智通财经APP讯，石药集团(01093)发布公告，公司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)(“该产品”)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)(“该适应症”)。
肺癌是中国和全球发病率和死亡率最高的恶性肿瘤，严重威胁人类健康。多数肺癌患者确诊时已分期较晚，其中Ⅲ期患者的5年生存率约20%，Ⅳ期患者的5年生存率低于5%，中位生存期为7个月。
亚裔和中国NSCLC患者的EGFR基因突变阳性率为40–50%。EGFR突变阳性晚期NSCLC靶向治疗的疗效与分子分型关系已在临床实践中得到充分证实，EGFR-TKI目前已成为EGFR突变阳性晚期NSCLC的一线标准治疗，TKI治疗失败后标准治疗为含铂双药化疗+/-贝伐珠单抗。但经EGFR-TKI及化疗治疗失败的EGFR突变阳性NSCLC患者，整体预后较差，该人群仍存在未被满足的临床需求。
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。
Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.