SINOMAB BIO-B (03681) soared over 18% intraday, hitting HK$2.42 with turnover reaching HK$50.8039 million. The biopharma firm voluntarily withdrew its Biologics License Application (BLA) for Sucirasertib (SM03) in treating rheumatoid arthritis (RA) following consultations with China's Center for Drug Evaluation (CDE).

This strategic decision stems from an internal assessment indicating supplemental early-phase efficacy data is required for BLA approval. SINOMAB maintains confidence in Sucirasertib's eventual approval in China and has initiated new clinical development plans targeting systemic lupus erythematosus (SLE) treatment.

Notably, breakthrough preclinical in-vivo results for SM03 - the world's first anti-CD22 monoclonal antibody - demonstrate its unique dual mechanism: modulating autoimmune networks through B-cell interaction while providing organ damage protection. This positions SM03 to address critical unmet needs in SLE management, particularly concerning long-term medication safety risks and absence of organ protection benefits. The therapy could potentially deliver safer, more effective treatment alternatives for global patients.