康哲药业阿尔茨海默病新药在中国申报上市

药渡
Jul 31

7月28日,康哲药业宣布,改良型新药ZUNVEYL(拟定通用名:葡萄糖酸苯加兰他敏肠溶片)的新药上市许可申请(NDA)已获得中国国家药品监督管理局(NMPA)受理。该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,属于新一代乙酰胆碱酯酶抑制剂(AChEI),通过抑制乙酰胆碱酯酶活性、提高中枢乙酰胆碱...

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