Core Viewpoint - The company, Heng Rui Medicine, has received acceptance for a new indication application for its drug SHR-A1811, aimed at treating HER2-positive breast cancer patients who have previously undergone one or more anti-HER2 therapies, and it has been included in the priority review process by the National Medical Products Administration [1] Group 1 - The company’s subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., has received a "Notice of Acceptance" from the National Medical Products Administration for SHR-A1811, which is intended for adult patients with locally advanced or metastatic HER2-positive breast cancer [1] - SHR-A1811 is part of a Phase III clinical trial (SHR-A1811-Ⅲ-301) designed to compare its efficacy and safety against pyrotinib combined with capecitabine in HER2-positive breast cancer patients who have previously received anti-HER2 therapies [2] - The primary endpoint of the study is progression-free survival (PFS) assessed by a blinded independent review committee (BIRC), with secondary endpoints including overall survival (OS) and objective response rate (ORR) [2] Group 2 - The drug SHR-A1811 was approved for domestic market use in May 2025 for treating adults with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) who have HER2 (ERBB2) activating mutations and have previously received at least one systemic therapy [3]