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科伦药业:子公司新药申请获国家药监局受理

Sichuan Kelun Pharmaceutical: The application for new drugs by its subsidiary has been accepted by the National Medical Products Administration.

Breakings ·  Jan 7 11:14

Sichuan Kelun Pharmaceutical announced that the new drug application for its subsidiary Sichuan Kelun Botai Biomedical's core product, Trastuzumab Deruxtecan, has been accepted by the China National Medical Products Administration. This drug is an antibody-drug conjugate targeting human epidermal growth factor receptor 2, intended for the treatment of adult patients with HER2-positive, unresectable or metastatic breast cancer who have previously received anti-HER2 therapy. Based on a multi-center, randomized, open-label, controlled Phase III clinical study, Trastuzumab Deruxtecan demonstrated significant statistical and clinical improvement in the primary endpoint of progression-free survival.

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