Core Viewpoint - Harbin Pharmaceutical Group Co., Ltd. (哈药股份) announced that its subsidiary, Harbin Pharmaceutical Group Pharmaceutical Factory (哈药总厂), received approval from the National Medical Products Administration for two formulations of injectable cefoperazone sodium and sulbactam sodium, indicating successful completion of the consistency evaluation for generic drug quality and efficacy [1] Group 1 - The company received approval for two formulations: injectable cefoperazone sodium and sulbactam sodium in two ratios (1:1 and 2:1) [1] - A total of four specifications for these drugs have passed the consistency evaluation [1]

Core Viewpoint - Harbin Pharmaceutical Group Co., Ltd. (哈药股份) has received approval from the National Medical Products Administration for two formulations of injectable cefoperazone sodium and sulbactam sodium, indicating a significant advancement in its product portfolio and compliance with quality and efficacy standards for generic drugs [1] Group 1 - The company’s subsidiary, Harbin Pharmaceutical Group Pharmaceutical Factory, has been granted a "Drug Supplement Application Approval Notice" for two formulations of injectable cefoperazone sodium and sulbactam sodium [1] - The approved products include four specifications that have passed the consistency evaluation of quality and efficacy for generic drugs [1]

Core Viewpoint - The antibacterial drug market in China is under pressure, with sales expected to drop below 100 billion yuan in 2024 and continue declining by approximately 18% in the first three quarters of 2025, reaching over 60 billion yuan [1][14]. Market Performance - The total sales of systemic antibacterial drugs in public medical institutions in China have been declining, with a significant drop in sales from 2024 to 2025 [1][14]. - The market for systemic antibacterial drugs includes 12 major therapeutic categories, with cephalosporins leading but experiencing four consecutive years of sales decline from 2022 to the first three quarters of 2025 [3][16]. Company Rankings - In the ranking of major companies, Pfizer, China National Pharmaceutical Group, and North China Pharmaceutical Group hold the top three positions, with sales exceeding 6.2 billion yuan, 2.1 billion yuan, and 1.9 billion yuan respectively in the first three quarters of 2025 [5][18]. - Nanjing Youke Biological, ranked fifteenth, showed remarkable growth with a year-on-year increase of 137.17%, marking its first entry into the top 20 groups [5][18]. Product Performance - The top 20 systemic antibacterial drugs accounted for over 50% of the market share, with the leading product, injectable cefoperazone/sulbactam (2:1), achieving sales of over 4.5 billion yuan [21][22]. - Notably, the compound injection of cefoperazone/sulbactam saw a dramatic increase of 219.32%, marking a significant rise in its market presence [21][23]. National Procurement Impact - Among the top 20 products, 15 have been included in the national procurement program, with 13 experiencing double-digit declines in sales [21][23]. - The tenth batch of national procurement saw injectable piperacillin/tazobactam drop by 55.61%, while the eleventh batch saw injectable cefoperazone/sulbactam decline by 47.56% [21][23]. New Drug Development - Currently, there are no domestic class 1 new drugs among the top 20 systemic antibacterial products, although five class 1 new antibacterial drugs have been approved since 2021 [25][26]. - Eight products meet the criteria for national procurement inclusion, with seven being injectable forms and one oral formulation [25][26].