectable or metastatic HER2-positive (immunohistochemical staining [IHC] 3+) solid tumors who have progressed after prior treatment and have no alternative treatment options,And for the treatment of HER2-positive (IHC 3+) metastatic colorectal cancer patients who have previously received two or more treatment regimregimes。Enhertu has been awarded a total of seven breakthrough therapy designations。
Enhertu is an ADC therapy jointly developed by Astrazeneca and Daiichi Sankyo。Designed using Daiichi Sankyo's proprietary DXd ADC technology platform, it consists of a HER2-targeting humanized monoclonal antibody linked to a topoisomerase-1 inhibitor payload via a tetrapeptide-lysable linker。
(Information source: ZhitongFinance)
Pan-cancer population expands, Novartis BRAF/MEK combination receives FDA approval for new indication
近日,FDA website shows,Tafinlar (dabrafenib) from Novartis,Dalafenib) +Mekinist (trametinib,The combination of trametinib has been approved for expanded indications,The population was expanded to include unresectable or metastatic solid tumors 1 year and older (previously 6 years and older) with BRAF V600E mutations,These patients developed disease progression after prior treatment,And there is no satisfactory alternative treatment。
Tafinlar+MekinistIt is the first and only BRAF/MEK inhibitor combination approved for the treatment of pan-cancer tumors carrying BRAF V600E mutation, and the only BRAF/MEK inhibitor combination approved for pediatric patients。
BRAFMutations have been identified as drivers of growth in a variety of solid tumors, including rare cancer types that are difficult to study in Phase III trials and where treatment options are often limited。BRAF V600E is the most common type of BRAF mutation, accounting for 90% of BRAF mutated cancers and driving tumor growth in more than 20 different cancer types。
In the previously published Phase II ROAR Basket study and NCI-MATCH subprotocol H study,Tafinlar+Mekinist achieved an overall response rate of up to 80% in patients with BRAF V600E solid tumors,These include high-grade and low-grade gliomas, biliary tract cancers, and certain gynecological and gastrointestinal cancers。Another Study (Study X2101) also demonstrated the clinical benefit and acceptable safety profile of Tafinlar+Mekinist in pediatric patients。
The safety profile of Tafinlar+Mekinist observed in these studies is consistent with the known safety profile of other approved indications。
(Information source: Medical Cube)

Industry data
Bozhou market September 6 news
Price of spiral flower:Spiral flower new goods listed, the market fell slightly, now the market spiral flower unified goods price 45-50 yuan /kg, the selection price 55-60 yuan /kg。
Price of locust rice:The market is affected by weak demand, the market is slowing down, the price is weak, and the previous purchase is mostly at a loss, and the current unified goods price is 30-35 yuan /kg。
Pearl Price:Pearl affected by Japan's nuclear sewage discharge, the origin of the source of goods to go fast, the market is rising, the market is good 260-270 yuan /kg。
Maca Price:Market maca supply is sufficient, the demand is general, the market is stable。At present, the market price of maca yellow unified goods is 15-20 yuan /kg, and black unified goods are 30-60 yuan /kg。
Gorgon seed price:The purchase and sale of Gorgon Ferox in the market are general, and the demand amount has not been significantly improved, and the market is stable。The current market price of Gordon Euryale round grain goods 30-35 yuan /kg, broken grain goods 22-23 yuan /kg, two pieces of goods about 30 yuan /kg。
Yellow cedar Price:The quantity of goods in the market is not large, merchants buy in bulk, and the market is temporarily stable。At present, the market price of Sichuan Huangbai leather unified goods is 38-40 yuan /kg, the price of leather goods is 70 yuan /kg, and the price of silk selection is about 75 yuan /kg。
Dodder Price:There are businesses looking for a source of goods, the demand is temporarily small, the market is temporarily stable。At present, the market dodder Ningxia unified goods 34-35 yuan /kg;Inner Mongolia unified goods 35-36 yuan /kg, washed goods 37-38 yuan /kg。
Knotweed Price:Recently, there are not many merchants to consult and buy, and the market is stable。At present, the market asks for 10-11 yuan /kg, 12-13 yuan /kg, and 7-8 yuan /kg。
Gastrodia Price:At present, the new Chen does not pick up, the supply of small quantities to move around, the market is strong。At present, the market general goods asking price of 130-140 yuan /kg, special grade goods price of 200 yuan /kg, first-class goods 180 yuan /kg, secondary goods 150-160 yuan /kg, three and four goods 130-135 yuan /kg。
Golden Cherry Price:New goods listed purchase and sale, the market fluctuated slightly。At present, the market price of gold cherry fruit Jiangxi unified goods 16-17 yuan /kg, gold cherry fruit meat price in 40-45 yuan /kg。
Yellow Essence Price:It will take some time for new products to come on the market, and prices are stabilizing。Now the market Hunan Tonga price 70-75 yuan /kg, chicken head yellow essence price 80-90 yuan /kg, yellow selection of different sizes of goods sold at 150-260 yuan /kg range。
(Information source: Kangmei Chinese Medicine Network)
Anguo market September 7 news
黄精:It will take some time for new products to come on the market, and prices are stabilizing。Now the market Hunan Tonga price 70-75 yuan /kg, chicken head yellow essence price 80 ~ 90 yuan /kg, yellow selection of different sizes of goods sold at 150 ~ 260 yuan /kg。
Cat's claw grass,This year, the supply of goods is small, the market rose after the new production, the recent shortage of market supply, the market continues to rise and the increase is obvious, and the market price of cat's paw grass washed goods is about 420 yuan。
白芷,Recent business attention is not reduced, the production area of the source of goods to buy and sell smoothly, the market has risen, the market price of angelica sulfur between 21 and 25 yuan, sulfur free goods between 25 and 28 yuan。
Burdock seed,After experiencing the rise of new sentiment in the early production market, the recent supply of goods has slowed down, the shipper's shipment willingness has increased, the market has been lowered, and the market is now burdock through the windmill goods price is around 37 yuan, and the color selection goods price is slightly higher。
Chicken bone grass,Market sales are not large, inventory is not large, recently there are businesses to look for goods, small batch of goods to go smoothly, the market has risen, the market is now big leaf chicken bone grass smooth rod cut goods price at 26 yuan。
香砂,In the near future, the supply of goods is not fast, the business attention is not high, the market has not changed significantly, and the current market price of fragrant sand is between 22 and 23 yuan。
Star anise,Due to a large number of new goods listed in the early stage, the market has fallen, and there are merchants to buy goods in the near future, driving the supply of goods to go smoothly, the market has rebounded, and the market is not enough to dry new goods at about 48 yuan。
花椒,The supply of goods is in a sufficient state, affected by low prices, more businesses are concerned about, the recent supply of goods has been sold in batches, and the current market Hancheng pepper unified goods price is between 40 and 45 yuan。
Puzzle kernel,There is sufficient supply of goods, although there are recent business discussions, but few people start, the supply is in a normal state of purchase and sale, and the current market price is 34 yuan。
Male clove,Sufficient supply of goods available in the market, the recent business attention to the general, the supply of goods to go fast, the market performance is weak, and the market price of public cloves is 70 yuan。
樟脑,The supply of goods is in a sufficient state, the recent supply of small batches of goods to go smoothly, the market has no significant change, the current market camphor price is about 36 yuan。
South schisandra,This year's production area has reduced production, but the market supply is mostly real sales, the recent sale is general, the price is not significantly adjusted, and the price of schisandra chinensis in the south of the market is more than 55 ~ 60 yuan。
(Information source: Chinese Herbal Medicine World)
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