Shang Hai Zheng Quan Bao·2025-09-16 19:02Core Viewpoint - Guangzhou Baiyunshan Pharmaceutical Group Co., Ltd. has received approval for supplementary applications for several drugs, enhancing their safety information and specifications, which is expected to improve market competitiveness [1][17]. Drug Information 1. Abukuan Tablets - Generic Name: Abukuan Tablets - Dosage Form: Tablets - Specification: Each tablet weighs 0.25g (equivalent to 3.33g of raw material) - Approval Notification Number: 2025B03040 - Application Content: Changes to safety information in the drug instructions and specifications [1][8]. - Market Sales: In 2024, the domestic sales amounted to RMB 27.74 million, with Baiyunshan's sales at RMB 6.3754 million [9]. 2. Kunling Pills - Generic Name: Kunling Pills - Dosage Form: Pills (Concentrated Pills) - Specification: Each 10 pills weigh 2.7g (equivalent to 2.6g of raw material) - Approval Notification Number: 2025B03908 - Application Content: Changes to safety information in the drug instructions [2][11]. - Market Sales: In 2024, the domestic sales amounted to RMB 13.15 million, with no sales recorded for Baiyunshan [11]. 3. Shenxidan - Generic Name: Shenxidan - Dosage Form: Pills (Water Pills) - Approval Notification Number: 2025B03811 - Application Content: Changes to safety information in the drug instructions [4][12]. - Market Sales: No sales recorded for Baiyunshan in 2024 [13]. 4. Yiganling Tablets - Generic Name: Yiganling Tablets - Dosage Form: Tablets - Specification: Each tablet contains 38.5mg of Silybin - Approval Notification Number: 2025B04192 - Application Content: Changes to safety information in the drug instructions [5][14]. - Market Sales: In 2024, the domestic sales amounted to RMB 13.71 million, with no sales recorded for Baiyunshan [15]. 5. Maian Granules - Generic Name: Maian Granules - Dosage Form: Granules - Specification: Each bag contains 20g - Approval Notification Number: 2025B04164 - Application Content: Changes to safety information in the drug instructions [7][16]. - Market Sales: In 2024, the domestic sales amounted to RMB 9.28 million, with no sales recorded for Baiyunshan [16]. Company Impact - The approval of supplementary applications for the drugs is expected to enhance their safety and effectiveness, thereby improving the market competitiveness of the products. However, the approval is not expected to have a significant impact on the company's current performance [17].