石药集团：自主研发ADC药物SYS6043获纳入突破性治疗品种名单

南方财经网07-02

　　南财智讯7月2日电，石药集团（01093.HK）发布自愿公告，公司自主研发的靶向B7-H3人源化单克隆抗体偶联药物SYS6043，已获国家药品监督管理局纳入突破性治疗品种名单，拟定适应症为单药治疗铂耐药卵巢癌、原发性腹膜癌及输卵管癌。背景与说明：卵巢癌晚期患者五年生存率仅约40.00%，70.00%-80.00%接受铂类化疗后出现疾病进展，现有非铂类单药化疗客观缓解率仅10.00%-15.00%，中位总生存期约12.00个月，临床需求迫切。SYS6043在临床研究中显示可使患者无进展生存期（PFS）翻倍，安全性良好；目前针对该适应症的Ⅲ期确证性临床试验已正式启动，同时小细胞肺癌、乳腺癌及其他实体瘤的多瘤种临床试验同步推进。影响与展望：纳入突破性治疗品种名单将显著加速各瘤种临床开发及上市审评进程，有望为晚期妇科肿瘤患者提供全新优质治疗选择；此举进一步丰富集团抗肿瘤药物研发管线，强化其在抗体偶联药物（ADC）领域的差异化研发优势与核心竞争力，助力公司在肿瘤创新药赛道持续深耕。

（文章来源：南方财经网）

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href=\"https://laohu8.com/S/01093\">石药集团</a></span>（01093.HK）发布自愿公告，公司自主研发的靶向B7-H3人源化单克隆抗体偶联药物SYS6043，已获国家药品监督管理局纳入突破性治疗品种名单，拟定适应症为单药治疗铂耐药卵巢癌、原发性腹膜癌及输卵管癌。背景与说明：卵巢癌晚期患者五年生存率仅约40.00%，70.00%-80.00%接受铂类化疗后出现疾病进展，现有非铂类单药化疗客观缓解率仅10.00%-15.00%，中位总生存期约12.00个月，临床需求迫切。SYS6043在临床研究中显示可使患者无进展生存期（PFS）翻倍，安全性良好；目前针对该适应症的Ⅲ期确证性临床试验已正式启动，同时小细胞肺癌、乳腺癌及其他实体瘤的多瘤种临床试验同步推进。影响与展望：纳入突破性治疗品种名单将显著加速各瘤种临床开发及上市审评进程，有望为晚期妇科肿瘤患者提供全新优质治疗选择；此举进一步丰富集团抗肿瘤药物研发管线，强化其在抗体偶联药物（ADC）领域的差异化研发优势与核心竞争力，助力公司在肿瘤<span>创新药</span><span></span>赛道持续深耕。</p><p>（文章来源：南方财经网）</p> </div></body></html>\n\n<div class=\"bt-text\">\n\n\n<p> 来源：<a href=\"http://finance.eastmoney.com/a/202607023792065330.html\">南方财经网</a> 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