SIMCERE PHARMA(02096): SIM0237 clinical study data for non-muscle invasive bladder cancer stages I/II will be released at the 2026 European Society of Urology annual meeting.

SIMCERE PHARMA (02096) announced that the innovative fusion protein developed by the group, SIM0237 (PD-L1/IL15v bispecific antibody), was presented at the 2026 European Association of Urology (EAU 2026) annual meeting for the treatment of Bacillus Calmette-Gurin (BCG) unresponsive high-risk non-muscle-invasive bladder cancer (NMIBC) in a Phase I/II clinical study. As of the data cut-off date (November 28, 2025), a total of 49 patients received treatment with SIM0237 as a single-agent bladder instillation. Among patients with carcinoma in situ (CIS) and at least one post-baseline tumor assessment, 80% achieved complete response (CR). In patients with only papillary lesions, the 12-month disease-free survival rate (DFS) was 65.8%. Overall results demonstrate promising clinical efficacy signals of SIM0237 in BCG unresponsive high-risk NMIBC patients. Regarding safety, bladder instillation of SIM0237 showed good safety and tolerability, and no systemic exposure of the drug was detected in serum sample analysis.