The neurotoxin, developed by Claruvis Pharmaceutical, uses a precision-engineered recombinant manufacturing process for botulinum toxin type A.
China’s National Medical Products Administration has approved Retoxin (recombinant botulinum toxin type A) for the temporary improvement of moderate-to-severe glabellar lines in adults, according to manufacturer Claruvis Pharmaceutical.
In a company release, Claruvis states that Retoxin is the world’s first approved recombinant botulinum toxin type A, representing a technological shift from traditional products derived from Clostridium botulinum extraction to a recombinant manufacturing process.
Developed with a proprietary recombinant platform, the process preserves the active 150kDA neurotoxin structure while eliminating biosafety risks associated with traditional production methods, delivering a product with high purity and high specific activity, according to the company.
The approval was supported by a randomized, double-blind, placebo- and active-controlled multicenter phase III clinical trial conducted in China. The company release notes that the study met all primary and secondary endpoints, showing efficacy, a favorable safety profile, and low immunogenicity.
“Retoxin represents the first commercial milestone from our recombinant platform and validates our vision of developing next-generation botulinum neurotoxins with improved purity, consistency, and safety,” says Dr Yang, chief scientific officer of Claruvis Pharmaceutical, in a release. “We are building a robust pipeline of recombinant products to address a broad range of neurological and aesthetic indications.”
Mr Liu, chairman and CEO of Claruvis Pharmaceutical, adds, “This approval in China is an important step forward. We remain committed to advancing our innovative recombinant botulinum toxin portfolio and bringing treatment options to patients and clinicians worldwide,” in a release.
Claruvis is also advancing Retoxin for therapeutic applications, including the treatment of adult upper limb spasticity. The company has completed a phase II clinical trial and is currently enrolling patients in a multicenter phase III program across more than 20 sites in China.
