#China #Chongqing #Botulinum Toxin #Claruvis #Retoxin

Claruvis Pharmaceutical Launches Retoxin® in China

In an exciting development for the biopharmaceutical sector, Claruvis Pharmaceutical Co., Ltd. has received marketing approval from China's National Medical Products Administration (NMPA) for its innovative drug, Retoxin® (recombinant botulinum toxin type A). This marks a landmark moment in pharmaceutical history as Retoxin® becomes the first approved recombinant botulinum toxin globally, shifting the paradigm from conventional toxin products derived from Clostridium botulinum to a cutting-edge recombinant manufacturing method.

Transition from Natural Extraction to Recombinant Technology

Retoxin® showcases a significant advancement in safety and efficacy. Developed through Claruvis’ proprietary recombinant platform, the drug maintains the crucial neurotoxin structure while mitigating the biosafety risks associated with traditionally extracted botulinum toxins. By employing precise genetic engineering, the production of Retoxin® results in a toxin of high purity and specific activity, making it a safer alternative for patients.

In a pivotal Phase III clinical trial, conducted across multiple centers in China, Retoxin® demonstrated exceptional performance, fulfilling all primary and secondary endpoints. With impressive efficacy, a favorable safety profile, and notably low immunogenicity, the clinical results illuminate the potential of recombinant technology to enhance both aesthetic and therapeutic applications of botulinum neurotoxins.

Expanding Therapeutic Applications

The innovations do not stop with aesthetic applications. Claruvis is furthering the potential of Retoxin® for treating conditions such as adult upper limb spasticity resulting from stroke or traumatic brain injuries. The company successfully completed a Phase II clinical trial in China and is currently recruiting for a multicenter Phase III trial at over 20 clinical sites nationwide. Through these advancements, Retoxin® is positioned to offer a more effective and safer option for individuals grappling with debilitating spasticity.

A New Era in Botulinum Neurotoxin Therapy

Dr. Yang, Chief Scientific Officer at Claruvis Pharmaceutical, expressed enthusiasm about this achievement, stating, "Retoxin® represents our first commercial milestone from our recombinant platform, validating our vision of creating next-generation botulinum neurotoxins with enhanced purity, consistency, and safety. We aim to build a robust pipeline of recombinant products targeting a wide range of neurological and aesthetic indications."

Similarly, Mr. Liu, the Chairman and CEO of Claruvis, emphasized the importance of this approval, sharing, "This approval in China is a crucial step forward. We are dedicated to advancing our innovative recombinant botulinum toxin portfolio and providing groundbreaking treatment options to patients and healthcare professionals worldwide."

About Claruvis Pharmaceutical

Claruvis Pharmaceutical Co., Ltd., a subsidiary of MingMed Biotechnology, has established itself as a pioneering biopharmaceutical company committed to the research, development, manufacture, and commercialization of recombinant botulinum toxin products. The company’s innovative approach signifies a transition from traditional natural extraction methods to precision recombinant production. Claruvis is driven by the mission of delivering higher quality, safer medicines for various aesthetic and therapeutic uses around the globe.

With the introduction of Retoxin®, the landscape of botulinum neurotoxin therapy is set to change, offering new hope to millions of patients searching for safe and effective treatments.