HENGRUI PHARMA (01276.HK): Trastuzumab Rezetecan Approved for Third Indication, Becoming China's First Anti-HER2 Product Approved for Colorectal Cancer

NewTimeSpace News: Jiangsu Hengrui Pharmaceuticals Co., Ltd. (stock code: 01276) issued an overseas regulatory announcement stating that the Company's subsidiary, Suzhou Shengdiya Biomedical Co., Ltd. , has received a notice from the National Medical Products Administration (NMPA), and the third indication of the Company's trastuzumab rezetecan for injection has been approved for marketing, making it the first anti-HER2 product approved for colorectal cancer in China. The newly approved indication is for adult patients with HER2-positive colorectal cancer whose disease has progressed following treatment with oxaliplatin, fluorouracil and irinotecan.

The announcement disclosed that the drug is an injection with a specification of 0.1g per vial, registered as a Category 2.2 therapeutic biological product under acceptance number CXSS2600018, and is a prescription drug. Trastuzumab rezetecan for injection had previously been approved for two indications in China, including adult patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) with HER2 (ERBB2) activating mutations who have received at least one prior systemic therapy, and adult patients with locally advanced or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2 therapies.

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