嘉和生物-B(06998):中国国家药品监督管理局批准来罗西利(GB491)新药上市申请

智通财经
May 29, 2025

智通财经APP讯,嘉和生物-B(06998)发布公告,中国国家药品监督管理局(“NMPA”)已批准来罗西利(GB491)的新药上市申请(“新药上市申请”)。来罗西利适用于激素受体(HR)阳性、人表皮生长因子受体2(HER2)阴性(“HR+╱HER2-”)局部晚期或转移性乳腺癌成人患者:与芳香化酶抑制剂联合使用作为初始内分泌治疗;与氟维司群联合用于既往接受内分泌治疗后疾病进展的患者。

NMPA批准来罗西利(GB491)的新药上市申请将为HR+╱HER2-局部晚期或转移性乳腺癌患者提供更好的治疗选择。这是公司发展历程中一个重要的里程碑,是跨部门团队紧密合作、执行力强的成功典范。董事会向为来罗西利(GB491)的成功临床开发作出贡献的所有患者及研究人员表示感谢。

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