智通财经APP获悉,康方生物(09926)早盘涨超5%,截至发稿,涨5.05%,报73.9港元,成交额2.8亿港元。
消息面上,11月21日,中国国家药监局药品审评中心官网公示,康方生物和正大天晴在研的抗PD-1抗体派安普利单抗注射液,以及正大天晴在研的盐酸安罗替尼胶囊上市申请获得受理。
据悉,派安普利单抗是一款新型差异化抗PD-1单抗,该产品由康方生物研发,并由康方生物与正大天晴合资的正大天晴康方负责后续开发和商业化。目前,派安普利单抗已经在中国获批3项适应症,涵盖非小细胞肺癌、霍奇金淋巴瘤、鼻咽癌。此外,该产品一线治疗转移性鼻咽癌的上市申请已提交,治疗肝癌、胃癌等适应症的后期阶段临床研究也正在推进。
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