Core Viewpoint - Sangfor Technologies (01530) experienced a significant stock increase of over 8%, reaching HKD 29.8 with a trading volume of HKD 550 million, following the announcement of its first market application for a self-developed drug [1] Company Developments - On October 15, Sangfor Technologies 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) for the indication of macular edema due to branch retinal vein occlusion (BRVO), which has been accepted by the National Medical Products Administration [1] - The Phase III clinical trial for 601A in BRVO has successfully completed, achieving its primary endpoint, showing 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 - In terms of central retinal thickness (CRT) changes, 601A demonstrated comparable efficacy to Ranibizumab at 12, 24, and 52 weeks, validating its effectiveness in improving macular edema [1] - The overall safety and tolerability of 601A treatment were reported to be good, indicating a positive benefit-risk profile [1]
港股异动 | 三生制药(01530)盘中涨超8% 眼科产品601A递交上市申请并获受理