SciClone Pharmaceuticals Inc (HKG: 6600) has announced that a clinical trial filing for its Vaborem (meropenem vaborbactam), a new antibacterial drug, has been approved by the National Medical Products Administration (NMPA). This approval allows the drug to enter a Phase III clinical study in China.
Study Objectives and Design
The Phase III clinical study will evaluate the efficacy and safety of Vaborem in Chinese patients with complex urinary tract infections, including pyelonephritis. Additionally, a pharmacokinetic study targeting healthy Chinese volunteers will assess the pharmacokinetic characteristics of Vaborem. These studies will help bridge foreign trial data and support the drug’s market filing in the local market.
Mechanism and Global Approvals
Vaborem is a fixed-dose combination of a carbapenem 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, restoring its activity against carbapenem-resistant strains. The drug has been specifically developed to inhibit carbapenem-resistant Enterobacteriaceae (CRE), including KPC-producing bacteria. Vaborem has received marketing authorizations in the United States and the European Union, among other countries, for adults with complicated urinary tract infections (cUTI) including pyelonephritis. In select territories, it is also approved for the treatment of complicated intra-abdominal infections (cIAI), hospital-acquired bacterial pneumonia (HABP), and ventilator-associated bacterial pneumonia (VABP).
Licensing Agreement and WHO Recognition
SciClone entered into a licensing agreement with A. Menarini Asia-Pacific Holdings Pte. Ltd, a part of The Menarini Group, in August 2022, securing exclusive rights to develop and commercialize Vaborem in China. The drug is included in the World Health Organization’s (WHO) Model List of Essential Medicines, highlighting its importance in global healthcare.-Fineline Info & Tech
