恒瑞医药:注射用瑞康曲妥珠单抗新适应症上市许可申请获受理并纳入优先审评程序

Core Viewpoint - Heng Rui Medicine announced that its subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., received a "Notice of Acceptance" from the National Medical Products Administration for the new indication application of SHR-A1811 (Injection of Rukang Qutuzumab) for the treatment of locally advanced or metastatic HER2-positive adult breast cancer patients who have previously received one or more anti-HER2 therapies. The application has been included in the priority review process [1] Group 1 - The application for SHR-A1811 has been accepted for a new indication [1] - The drug is intended for patients with locally advanced or metastatic HER2-positive breast cancer [1] - The application has been prioritized for review by the National Medical Products Administration [1]