Baiyunshan subsidiary's generic drugs pass key efficacy evaluation

Guangzhou Baiyunshan Pharmaceutical Holdings Company Limited announced that its controlling subsidiary, Guangzhou Baiyunshan Tianxin Pharmaceutical Co., Ltd. (Tianxin Pharmaceutical), received approval from the National Medical Products Administration for its generic drugs, Cefoperazone Sodium and Sulbactam Sodium for Injection (1.0g, 1.5g, 2.0g) and Clindamycin Phosphate Injection (2ml: 0.3g, 4ml: 0.6g), to pass the consistent efficacy evaluation. These approvals are expected to bolster the market competitiveness of these products.

Tianxin Pharmaceutical obtained registration approval for Cefoperazone Sodium and Sulbactam Sodium for Injection (1.0g and 2.0g) in 2002, with the 1.5g specification approved in 2005. The company submitted its consistent efficacy evaluation application for all three specifications in December 2023. In 2024, sales revenue for this product reached 15.9m yuan, with cumulative research and development expenses for the evaluation project totaling approximately 7.9m yuan (unaudited).

Clindamycin Phosphate Injection (2ml: 0.3g and 4ml: 0.6g) was launched by Tianxin Pharmaceutical in 2006. The consistent efficacy evaluation application for these specifications was submitted in June 2024. In 2024, sales revenue for this product amounted to 75.1m yuan, with research and development expenses for the evaluation project approximately 2.7m yuan (unaudited). Investors are cautioned regarding potential risks due to inherent uncertainties in drug development, production, and sales influenced by national policies and market conditions.