Meropenem

In response to the clinical treatment gap for multidrug-resistant bacterial infections, carbapenem antibiotics have long been the core medication option in the field of severe infections. As a representative drug of the second-generation carbapenems, meropenem exerts broad-spectrum antibacterial activity by inhibiting the synthesis of bacterial cell walls. It has potent bactericidal effects against Gram-positive bacteria, Gram-negative bacteria including Pseudomonas aeruginosa, and anaerobic bacteria. Compared with first-generation carbapenems, it has lower nephrotoxicity and fewer adverse reactions in the central nervous system. At present, it is clinically mainly used for the treatment of moderate to severe bacterial infections such as pneumonia, urinary tract infection, abdominal infection, sepsis and meningitis. The applicable population covers adults and children over 3 months old, and it is one of the core medications for departments such as ICU, hematology department and infectious disease department to respond to drug-resistant bacterial infections.

Driven by the rising global bacterial resistance rate and the expansion of diagnosis and treatment demand for severe infections in recent years, the market size of meropenem has continued to grow. Data show that in 2023, the sales of meropenem at terminals of Chinese public medical institutions exceeded 9 billion yuan, with a compound annual growth rate of more than 6%, making it the variety with the highest market share among carbapenems. In terms of the competitive landscape, domestic generic drugs dominate, with more than 80 preparation approvals. After the implementation of centralized procurement, the price has dropped by more than 70%, further promoting the improvement of clinical accessibility. The localization rate of upstream API has exceeded 90%, with East China and South China as the main production clusters.

The original research enterprise of meropenem is Sumitomo Pharma of Japan, and the original research brand name is "Mepem". Its core compound patent expired around 2010 in major global markets, and the Chinese compound patent also expired in 2010. The main dosage form approved for the original research is meropenem for injection, with conventional specifications including 0.25g, 0.5g and 1.0g, which has been included in the Chinese Catalogue of Reference Preparations of Chemical Drugs and the FDA reference preparation catalogue. In terms of domestic API registration, more than 30 enterprises have completed the CDE registration of meropenem APIs, among which there are more than 20 registration numbers with status A, corresponding to more than 80 approved domestic preparations, and the original research preparation has also been approved for marketing in China. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of meropenem impurity reference standards. Most products are in stock, and orders for in-stock products placed before 16:00 will be shipped on the same day. They fully comply with the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the multi-scenario needs of pharmaceutical enterprises such as drug R&D, quality control and generic drug consistency evaluation.