GENE ONLINE|News &
The World First Liquid Formulation of Recombinant Botulinum Toxin Type A Has Obtained IND Approval by the FDA
MingMed's Claruvis receives FDA approval for YY003, the first liquid recombinant BoNT/A for glabellar lines treatment.
MingMed Biotechnology, an innovative company focused on the in-house discovery and development of novel drugs, recently announced that its partially owned subsidiary, Claruvis Pharmaceutical Co., has received approval from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for YY003, the world’s first liquid formulation of recombinant BoNT/A, packaged in a pre-filled syringe, developed for the treatment of glabellar lines.
“We are thrilled to receive FDA approval to advance the novel liquid formulation of rBoNT/A (YY003) into clinical development. This liquid-formulated recombinant BoNT/A, delivered via a prefilled device, represents a safer and more convenient option for users. The combination of a super-pure, highly effective product and its ease-of-use design offers BoNT/A users an optimized solution,” said Dr. Wu Yang, Chief Scientific Officer of Claruvis, who has over 20 years of experience in botulinum toxin research and development.
Claruvis Pharmaceutical, one of the few pioneering biotech companies in China, has developed the world’s first recombinant BoNT/A product to reach clinical studies. The company recently completed its Phase III clinical trial for treatment of medium to severe glabellar lines and achieved all the study end points. The efficacy, safety and immunogenicity profiles demonstrated in the trial have set a remarkable milestone in the field of cosmetical use of BoNTs. On September 14th, the company has also successfully dosed the first patient in a phase II clinical trial for treatment of adult upper arm spasm in China, setting another new world record utilizing recombinant BoNT/A for the therapeutic indication. The company has started its first Biologics License Application (BLA) in China, backed by a comprehensive set of successful Phase I, II, and III clinical results.
Dr. Yang added, “We believe the FDA’s approval of YY003 for clinical evaluation is a significant milestone towards launching a high-quality product in the Botulinum toxin market.”
About MingMed
MingMed Biotechnology Co., Ltd. is an innovative company dedicated to the in-house discovery and development of novel drugs that address global unmet medical needs. Our R&D team is led by global top-notch scientists and specialists. Leveraging our research and development capabilities and efficient operations, we have built an internally developed product portfolio with a diverse yet synergistic suite of four major therapeutic areas, namely recombinant botulinum toxin, ophthalmic drugs, immuno-oncology drugs and pet immune drugs. Our product pipelines include a number of first-in-class drug candidates, and the major products have moved forward to commercialization.
About Claruvis Pharmaceutical
Claruvis, a non-wholly owned subsidiary of MingMed Biotechnology, is strategically focus on the development, production and commercialization of botulinum toxin products utilizing recombinant protein technology. The R&D team is formed by top-notch global scientists and senior American Chinese scholars with in-depth knowledge and experience in botulinum toxin products. Marking a significant milestone, Claruvis has pioneered the development of the world’s first recombinant type A BoNT product on a self-developed R&D platform. Excellent operational capability supported by a globally competitive R&D platform will continue to drive Claruvis’ innovation and fast development in the rBoNT area to address the vast number of unmet aesthetic and therapeutic medical needs worldwide.
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