China approved the market entry of 76 innovative drugs in 2025 as part of efforts to improve patient access to new, high-quality treatments, the National Medical Products Administration (NMPA) said on Saturday.
The figure set a new high, increasing nearly 60 percent compared with that of 2024.
The 76 drugs include 47 chemical drugs, 23 biological products, and 6 traditional Chinese medicines.
Among the 47 chemical drugs, 38 are homegrown innovations, while nine are imported. Of the 23 biological products, 91.3 percent, or 21, are local innovations while two are imports.
An official from the NMPA noted that First-In-Class drugs, which feature entirely new therapeutic mechanisms, are the most challenging to develop. In 2025, China approved 11 First-In-Class drugs, four of which were developed domestically.
"The market entry of these innovative drugs in China enables patients to access the latest advancements in global biomedical research sooner. This development marks a significant leap for our biopharmaceutical sector, transitioning from a position of lagging to one of keeping pace, and in some areas, taking the lead. It underscores China's emergence as a crucial player in the global biopharmaceutical innovation landscape," said Lan Gongtao, Deputy Director-General of NMPA Department of Drug Registration.
The NMPA also revealed that the total value of China's outbound innovative drug licensing transactions exceeded 130 billion USD in 2025 with more than 150 licensing deals, far surpassing the 51.9 billion USD of 94 deals in 2024, setting a new record. China's pipeline of new drugs under development accounts for approximately 30 percent of the global total, ranking second in the world.
"In 2025, the total value of China's innovative drug licensing transactions abroad has roughly doubled compared to the previous year, and the number of innovative drug approvals also reached a record high. This reflects the significant outcomes of our ongoing reforms in the drug review and approval system and the implementation of various policies to encourage innovation. While celebrating the growth in the number of innovative drugs, we remain steadfast in maintaining high standards that align with international norms. The substantial growth in licensing also reflects the international community's recognition of the value of China's innovative pharmaceuticals," Lan said.
The Administration stated that it will introduce more measures to accelerate the rapid development of innovative drugs in China.
China sets record with 76 innovative drugs approved in 2025
