China-based SciClone Pharmaceuticals Inc and its Italy-based strategic partner Menarini have announced the submission of a New Drug Application (NDA) for Vaborem (meropenem vaborbactam) to the National Medical Products Administration (NMPA). The sought-after indication is complex urinary tract infections, including pyelonephritis. This submission marks a significant step in making this innovative antibacterial drug available to patients in China.
Vaborem: Drug Profile and Mechanism of Action
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. Specifically developed to inhibit carbapenem-resistant Enterobacteriaceae (CRE), including the commonly found Klebsiella pneumoniae Carbapenemase (KPC)-producing bacteria, Vaborem offers a new treatment option for combating antibiotic resistance.
Global Approvals and Market Presence
Vaborem has already been granted marketing authorizations in the United States for adults with complicated urinary tract infections (cUTI) including pyelonephritis, and in the European Union for cUTI, complicated intra-abdominal infections (cIAI), and hospital-acquired pneumonia (HAP). These approvals highlight the drug’s efficacy and safety in treating serious infections, positioning it as a valuable addition to the global armamentarium against antibiotic-resistant bacteria.
Strategic Partnership and Market Expansion
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. This strategic move aims to expand the drug’s market reach and improve access for patients in need. Additionally, an import drug pre-license filing for Vaborem was made in Macau in February 2023, further demonstrating the commitment to making this important therapy available across the region.
Strategic Implications
The submission of the NDA for Vaborem to the NMPA is a strategic milestone for SciClone and Menarini. It underscores the companies’ dedication to addressing the growing challenge of antibiotic resistance and enhancing patient care. By bringing Vaborem to the Chinese market, SciClone and Menarini aim to contribute to the global effort to combat multidrug-resistant infections and improve outcomes for patients with complex urinary tract infections and other serious conditions.-Fineline Info & Tech
