Give up PD-1, sell coagulation factor Ⅷ, what's the star company doing right? |Medical line observation

On November 17, Corning Jerry was listed on the Hong Kong stock exchange This is the substantial progress the company has made since it submitted its IPO application in July As the 17th biotech company to submit an IPO application since the new deal of Hong Kong stock exchange, Corning Jerry is also considered to be the first unprofitable biotech company in Hong Kong that focuses on bispecific antibody According to the prospectus, among the eight research projects of Corning Jerry, except for PD-L1, which is the fastest developing, and another antibody fusion protein in clinical phase II, the remaining six projects are all bispecific antibodies, so the next generation product layout is also positioned as "allin bispecific antibody" by the market However, at present, "pre IPO flash financing", "three-year loss of 310 million" and "no product commercialization" seem to be more media concerns, especially for the first PD-L1 McAb kn035 that is expected to be commercialized by Corning Jerry, which has triggered the controversy of "unlisted products, Red Sea market" However, we find that as early as 2012, Xu Ting, founder of Corning Jerry, has predicted the "Red Sea" of the current PD-1 / PD-L1 market At the beginning of 2017, he again proposed that "business always needs to consider business prospects, rather than" hot "to do it." he said that he should be alert to the continuous overheating of biological drugs From this interesting phenomenon, today we try to pick up the story behind kn035 At present, PD-L1 McAb kn035 is in phase III clinical In addition to being regarded as the first commercial product of corningeri, it is also one of the fastest-growing products in China However, looking at the crowded track of PD-1 / PD-L1, it seems that the market cannot be optimistic about this product After all, in addition to the five PD-1 products that have been approved for listing in China, as of August 31 of this year, 21 of them have been registered with the State Food and drug administration, and 10 of them are undergoing phase III clinical trials How to get a share in the fierce competition is also a big challenge for Corning Jerry As we mentioned above, Xu Ting, a few years ago, had expected all this In 2011, due to better clinical results in melanoma, the CTLA-4 antibody of BMS, ibiliumab, was approved for marketing, and tumor immunotherapy gradually entered the mainstream field of vision However, due to the limitation of the side effects of apiliumab, the pharmaceutical giant began to turn to the target of other immune checkpoints, and PD-1 / PD-L1 became a hot spot In the growing trend of tumor immunity in foreign countries, Corning Jerry started the research of PD-L1 antibody in 2012 Xu Ting later recalled to the media that at that time, he also wanted to quickly follow up and make a similar PD-L1 molecule, striving to become the first tumor immune targeted drug in China But then he was vaguely worried about the coming homogeneous competition "On the other hand, if our product is still in clinical research and there are similar products on the market, we need to consider the advantages and differences of the product if we want to compete." In 2013, the results of opdivo, an anti-PD-1 antibody of BMS, was published in New England Medical Journal, and then tumor immunotherapy was rated as one of the top ten scientific breakthroughs by science magazine Tumor immunotherapy began to usher in a rapid development period, accompanied by the size of Biopharmaceutical Enterprises "follow the trend" layout Xu Ting, who is more and more determined about his speculation, decided to suspend the early PD-1 project and focus on PD-L1 "Although there are some signs that PD-L1 is safer, this is not enough to support you to compete Now in retrospect, whether PD-1 or PD-L1, the target will tend to be homogenous, and the difference between the last two drugs may not be too large " Xu Ting also knows that PD-L1 must have clinical and commercial advantages to find out the differences between products The continuous "change" of these ideas and directions has created today's kn035 At present, kangningjeri is carrying out clinical trials jointly developed by kn035 and thingdi, including phase II clinical trial of DNA mismatch repair / high risk satellite instability (dmmr / MSI-H) solid tumor and phase III critical trial of cholangiocarcinoma (BTC) in China The two main selling points of the product are: one is single domain antibody, and the other is "micro innovation" in the way of medication It is reported that kn035 is the only PD-L1 inhibitor that can be injected subcutaneously in the world at present It has the advantages of safety, convenience, compliance, being suitable for patients who are not suitable for infusion and low medical cost Single domain antibody not only has small molecular weight, good stability and high activity, but also has the characteristics of low immunogenicity, low toxicity and strong penetration to tumor tissue At present, there are not many enterprises studying single domain antibody in the world In September 2018, the nanoantibody drug cablivi was approved by EMA for the treatment of adult acquired thrombocytopenic purpura (attP), which is the first nanoantibody drug on the market In addition, in June this year, kn035 obtained the implied permission from the drug evaluation center for clinical trials, indicating sepsis and septic shock This is another indication of PD-L1 after advanced colorectal cancer, adenocarcinoma at the junction of stomach and esophagus, cholangiocarcinoma and other advanced solid tumors It is also the first exploration of PD-L1 in non tumor indication Looking back, from PD-1 to PD-L1, and then to PD-L1, Corning Jerry's other side is cautious In an interview with Wuxi apptec, Xu Ting described the overall R & D level of antibody drugs in China as the mobile phone industry 15 years ago, with more homogeneous products and insufficient core competitiveness When it comes to commercialization, Xu Ting once said, "commerce is a barrier that can't be avoided Based on business and scientific judgment, if you can find what others can't find, then the rest of the market is yours." However, whether kn035 can be successfully commercialized remains to be verified by the market At the end of the article, we noticed that the key word "changing with the trend" was not only reflected in the development strategy of PD-L1, but also throughout the development of the company Another typical case is the transfer of recombinant human factor Ⅷ In fact, Corning Jerry started to develop anticoagulant drugs for hemophilia, and "Corning" means "anticoagulant" In 2009, Xu Ting, who was engaged in the research work related to coagulation factors in the United States, returned home to start his own business At that time, the drugs used for hemophilia treatment were still difficult to enter China Xu Ting set up Corning Jerry with only one goal: to make factor Ⅷ of coagulation Unfortunately, in the depressed financing environment at that time, in order to "survive", factor Ⅷ of coagulation was transferred to Zhengda Tianqing Xu Ting's mood seems to be complicated when he talks about the change of choice in public But perhaps from this beginning, Corning Jerry has a new direction Throughout its product pipeline changes in the past decade, especially in the field of bio similar drugs, Corning Jerry has supported the bio macromolecule product line of many famous domestic pharmaceutical companies, and even successfully topped the "Langya list" of Thomson Reuters bio similar drugs with 28 drugs At present, Xu Ting repeatedly stressed in an interview with the media that "we can't do double resistance in order to do double resistance, we must do what only double resistance can do." Nowadays, "change" is not only a choice in a dilemma, but also a rational persistence And this is precious in the field of innovative drug research and development, which is easy to follow the trend Penicillin is the reprinted content of yaozhi.com, and the copyright belongs to the original author The purpose of reprinting is to transmit more information, which does not represent the view of this platform If the content of the work, copyright and other issues are involved, please contact our website message, we will delete the content in the first time.