Breakthrough approval marks a shift to precision engineered neurotoxins, offering improved safety, purity, and clinical performance for aesthetic and therapeutic applications
Chongqing Claruvis Pharmaceutical Co., Ltd. recently announced that the China’s National Medical Products Administration (NMPA) has approved its Retoxin® (recombinant botulinum toxin type A, project code YY001) for the temporary improvement of moderate-to-severe glabellar lines in adult patients.
Retoxin® is the world’s first approved recombinant botulinum toxin type A, marking a significant technological shift from traditional botulinum toxin products derived from Clostridium botulinum extraction to a precision-engineered recombinant manufacturing process.
From Natural Extraction to Precision Genetic Engineering
Developed using Claruvis Pharmaceutical’s proprietary recombinant platform and manufacturing system, Retoxin® preserves the active protein molecular structure (the core 150kDA neurotoxin structure) while eliminating the biosafety risks associated with the traditional Clostridium botulinum-derived production, and delivers a toxin with high purity and high specific activity.
In a pivotal randomized, double-blind, placebo- and active-controlled multicenter Phase III clinical trial conducted in China, Retoxin® met all primary and secondary endpoints. The study demonstrated superior efficacy, favorable safety profile, and low immunogenicity, highlighting the potential advantages of recombinant technology in both aesthetic and therapeutic applications of botulinum neurotoxins.
Advancing Therapeutic Applications
Claruvis Pharmaceutical is also advancing Retoxin® for the treatment of adult upper limb spasticity secondary to stroke or traumatic brain injury. The company has successfully completed Phase II clinical trial in China, and is currently enrolling patients in a multicenter Phase III program across more than 20 clinical sites in China. With its quality advantages, Retoxin® aims to offer a safer, more effective treatment option for patients suffering from debilitating spasticity.
A New Era of in Botulinum Neurotoxin Therapy
“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,” said Dr. Yang, Chief Scientific Officer of Claruvis Pharmaceutical. “We are building a robust pipeline of recombinant products to address a broad range of neurological and aestheticindications.”
Mr. Liu, Chairman and CEO of Claruvis Pharmaceutical, added, “This approval in China is an important step forward. We remain committed to advancing our innovative recombinant botulinum toxin portfolio and bringing breakthrough treatment options to patients and clinicians worldwide.”