Cumberland Pharmaceuticals Inc. (CPIX) and SciClone Pharmaceuticals (Holdings) Limited, on Tuesday announced that Vibativ or telavancin injection has received approval from China's National Medical Products Administration or NMPA.
This approval follows an agreement granting SciClone exclusive rights to register, promote, and distribute the antibiotic in China.
Vibativ is an FDA-approved, life-saving antibiotic used to treat hospital-acquired and ventilator-associated pneumonia and complicated skin and skin structure infections or cSSSI caused by Gram-positive bacteria, including multidrug-resistant strains like MRSA. The drug generated net revenue of $8.8 million in 2023.
The approval in China opens the door for Vibativ's availability in the world's second-largest pharmaceutical market, offering hope to patients with difficult-to-treat infections.
SciClone Pharmaceuticals' Executive Director and CEO, Zhao Hong, stated, "Vibativ's life-saving potential for patients with serious infections makes it an important addition to our portfolio, and we look forward to making it available to patients in China."
Vibativ's proven efficacy and in vitro potency against resistant bacteria make it a key treatment for addressing the growing issue of drug-resistant infections.
Cumberland Pharmaceuticals plans to launch Vibativ in China later this year with SciClone leading distribution efforts.
CPIX closed Friday's (Feb.14 2025) trading at $5.15 up by 10.99%. In premarket trading Tuesday the stock is down by 2.35% at $5.03.
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