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上海医药:二羟丙茶碱注射液通过仿制药一致性评价
Zhi Tong Cai Jing·2025-09-04 07:39

Core Viewpoint - Shanghai Pharmaceuticals (601607.SH) announced that its subsidiary, Shanghai Xinyi Jinzhu Pharmaceutical Co., Ltd. (referred to as "Xinyi Jinzhu"), has received a Supplementary Application Approval Notice from the National Medical Products Administration (NMPA) for its Dihydroxypropyl Theophylline Injection, which has passed the consistency evaluation of generic drug quality and efficacy [1] Group 1 - The Dihydroxypropyl Theophylline Injection is indicated for bronchial asthma, asthmatic bronchitis, obstructive pulmonary emphysema, and relief of wheezing symptoms [1] - The drug can also be used for wheezing caused by cardiogenic pulmonary edema [1] - The drug was developed by Eisai Co., Ltd. and was launched in Japan in October 1952 [1] Group 2 - In August 2024, Xinyi Jinzhu submitted a supplementary application to the NMPA for the new specification and consistency evaluation of the generic drug, which has been accepted [1] - As of the date of the announcement, the company has invested approximately RMB 3.05 million in research and development costs for this drug [1]