Core Viewpoint - Cumberland Pharmaceuticals and SciClone Pharmaceuticals announced the NMPA approval of Vibativ® (telavancin) in China, enabling its launch in a significant market for treating pneumonia and serious skin infections [1][4]. Company Overview - Cumberland Pharmaceuticals is focused on developing and commercializing unique products to improve patient care, with a portfolio that includes six FDA-approved brands [15][16]. - SciClone Pharmaceuticals is a global biopharmaceutical company dedicated to innovative therapies for cancer and severe infections, emphasizing a strategic transformation towards differentiated product offerings [12][13]. Product Details - Vibativ is an FDA-approved injectable antibiotic effective against hospital-acquired and ventilator-associated pneumonia caused by multidrug-resistant Gram-positive bacteria, including MRSA [2][6]. - The drug is administered once daily and does not require therapeutic drug monitoring, which reduces healthcare professionals' exposure to patients [2][5]. - Vibativ has demonstrated consistent efficacy against difficult-to-treat bacteria over the past decade, maintaining its potency against multidrug-resistant strains [3][9]. Clinical Evidence - Studies involving over 24,000 clinical isolates show Vibativ's effectiveness against challenging Gram-positive infections, with higher cure rates compared to vancomycin [3][9]. - Recent research published in Antimicrobial Agents and Chemotherapy indicates that Vibativ is safe for use in children aged 2 to 17, with reduced exposure compared to adults [10]. Market Strategy - SciClone has secured exclusive rights to register, promote, and distribute Vibativ in China, leveraging its strong distribution network to maximize patient access [1][4]. - The companies plan to launch Vibativ in China later in 2025, aiming to address the needs of patients with serious infections [4].
VIBATIV® RECEIVES MARKETING APPROVAL IN CHINA