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广州白云山医药集团股份有限公司关于分公司获得药品补充申请批件的公告
Core 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].
白云山分公司白云山制药总厂获得药品补充申请批件
Zhi Tong Cai Jing· 2025-09-16 09:16
Core Viewpoint - Recently, the company’s subsidiary, Guangzhou Baiyunshan Pharmaceutical Group Co., Ltd. Baiyunshan Pharmaceutical Factory, received the "Drug Supplement Application Approval Notice" from the National Medical Products Administration, enhancing the safety information of several products [1] Group 1 - The approved products include Abukuan Tablets, Kunling Pills, Shenxidan, Yiganling Tablets, and Maian Granules, which will improve the safety, effectiveness, and rational use of these drugs [1] - The approval is expected to enhance the market competitiveness of the products [1] - The approval will not have a significant impact on the company's current performance [1]
白云山(00874)分公司白云山制药总厂获得药品补充申请批件
智通财经网· 2025-09-16 09:13
Core Viewpoint - Recently, Baiyunshan Pharmaceutical Group Co., Ltd. received the "Drug Supplement Application Approval Notice" from the National Medical Products Administration, enhancing the safety information of several drugs and improving market competitiveness [1] Group 1 - Baiyunshan Pharmaceutical's total factory received approval for the following drugs: Abdominal Ankang Tablets, Kunling Pills, Shenxi Dan, Yiganling Tablets, and Mai'an Granules [1] - The approval aims to improve the safety, effectiveness, and rational use of the mentioned drugs [1] - The approval is not expected to have a significant impact on the company's current performance [1]
白云山(00874.HK):国家药监局批准腹可安片等药品补充申请
Ge Long Hui· 2025-09-16 09:11
Core Viewpoint - Recently, the company announced that its subsidiary, Guangzhou Baiyunshan Pharmaceutical Group Co., Ltd., received the "Drug Supplement Application Approval Notice" from the National Medical Products Administration, enhancing the safety and effectiveness information of several drugs [1] Group 1 - The company obtained approval for the following drugs: Abukuan Tablets, Kunling Pills, Shenxidan, Yiganling Tablets, and Maian Granules [1] - The approval is expected to improve the safety, effectiveness, and rational use of these drugs, thereby enhancing their market competitiveness [1]
白云山:分公司获得药品补充申请批件
Xin Lang Cai Jing· 2025-09-16 08:22
Group 1 - The company Baiyunshan Pharmaceutical has received approval from the National Medical Products Administration for several drug products [1] - The approved drugs include Abukuan Tablets, Kunling Pills, Shenxidan, Yiganling Tablets, and Maian Granules [1] - Projected sales for Abukuan Tablets in the domestic market for 2024 are estimated at 27.74 million yuan, with Baiyunshan's sales for this product at 6.3754 million yuan [1] - Projected sales for Kunling Pills in the domestic market for 2024 are estimated at 13.15 million yuan [1] - Projected sales for Yiganling Tablets in the domestic market for 2024 are estimated at 13.71 million yuan [1] - Projected sales for Maian Granules in the domestic market for 2024 are estimated at 9.28 million yuan [1]