By Fineline Cube 
SinoMab BioScience Ltd (HKG: 3681) announced the voluntary withdrawal of its Biologics License Application (BLA) for suciraslimab (SM03), an anti-CD22 monoclonal antibody (mAb), as a treatment for rheumatoid arthritis (RA) in China. The company cited the need for additional early efficacy data to meet regulatory requirements emphasized by China’s Center for Drug Evaluation (CDE).
BLA Background
The BLA filing was based on positive results from a Phase III trial that met primary endpoints in 2023. Despite the positive outcomes, SinoMab BioScience identified the need for further data through an internal review process.
Company Confidence
SinoMab BioScience maintains confidence in the ultimate approval of suciraslimab in China. The company remains committed to addressing the regulatory requirements and advancing the development of this potential treatment option for rheumatoid arthritis patients.-Fineline Info & Tech