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).
Chinese regulators approved three new molecular entities (NME) in October, including two innovative diabetes drugs.
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.
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
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.
NMPA Expands Three PD-1(L1) Antibodies to Key Patient Populations in China.