Beijing News (reporter Wang Kara) has a lot to do with innovative drug policy encouragement and centralized procurement policy, etc. Under pressure, the clinical research and development of innovative drugs in my country is advancing rapidly. On April 11, a reporter from the Beijing News conducted an inventory based on the Lilac Garden Insight database. In the first quarter of this year, a total of 347 new drugs were approved for clinical trials in China, an increase of nearly 50% from the first quarter of last year. Among them, the largest number of clinical trials were approved in March this year, with a total of 230 acceptance numbers involving 145 new drug varieties.
From the perspective of enterprises, in March, Hengrui Medicine, Innovent Bio, Chia Tai Tianqing, and Kelun Pharmaceutical had the most new drugs approved for clinical trials, with 9, 5, 4, 4. From the statistics of drug types, anti-tumor drugs are still the most popular disease areas for research and development. In March, a total of 87 drugs under development were anti-tumor drugs, accounting for 60%.
BPI-361175 Tablets independently developed by Betta Pharmaceuticals is a novel potent and selective fourth-generation EGFR oral small-molecule inhibitor. Treatment of solid tumors such as advanced non-small cell lung cancer carrying EGFR C797S mutation and other EGFR-related mutations. Lung cancer still presents challenges to modern medicine, and the market for innovative lung cancer drugs still has great growth potential.
Lung cancer is also the field of tumor diseases that Betta Pharmaceuticals focuses on. The company’s first listed core product, Conmana (icotinib), is an innovative brand in the field of lung cancer treatment in China. Its sales and the number of beneficiary patients are leading among domestic lung cancer targeted innovative drugs, with cumulative sales exceeding 10 billion yuan. . Betta Pharmaceuticals 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 plans or potential solutions have been developed. In addition to Conmana, its other two listed products, Bemena (ensatinib) and Bevacizumab (bevacizumab biosimilar), both contain indications for lung cancer, followed by a number of products targeting EGFR New drug candidates with mutations, KRAS mutations, ALK mutations, and other mutations.
Another company focusing on the research and development of new drugs in the field of oncology is Heyu Medicine. Since its establishment, Heyu Pharma has built a comprehensive pipeline of 14 innovative and focused on tumor precision therapy and tumor immunotherapy small molecule projects.
In March, Heyu Medicine has two new anti-cancer drugs approved for clinical trials . Among them, ASK061 capsule is the first selective FGFR2/3 small molecule inhibitor in the world that has been approved for clinical trials by the U.S. Food and Drug Administration and the State Food and Drug Administration of China. FGFR inhibitor, ASK061 capsule is expected to achieve better safety window and efficacy in clinical practice, and gradually replace the first-generation pan-FGFR inhibitor. Another drug candidate of Heyu Pharmaceuticals, ABSK043 capsules, which was approved for clinical trials 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 multiple preclinical models, ABSK043 capsules have demonstrated anti-tumor efficacy comparable to that of an approved anti-PD-L1 antibody, and the drug is currently undergoing Phase 1 clinical trials against solid tumors in Australia.
From composition statistics, new drug clinical trials of chemical drugs and therapeutic biological products in March The number of trial approvals was almost the same, at 74 and 70, respectively, and one for preventive biological products.
The recombinant 15-valent HPV vaccine ( Escherichia coli), is the only prophylactic biological product approved for clinical trials in March. Liaoning Chengda University mentioned in the announcement released in March that the vaccine can prevent all high-risk HPV viruses and HPV6/11 viruses that are highly related to condyloma acuminatum, and the preventive effect on cervical cancer reaches more than 96%.