石药集团(01093)戈舍瑞林缓释注射液SYH 9102获中国临床试验批准

公告速递
Sep 09

2026年9月9日,石药集团有限公司(01093)发布自愿公告称,其自主研发的促性腺激素释放激素(GnRH)受体激动剂——戈舍瑞林缓释注射液(SYH 9102注射液)已获国家药品监督管理局批准在中国开展临床试验。 据公告,SYH 9102为全球首款获批开展临床试验的即用型戈舍瑞林缓释注射液。产品采用石药集团长效递送技术平台,通过皮下注射后形成原位药物贮库,实现每月给药一次的长效释放。 与已上市的戈舍瑞林长效制剂相比,该产品使用更细针头、无需专用植入针或复杂配制操作,且注射体积更小,旨在降低注射部位损伤与疼痛感,从而提升患者用药便捷性和依从性。 临床前研究结果显示,SYH 9102在血浆睾酮抑制、睾酮去势率及去势状态维持时长方面均优于市售微球制剂,且具备良好安全性。 此次获批的临床适应症为治疗实体瘤患者。公告同时指出,SYH 9102亦可应用于子宫内膜异位症等雌激素依赖性疾病领域,具备进一步开发潜力。石药集团表示,该项目的推进为公司长效制剂技术平台及产品管线扩展奠定了基础。

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