智通财经APP获悉，石药集团(01093)早盘涨近3%，截至发稿，涨2.66%，报4.65港元，成交额2193.74万港元。
消息面上，近日，石药集团公布，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)。
据悉，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着优于标准治疗。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。
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