石药集团(01093)：恩尼妥®(安尼妥单抗注射液)获国家药监局批准上市

智通财经05-29 17:03

智通财经APP讯，石药集团(01093)发布公告，本集团附属公司上海津曼特生物科技有限公司与江苏康宁杰瑞生物制药有限公司合作开发的安尼妥单抗注射液(商品名：恩尼妥^®)(该产品)已获得中华人民共和国国家药品监督管理局(国家药监局)批准上市。

该产品是靶向人表皮生长因子受体2(HER2)的重组人源化双特异性抗体(IgG1型)。本次获批的适应症为本品联合化疗用于治疗既往至少接受过一种含曲妥珠单抗治疗方案的局部晚期或转移性HER2阳性成人胃或胃食管结合部腺癌患者(该适应症)。

本次获批主要是基于一项关键Ⅱ╱Ⅲ期临床试验(KC-WISE)，入组对象为至少一线治疗失败的HER2阳性胃╱胃食管结合部腺癌患者。研究结果显示，与标准化疗相比，该产品联合化疗可显著延长无进展生存期(PFS)(7.1个月vs 2.7个月，风险比(HR)为0.25，疾病进展或死亡风险降低75%)和总生存期(OS)(19.6个月vs 11.5个月，HR为0.29，死亡风险降低 71%)，各亚组人群获益趋势一致，客观缓解率(ORR)和缓解持续时间(DOR)均观察到一致的获益趋势，且安全性良好。

该适应症为该产品首个获批上市的适应症。此外，该产品联合本集团自主研发的注射用多西他赛(白蛋白结合型)(HB1801)用于HER2阳性早期或局部晚期乳腺癌新辅助治疗的III 期临床研究，亦已于2026年3月达到预先设定的总体病理完全缓解率(tpCR)的主要终点，结果具有显著的统计学和临床意义。该产品联合HB1801用于一线HER2阳性乳腺癌的关键注册III期临床研究结果预计在今年公布。

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href=\"https://laohu8.com/S/09966\">康宁杰瑞</a>生物制药有限公司合作开发的安尼妥单抗注射液(商品名：恩尼妥<sup>®</sup>)(该产品)已获得中华人民共和国国家药品监督管理局(国家药监局)批准上市。</p><p>该产品是靶向人表皮生长因子受体2(HER2)的重组人源化双特异性抗体(IgG1型)。本次获批的适应症为本品联合化疗用于治疗既往至少接受过一种含曲妥珠单抗治疗方案的局部晚期或转移性HER2阳性成人胃或胃食管结合部腺癌患者(该适应症)。</p><p>本次获批主要是基于一项关键Ⅱ╱Ⅲ期临床试验(KC-WISE)，入组对象为至少一线治疗失败的HER2阳性胃╱胃食管结合部腺癌患者。研究结果显示，与标准化疗相比，该产品联合化疗可显著延长无进展生存期(PFS)(7.1个月vs 2.7个月，风险比(HR)为0.25，疾病进展或死亡风险降低75%)和总生存期(OS)(19.6个月vs 11.5个月，HR为0.29，死亡风险降低 71%)，各亚组人群获益趋势一致，客观缓解率(ORR)和缓解持续时间(DOR)均观察到一致的获益趋势，且安全性良好。</p><p>该适应症为该产品首个获批上市的适应症。此外，该产品联合本集团自主研发的注射用多西他赛(白蛋白结合型)(HB1801)用于HER2阳性早期或局部晚期乳腺癌新辅助治疗的III 期临床研究，亦已于2026年3月达到预先设定的总体病理完全缓解率(tpCR)的主要终点，结果具有显著的统计学和临床意义。该产品联合HB1801用于一线HER2阳性乳腺癌的关键注册III期临床研究结果预计在今年公布。</p></body></html>\n\n<div class=\"bt-text\">\n\n\n<p> 来源：<a href=\"http://www.zhitongcaijing.com/content/detail/1447759.html\">智通财经</a> 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