注射用头孢哌酮钠舒巴坦钠
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联邦制药:注射用头孢哌酮钠舒巴坦钠通过一致性评价
Zhi Tong Cai Jing· 2025-11-26 09:14
Core Viewpoint - The announcement highlights that the company's wholly-owned subsidiary, Zhuhai United Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration of China for its injectable Cefoperazone Sodium and Sulbactam Sodium (2.0g), which has passed the consistency evaluation of generic drug quality and efficacy [1] Group 1: Product Approval and Specifications - The injectable Cefoperazone Sodium and Sulbactam Sodium is a third-generation cephalosporin antibiotic with broad-spectrum antibacterial activity, suitable for monotherapy or combination therapy [1] - It is indicated for the treatment of infections caused by sensitive bacteria, including respiratory, urinary, intra-abdominal, septicemia, meningitis, skin and soft tissue, bone and joint, and reproductive tract infections [1] Group 2: Market Position and Future Prospects - The product is listed as a Class B drug in the National Medical Insurance Directory (2024 edition), which may enhance its market accessibility [1] - The approval is expected to help the company strengthen its competitive position in the anti-infection field and contribute to greater returns for the company and its shareholders through ongoing product development and consistency evaluations [1]
联邦制药(03933):注射用头孢哌酮钠舒巴坦钠通过一致性评价
智通财经网· 2025-11-26 09:13
Core Viewpoint - Federal Pharmaceutical's subsidiary has received approval for a generic injectable antibiotic, which will strengthen its position in the anti-infection market and contribute to future revenue growth [1] Group 1: Product Approval - The injectable Cefoperazone Sodium and Sulbactam Sodium (2.0g) has been approved by the National Medical Products Administration of China [1] - This antibiotic is a third-generation cephalosporin with broad-spectrum antibacterial activity, suitable for treating various infections [1] Group 2: Therapeutic Applications - The drug is effective against respiratory infections, urinary tract infections, intra-abdominal infections, sepsis, meningitis, skin and soft tissue infections, bone and joint infections, and reproductive tract infections [1] - It shows significant therapeutic effects on inflammation and infections caused by sensitive bacteria [1] Group 3: Market Position and Future Plans - The drug is listed as a Class B medication in the National Medical Insurance Directory (2024 edition) [1] - The approval will help the company consolidate its competitive advantage in the anti-infection field [1] - The company is committed to ongoing product development and consistency evaluation, which is expected to generate greater returns for the company and its shareholders [1]
联邦制药(03933.HK):注射用头孢哌酮钠舒巴坦钠通过一致性评价
Ge Long Hui· 2025-11-26 09:05
Core Viewpoint - The approval of the injectable Cefoperazone Sodium and Sulbactam Sodium by the National Medical Products Administration of China enhances the company's position in the anti-infection sector and is expected to generate greater returns for the company and its shareholders [1] Group 1: Product Approval - The company's wholly-owned subsidiary, Zhuhai United Pharmaceutical Co., Ltd., has received approval for the injectable Cefoperazone Sodium and Sulbactam Sodium (specification: 2.0g) [1] - This product has passed the consistency evaluation for generic drug quality and efficacy [1] Group 2: Product Characteristics - Injectable Cefoperazone Sodium and Sulbactam Sodium is a third-generation cephalosporin antibiotic with broad-spectrum antibacterial activity [1] - It can be used alone or in combination for treating infections caused by sensitive bacteria, including respiratory, urinary, intra-abdominal infections, sepsis, meningitis, skin and soft tissue infections, bone and joint infections, and reproductive tract infections [1] Group 3: Market Position and Future Plans - The product is listed as a Class B drug in the National Medical Insurance Directory (2024 edition) [1] - The approval is expected to help the company strengthen its competitive advantage in the anti-infection field [1] - The company will continue to focus on new product development and advancing consistency evaluations to create greater value for the company and its shareholders [1]
金城医药:子公司收到药品补充申请批准通知书
Zheng Quan Ri Bao· 2025-10-29 14:21
Core Viewpoint - The company announced that its subsidiary, Guangdong Jincheng Jinsu Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the supplemental application of injectable Cefoperazone Sodium and Sulbactam Sodium [2] Group 1 - The approval is significant for the company's product portfolio and may enhance its market position in the pharmaceutical industry [2] - The injectable form of Cefoperazone Sodium and Sulbactam Sodium is expected to meet the growing demand for effective antibiotics in the healthcare sector [2]
广州白云山医药集团股份有限公司关于子公司药品通过仿制药一致性评价的公告
Shang Hai Zheng Quan Bao· 2025-09-01 21:11
Core Viewpoint - Guangzhou Baiyunshan Pharmaceutical Group Co., Ltd. announced that its subsidiary, Guangzhou Baiyunshan Tianxin Pharmaceutical Co., Ltd., has received approval for its generic drugs to pass the consistency evaluation of quality and efficacy, which is expected to enhance market competitiveness for the products [1][11]. Drug Information 1. Cefoperazone Sodium and Sulbactam Sodium Injection - The drug has been approved in three specifications: 1.0g, 1.5g, and 2.0g [1][6] - It is a third-generation cephalosporin antibiotic used for various infections, including respiratory, urinary, and intra-abdominal infections [6] - The product was originally developed by Pfizer and was first launched in Japan in June 1986, with its 1.0g specification approved in China in 1996 [6] - The sales revenue for Tianxin Pharmaceutical's cefoperazone sodium and sulbactam sodium injection in 2024 is projected to be RMB 15.897 million [7] - The company has invested approximately RMB 7.9186 million in the research and development of this product [7] 2. Clindamycin Phosphate Injection - The drug is available in two specifications: 2ml: 0.3g and 4ml: 0.6g, and was launched in 2006 [8][9] - It is primarily used for severe infections caused by sensitive anaerobic bacteria [9] - The sales revenue for Tianxin Pharmaceutical's clindamycin phosphate injection in 2024 is projected to be RMB 7.50787 million [10] - The company has invested approximately RMB 2.7329 million in the research and development of this product [10]
股市必读:白云山(600332)9月1日主力资金净流出2759.11万元,占总成交额4.24%
Sou Hu Cai Jing· 2025-09-01 18:01
Trading Information Summary - On September 1, 2025, Guangzhou Baiyunshan Pharmaceutical Holdings Company Limited (600332) closed at 26.61 yuan, up 0.23%, with a turnover rate of 1.73% and a trading volume of 243,300 shares, amounting to a transaction value of 651 million yuan [1] - On the same day, the net outflow of main funds was 27.59 million yuan, accounting for 4.24% of the total transaction value; the net outflow of retail funds was 25.91 million yuan, accounting for 3.98% of the total transaction value; while retail investors saw a net inflow of 53.50 million yuan, accounting for 8.22% of the total transaction value [1][3] Company Announcements Summary - Guangzhou Baiyunshan Pharmaceutical Holdings Company Limited's subsidiary, Guangzhou Baiyunshan Tianxin Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration for the consistency evaluation of generic drugs for two products: injectable cefoperazone sodium and sulbactam sodium (1.0g, 1.5g, 2.0g) and clindamycin phosphate injection (2ml: 0.3g, 4ml: 0.6g) [2] - The domestic sales revenue for injectable cefoperazone sodium and sulbactam sodium is projected to be 688.93 million yuan in 2024, with Tianxin Pharmaceutical's sales revenue for this product at 15.90 million yuan and R&D expenses around 7.92 million yuan [2] - The domestic sales revenue for clindamycin phosphate injection is expected to be 13.51 million yuan in 2024, with Tianxin Pharmaceutical's sales revenue for this product at 7.51 million yuan and R&D expenses approximately 2.73 million yuan [2]
白云山子公司药品通过仿制药一致性评价
Zhi Tong Cai Jing· 2025-09-01 10:33
Core Viewpoint - Baiyunshan (600332.SH) announced that its subsidiary, Guangzhou Baiyunshan Tianxin Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration for the supplementary application of two injectable drugs, indicating a successful consistency evaluation of quality and efficacy for generic drugs [1] Group 1: Product Approval - The injectable drugs approved include Cefoperazone Sodium and Sulbactam Sodium (1.0g, 1.5g, 2.0g) and Clindamycin Phosphate Injection (2ml: 0.3g, 4ml: 0.6g) [1] - Cefoperazone Sodium and Sulbactam Sodium is a third-generation cephalosporin antibiotic, effective against respiratory infections, urinary tract infections, and various intra-abdominal infections among others [1] - Clindamycin Phosphate Injection is primarily used for severe infections caused by sensitive anaerobic bacteria [1]
白云山注射用头孢哌酮钠舒巴坦钠等药品通过仿制药一致性评价
Bei Jing Shang Bao· 2025-09-01 10:22
Core Viewpoint - Baiyunshan's subsidiary, Guangzhou Baiyunshan Tianxin Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for two injectable drugs, indicating a successful step in the company's pharmaceutical development and regulatory compliance [1] Group 1: Drug Approvals - The approved drugs include injectable Cefoperazone Sodium and Sulbactam Sodium (1.0g, 1.5g, 2.0g) and Clindamycin Phosphate Injection (2ml: 0.3g, 4ml: 0.6g) [1] - Cefoperazone Sodium and Sulbactam Sodium is a third-generation cephalosporin antibiotic, effective against respiratory infections caused by sensitive bacteria [1] - Clindamycin Phosphate Injection is primarily used for severe infections caused by sensitive anaerobic bacteria [1]
白云山:天心制药收到国家药监局核准签发的《药品补充申请批准通知书》
Zhi Tong Cai Jing· 2025-09-01 10:16
Core Viewpoint - Baiyunshan (00874) announced that its subsidiary, Guangzhou Baiyunshan Tianxin Pharmaceutical Co., Ltd. ("Tianxin Pharmaceutical"), has received approval from the National Medical Products Administration for its supplementary drug application, indicating that its injectable formulations of Cefoperazone Sodium and Sulbactam Sodium (1.0g, 1.5g, 2.0g) and Clindamycin Phosphate Injection (2ml: 0.3g, 4ml: 0.6g) have passed the consistency evaluation for generic drug quality and efficacy [1] Group 1 - Tianxin Pharmaceutical's injectable formulations have successfully passed the consistency evaluation, which will enhance the market competitiveness of these products [1]
白云山(00874):天心制药收到国家药监局核准签发的《药品补充申请批准通知书》
智通财经网· 2025-09-01 10:12
Core Viewpoint - Baiyunshan (00874) announced that its subsidiary, Guangzhou Baiyunshan Tianxin Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration for its supplementary drug application, enhancing the market competitiveness of its products [1] Group 1: Product Approval - Tianxin Pharmaceutical's injectable Cefoperazone Sodium and Sulbactam Sodium (1.0g, 1.5g, 2.0g) and Clindamycin Phosphate Injection (2ml: 0.3g, 4ml: 0.6g) have passed the consistency evaluation for generic drug quality and efficacy [1] - The approval is expected to improve the market competitiveness of the aforementioned products [1]