Shanghai Pharmaceuticals (601607.SH): Diprophylline Injection Passes Generic Drug Consistency Evaluation

Stock News
2025/09/04

Shanghai Pharmaceuticals (601607.SH) announced that its subsidiary Shanghai Sine Pharmaceutical Co., Ltd. ("Sine Pharmaceutical") has received the "Drug Supplementary Application Approval Notice" (Notice No.: 2025B04012) from the National Medical Products Administration (NMPA) for its diprophylline injection. The drug has successfully passed the generic drug quality and efficacy consistency evaluation.

Diprophylline injection is indicated for relieving dyspnea symptoms in conditions including bronchial asthma, asthmatic bronchitis, and obstructive pulmonary emphysema. It can also be used for dyspnea caused by cardiogenic pulmonary edema.

The diprophylline injection was originally developed by Eisai Co., Ltd. and first launched in Japan in October 1952. In August 2024, Sine Pharmaceutical submitted a supplementary application to the NMPA for additional specifications combined with generic drug consistency evaluation, which was subsequently accepted.

As of the announcement date, the company has invested approximately RMB 3.05 million in research and development costs for this drug.

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