SINOMAB BIO-B (03681) surged more than 18% during trading, marking a significant intraday leap. At publication time, shares climbed 17.48% to HK$2.42, generating turnover worth HK$50.8 million.

The biopharmaceutical firm announced its voluntary withdrawal of the Biologics License Application (BLA) for Suciraslimab in treating rheumatoid arthritis (RA) in China. This strategic decision followed recent consultations with the Center for Drug Evaluation (CDE) under China's National Medical Products Administration and an internal review identifying the need for supplementary early-stage efficacy data to support regulatory approval. Despite the withdrawal, SINOMAB maintains strong confidence in Suciraslimab's eventual market authorization and has initiated new clinical development plans exploring the drug's application for systemic lupus erythematosus (SLE).

Notably, the company recently revealed breakthrough in-vivo preclinical results for its first-in-class drug SM03 (Suciraslimab) targeting SLE. As a CD22-targeting monoclonal antibody, SM03 demonstrates unique dual mechanisms: modulating autoimmune networks through B-cell interactions while providing organ damage protection. This positions the therapy to address critical unmet needs in SLE treatment - mitigating long-term medication safety risks and delivering tangible organ protection benefits. The novel approach could offer global patients a safer, more effective therapeutic alternative.