Targeted drug approvals in 2023: breakthroughs by the FDA and NMPA

Abstract

According to the official website of China’s National Medicines and Pharmaceutical Administration (NMPA), a total of 87 novel drugs were approved in China in 2023, with targeted drugs accounting for 67.8% of the total, amounting to 59 drugs (Fig. 1a ; Table 1 ) [ https://www.nmpa.gov.cn/yaopin/ypjgdt/index.html ]. Notably, domestic innovation is flourishing, with five first-in-class drugs, including Glumetinib, a c-Met inhibitor from Haihe Biopharma; Leritrelvir, a 3CL protease inhibitor from Raynovent; Anaprazole, a proton pump inhibitor from Xuanzhu Biopharm; Pegol-Sihematide, an EPO drug from Hansoh Pharma; and Zuberitamab from BioRay Biopharmaceutical Co., Ltd. Additionally, the world’s first allosteric inhibitor targeting TYK2, Sotyktu (deucravacitinib), has been approved for the treatment of psoriasis and Selumetinib, a MEK inhibitor co-developed by AstraZeneca and Merck Sharp & Dohme (MSD), became the first approved drug in China for the treatment of neurofibromatosis type I (NF1). Beyond these drugs, the approval of novel drug types such as CAR-T cell products, siRNA, monoclonal antibodies, dual antibodies, and ADCs in China is a significant development in the country’s pharmaceutical industry (Fig. 1a ). Notably, Equecabtagene autoleucel, jointly developed by IASO Biotherapeutics and Innovent Biologics, became the first approved BCMA-targeted CAR-T cell therapy product in China. Additionally, Inaticabtagene autoleucel developed by Juventas was the first approved CAR-T cell therapy product in the field of leukemia treatment in China. In parallel, the acceleration in the rate of new drug approvals in China is also noteworthy. Glofitamab, for example, was approved in China only five months after its approval in the United States. Furthermore, numerous clinical trials for novel drugs are currently underway in China, and it is anticipated that these new medications will soon bring significant benefits to Chinese patients. Fig. 1 NMPA and FDA-approved targeted drugs by modality, 2023. a Small molecules and protein-based drugs comprised a significant majority of NMPA approvals, while oligonucleotides only represented a single case. b The majority of FDA approvals for targeted drugs consist of small molecules and protein-based drugs, with small molecules being approved as new molecular entities (NMEs). Approved in four cases, oligonucleotides were also classified as new molecular entities (NMEs). Source: NMPA, FDA and Nature Reviews Drug Discovery ( https://doi.org/10.1038/d41573-024-00001-x ) Full size image Table 1 Targeted drugs approved by the FDA and NMPA in 2023 Full size table

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