BAIYUNSHAN PH (00874.HK): Subsidiary's Norepinephrine Bitartrate Injection Passes Generic Drug Consistency Evaluation

NewTimeSpace News: On 24 August 2026, Guangzhou Baiyunshan Pharmaceutical Holdings Company Limited (stock code: 00874) published an overseas regulatory announcement, disclosing that its wholly-owned subsidiary Guangzhou Baiyunshan Mingxing Pharmaceutical Co., Ltd. has received the Drug Supplementary Application Approval Notice issued by the National Medical Products Administration (NMPA), and that Norepinephrine Bitartrate Injection (1ml:2mg) has passed the consistency evaluation of the quality and efficacy of generic drugs.

The announcement disclosed that the drug is an injection classified as a chemical drug, with the original drug approval number Guoyao Zhunzi H44022396. The approval also consented to changes to the drug formulation and production process, changes to the drug registration standard, changes to the packaging materials and containers in direct contact with the drug, and revision of the drug instructions.

The drug was approved for marketing in 1982. Mingxing Pharmaceutical submitted the consistency evaluation application for Norepinephrine Bitartrate Injection (1ml:2mg) to the NMPA on 16 April 2025, and the application was accepted on 30 April 2025. The drug is indicated for blood pressure control in certain acute hypotensive states, such as pheochromocytomectomy, sympathectomy, poliomyelitis, spinal anaesthesia, myocardial infarction, septicaemia, blood transfusion and drug reactions.

According to the announcement, the main manufacturers of the drug in mainland China include Grand Pharmaceutical (China) Co., Ltd., Hefei Yifan Biopharmaceutical Co., Ltd. and Tianjin Jinyao Heping Pharmaceutical Co., Ltd., among others. According to data from Minet, sales of Norepinephrine Bitartrate Injection in domestic city and county-level public hospitals and city and online pharmacies in 2025 amounted to RMB 768.58 million. As of the date of this announcement, Mingxing Pharmaceutical had invested approximately RMB 1.2557 million (unaudited) in research and development expenses for the consistency evaluation of the drug.

The Company stated that the drug's passing of the generic drug quality and efficacy consistency evaluation is conducive to enhancing the market competitiveness of the drug, while noting that drug production and sales are subject to considerable uncertainty due to factors such as national policies and market conditions.

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