华海药业HB0025注射液Ⅲ期临床启动，3亿研发加码多靶点抗癌药领域！

摩熵医药大数据2025-12-29

12月26日，据$华海药业(600521)发布公告，其下属子公司上海华奥泰生物的 HB0025 联合化疗一线治疗鳞状和非鳞状非小细胞肺癌经过与国家药品监督管理局药品审评中心Ⅱ期临床试验结束/Ⅲ期临床试验启动前的会议沟通，公司将正式启动 HB0025注射液的III期临床试验。截图来源：企业公告HB0025 是由华奥泰自主研发的一款创新型抗PD-L1/VEGF双特异性融合蛋白，同时靶向肿瘤免疫逃逸...

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联合化疗一线治疗鳞状和非鳞状非小细胞肺癌经过与国家药品监督管理局药品审评中心Ⅱ期临床试验结束/Ⅲ期临床试验启动前的会议沟通，公司将正式启动 HB0025注射液 的III期临床试验。截图来源：企业公告HB0025 是由华奥泰自主研发的一款创新型抗PD-L1/VEGF双特异性融合蛋白，同时靶向肿瘤免疫逃逸通路PD-L1和肿瘤血管生成通路VEGF。该药物设计实现了两个靶点的高亲和力结合，协同调控肿瘤免疫微环境与血管生成，具备“免疫增强+抗血管”双重抗肿瘤机制。根据和CDE的会议沟通，华海药业将启动两项确证性III期临床试验。截图来源：摩熵医药数据库-全球药物研发数据库目前，$康方生物(HK9926)研发的 依沃西单抗（PD-1/VEGF双抗）已在中国获批上市，BMS的 PM8002（PD-L1/VEGF双抗）、$PFE(PFE)的 SSGJ-707（PD-1/VEGF双抗）已进入临床III期。华奥泰在2025年ESMO会议（欧洲肿瘤内科学会）公布的 HB0025 联合化疗一线治疗晚期肺鳞癌和肺腺癌II期临床数据，具有较好的客观缓解率和疾病控制率，尤其在PD-L1阴性人群中ORR的响应率高，3级以上免疫相关不良事件（irAEs）发生率低。HB0025国内研发状态（部分）截图来源：摩熵医药-全球药物研发数据库此外，HB0025 多个II期临床试验正在评估中，涵盖包括子宫内膜癌、结直肠癌、三阴乳腺癌等多种实体瘤。截至目前，华海药业已在 HB0025 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