石药(01093.HK)开发SYS 6010于中国获突破性治疗认定

阿斯达克财经
02 Jan

石药集团(01093.HK) 公布,其附属公司巨石生物制药有限公司开发的SYS 6010(抗人EGFR人源化单抗–JS-1偶联注射剂)获中国国家药品监督管理局授予突破性治疗认定,拟定适应症为单药用于经EGFR-TKI和含铂化疗治疗失败的EGFR突变阳性晚期非小细胞肺癌(NSCLC)。

目前该产品在多种实体瘤的开发正在进行中,现有临床数据证实该产品单药在该适应症中的疗效显著优于标准治疗。该产品获授予突破性治疗认定,将有助于进一步促进与监管机构的沟通,加快开发进度。(sl/w)(港股报价延迟最少十五分钟。沽空资料截至 2025-01-02 16:25。)

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