SciClone Pharmaceuticals (Holdings) Limited announced that the Center for Drug Evaluation of the China National Medical Products Administration has officially accepted the Company's Investigational New Drug application for Vaborem (Meropenem+Vaborbactam), a new antibacterial drug. This IND application consists of a Phase III clinical study to evaluate the efficacy and safety of Vaborem in Chinese patients with complicated urinary tract infections including pyelonephritis, as well as a pharmacokinetic study in healthy volunteers in China to evaluate the pharmacokinetic profile of Vaborem. These two clinical studies in China are to bridge foreign clinical trial data and eventually support the New Drug Application of Vaborem in China.

Vaborem is a fixed-dose combination of a carbapenem and a novel boronic acid -lactamase inhibitor of class A and Class C serine -lactamase. Vaborbactam can inhibit various class A and class C -lactamases. It protects meropenem from degradation by serine carbapenemases, restoring its activity against carbapenem-resistant strains, and has been specifically developed to inhibit carbapenem-resistant enterobacterales including the commonly found Klebsiella pneumoniae Carbapenemase -producing bacteria.

Currently Vaborem has been granted marketing authorizations in the United States of America and the European Union, among other countries, for adults with cUTI including pyelonephritis. In select territories, it has also been approved for the treatment of complicated intra-abdominal infections and hospital- acquired bacterial pneumonia and ventilator-associated bacterial pneumonia. Pursuant to the License and Collaboration Agreement entered into between SciClone Pharmaceuticals and A. Menarini Asia-Pacific Holdings Pte.

Ltd., part of The Menarini Group in August 2022, the Company has the exclusive right to develop and commercialize Vaborem in China, under Menarini's head license agreement with Melinta Therapeutics Inc. This collaboration aims to address the public health threat of antimicrobial infections, specifically CRE. As an effective alternative therapy to treat severe infections caused by CRE, Vaborem is listed in the World Health Organization Model List of the Essential Medicines, and has been defined as an innovative antibiotic by the WHO among various recent developed drugs for the treatment of multi-drug resistant Gram-negative bacterial infections. The Company looks forward to conducting these clinical studies as soon as possible to support the NDA of Vaborem in China, thereby benefiting more patients.