Shang Hai Zheng Quan Bao·2025-06-09 20:17Core Viewpoint - Shanghai Pharmaceuticals has received approval for the production of Formoterol Fumarate Inhalation Solution, which is intended for the maintenance treatment of chronic obstructive pulmonary disease (COPD) [1][2]. Group 1: Drug Information - The drug is classified as a Class 3 chemical drug and is registered under the approval number H20254361 [1]. - The formulation is an inhalation solution with a specification of 2ml:20μg [1]. - The drug is indicated for maintaining airway obstruction in COPD patients, including chronic bronchitis and emphysema, to be administered twice daily [2]. - The product was originally developed by Mylan Specialty L.P. and was first approved in the U.S. in May 2007 under the brand name PERFOROMIST [2]. - As of the announcement date, the company has invested approximately RMB 4.4055 million in the research and development of this drug [2]. - The projected procurement amount for Formoterol Fumarate Inhalation Solution in Chinese hospitals for 2024 is RMB 461.55 million [2]. Group 2: Market Impact - The approval of this drug is expected to enhance market share and competitiveness for Shanghai Pharmaceuticals, as new registered generic drugs will receive greater support in medical insurance and procurement [3]. - The experience gained from this approval will be valuable for the company in future generic drug applications [3].