By Fineline Cube SciClone Pharmaceuticals Inc (HKG: 6600) has announced that an Investigational New Drug (IND) filing for its Vaborem (meropenem vaborbactam), a new antibacterial drug, has been accepted for review by the National Medical Products Administration (NMPA). The IND application covers a Phase III clinical study to evaluate the efficacy and safety of Vaborem in Chinese patients, as well as a pharmacokinetic study in healthy volunteers in China to evaluate the pharmacokinetic profile of Vaborem. These two China-based studies aim to bridge foreign clinical trial data and eventually support the New Drug Application (NDA) for Vaborem in the country.
Drug Profile and Development
Vaborem is a fixed-dose combination of a carbapenem and a novel boronic acid β-lactamase inhibitor of 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 CRE, including the commonly found Klebsiella pneumoniae Carbapenemase (KPC)-producing bacteria. Currently, Vaborem has been granted 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 has also been approved for the treatment of complicated intra-abdominal infections (cIAI), hospital-acquired bacterial pneumonia (HABP), and ventilator-associated bacterial pneumonia (VABP).
Licensing Agreement and Future Prospects
SciClone Pharma entered into a licensing agreement with A. Menarini Asia-Pacific Holdings Pte. Ltd, a part of The Menarini Group, in August 2022, taking the exclusive rights to develop and commercialize Vaborem in China. The acceptance of the IND filing by the NMPA marks a significant milestone in bringing Vaborem to the Chinese market, addressing significant unmet medical needs in the treatment of antibiotic-resistant infections.-Fineline Info & Tech