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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Pfizer leads April approvals in China with two JAK inhibitors
Danni Yin · 05/16/2022
April 2022 saw a number of foreign and licensed drugs approved in China, with the majority of them in oncology and rheumatology.
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China clears homegrown PD-1 inhibitors for solid tumors in March
Danni Yin · 04/25/2022
The month of March saw a string of approvals handed out by the NMPA, with the most significant being two domestically developed anti-PD-1 inhibitors getting green lighted to treat MSI-H/dMMR solid tumors in China for the first time ever.
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China approved more drugs for atopic dermatitis in February
Danni Yin · 03/09/2022
Chinese regulators approved 11 drugs in February. Uses and indications ran a wide gamut, including two drugs for atopic dermatitis and six new molecular entities that were approved for the first time.
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JAK inhibitors take center stage in January
Danni Yin · 02/21/2022
January 2022 saw 11 drugs get approval by Chinese drug regulators. JAK inhibitors started the year with momentum, with Eli Lilly's Olumiant, Pfizer's Xeljanz, and AbbVie's Rinvoq filing marketing applications for new indications.
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New drug approvals in 2021: 64 new molecular entities, 24 from local players
Minhua Chu · 01/26/2022
Chinese drug regulators are approving more new drugs and more of them are developed by local players.
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Anti-tumor drugs became the hottest treatments in December
Danni Yin · 01/19/2022
The NMPA’s run of speedy approvals continued in the last month of 2021 as Chinese regulators granted the first marketing approvals to 16 new drugs and accepted NDAs for 11 more new ones.
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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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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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