China-based SciClone Pharmaceuticals Inc. announced that it has received market approval from the National Medical Products Administration (NMPA). The approval allows its Vibativ (telavancin) to treat hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by sensitive isolates of Staphylococcus aureus.
Drug Details
Vibativ is a rapidly bactericidal glycopeptide antibiotic with bactericidal activity against Gram-positive pathogens, including MRSA. It features a unique dual antibacterial mechanism. On one hand, it inhibits bacterial cell wall synthesis. On the other hand, it binds to bacterial cell membranes, interfering with membrane barrier function-a mechanism that vancomycin does not possess. This allows Vibativ to rapidly exert its bactericidal effect. Compared with vancomycin, Vibativ has a longer half-life and only needs to be administered once a day, greatly improving patient compliance and clinical convenience.
Background and Licensing
Originated by US firm Theravance Biopharma Inc. (NASDAQ: TBPH), Vibativ was first approved in the US in 2009. Its indications cover complex skin and soft-tissue infections (cSSTI) caused by Gram-positive bacteria including MRSA, and HABP/VABP caused by susceptible isolates of Staphylococcus aureus. SciClone struck a licensing deal with Theravance in May 2021, obtaining development and commercialization rights to the drug in Greater China and Vietnam.-Fineline Info & Tech
