Chinese regulators clarify factors for picking drugs for reimbursements
Sarina Yang · 06/27/2022
Chinese regulators have shared their considerations on selecting drugs for inclusion in state medical insurance, which should give drugmakers food for thought in terms of their strategy.
May approvals spotlight the rise of pediatric drugs under policy support in China
Danni Yin · 06/16/2022
Chinese regulators gave their nod to more pediatric medicines in May 2022, a move in line with the country’s commitment to supporting the development of these drugs.
Opinion: Contrary to what the FDA says, Chinese regulators do care about clinical data integrity
PharmaDJ · 03/04/2022
Peking University professor Yao Chen argued that it is wrong to blame the quality of recent clinical trial data in China based on a 2016 report that tells only one side of the story.
China approves world’s first subcutaneous PD-L1 antibody
Danni Yin · 12/14/2021
Chinese regulators approved six new drugs in November, including the homegrown subcutaneous PD-L1 antibody KN035 (envafolimab) and third-generation BCR-ABL inhibitor HQP135 (olverembatinib).
Clinical value a top priority in cancer drug trials, CDE says
PharmaDJ · 11/29/2021
While Chinese regulators have been receiving more IND filings for oncology drugs, treatment targets and indications have been jammed into a few choices, such as PD-1/L1 and VEGFR. Regulators are now trying to turn things around with a top-down approach.
China approves two innovative diabetes drugs in October
Danni Yin · 11/26/2021
Chinese regulators approved three new molecular entities (NME) in October, including two innovative diabetes drugs.
Chinese drugmakers’ setbacks in capital market signal need for true innovation
Elise Mak · 11/25/2021
Chinese regulators’ recent rejection of Shanghai HaiHe Pharmaceutical’s IPO on the STAR market casts doubts on the in-licensing model. Amid a market slump in the biotech sector, Chinese drugmakers need to think about innovation differently to win back investors’ confidence.
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