智通财经APP获悉,康哲药业(00867)涨超3%,截至发稿,涨2.84%,报13.78港元,成交额7164.02万港元。
消息面上,7月28日,康哲药业发布公告,改良型新药ZUNVEYL(拟定通用名:葡萄糖酸苯加兰他敏肠溶片)(ZUNVEYL)新药上市许可申请(NDA)已于2025年7月28日获得中国国家药品监督管理局(NMPA)受理。产品拟用于治疗成人轻度至中度阿尔茨海默型痴呆症状。
ZUNVEYL于2024年7月获得美国食品和药物管理局(FDA)批准上市用于治疗成人轻度至中度阿尔茨海默型痴呆症状,属于新一代乙酰胆硷酯酶抑制剂(AChEI),通过抑制乙酰胆硷酯酶活性、提高中枢乙酰胆硷水平从而改善阿尔茨海默病患者的认知和记忆功能。
公告称,ZUNVEYL将使该集团创新药产品矩阵更加多元化,提升集团综合竞争实力,且产品可与集团在售创新药维图可(地西泮鼻喷雾剂)、原研品牌药黛力新(氟哌噻吨美利曲辛片)以及在研创新产品注射用Y-3等系列中枢神经品种在专家网络与市场资源方面协同。
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