长风药业(02652):NMPA受理噻托溴铵吸入粉雾剂的上市许可申请

智通财经
May 26

智通财经APP讯,长风药业(02652)发布公告,本公司噻托溴铵吸入粉雾剂(该产品)的上市许可申请已获中华人民共和国国家药品监督管理局(NMPA)受理。

噻托溴铵是一种长效毒蕈硷拮抗剂(LAMA),通过与支气管平滑肌上的毒蕈硷受体结合,抑制乙酰胆硷的胆硷能(支气管收缩)作用,提供持续24小时的支气管扩张效果。该产品经特定的吸入装置递送至深肺部位。噻托溴铵吸入粉雾剂系全球用于治疗COPD的最广泛处方的吸入制剂品种之一。

凭借已建立的体系化经口鼻吸入给药技术平台,本公司迄今已构建涵盖呼吸道及鼻炎病症多种适应症的全面产品组合。该产品报产,标志着本公司在COPD治疗领域的吸入制剂产品矩阵进一步完善,产品线覆盖度与治疗纵深持续拓展,巩固了在大呼吸道制剂领域的专业布局。

本集团将积极与NMPA沟通,并根据监管要求推进后续审查程序。

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