BAIYUNSHAN PH (00874.HK): subsidiary's Cefazolin Sodium for Injection obtains Macao pharmaceutical registration certificate, to be sold in Macao under authorization
NewTimeSpace News: On 17 August 2026, Guangzhou Baiyunshan Pharmaceutical Holdings Co., Ltd. (A-share: 600332; H-share stock code: 00874) announced that its controlling subsidiary Guangzhou Baiyunshan Tianxin Pharmaceutical Co., Ltd. has received the Pharmaceutical Registration Certificate issued by the Macao Special Administrative Region Government Pharmaceutical Administration Bureau for Cefazolin Sodium for Injection (0.5g, 1.0g), in injection dosage form and classified as a prescription drug, with registration numbers MAC-08047 and MAC-08048, manufactured by Tianxin Pharmaceutical.
According to the announcement, Tianxin Pharmaceutical submitted the drug registration application to the Macao Pharmaceutical Administration Bureau on 22 June 2026 and obtained pre-approval acceptance on 31 July 2026. Cefazolin Sodium for Injection is indicated for the treatment of respiratory tract infections, urinary tract infections, skin and soft tissue infections, bone and joint infections, septicemia, infective endocarditis, hepatobiliary system infections, reproductive system infections caused by susceptible bacteria, and perioperative infection prophylaxis.
The announcement states that the drug has passed the national consistency evaluation of generic drug quality and efficacy, and upon obtaining the certificate, it will be sold in Macao by Guangyao International (Macao) Drug Products Import, Export and Wholesale Firm under authorization from Tianxin Pharmaceutical, helping to expand overseas market business and enhance the market competitiveness of the Company's products; obtaining the certificate has no material impact on the Company's current-period performance. As of the date of the announcement, Tianxin Pharmaceutical had accumulated R&D investment of approximately RMB 6.1086 million (unaudited) in the project, and its sales revenue of the drug in 2025 was RMB 715,800.
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