Core Viewpoint - Sanofi Pharmaceutical (01530) experienced a significant intraday increase of over 8%, currently trading at 29.8 HKD with a transaction volume of 550 million HKD, following the announcement of its first market application for a self-developed drug targeting BRVO-related macular edema [1] Company Developments - On October 15, Sanofi Pharmaceutical announced that it has submitted its first market application for the recombinant anti-VEGF humanized monoclonal antibody (generic name: Bevacizumab intravitreal injection solution, research code: 601A) to the National Medical Products Administration, which has been accepted [1] - The Phase III clinical study of 601A for BRVO has successfully completed, achieving its primary endpoint, demonstrating that the best-corrected visual acuity (BCVA) improvement at 24 weeks post-treatment is non-inferior to that of Ranibizumab [1] - In secondary efficacy endpoints, the proportion of patients with BCVA improvement of ≥5, ≥10, and ≥15 letters at 12, 24, and 52 weeks post-treatment was comparable between 601A and Ranibizumab, confirming the clear and sustained effect of 601A on vision improvement [1] Efficacy and Safety - The central retinal thickness (CRT) changes, reflecting the improvement of macular edema, were also comparable between 601A and Ranibizumab at 12, 24, and 52 weeks, validating the efficacy of 601A in improving macular edema [1] - Overall safety and tolerability of 601A treatment were reported to be good, indicating a positive benefit-risk profile [1]
三生制药盘中涨超8% 眼科产品601A递交上市申请并获受理