恒瑞医药：注射用瑞康曲妥珠单抗获药物临床试验批准通知书

Core Insights - Heng Rui Medicine announced that its subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., received approval from the National Medical Products Administration for the clinical trial of injection-use Ruikang Trastuzumab [1] Group 1: Clinical Trial Details - The clinical trial will focus on Ruikang Trastuzumab as a monotherapy compared to Docetaxel + Carboplatin + Trastuzumab + Pertuzumab for neoadjuvant treatment of early-stage or locally advanced HER2-positive breast cancer [1] - This study is a randomized, open-label, multi-center Phase III clinical trial [1] Group 2: Product Approval and Indications - Injection-use Ruikang Trastuzumab has already been approved for use in China, specifically for adult patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) who have HER2 activation mutations and have previously received at least one systemic treatment [1]