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Chongqing Claruvis Pharmaceutical, a subsidiary of MingMed Biotechnology, has 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.
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.
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.
