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.
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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.
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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.
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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).
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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.
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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.
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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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