Hong Kong Stock Movement | 3SBIO (01530) Surges Over 8% After Submitting and Obtaining Approval for 601A Ocular Product

Stock News
Oct 16

3SBIO (01530) saw a significant intraday increase of over 8%, rising 8.13% to HKD 29.8 with a trading volume of HKD 550 million as of the report time. According to 3SBIO's official microblog, on October 15, the company announced that its independently developed recombinant anti-VEGF humanized monoclonal antibody (generic name: Bevacizumab Intravitreal Injection Solution, code name: 601A), indicated for macular edema due to BRVO, has submitted its first market application to the National Medical Products Administration and received acceptance. Currently, the Phase III clinical trial of 601A in treating BRVO has been successfully completed, achieving its primary endpoint: after 24 weeks of treatment, the best-corrected visual acuity (BCVA) of participants with BRVO-related macular edema showed non-inferior improvement compared to Ranibizumab. In other secondary efficacy endpoints, the proportion of subjects with an increase in BCVA of ≥5 letters, ≥10 letters, and ≥15 letters from baseline after 12, 24, and 52 weeks of treatment showed comparable results between 601A and Ranibizumab, confirming the clear and sustained effect of 601A on vision improvement. Additionally, in terms of efficacy indicators reflecting the improvement of macular edema, such as changes in central retinal thickness (CRT) compared to baseline, 601A's values at weeks 12, 24, and 52 were also comparable to those of Ranibizumab, validating the efficacy of 601A in improving macular edema. Regarding safety, the overall safety and tolerance of 601A treatment were good, indicating a positive benefit-risk profile.

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