Writing in the May edition of DIA’s Global Forum magazine, Xu Wang of Novo Nordisk China looks at the new drug approvals in China in 2021. Among other highlights, the approval of two CAR-T products signal that CAR-T treatment has finally entered the commercialization stage.
The number of new drug approvals in China set a new record high in 2021. A total of 61 new drugs were approved by the National Medical Products Administration (NMPA), up from 46 in 2020. “New drug” is defined in this article as new chemical drugs or new biological products approved for the first time in China, excluding any new indications, new dosage forms, or new combination of approved drugs.
Among the approvals, 37 were new chemical drugs and 24 were biological products. Forty-two (42) drugs were granted priority review by the Center for Drug Evaluation (CDE). Thirty-one (31) newly approved drugs were developed by local companies, accounting for slightly over half of all approvals (51%). This was the first time that domestic companies received more new drug approvals than foreign companies in a given year. The domestic biopharma industry has progressed from R&D to commercial stage and has yielded successful results. A number of companies achieved the goal of bringing their first commercial products to the market.Under the current Chinese regulatory framework, a Category 1 new drug is any product that has not been approved in any country when the NDA is submitted in China (i.e., the so-called global new drug). In 2021, the NMPA CDE approved 29 Category 1 drugs, 27 of which were developed by local companies. This was a notable increase compared with 2020 (16 Category 1 drugs approved) and 2019 (12 Category 1 drugs approved), providing another indication of the progress of local new drug research and development.
By therapeutic area, 27 anticancer drugs were approved, accounting for the largest proportion (44%) of approvals. In November 2021, against the backdrop of the highly active and competitive landscape of oncology drug research and development, the CDE issued its Guideline for Clinical R&D of Anti-tumor Drugs Guided by Clinical Value, which emphasized the importance of patient centricity in the development of new oncology drugs to develop more effective, safer, or more convenient treatments based on real clinical value.
New Drugs approved by NMPA in 2021
Read the full article on the DIA Global Forum website here
