Core Viewpoint - The successful completion of subject enrollment in the Phase III clinical trial of Vaborem® in China marks a significant milestone in its development process, demonstrating the capabilities of the clinical development team at the company [1][2]. Group 1: Clinical Trial Details - The Phase III clinical trial for Vaborem® is a randomized, double-blind, positive drug-controlled, multi-center study aimed at evaluating the efficacy and safety of Vaborem® in patients with complicated urinary tract infections (cUTI), including acute pyelonephritis [1]. - The trial involved 108 subjects enrolled across 27 research centers in China, led by prominent researchers from Fudan University Huashan Hospital and Shanghai Jiao Tong University School of Medicine [1]. - The results from this trial, along with a pharmacokinetic study in healthy volunteers, will bridge foreign clinical trial data and support the application for Vaborem®'s market approval in China [1]. Group 2: Drug Composition and Mechanism - Vaborem® is a fixed-dose combination of a carbapenem antibiotic and a novel boronic acid β-lactamase inhibitor, designed to inhibit various classes of β-lactamases, thereby restoring the activity of meropenem against carbapenem-resistant Enterobacteriaceae (CRE) [1]. - The drug specifically targets common carbapenemase-producing Klebsiella pneumoniae (KPC) bacteria, which are known for their resistance [1]. Group 3: Regulatory and Commercialization Aspects - The clinical trial application for Vaborem® was approved by the National Medical Products Administration (NMPA) of China in March 2023, with the first subject enrolled in July 2023 [1]. - The company has an exclusive development and commercialization agreement for Vaborem® in China, established in August 2022 with Melinta Therapeutics, Inc. [1].
赛生药业(06600)：Vaborem®在中国的III期临床试验完成全部受试者入组