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China Approvals Rise But Conditional-To-Full Conversion Slips

Oncology Still Top For Drugs, Biologics

 
• By Xu Hu

A new annual report from China's CDE shows a rise in overall product approvals but a fall in the transition rate for conditional to full approvals, possibly signalling more stringent requirements.

Annual review
China's Central for Drug Evaluation recently published the annual report of drug review over the past year in 2024. (Shutterstock)

The newly released annual drug review report for 2024 from China’s Center for Drug Evaluation (CDE) shows the center approved a total of 45 innovative small molecules and biologics last year, of which 17 (38%), 11 (24%) and 13 (29%) were approved via priority review, conditional or breakthrough therapy designation (BTD) pathways, respectively.

This compares with the total of 35 innovative small molecules and biologics approved by the CDE in 2023 (for which no comparative breakdown figures are available), reflecting

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Xu Hu

Read more by Xu Hu

Xu is a senior reporter and covers aspects on policy and regulations in China pharma industry within the APAC Pharma news team.

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China Approvals Rise But Conditional-To-Full Conversion Slips

 
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