Lefamulinum

Drug-resistant bacterial infections have become a severe challenge in the global public health sector, and the clinical demand for new antibacterial drugs continues to rise. Lefamulin is a new type of pleuromutilin antibiotic. It inhibits protein synthesis by binding to the 50S subunit of bacterial ribosomes, and has good antibacterial activity against Gram-positive bacteria such as Staphylococcus aureus and Streptococcus pneumoniae, as well as atypical pathogens. In addition, it has low cross-resistance with other classes of antibiotics. Clinically, it is mainly used for the treatment of community-acquired bacterial pneumonia in adults, and can also be used for acute bacterial skin and skin structure infections, providing a brand-new treatment option for patients who are intolerant to traditional antibiotics or infected with drug-resistant bacteria.

The global market size of lefamulin was approximately USD 210 million in 2023, and it is expected to grow at a compound annual growth rate of 12.7% from 2024 to 2030. The growth momentum mainly comes from the increase in the diagnosis and treatment rate of community-acquired pneumonia and the expanding demand for the prevention and control of drug-resistant bacterial infections. At present, the original research product still occupies a dominant position in the global market, and no generic drug has been approved for marketing in China. With the expiration of potential patents, the enthusiasm of domestic generic drug companies for layout is gradually rising.

The original research enterprise of lefamulin is Nabriva Therapeutics, and the original trade name is Xenleta. The compound patent in the United States will expire in 2026, and the core compound patent in China will expire in 2027. The main marketed dosage forms of the original research product include 150mg/15mL injection and 600mg oral tablet. Both its oral and injection dosage forms have been included in the FDA Reference Listed Drug Catalogue, but have not yet been included in the *Catalogue of Reference Preparations for Chemical Drugs* of China. At present, no lefamulin API has been approved for marketing in China, and no corresponding preparation varieties have been approved for import or domestic production. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for lefamulin API. Most products are available from stock. Stock orders paid before 16:00 can be shipped on the same day. All reference standards meet the requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA. Parameters such as impurity structure and purity have been strictly verified, which can fully meet the use needs of enterprises in the whole process from API R&D, quality research to declaration and registration.