China Greenlit 40 New Class One Drugs Last Year, Nearly Double That of Year Before(Yicai) Feb. 6 -- China’s drug regulator approved 40 Class One new drugs last year. This was nearly twice the number approved to go to market in 2022 and close to the historic high, according to the latest data.
The new medicines, which have never been sold within or outside China, target a wide variety of ailments, from cancer, insomnia and diabetes to reducing blood lipids, the National Medical Products Administration said in its annual report released on Feb. 4.
But the majority, at almost 40 percent, are cancer treatments, such as Beijing Pearl Biotechnology’s Vebreltinib for advanced lung cancer and IASO Biotherapeutics’ Equecabtagene Autoleucel for multiple myeloma, the report said.
Fifteen of the 40 innovative new drugs were fast tracked through the NMPA’s four fast track channels, which are conditional approval, priority approval, breakthrough therapy approval and special approval. And most of these were the cancer drugs.
The NMPA greenlit 47 Class One drugs to go to market in 2021, the most ever, but this figure more than halved to 21 in 2022 due to the resurgence of Covid-19 pandemic.
China is integrating more drugs into the national medical insurance program to give people access to the latest treatments. Some 126 drugs were added in 2023, at least 15 of which were newly approved that year, according to the National Healthcare Security Administration. There are now 3,088 drugs on the list.
Last year, the NMPA also approved 45 drugs for rare diseases and 92 medicines for children last year, the report said.
Editors: Dou Shicong, Kim Taylor
