Home Rayans Pharma's Recombinant Botulinum Toxin Type A Receives CDE Approval for First Therapeutic Indication – Adult Upper Limb Spasticity

Rayans Pharma's Recombinant Botulinum Toxin Type A Receives CDE Approval for First Therapeutic Indication – Adult Upper Limb Spasticity

Jul 12, 2024 11:23 CST Updated 11:24
MingMed

Innovative Drug Developer

MingMed Biotechnology Co., Ltd. (hereinafter referred to as "MingMed") announced that the first medical indication YY001-002 - adult upper limb muscle spasticity of its self-developed recombinant botulinum toxin type A for injection with global intellectual property rights, developed by its holding company Chongqing Yuyan Pharmaceutical Co., Ltd. (hereinafter referred to as "Yuyan Pharmaceutical"), was approved by the National Medical Products Administration on July 2.ManagementThe Center for Drug Evaluation (CDE) has approved the initiation of clinical trials. This marks an important milestone as the world's first application of recombinant Botulinum Toxin Type A in the medical field.

Chongqing Yuyan Pharmaceutical Co., Ltd.'s Recombinant Type A Botulinum Toxin, while maintaining protein activity, avoids the biosafety risks associated with traditional production methods of botulinum toxin. Combined with its innovative triple-filtration technology, the developed botulinum toxin boasts high purity, high specific activity, and a significantly improved response rate, being regarded by the industry as a new generation of botulinum toxin. As the world’s first innovative pharmaceutical company to apply recombinant Type A botulinum toxin in human clinical research, all subjects in the Phase III clinical trial of YY001-001 – for the treatment of moderate to severe glabellar lines – have now completed the study.

Dr. Yang Wu, Chief Scientific Officer of Chongqing Yuyan Pharmaceutical Co., Ltd., introduced: "The drugs used in this clinical trial were all produced by the GMP facility of Chongqing Yuyan Pharmaceutical Co., Ltd. The team has expertise in plasmid construction, bacterial expansion,Precision"Significant technological breakthroughs have been achieved in key areas such as activation and highly efficient purification, establishing the world's first international high-standard recombinant protein botulinum toxin production line."

Liu Miao, Chairman and CEO of Yuyan Pharmaceutical, stated, "The clinical approval of YY001-002 marks an important scientific breakthrough for Yuyan Pharmaceutical in the field of serious medical treatment. Developing high-quality drugs through innovative technology to serve patients' health has always been the original aspiration of Yuyan Pharmaceutical since its establishment. The application of recombinant botulinum toxin products in the medical field is still a vast blue ocean with tremendous commercial value. We look forward to Yuyan’s recombinant Type A botulinum toxin serving a wide range of patients more quickly!"

About MingMed

MingMed Biotechnology Co., Ltd. is a Chinese enterprise focused on the independent research and development of innovative drugs with global competitiveness. The company has a research and development team led by several world-renowned scientists and experts. With our strong R&D capabilities and highly efficient operational abilities, we have independently developed a diversified and synergistic product pipeline, including recombinant protein botulinum toxin, pet-related products, and more.ImmunityDrugs, Ophthalmic Drugs andTumor ImmunologyDrugs, including multiple potential first-in-class innovative drugs, and all major products have entered the clinical stage.

About Chongqing Yuyan Pharmaceutical Co., Ltd.

Chongqing Yuyan Pharmaceutical Co., Ltd. is a pharmaceutical enterprise held by MingMed, dedicated to the research, development, production, and commercialization of botulinum toxin using recombinant protein technology. It has a scientific research team composed of internationally renowned scientists in the field of botulinum toxin basic research and senior Chinese-American scholars with extensive experience in botulinum toxin drug development. The company has established a series of recombinant protein drug research and development platforms and successfully developed the world's first recombinant type A botulinum toxin. Outstanding operational capabilities and a globally competitive R&D platform will continue to empower Chongqing Yuyan Pharmaceutical Co., Ltd. to achieve continuous innovation and efficient development in the botulinum toxin field, replacing imported products with higher-quality domestic alternatives and contributing to the health and beauty of the Chinese people.