#China #Shanghai #Cumberland #Vibativ #SciClone

Vibativ® Receives Regulatory Approval in China

Cumberland Pharmaceuticals Inc. and SciClone Pharmaceuticals have announced a significant advancement in the fight against severe infections. Vibativ® (telavancin), a life-saving antibiotic, has received approval from the National Medical Products Administration (NMPA) in China, signifying a substantial development in the country's healthcare landscape. The approval enables SciClone to register, promote, and distribute Vibativ to patients throughout China, one of the world's largest pharmaceutical markets.

Vibativ is an injectable antibiotic that plays a critical role in treating hospital-acquired and ventilator-associated pneumonia caused by various Gram-positive bacteria, particularly multidrug-resistant strains. Additionally, it is effective in treating complicated skin infections, including those resulting from methicillin-resistant Staphylococcus aureus (MRSA). The drug's unique formulation allows for once-daily dosing, alleviating the need for intensive monitoring by healthcare professionals, thus streamlining patient care.

Over the last decade, increasing rates of antibiotic resistance have made it increasingly challenging to effectively treat infections. Vibativ was specifically designed to tackle this issue. Clinical studies involving tens of thousands of bacterial isolates reveal that it maintains its potency and effectiveness against resistant strains.

Zhao Hong, Executive Director and CEO of SciClone Pharmaceuticals, expressed enthusiasm regarding the impact of Vibativ on patient care: "Vibativ's life-saving potential for patients with difficult-to-treat infections makes it an important addition to our portfolio. We look forward to making this vital treatment available to patients in China."

Cumberland's CEO, A.J. Kazimi, voiced confidence in SciClone's ability to effectively distribute the product: "SciClone has a robust distribution network in China. We are excited about this partnership and are committed to ensuring that Vibativ reaches as many patients as possible."

The collaboration between Cumberland and SciClone aims to launch Vibativ in the Chinese market later this year, further addressing the growing need for effective medical therapies in combating bacterial infections.

About Vibativ®

Vibativ (telavancin) is a lipoglycopeptide antibiotic, offering bactericidal activity that is rapid and effective against Gram-positive bacterial pathogens, including drug-resistant strains. The drug has demonstrated significant success rates in treating patients with infections despite the challenges posed by resistant bacteria. Its use extends to cases complicated by concurrent bacteremia, making it a versatile tool in antibiotic therapy.

Recent research published in Antimicrobial Agents and Chemotherapy has established a safety profile for Vibativ in pediatric patients, adding further importance to the drug's capabilities and potential applications. Vibativ is currently approved in the U.S., China, and the Middle East, and has been instrumental in advancing treatment for challenging infections.

About SciClone Pharmaceuticals

SciClone Pharmaceuticals is a global biopharmaceutical company dedicated to developing and commercializing innovative therapies. Its strategic transformation aims to establish a product portfolio enriched with first-in-class offerings, particularly in the areas of cancer and severe infections. With a mission of improving health through high-quality care products and services, SciClone remains committed to enhancing patient outcomes.

For further details about SciClone, visit www.sciclone.com.

About Cumberland Pharmaceuticals

Cumberland Pharmaceuticals, headquartered in Tennessee, focuses on developing and marketing unique medical products that significantly improve patient care quality. Their portfolio includes six FDA-approved brands, and the firm continues to innovate with ongoing clinical programs aimed at addressing various medical conditions.

For more information about Cumberland's approved products, visit www.cumberlandpharma.com.