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港股异动 | 复宏汉霖(02696)涨超5% HLX22的国际多中心III期临床试验美国获批

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复宏汉霖(02696)涨超5%,截至发稿,涨5.42%,报17.52港元,成交额301.93万港元。

消息面上,复宏汉霖宣布,公司创新型抗HER2单抗HLX22的国际多中心III期的新药临床试验(IND)申请已经获得美国FDA许可,拟用于联合曲妥珠单抗及化疗一线治疗HER2阳性晚期胃癌。目前,全球尚无同类用于治疗HER2阳性胃癌的HER2双靶向疗法获批准上市。

临床前表明,HLX22与曲妥珠单抗联合治疗可抑制表皮生长因子(EGF)和HRG1(Histidine-Rich Glycoprotein 1)诱导的细胞增殖,增强体外和体内的抗肿瘤活性。此前,HLX22针对HER2过表达的晚期实体瘤的I期临床数据显示,HLX22在HER2过表达的晚期实体瘤患者中具有良好的安全性和耐受性。

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