GUANGZHOU, July 5^th, 2024 -- MingMed Biotechnology Co., Ltd today announced that its subsidiary, Claruvis Pharmaceutical, has obtained approval from the Center for Drug Evaluation (CDE) on July 2^nd, 2024, to initiate a groundbreaking clinical trial of YY001-002. This pioneering study aims to evaluate the efficacy of Claruvis Pharmaceutical’s recombinant Botulinum Toxin Type A product in the treatment of adult upper limb muscle spasm, marking a significant milestone as the world’s first clinical trial utilizing recombinant Botulinum Toxin Type A for therapeutic purposes.

Claruvis Pharmaceutical has  developed a revolutionary method to produce recombinant Botulinum Toxin Type A, eliminating the biosafety risks associated with the traditional extraction of Botulinum Toxin from Clustridium Botulinum, while maintaining the protein's activity. The production process incorporates an innovative triple filtration technology, ensuring high purity, exceptional specific activity and a remarkable response rate. YY001 represents the next-generation Botulinum Toxin, setting new industry standards. Claruvis Pharmaceutical has already completed the last patient out (LPO) for the Phase III clinical study of its recombinant Botulinum Toxin Type A product (YY001-001), focusing on improving glabellar lines for aesthetic indications.

Dr. Wu Yang, Chief Scientific Officer of Claruvis Pharmaceutical, commented, "All YY001 products are manufactured within Claruvis Pharmaceutical’s own state-of-the-art GMP facility. Our research team has achieved significant technological breakthroughs in critical production processes, including plasmid construction, cell expansion, precise activation, and efficient purification. This has allowed us to establish high-standard production lines, setting a new benchmark for the manufacturing of recombinant Botulinum Toxin products."

Mr. Aiken Liu, Chairman and CEO of Claruvis Pharmaceutical, stated, "The approval of YY001-002 clinical trial  represents a major milestone for Claruvis Pharmaceutical in the field of recombinant Botulinum Toxin application in the therapeutic area. Our vision has always been to utilize innovative technology to develop high-quality drugs that enhance patients' well-being. The therapeutic application of recombinant Botulinum Toxin  also represents an immense commercial opportunity. We are excited to expand our reach and serve a wider patient populatin with our pioneering recombinant Botulinum Toxin Type A!"

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 ophthalmic drugs, recombinant botulinum toxin, immuno-oncology drugs and pet immune drugs. Our product pipelines include a number of first-in-class drug candidates, and all of our major products are at clinical stage. 

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. Our 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 self-developed R&D platform. Excellent operational capability supported by globally competitive R&D platform will continue to drive Claruvis' innovation and fast development in rBoNT area to address the huge unmet aesthetic and therapeutic medical needs globally.