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

Stock News

03/17

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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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.</p>\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"BK1583","symbol_name":"高瓴概念","start_time":0,"source_url":"","article_id":"1195024580","we_media_id":"1036600163","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=1195024580","pubTimestamp":1773744499,"columns":[],"sourceInfo":null,"weMediaInfo":{"media_name":"Stock News","introduction":"Global Stock News First-Time Broadcast","home_visible":1,"id":"1036600163","head_image":"https://community-static.tradeup.com/news/b3bf6d02ad1a6e9e7377eebbb162346a"},"summary":"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...","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK1583":"高瓴概念","02096":"先声药业","BK1191":"制药"},"translate_title":"先声药业(02096)在2026年欧洲泌尿外科会议上公布SIM0237治疗膀胱癌I/II期临床试验数据","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"02096":1},"content_text":"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). 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