FDA Approves First Liquid Form of Recombinant Botulinum Toxin Type A

CHONGQING, China, Sept. 25, 2024 /PRNewswire/ -- MingMed Biotechnology, a pioneering company in drug discovery and development, has announced a significant milestone for its subsidiary, Claruvis Pharmaceutical Co. The U.S. Food and Drug Administration (FDA) has approved Claruvis's Investigational New Drug (IND) application for YY003, the world's first liquid formulation of recombinant Botulinum Neurotoxin Type A (BoNT/A), designed for glabellar lines treatment and packaged in a pre-filled syringe.

Dr. Wu Yang, Chief Scientific Officer of Claruvis, expressed enthusiasm over the FDA's approval for YY003 to proceed into clinical development. He highlighted the advantages of the liquid-formulated recombinant BoNT/A, which integrates a super-pure, highly effective product with a user-friendly design, offering a safer and more convenient option for consumers. Dr. Yang, who has over two decades of expertise in botulinum toxin research, underscored the innovative nature of this development.

Claruvis Pharmaceutical stands out as one of China's leading biotech companies focusing on botulinum toxin products. The company has progressed significantly, having developed the first recombinant BoNT/A product to enter clinical trials. It recently completed a Phase III clinical trial for treating moderate to severe glabellar lines, meeting all the study endpoints. The success of this trial, demonstrated through its efficacy, safety, and immunogenicity profiles, marks a significant achievement in the cosmetic application of botulinum toxins.

Additionally, on September 14th, Claruvis dosed the first patient in a Phase II clinical trial for treating adult upper arm spasm in China, setting a record for using recombinant BoNT/A for therapeutic purposes. The company has initiated its first Biologics License Application (BLA) in China, supported by robust Phase I, II, and III clinical results.

Dr. Yang emphasized the importance of the FDA's approval for YY003, viewing it as a crucial step toward introducing a high-quality product in the botulinum toxin market.

About MingMed
MingMed Biotechnology Co., Ltd. is an innovative company dedicated to discovering and developing novel drugs that address significant unmet medical needs globally. The company's research and development team comprises world-renowned scientists and specialists. Through its robust R&D capabilities and efficient operations, MingMed has created an internally developed product portfolio that spans four major therapeutic areas: recombinant botulinum toxin, ophthalmic drugs, immuno-oncology drugs, and pet immune drugs. Its product pipelines feature numerous first-in-class drug candidates, with several major products advancing toward commercialization.

About Claruvis Pharmaceutical
Claruvis, a subsidiary of MingMed Biotechnology, focuses on developing, producing, and commercializing botulinum toxin products using recombinant protein technology. The research and development team at Claruvis includes top global scientists and senior American Chinese scholars with extensive knowledge and experience in botulinum toxin products. Claruvis has pioneered the development of the world's first recombinant type A BoNT product on its self-developed R&D platform. The company’s operational excellence, bolstered by a globally competitive R&D platform, will continue to drive innovation and rapid development in the recombinant BoNT field, addressing numerous unmet aesthetic and therapeutic medical needs worldwide.