Hengrui Pharma(SH:600276) Shang Hai Zheng Quan Bao·2025-09-17 20:02Core Viewpoint - Jiangsu Hengrui Medicine Co., Ltd. has received acceptance for its drug application for SHR-A1811, which is intended for the treatment of HER2-positive breast cancer, and it has been included in the priority review process by the National Medical Products Administration (NMPA) [1] Group 1: Drug Information - The drug SHR-A1811 is an injectable formulation intended for adult patients with locally advanced or metastatic HER2-positive breast cancer who have previously received one or more anti-HER2 therapies [1] - The application for SHR-A1811 is currently in the listing phase, with the acceptance number CXSS2500094 [1] - The drug has already been approved for treating non-small cell lung cancer (NSCLC) in adults with HER2 mutations who have received at least one systemic therapy [2] Group 2: Clinical Trial Details - The SHR-A1811-Ⅲ-301 study is a randomized, open-label, positive drug-controlled, multi-center Phase III clinical trial comparing SHR-A1811 with pyrotinib plus capecitabine in HER2-positive breast cancer patients [2] - The primary endpoint of the study is progression-free survival (PFS) assessed by an independent imaging review committee (BIRC) based on RECIST v1.1 [2] - The interim analysis confirmed that SHR-A1811 met the predefined superiority criteria for PFS, significantly reducing the risk of disease progression or death compared to the control group [2] Group 3: Market Context - Breast cancer is one of the leading causes of morbidity and mortality among women globally, with HER2-positive breast cancer accounting for approximately 15-20% of all breast cancer cases [4] - There is a significant unmet medical need for effective treatments for advanced HER2-positive breast cancer due to limited drug options and early resistance to existing therapies [4] - The global sales of similar products are projected to reach approximately $6.557 billion by 2024, indicating a substantial market opportunity for SHR-A1811 [5] Group 4: Additional Drug Information - HRS-5635 injection, developed by the company's subsidiary, has been included in the list of proposed breakthrough therapies for chronic hepatitis B [8] - The drug is a new generation of liver-targeted siRNA therapy, showing potential for improving functional cure rates in chronic hepatitis B patients [11] - The current global burden of chronic hepatitis B is significant, with approximately 257 million infected individuals, highlighting the need for more effective treatment options [10]