三生国健业绩会：611（IL-4Rα）项目预计2026年递交NDA申请

Core Viewpoint - Sanofi Guojian reported a revenue of 642 million yuan for the first half of 2025, marking a year-on-year growth of 7.61%, and a net profit of 190 million yuan, reflecting a significant increase of 46.96% [1] Group 1: Financial Performance - The company achieved a revenue of 642 million yuan in the first half of 2025, which is a 7.61% increase compared to the previous year [1] - The net profit for the same period was 190 million yuan, showing a substantial growth of 46.96% year-on-year [1] Group 2: Research and Development Focus - Sanofi Guojian is one of the first Chinese biopharmaceutical companies focusing on innovative antibody drug research, with 13 innovative drugs in various stages of development [1] - The company emphasizes a strategic focus on autoimmune diseases as the next key area after oncology, aiming to build a competitive advantage through differentiation, precision, and platform-based strategies [2] Group 3: Strategic Partnerships and Licensing - In May, Sanofi Guojian entered a global licensing agreement with Pfizer for the SSGJ-707 (PD-1/VEGF dual antibody), achieving a record upfront payment exceeding 6 billion USD, with a total transaction value over 60 billion USD [1] - The profit distribution from this licensing agreement will be shared between Sanofi Guojian and its partners at a ratio of 30% and 70% respectively [1] Group 4: Clinical Development and Regulatory Environment - The company has accelerated its clinical project progress due to internal efficiencies and a focused strategy on autoimmune diseases, supported by a highly experienced clinical team [3] - Recent regulatory reforms in China have improved the clinical trial approval process, enhancing overall efficiency for innovative drug development [3] - The company’s product 608 (IL-17) has shown promising results with low relapse rates and immunogenicity, while the 611 (IL-4Rα) project is expected to submit an NDA application by 2026 based on positive mid-term data [3]