智通财经APP讯，复宏汉霖(02696)发布公告，近日，汉斯状® (斯鲁利单抗注射液)联合化疗新辅助/辅助治疗胃癌获国家药品监督管理局(NMPA) 药品审评中心(CDE)正式纳入突破性治疗药物程序。
汉斯状®为公司自主开发的创新型抗PD-1单抗，其于中国内地已获批上市的适应症包括联合化疗一线治疗鳞状非小细胞肺癌(sq-NSCLC)、广泛期小细胞肺癌(ES-SCLC)、食管鳞状细胞癌(ESCC) 及非鳞状非小细胞肺癌(nsq-NSCLC)。同时，汉斯状®亦已分别于欧盟、英国、印度尼西亚、柬埔寨、泰国、马来西亚、新加坡及印度等国家/地区获批上市，并分别获美国、欧盟、瑞士及韩国等国家/地区的药品监督管理部门授予孤儿药资格认定。
此外，公司正有序推进汉斯状®及相关联合疗法在全球开展的多项临床试验，广泛覆盖肺癌、食管癌、头颈鳞癌、结直肠癌和胃癌等适应症。
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