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新诺威:乌司奴单抗注射液上市申请获受理

CSPC Innovation Pharmaceutical: The market application for Ustekinumab injection has been accepted.

Breakings ·  Nov 26 16:24

CSPC Innovation Pharmaceutical announced that the market application for Ustekinumab injection of its holding subsidiary Jushishi Biosciences has been accepted by the National Medical Products Administration. Ustekinumab injection is a fully human IgG1κ monoclonal antibody mainly used to treat plaque psoriasis in adults and children. Clinical trial results show that the drug has good efficacy and safety in treating moderate to severe plaque psoriasis, highly consistent with the reference drug, Stelara. The drug is expected to be administered every 12 weeks, with significant clinical advantages. Currently, this application is based on key Phase III clinical trials and has been accepted. The drug's market approval still requires further approval from the National Medical Products Administration.

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