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

作　　者：Lang Zheng Wenjing Wang Qiu Sun 

机构地区：[1]Department of Biotherapy,Cancer Center and State Key Laboratory of Biotherapy,West China Hospital,Sichuan University,Chengdu 610041,China [2]West China Medical Publishers,West China Hospital,Sichuan University,Chengdu 610041,China

出　　处：《Signal Transduction and Targeted Therapy》2024年第3期813-821,共9页信号转导与靶向治疗（英文）

摘　　要：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).

关 键 词：DRUGS MERCK APPROVAL 

分 类 号：R95[医药卫生—药学]