news flash·2025-07-03 10:35Core Viewpoint - The approval of "Recombinant Human Coagulation Factor VIIa Injection N01" by the National Medical Products Administration of China marks a significant milestone for the company as it is the first domestically approved product of its kind, providing a more economical and high-quality treatment option for patients [1] Group 1 - The product is the company's first recombinant human coagulation factor VIIa injection and the first of its kind in China [1] - The production process of recombinant human coagulation factor VIIa is complex, facing challenges such as degradation, oxidation sites, and various impurities [1] - The company has innovatively developed proprietary processes for cell culture, separation, purification, and formulation, resulting in two original patents [1] Group 2 - The product has successfully undergone multiple batches of commercial-scale production, demonstrating good consistency in quality between batches, which proves the robustness of the production process [1] - As the first domestically approved recombinant human coagulation factor VIIa product, it is expected to provide a more economical and high-quality treatment option for patients [1] - The company plans to offer a combination treatment solution through Anhengji and Anqixin, addressing the full spectrum of needs from routine replacement therapy to inhibitor management, potentially benefiting a broader population of hemophilia patients [1]