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恒瑞医药:与GlenmarkSpecialty签署瑞康曲妥珠单抗项目授权协议,收益或超11亿美元

Core Viewpoint - HengRui Medicine has signed a licensing agreement with Glenmark Specialty for the innovative drug SHR-A1811, expanding its market reach and enhancing its global presence in cancer treatment [1][3]. Group 1: Licensing Agreement Details - The agreement allows Glenmark Specialty to license SHR-A1811, an antibody-drug conjugate targeting HER2, which is designed to induce apoptosis in tumor cells [1]. - Glenmark Specialty will pay an upfront fee of $18 million to HengRui, with potential milestone payments related to registration and sales reaching up to $1.093 billion [2]. Group 2: Clinical Development and Approvals - SHR-A1811 has received approval for use in adult patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) with HER2 mutations, marking it as the first Chinese-developed ADC for this indication [1]. - Multiple clinical studies are ongoing, with SHR-A1811 receiving orphan drug designation from the FDA for use in gastric cancer and related conditions, and a new indication for breast cancer under priority review by the National Medical Products Administration [2]. Group 3: Strategic Implications - The agreement is expected to broaden the overseas market for SHR-A1811, providing high-quality treatment options for global patients and enhancing HengRui's innovative brand and international performance [3]. - The company aims to strengthen international cooperation while maintaining a focus on independent research and development, facilitating rapid transformation of research outcomes into marketable products [3].