恒瑞医药:注射用瑞康曲妥珠单抗新适应症上市申请获受理并纳入优先审评

Core Viewpoint - Heng Rui Medicine's subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., has received a "Notice of Acceptance" from the National Medical Products Administration for the new indication of SHR-A1811, a drug for treating HER2-positive breast cancer in patients who have previously received one or more anti-HER2 therapies [1] Group 1 - The drug SHR-A1811 is now accepted for a new indication to treat locally advanced or metastatic HER2-positive adult breast cancer patients [1] - The application has been included in the priority review process by the National Medical Products Administration [1] - SHR-A1811 is already approved in China for treating non-small cell lung cancer (NSCLC) patients with HER2 activation mutations who have received at least one systemic therapy [1]