港股异动 | 复宏汉霖(02696)涨幅扩大逾12% 创新型抗HER2单抗HLX22获美国FDA孤儿药资格认定

智通财经
20 Mar

智通财经APP获悉,复宏汉霖(02696)涨幅扩大逾12%,1月底至今该股股价累计涨幅达1.1倍。截至发稿,涨12.07%,报33.9港元,成交额1.04亿港元。

消息面上,3月19日,复宏汉霖宣布,公司创新型抗HER2单抗HLX22获得美国食品药品监督管理局(FDA)授予的孤儿药资格认定(Orphan Drug Designation, ODD),用于胃癌的治疗。HLX22此次获得孤儿药资格认定,是基于其在胃癌治疗领域展现出的巨大潜力。这是HLX22全球多地相继启动国际多中心III期临床试验后,取得的又一重要里程碑,标志着其在全球范围内的开发进程迈出关键一步。

招商证券近期研报指出,全球化进入实质性发展阶段,生物类似药持续出海可期。复宏汉霖PD-1、曲妥珠单抗、利妥昔单抗、贝伐珠单抗已经完成出海。未来储备上,生物类似药产品帕妥珠单抗、地舒单抗均与Organon合作,帕妥珠单抗有望成为首个欧美获批的生物类似药,地舒单抗同样进度领先,期待后续海外获批与放量。

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