BAIYUNSHAN PH (00874) has announced a key regulatory milestone for its controlled subsidiary. Guangzhou Baiyunshan Pharmaceutical Holdings Company Limited confirmed that its subsidiary, Guangzhou Baiyunshan Tianxin Pharmaceutical Co., Ltd., has received the 成药登记证书 (Proprietary Chinese Medicine Registration Certificate) from the Macau Special Administrative Region's Pharmaceutical Administration Bureau.

Tianxin Pharmaceutical submitted the registration application for cefazolin sodium for injection (0.5g and 1.0g) to the Macau health authority on June 22, 2026. The application was granted preliminary acceptance on July 31, 2026. This drug is indicated for treating various infections caused by sensitive bacteria, including respiratory tract infections, urinary tract infections, skin and soft tissue infections, bone and joint infections, sepsis, infective endocarditis, hepatobiliary system infections, reproductive system infections, and perioperative infection prophylaxis. The drug is not suitable for central nervous system infections. For chronic urinary tract infections, particularly those with urinary tract anatomical abnormalities, efficacy is comparatively poor. It is also not recommended for treating gonorrhea and syphilis.

According to data from Menet, the total sales value of cefazolin sodium for injection in China's domestic urban and county-level public hospitals, as well as urban and online pharmacies, reached RMB 824.81 million in 2025. Key domestic manufacturers of this product currently include Qilu Antibiotic Pharmaceutical Co., Ltd., Guangdong Jincheng Jinsu Pharmaceutical Co., Ltd., and Chengdu Beite Pharmaceutical Co., Ltd. In 2025, Tianxin Pharmaceutical recorded sales revenue of RMB 715,800 from cefazolin sodium for injection. As of the date of this announcement, the company has accumulated total R&D expenses of approximately RMB 6.1086 million (unaudited) for this project.