Simcere Pharmaceutical Group Limited (02096.HK) released Phase I/II data for its in-house PD-L1/IL-15v bispecific fusion protein SIM0237 at the European Association of Urology Congress 2026, targeting Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle-invasive bladder cancer (NMIBC).

As of the 28 November 2025 data cutoff, 49 patients had received intravesical SIM0237 monotherapy. Among carcinoma in situ (CIS) patients with at least one post-baseline tumour assessment, 80% achieved complete response. In the papillary-only cohort, the 12-month disease-free survival rate reached 65.8%.

Safety readings showed favourable tolerability; intravesical administration produced no detectable systemic exposure in serum samples.

SIM0237 combines an anti-PD-L1 monoclonal antibody with an IL-15/IL-15Rα sushi domain, simultaneously blocking the PD-1/PD-L1 inhibitory pathway and activating immune responses, aiming to deliver synergistic anti-tumour activity.

Simcere Pharma operates a State Key Laboratory of Neurology and Oncology Drug Development and focuses on neuroscience, oncology, autoimmune and anti-infective therapeutics, supported by internal R&D and external partnerships.