Review of the new drug market this week: from December 27, 2021 to December 31, 2021, the top 5 enterprises in the new drug sector: Guangdong Zhongsheng Pharmaceutical Co.Ltd(002317) (+ 14.4%), Shanghai Junshi Biosciences Co.Ltd(688180) (+ 13.0%), kangnaide (+ 12.0%), Rongchang Biology (+ 10.9%), Geli Pharmaceutical (+ 10.8%); The top 5 enterprises with decline: Kaifa Pharmaceutical (- 72.8%), tengshengbo Pharmaceutical (- 15.2%), Yaoming junuo (- 13.8%), Fuhong Hanlin (- 13.7%), Keji Pharmaceutical (- 11.0%).
Key analysis of the new drug industry this week: China's innovative drug industry is booming. In recent years, the number of new drugs approved for listing has reached a new high every year. According to the data of nmpa and Yaodu, in 2021, nmpa approved about 60 new drugs (excluding new indications, improved new drugs, biological analogues, traditional Chinese medicine and vaccines), of which 24 were the first batch of new drugs in the world, a new high in recent 5 years. According to the data, 50 new drugs were approved in 2020 and 45 in 2019. Overall situation: among the 60 new drugs approved in 2021, there were 26 domestic new drugs (accounting for 43%) and 34 imported new drugs (accounting for 57%); There are 39 new small molecule drugs (65%) and 21 new biological drugs (35%); 26 new anti-tumor drugs (43%) and 34 new non-tumor drugs (57%). Specific varieties: (1) PD-1 / PD-L1 monoclonal antibodies: in 2021, two domestic PD-1 monoclonal antibodies and two domestic PD-L1 monoclonal antibodies were approved for listing for the first time. As of December 31, 2021, a total of 8 PD-1 monoclonal antibodies (6 domestic and 2 imported) and 4 PD-L1 monoclonal antibodies (2 domestic and 2 imported) were approved in China; (2) ADC drugs: in 2021, a total of 2 ADC drugs (1 domestic and 1 imported) were approved for listing for the first time. As of December 31, 2021, a total of 4 ADC drugs (1 domestic and 3 imported) were approved in China; (3) Car-t drugs: in 2021, two car-t drugs were approved for marketing for the first time.
Approval & acceptance of new drugs this week: this week, 4 new drugs or new indications of new drugs in China were approved for listing, 59 new drugs were approved for ind, 48 new drugs for ind and 9 new drugs for NDA.
Top 3 of China's new drug industry this week focuses on:
(1) On December 28, cornerstone pharmaceutical announced that the targeted drug ayvakit (avapritinib) was approved for listing in Hong Kong, China to treat adult patients with unresectable or metastatic gastrointestinal stromal tumor (GIST) carrying pdgfrad842v mutation. The BlueprintMedicines is a highly specific KIT and PDGFRA mutant kinase inhibitor developed by the KIT. The cornerstone pharmaceutical company has exclusive development and commercial authorization in the Greater China region (including Chinese mainland, Hongkong, Macao and the Taiwan region).
(2) in December 31st, Jiangsu Hengrui Medicine Co.Ltd(600276) announced that the CDK4/6 inhibitor, Dulcie's tablets, was approved by NMPA and was administered to patients with recurrent or metastatic breast cancer who had been progresses in hormone receptor positive and human epidermal growth factor receptor 2 negative after previous endocrine therapy.
(3) in December 31st, Jiangsu Hengrui Medicine Co.Ltd(600276) announced proline Heng Ge Jing Jing tablets (trade name: re Qin) approved by NMPA for improving glycemic control in adults with type 2 diabetes. Proline hengglijing is a sodium glucose cotransporter 2 (SGLT2) inhibitor. It is a class 1 innovative drug independently developed by China and with independent intellectual property rights.
Top 3 of overseas new drug industry this week focuses on:
(1) On December 30, Roche announced that it had submitted four applications for the listing of vibotuzumab for injection in China. Public data show that vibotuzumab is a first inclassadc drug targeting CD79b, which has been approved for marketing in more than 60 countries and regions around the world to treat recurrent or refractory diffuse large B-cell lymphoma.
(2) On December 27, Novartis announced that cosentyx (secukinumab) was approved by FDA for the treatment of active attachment point associated arthritis (ERA) in patients aged 4 and over and active juvenile psoriatic arthritis (jpsa) in patients aged 2 and over. Public information shows that cosentyx is the first all human biological product that can directly inhibit interleukin-17A (IL-17A), and it is also the first biological product approved for the treatment of era.
(3) On December 30, Johnson & Johnson announced that teclistamab had submitted a biological product licensing application (BLA) to the FDA for the treatment of patients with recurrent or refractory (R / R) multiple myeloma (mm). This BLA submission is based on the positive results of a multicenter phase 1 / 2 clinical trial evaluating the efficacy and safety of teclistamab.
Risk warning: the risk that the progress of clinical trials is less than expected, the risk that the results of clinical trials are less than expected, and the risk of changes in medical policies.
