比阿培南

Multidrug-resistant bacterial infection has become a core challenge in global clinical anti-infective therapy. As an important defense line against such infections, carbapenem drugs have always been the focus of research and development in the anti-infective field. Biapenem belongs to 1β-methyl carbapenem antibiotics. It exerts broad-spectrum antibacterial activity by inhibiting the synthesis of bacterial cell walls, and has strong effects on Gram-positive bacteria, Gram-negative bacteria including Pseudomonas aeruginosa and anaerobic bacteria. Moreover, it has higher stability against renal dehydropeptidase-1 and does not need to be used in combination with enzyme inhibitors. Clinically, it is mainly used to treat pneumonia, lung abscess, sepsis, complicated intra-abdominal infection, complicated urinary tract infection, etc. caused by sensitive bacteria, and is applicable to adults and children aged ≥3 months with moderate to severe bacterial infections. It is a common choice for empirical treatment of patients with severe infections.

The global market size of carbapenem antibiotics has maintained steady growth in recent years, among which the penetration rate of biapenem in the Asian market has increased particularly significantly. Data show that in 2023, the market size of carbapenems in China's public hospitals exceeded 18 billion yuan, with biapenem accounting for about 14%, and the compound annual growth rate remained at around 6%. In terms of the competitive landscape, in addition to the original research products in the domestic market, more than 15 enterprises have been approved to produce biapenem preparations, among which 5 enterprises' preparations have passed the consistency evaluation. The winning bid price in centralized procurement has dropped by more than 80% compared with the original research price. The overall market has shown a situation of full competition between original research and generic drugs, and clinical accessibility has been greatly improved.

The original research enterprise of biapenem is Asahi Kasei Pharma Corporation of Japan, and the original research trade name is "Omegacin". The expiration time of its core compound patent in major markets such as Japan and the United States is 2009, and the expiration time of the compound patent in China is 2010. The main dosage form approved for the original research product is biapenem for injection, with a specification of 0.3g. It has been included in the Chinese *Catalogue of Reference Preparations of Chemical Drugs*, and also included in the FDA Reference Preparations Catalogue. In terms of domestic API registration, at present, biapenem APIs from more than 10 enterprises have completed registration with the status of "A" in the CDE. All biapenem preparation varieties approved for marketing in China are injection dosage forms, and products from multiple manufacturers have passed the consistency evaluation of generic drugs. (The data is as of November 2024, please refer to the official CDE website for the latest information.)

CATO can provide a full set of biapenem impurity reference standards, which can meet the full-process research needs of pharmaceutical enterprises in API synthesis process research, quality research, stability study, etc. Most impurities are available from stock. Spot orders placed before 16:00 can be shipped on the same day. All products meet the quality standard requirements under multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can be directly used for the submission of application documents.