BAIYUNSHAN PH (00874.HK): subsidiary's Citicoline Sodium Injection obtains supplementary drug application approval and consistency evaluation

NewTimeSpace News: On 19 August 2026, Guangzhou Baiyunshan Pharmaceutical Holdings Co., Ltd. (A-share: 600332; H-share stock code: 00874) published an overseas regulatory announcement stating that its controlling subsidiary Guangzhou Baiyunshan Tianxin Pharmaceutical Co., Ltd. has received the Supplementary Drug Application Approval Notice issued by the National Medical Products Administration for Citicoline Sodium Injection (2ml:0.25g, 4ml:0.5g). The 2ml:0.25g specification passed the consistency evaluation of generic drug quality and efficacy, with approval of changes to the prescription and manufacturing process, registration standards, and packaging materials and containers in direct contact with the drug; the 4ml:0.5g specification was approved for adding the specification with a new drug approval number, also passing the consistency evaluation.

According to the announcement, Tianxin Pharmaceutical's Citicoline Sodium Injection (2ml:0.25g) has been on the market since 1986; the Company submitted the consistency evaluation application and applied to add the 4ml:0.5g specification on 30 April 2025, which was accepted on 3 June 2025. Citicoline Sodium Injection is indicated for consciousness disorders following acute craniocerebral trauma and brain surgery. According to Menet data, sales of the drug in domestic city, county-level public hospitals, city and online pharmacies in 2025 reached RMB 80.31 million.

The announcement states that the supplementary approval adds a drug specification and passes the consistency evaluation, helping to enhance the product's market competitiveness; as of the date of the announcement, Tianxin Pharmaceutical had invested approximately RMB 2.5674 million (unaudited) in the R&D project, with 2025 sales revenue of the drug of RMB 1.6504 million.

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