Corning Jerry has established a research and development technology platform for biomacromolecule drugs with independent intellectual property rights, including protein Engineering Platform, Multifunctional Antibody Research and Development Platform and Antibody Screening Platform. At present, the company has eight research projects, except for PD-L 1 monoclonal antibody (KNO35) in clinical phase III and CD80 fusion protein (K0 19) in clinical phase II, the other six projects are all double antibodies. Of these six bispecific antibody projects, two have entered the phase II clinical stage, and the other four are in the preclinical research stage.
R&D channel
One, KN035
KN035 is the monoclonal antibody of PD-L 1, and it is the monoclonal antibody of PD-L 1 with completely independent intellectual property rights of Corning Jerry. It is in the third clinical phase, with the fastest development progress, and is expected to become the first commercialized product of Corning Jerry. At present, there are three kinds of monoclonal antibodies against PD-L 1 listed in the world, namely Atzumab from Roche, Duvalizumab from AstraZeneca and Avelumab from Merck/Pfizer. The top two global sales of 20 19 are:18.86 million,14.69 million (USD). Both are listed in China. At present, the fastest progress in China is Cornerstone Pharmaceutical Co., Ltd. CS 100 1 of Cornerstone Pharmaceutical Co., Ltd. is the first PD-L 1 monoclonal antibody combined chemotherapy as a first-line treatment drug for stage ⅳ squamous and non-squamous non-small cell lung cancer, and it is planning to apply for listing. Corning Jerry's KN035 is used to treat patients with clinical stage 3 biliary tract cancer. Hengrui Pharmaceutical, Zheng Da Tianqing and Zhao Ke Pharmaceutical are also in clinical phase 3.
Second, KN046
KN046 is a PD-L 1/CTLA-4 double antibody, and KN046 is developed by its own internal double antibody technology platform CRIB. The market size of China's anti-PD-(L) 1/CTLA-4 is expected to be 1 billion dollars in 2022, and it is expected to increase to 2.9 billion dollars in 2030, with a compound annual growth rate of 47.5%. The total market size of US anti-PD-(L) 1/CTLA-4 is estimated to be 500 million US dollars in 20021year, and will increase to11900 million US dollars in 2030, with a compound annual growth rate of 40.8%. As a broad-spectrum target, PD-(L) 1 will not be easily abandoned by any biopharmaceutical enterprise. The double antibody based on PD-(L) 1 is expected to continue the broad spectrum of PD-(L) 1 and create the brilliance of the next antibody, while PD-(L) 1/.
PD-(L) 1/CTLA-4 There are Kangning Jerry and Kangfang Bio in China, and these two companies are also the fastest developed targets in China and even in the world, both of which are in phase II clinical practice. At present, there is no product based on PD-(L) 1 on the market in the world, only the combination therapy of PD- 1 monoclonal antibody and CTLA-4, and Oppo and Yervoy are the only combination therapies of PD- 1 and CTLA-4 approved for marketing in the world. Compared with single drug therapy, combined therapy can achieve better results. However, the incidence of serious adverse events in the combination therapy of PD- 1 and CTLA-4 is high, and the combination therapy of PD- 1 and CTLA-4 has not been approved for domestic marketing. Kangfang Bio and Kangning Jerry are both PD-(L) 1/CTLA-4 double antibodies. The clinical data of 1 show that the safety of AK 104 of Kangfang Bio is better than KN046 of Corning Jerry. At present, both companies have arranged phase 2 clinical trials with multiple indications. Kangning Jerry KN-406 is a single drug for the treatment of third-line nasopharyngeal carcinoma, with the best curative effect and the highest success rate. KN-046 is expected to be the first indication to be listed. The most promising first indication of Kangfang is AK 104 combined with chemotherapy for advanced gastric cancer or adenocarcinoma of gastroesophageal junction. The latest clinical data is good, and the success rate is the highest. AK 104 may be listed in China first. Liang Kang, look who's quick. It is estimated that it is almost the second half of 202 1. But as far as two indications are concerned, Kangfang's first-line treatment of gastric cancer is more valuable. Of course, these two companies are excellent double antibody enterprises, both developed by their own technical platforms, and their goals are broad-spectrum. Like the current PD- 1, it is full of competition, but it is also full of opportunities. The specific development depends on the next clinical research and development of other indications.
Third, KN026
KN026 is a double antibody of HER2, which has a double function of blocking HER2 signal. KN026 is the first double antibody developed by CRIB, its internal double antibody technology platform. Later, Corning Jerry focused on developing KN046, so the progress of KN026 slowed down. Currently, the US 1 phase clinical trial and China's phase 2 clinical trial for various indications are under way. Roche's sales of trastuzumab in 2065438+2009 were $6.075 billion. There are many companies of monoclonal antibodies in China, such as Fu Honghanlin and Sansheng Guo Jian. At present, there are no products listed in the world. Domestic clinical research and development include Corning Jerry, Tian and You Zhiyou. The fastest is KN026 from Corning Jerry, which is currently in Phase 2. The other two are in 1 period. What will happen in the future is unknown.
Iv. KN0 19
KN0 19 is a biologically similar drug of latecept of BMS, and the drug improved by latecept of BMS has stronger curative effect. Arbasip is approved for the treatment of rheumatoid arthritis, idiopathic arthritis and psoriatic arthritis. In 20 19, the global sales of abbasip was about $2.977 billion. So far, no other company in the world has been able to develop a biosimilar product of Bellasip. KN0 19 is expected to become the first biologically similar drug of Baileji, which is currently in clinical phase 2. On June 9, 2020, the 65438 abalisp jointly applied by BMS/ simcere was listed in China, and its indication was rheumatoid arthritis.
Several other KN 052, KN 53, KN 55 and KN 58 are also double antibodies, which are still under preclinical study. I won't tell.
Conclusion: From the assembly line of Corning Jerry, it can be seen that double antibody is the main development direction of Corning Jerry, and its double antibody products are all based on its own internal double antibody technology platform crib, which shows that Corning Jerry's double antibody technology platform is still relatively mature and has certain internal strength! Future products will go on the market, and the platform technology will be further verified, and the future will be bright. It is developing well at present!
Of course, if the product fails, it is also a huge risk! New drug research and development cycle is long, risky and technology-intensive, which is really not as smooth as the market imagined.
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