Group 1 - The core point of the news is that the company has submitted a Biologics License Application (BLA) for Shuxili monoclonal antibody for the treatment of rheumatoid arthritis (RA) in China after achieving significant efficacy in Phase III clinical trials [1] - The Phase III trial results showed an ACR20 response rate of approximately 50% at week 24, with improvement over time, exceeding 65% at week 52 and over 70% at week 104, with no new safety risks identified [1] - The company voluntarily withdrew the BLA application due to the need for additional early efficacy evidence as emphasized by the Center for Drug Evaluation (CDE) in China [1] Group 2 - The company remains confident in obtaining approval for Shuxili monoclonal antibody in China, believing in its unique mechanism of action to achieve long-term efficacy and safety in treating autoimmune diseases [2] - The company has initiated planning for new clinical development programs for Shuxili monoclonal antibody targeting systemic lupus erythematosus [2] - The company has a diverse pipeline with multiple clinical and preclinical candidates, including two innovative drugs in clinical stages and four in preclinical stages, and will continue advancing its research and clinical development [2]
中国抗体-B(03681.HK)自愿撤回舒西利单抗在中国用于治疗RA的BLA申请