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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Market eyes CAR-T pricing as China grants second approval in September
Danni Yin · 10/22/2021
Chinese regulators gave their nod to the second domestic CAR-T cell therapy in three months, raising concerns in the market about how companies will make these expensive, advanced treatments more accessible to Chinese patients. The PD-1 frenzy also continued with PD-1 biosimilars.
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August PD-1 approvals may stir a price war in China
Elise Mak · 09/27/2021
A string of NDA approvals and submissions for PD-1 drugs in August is setting the stage for a price war in China. Regulators approved two homegrown PD-1 antibodies and received more submissions for them
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China Approves Two Innovative Cancer Drugs and Puts Nine Under Review in July
Minhua Chu · 09/01/2021
China’s pursuit of innovative oncology drugs has kept Chinese regulators busy in July, as they granted the first marketing approvals to two foreign drugs and accepted NDAs for nine more new ones.
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China Market Approvals Surge in June
Minhua Chu · 07/23/2021
China Market Approval Tracker: Jun 2021
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China Market Approval Tracker: May 2021
Minhua Chu · 07/19/2021
The NMPA Grants Three Orphan Drugs Market Approval.
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China Market Approval Tracker: Apr 2021
Minhua Chu · 07/19/2021
NMPA Expands Three PD-1(L1) Antibodies to Key Patient Populations in China.
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