New Drug Approvals in China Reach Record High in 2023

In 2023, the first full year after the COVID-19 pandemic, the National Medical Products Administration (NMPA) set a new record by approving the highest number of new drugs in China in a single year, write Chunrong Yu of Gracell Biotechnologies and Xu Wang of Novo Nordisk (China) Pharmaceuticals in the April 2024 edition of DIA’s Global Forum magazine.

A total of 104 new drugs were approved in 2023, compared with 77 new drugs approved in 2022. “New drugs” are defined as new chemical drugs, new biological products, gene and cell therapies, new vaccines, and new traditional Chinese medicines approved for the first time in mainland China. Chemical drugs accounted for the largest proportion of new drug approvals (72, or 69.2%), followed by biological products (27, 26.4%) including two CAR-T products and two vaccines. More imported new drugs were approved (68, 65.4%) than new drugs developed by local companies.

Notable Approvals

By therapeutic areas, oncology drugs (25, 24%) continue to be the top ranking with the most drugs approved, followed by 21 anti-infective drugs and 12 CNS drugs. Notable approvals include two CAR-T products (equecabtagene autoleucel and inaticabtagene autoleucel) that were independently developed in China, mobocertinib as the first approved oral targeted therapy for advanced non-small cell lung cancer with EGFR exon 20 insertion mutation, and trastuzumab deruxtecan as the first innovative therapy for metastatic breast cancer with low HER2 expression. It is noteworthy that two new imported drugs (glofitamab and ritlecitinib) were approved in the same year in both the US and China, a sign of the emerging trend of simultaneous global development which results in a shortened drug lag for Chinese patients.

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