By Fineline Cube 
Japan-based Sumitomo Pharma Co., Ltd announced that it has received market approval in China for Xenleta (lefamulin). The drug, a truncated amphotericin antibiotic, was awarded priority review status by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). It is approved for the treatment of community-acquired pneumonia (CAP) as a Category 4 chemical generic drug. Previously, Xenleta was approved as a Category 5.1 chemical drug (imported new drug) in November 2023 under Sumitomo Pharmaceuticals (Suzhou) Co., Ltd.
Mechanism of Action
Lefamulin binds to both the A-site and P-site of bacterial ribosomes, blocking the proper positioning of tRNA and peptide transfer, thereby inhibiting bacterial protein synthesis. This dual-site binding mechanism not only enhances the drug’s binding affinity to ribosomes but also makes it less prone to inducing resistance. The tricyclic core and C-14 side chain structure of lefamulin further stabilize its binding to ribosomes. This gives it potent antibacterial activity against various pathogens, including drug-resistant strains such as MRSA (methicillin-resistant Staphylococcus aureus) and MDR-SP (multidrug-resistant Streptococcus pneumoniae), as well as atypical pathogens like Mycoplasma pneumoniae, which exhibits over 80% resistance to macrolide antibiotics.
Development and Rights Acquisition
Originally developed by Nabriva Therapeutics, Sumitomo Pharmaceuticals (Suzhou) acquired the exclusive development and commercial rights to lefamulin for Mainland China, Hong Kong, Macau, and Taiwan (Greater China) in May 2021. Sumitomo Pharma subsequently obtained the Greater China rights to the drug from Nabriva in July 2023.-Fineline Info & Tech