石药集团抗癌新药SYS6010获突破性治疗认定
财中社1月2日电石药集团（01093）发布公告，宣布其附属公司巨石生物制药有限公司开发的SYS6010（抗人EGFR人源化单抗–JS-1偶联注射剂）获得中华人民共和国国家药品监督管理局授予的突破性治疗认定。该产品拟定的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）。肺癌在中国和全球的发病率及死亡率均位居恶性肿瘤之首，严重威胁人类健康。
公告指出，EGFR突变阳性晚期NSCLC患者的整体预后较差，现有治疗手段无法满足其临床需求。SYS6010在多种实体瘤的开发中，已有临床数据表明其单药治疗的疗效显著优于标准治疗。获得突破性治疗认定将有助于公司进一步与监管机构沟通，加快产品开发进度。
（文章来源：财中社）
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