Under the pressure of innovative drug policy encouragement and centralized purchase policy, the clinical research and development of innovative drugs in China is advancing rapidly. On April 11, according to the inventory of dingxiangyuan insight database, a reporter from the Beijing News found that 347 new drugs were approved for clinical trials in the first quarter of this year, an increase of nearly 50% over the first quarter of last year. Among them, the largest clinical volume was approved in March this year, with 230 acceptance numbers, involving 145 new drug varieties.
From the perspective of enterprises, in March, Jiangsu Hengrui Medicine Co.Ltd(600276) , Xinda biology, Zhengda Tianqing and Sichuan Kelun Pharmaceutical Co.Ltd(002422) received the most clinical trials, with 9, 5, 4 and 4 new drugs respectively. According to the statistics of drug types, antitumor drugs are still the most popular disease field in research and development. In March, 87 drugs under research were antitumor drugs, accounting for 60%.
Betta Pharmaceuticals Co.Ltd(300558) independently developed bpi-361175 tablet is a new powerful and selective oral small molecule inhibitor of the fourth representative skin growth factor receptor (EGFR). It is intended to treat advanced non-small cell lung cancer and other solid tumors carrying EGFR c797s mutation and other EGFR related mutations. Lung cancer is still a challenge to modern medical treatment, and the market of innovative drugs for lung cancer still has great growth potential.
Lung cancer is also the tumor disease field of Betta Pharmaceuticals Co.Ltd(300558) key layout. Kemena (ektini), the company's first listed core product, is an innovative brand in the field of lung cancer treatment in China. Its sales and the number of benefited patients have maintained a leading position in China's lung cancer targeted innovative drugs, with a cumulative sales of more than 10 billion yuan Betta Pharmaceuticals Co.Ltd(300558) also focuses on new drug development and strategic cooperation in the field of lung cancer. As of April this year, a variety of lung cancer treatment schemes or potential schemes have been developed. In addition to Kemena, its other two products already on the market, bemina (ensatinib) and beianting (bevacizumab biological analogue), contain indications for lung cancer, followed by a number of new drugs under development for EGFR mutation, KRAS mutation, ALK mutation and other mutations.
Another enterprise focusing on the research and development of new drugs in the field of cancer is Heyu medicine. Since its establishment, Heyu medicine has established 14 integrated pipelines that are innovative and focus on small molecule projects of tumor precision therapy and tumor immunotherapy.
In March, two new anti-cancer drugs of Heyu pharmaceutical were approved for clinical trials. Among them, ask061 capsule is the first selective FGFR2 / 3 small molecule inhibitor approved by the U.S. Food and Drug Administration and China's State Food and Drug Administration for clinical trials in the world. The drug was originally created by Heyu medicine. As a second-generation FGFR inhibitor, ask061 capsule is expected to achieve better safety window and curative effect in clinical practice, and gradually replace the first generation pan FGFR inhibitor. Another developing drug absk043 capsule of Heyu medicine, which was approved for clinical trial in March, is a small molecule PD-L1 inhibitor. Up to now, a number of PD-1 / PD-L1 antibody drugs have been approved for marketing in the world, but no PD-1 / PD-L1 small molecule drugs have been approved. In several preclinical models, absk043 capsule shows anti-tumor efficacy equivalent to the approved anti-PD-L1 antibody. The drug is currently conducting phase I clinical trials against solid tumors in Australia.
According to the composition statistics, the number of new drug clinical trials approved for chemical drugs and therapeutic biological products in March was almost the same, 74 and 70 respectively, and 1 preventive biological product.
the recombinant fifteen valent HPV vaccine (Escherichia coli) developed by Liaoning Chengda Co.Ltd(600739) and Beijing Kangle guard is the only preventive biological product approved for clinical trial in March More than 96% of the high-risk HPV vaccine can be released in November.
