Around the Globe: China
New Drug Approvals in China Reached Record High in 2023
Chunrong Yu
Gracell Biotechnologies
Xu Wang
Novo Nordisk (China) Pharmaceuticals
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n 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.

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.

New Drugs for Rare Diseases and the Pediatric Population

In recent years, there has been a tremendous effort by NMPA to encourage industry to develop new drugs that address unmet clinical needs such as drugs for rare diseases and for the pediatric population, to close the gaps in treatment options for these underserved patient populations.

In 2023, 15 new drugs were approved for rare diseases, the largest number of rare disease drugs approved in a single year in China. These approvals included anakinra for familial Mediterranean fever, avalglucosidase alfa for type II glycogen storage disease, and others.

Twenty-six pediatric drugs were approved in 2023, with several important approvals. Ritlecitinib is currently the only available Alopecia areata treatment for adolescents. Maralixibat Chloride Oral Solution treating Alagille syndrome for pediatric patients 1 year of age or older was approved by the US FDA in 2022 as the first product for this disease, and then approved in China only one year after this first worldwide approval. Nirsevimab is the first and only approved respiratory syncytial virus infection prevention treatment to protect infant populations against RSV infection in China.

Expedited Regulatory Pathways

In China, there are four expedited regulatory pathways: priority review, conditional approval, breakthrough designation, and a special approval procedure for urgent public health needs. In 2023, 35.6% (37/104) of the new drugs approved were channeled through at least one expedited pathway. Specifically, 29 drugs were approved under priority review, which allows 130 working days of review timeline instead of the standard review timeline of 200 working days. According to regulations, all new pediatric drugs and new drugs for rare diseases are automatically granted priority review. There were 16 conditional approvals and 12 breakthrough designations. Four new drugs treating COVID-19 were approved through the special approval procedure.

New drug approvals in 2023 in China showed robust growth in new drugs approved across a wide spectrum of modalities and therapeutic areas. The number of approved imported and locally developed new drugs suggests that global and local companies are now almost equally important in bringing innovative new drugs to the Chinese market. The regulatory reform over the last several years is serving its purpose of accelerating innovative drug development and product approval and launch and ultimately achieving the goal of bringing innovative medicines to patients in China sooner and faster.

See the complete list of new drug approvals in China in 2023.
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