上海医药集团股份有限公司 关于二羟丙茶碱注射液通过仿制药一致性评价的公告

Group 1 - The company Shanghai Pharmaceutical Group Co., Ltd. announced that its subsidiary, Shanghai Xinyi Jinzhu Pharmaceutical Co., Ltd., received a notification from the National Medical Products Administration approving the supplementary application for the drug Dihydroxypropyl Theophylline Injection, which has passed the consistency evaluation of quality and efficacy for generic drugs [1][2] - The drug Dihydroxypropyl Theophylline Injection is indicated for bronchial asthma, wheezing bronchitis, and obstructive pulmonary emphysema, and it was developed by Eisai Co., Ltd. and launched in Japan in October 1952 [2] - As of the announcement date, the company has invested approximately RMB 3.05 million in research and development for this drug [2] Group 2 - The approval of the drug's consistency evaluation is expected to enhance its market share and competitiveness, as products that pass this evaluation will receive greater support in medical insurance payments and procurement by medical institutions [2] - The total procurement amount for Dihydroxypropyl Theophylline Injection (2ml:0.3g) in hospitals in mainland China for 2024 is reported to be RMB 9.737 million [2]