Cumberland Pharmaceuticals and SciClone Pharmaceuticals have received China’s National Medical Products Administration (NMPA) approval for Vibativ (telavancin) injection.
The announcement follows an agreement between both firms granting SciClone exclusive rights to register, promote, and distribute Vibativ in China.
Vibativ is a US Food and Drug Administration (FDA)-approved injectable anti-infective for hospital-acquired and ventilator-associated pneumonia, treating a range of Gram-positive bacteria, including multidrug-resistant strains.
It is also used for complicated skin infections, like Methicillin-resistant Staphylococcus aureus (MRSA).
With once-daily dosing and no need for therapeutic drug monitoring, Vibativ reduces healthcare professionals’ exposure to patients.
SciClone and Cumberland plan to launch telavancin in China later this year.
SciClone Pharmaceuticals president, CEO and executive director Zhao Hong said: “Vibativ’s life-saving potential for patients with certain difficult-to-treat infections makes it an important addition to our portfolio and supports our mission to provide quality medical products that improve patient care.”
Unlike many new antibiotics losing effectiveness against drug-resistant bacteria, telavancin was designed to combat these tough pathogens.
According to Cumberland Pharmaceuticals, two studies, testing over 24,000 and 15,000 clinical isolates, confirm Vibativ’s continued potency against multidrug-resistant bacteria, even after more than 10 years since its introduction.
The drug has also proven efficacy against difficult-to-treat Gram-positive infections, demonstrated in large multinational studies.
These studies showed significantly higher cure rates for Vibativ compared to vancomycin in treating HABP/VABP caused by Gram-positive pathogens or S. aureus with vancomycin MIC ≥1 µg/mL.
Extensive evidence supports Vibativ’s in vitro potency and in vivo activity against multidrug-resistant Gram-positive bacteria.
In October 2023, a study showed telavancin is safe for children aged 2-17, with reduced exposure compared to adults.
Cumberland Pharmaceuticals CEO A.J. Kazimi said: “SciClone has a strong distribution network throughout China, and we are proud to partner with them to introduce Vibativ for the benefit of patients in their market.”
Cumberland Pharmaceuticals, a biopharmaceutical company based in Tennessee, develops, acquires, and commercialises treatments for hospital acute care, gastroenterology, and oncology markets.
Its portfolio includes six FDA-approved brands, along with ongoing Phase 2 clinical programmes evaluating its ifetroban product candidate for cardiomyopathy in Duchenne muscular dystrophy (DMD), Systemic Sclerosis, and Idiopathic Pulmonary Fibrosis.
In November 2024, the biopharmaceutical company was granted FDA Orphan Drug Designation and Rare Pediatric Disease Designation for Ifetroban to treat cardiomyopathy associated with DMD.
