SIMCERE PHARMA (02096) Unveils Phase I/II Clinical Trial Data for SIM0237 in Bladder Cancer at 2026 European Urology Conference

Stock News

Mar 17

SIMCERE PHARMA (02096) announced that data from a Phase I/II clinical study of its self-developed innovative fusion protein SIM0237 (a PD-L1/IL15v bispecific antibody) for the treatment of high-risk non-muscle-invasive bladder cancer (NMIBC) unresponsive to Bacillus Calmette-Guérin (BCG) therapy were presented at the 2026 European Association of Urology Annual Meeting (EAU 2026). As of the data cutoff date (November 28, 2025), a total of 49 patients had received SIM0237 monotherapy via bladder instillation. Among patients with carcinoma in situ (CIS) who completed at least one post-baseline tumor assessment, 80% achieved a complete response (CR). In patients with papillary lesions only, the 12-month disease-free survival (DFS) rate was 65.8%. Overall results indicate that SIM0237 demonstrates promising clinical efficacy signals in BCG-unresponsive high-risk NMIBC patients. Regarding safety, SIM0237 administration via bladder instillation showed a favorable safety profile and tolerability, with no systemic exposure of the drug detected in serum sample analyses.

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