SciClone Pharmaceuticals Inc (HKG: 6600) has announced that its Italy-based strategic partner Menarini has submitted an import drug pre-license filing for Vaborem (meropenem vaborbactam) in Macau. The company is seeking regulatory approval for the new antibacterial drug to treat complicated intra-abdominal infections (cIAI), hospital-acquired pneumonia (HAP), and complicated complex urinary tract infections (cUTI).
Vaborem is a fixed-dose combination of a carbapenem antibiotic and a novel boronic acid β-lactamase inhibitor, targeting class A and class C serine β-lactamases. It protects meropenem from degradation by serine carbapenemases, thereby restoring its activity against carbapenem-resistant strains. The drug has been specifically developed to combat carbapenem-resistant Enterobacteriaceae (CRE), including the prevalent Klebsiella pneumoniae Carbapenemase (KPC)-producing bacteria. Vaborem has already received marketing authorizations in the United States for the treatment of complicated urinary tract infections (cUTI) including pyelonephritis and in the European Union for cUTI, cIAI, and HAP.
In August 2022, SciClone entered into a licensing agreement with A. Menarini Asia-Pacific Holdings Pte. Ltd, a subsidiary of The Menarini Group, securing exclusive rights to develop and commercialize Vaborem in China. The drug is currently undergoing a Phase III clinical study in China, with all subjects enrolled as of January this year.- Flcube.com
