Guangdong Medical Valley Park Enterprise - MingMed Biotechnology Co., Ltd. (hereinafter referred to as "MingMed") announced that its holding company, Chongqing Yuyan Pharmaceutical Co., Ltd. (hereinafter referred to as "Yuyan Pharmaceutical"), has successfully completed its independent innovation research.Phase III Clinical Study (Code: YY001-001) for the Treatment of Moderate to Severe Glabellar Lines with Recombinant Botulinum Toxin Type A for Injection, which was Developed and Holds Global Intellectual Property RightsOn September 12, a clinical summary meeting was jointly organized by 16 research centers. The data disclosed at the meeting showed that YY001 demonstrated a high degree of consistency with the completed Phase I/II clinical results in the large-scale population Phase III clinical trial; its efficacy, safety, and immunogenicity all reached the pre-established clinical endpoints, outperforming the control drug. The success of Chongqing Yuyan Pharmaceutical Co., Ltd.'s recombinant Type A botulinum toxin Phase III clinical trial marks an important milestone in the global botulinum toxin field, transitioning from natural botulinum toxin to recombinant botulinum toxin.Chongqing Yuyan Pharmaceutical Co., Ltd.'s Recombinant Type A Botulinum Toxin, while maintaining protein activity, avoids the biosafety risks associated with traditional production methods using Clostridium botulinum. 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 complete Phase III clinical trials for recombinant Type A botulinum toxin, its clinical study (code name YY001-002) for treating upper limb muscle spasticity in adults was also approved by the CDE in July this year and has begun enrolling participants. The initiation of the YY001-002 clinical trial marks another global first for Chongqing Yuyan Pharmaceutical Co., Ltd. in applying recombinant Type A botulinum toxin in the medical field.
Regarding the Phase III clinical results, Dr. Wu Yang, Chief Scientific Officer of Yuyan Pharmaceutical, stated: "The new technological approach for recombinant Type A botulinum toxin represents a significant transformation from the traditional botulinum fermentation process for producing botulinum toxin. The outstanding performance of Yuyan Pharmaceutical's first recombinant botulinum toxin product, YY001, in Phase I/II and particularly in the confirmatory Phase III clinical trials, validates the advantages of recombinant bioengineering technology. This new scientific achievement is the culmination of decades of R&D experience accumulated by Yuyan Pharmaceutical’s expert team in the field of botulinum toxin research, as well as the capabilities, wisdom, and hard work of the company’s teams spanning management, production, quality control, and clinical operations. All drugs used in the Phase III clinical trial were produced on Yuyan Pharmaceutical’s global-first international high-standard recombinant botulinum toxin production line. Successfully developing and manufacturing such a high-quality innovative product fills us, the entrepreneurs, with pride and satisfaction." Liu Miao, Chairman and CEO of Yuyan Pharmaceutical, stated, "Following the completion of the YY001-001 Phase III clinical trial, we will soon enter the new drug registration phase. The company will do everything in its power to bring this innovative, highly effective, and safer high-quality product to market as soon as possible. At the same time, we will fully commit ourselves to advancing the clinical research of our recombinant botulinum toxin products in the medical field, quickly bringing Yuyan Pharmaceutical's premium recombinant Type A botulinum toxin products to the two key markets of medical aesthetics and healthcare!"
On September 14, the world's first subject in the Phase II clinical trial of recombinant botulinum toxin type A, independently developed by Chongqing Yuyan Pharmaceutical Co., Ltd. with global intellectual property rights for the treatment of upper limb muscle spasticity in adults, was successfully enrolled at Yangzhi Rehabilitation Hospital (Shanghai Sunshine Rehabilitation Center) affiliated to Tongji University., and the injection treatment was successfully completed by Professor Jin Lingjing, the principal investigator of the center.
Professor JinWorld's First Subject Receives InjectionChongqing Yuyan Pharmaceutical Co., Ltd.'s Recombinant Type A Botulinum Toxin: Without Altering Protein Activity, It Avoids Biosafety Risks Associated with Traditional Production Methods Using Clostridium Botulinum. Combined with Its Innovatively Designed Triple Filtration Technology, the Developed Botulinum Toxin Exhibits High Purity, High Specific Activity, and Significant Reactivity, Being Regarded as a New Generation of Botulinum Toxin in the Industry.
Phase II Clinical Trial of Recombinant Botulinum Toxin Type A for the Treatment of Upper Limb Muscle Spasticity in Adults, led by Professor Xinhua Wan from the Department of Neurology at Peking Union Medical College Hospital and involving nearly 20 research centers across China, is a nationwide double-blind, randomized, multicenter clinical study. This marks the first application of the world's first recombinant botulinum toxin type A in the medical field. The successful enrollment of the first participant represents an important milestone in the development progress of the recombinant botulinum toxin. Chongqing Yuyan Pharmaceutical Co., Ltd. will continue to fully advance the clinical research of this product, striving to provide more and better treatment options for clinical patients as soon as possible.
MingMed Biotechnology Co., Ltd. is a Chinese enterprise focused on the independent research and development of innovative drugs, possessing 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 botulinum toxin, ophthalmic drugs, cancer immunotherapy drugs, and pet immunotherapy drugs. Among these are multiple potential first-in-class innovative drugs, with key products already entering the commercialization stage.About Chongqing Yuyan Pharmaceutical Co., Ltd.Chongqing Yuyan Pharmaceutical Co., Ltd. is a pharmaceutical company held by MingMed Biotechnology Co., Ltd., which is 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. Excellent 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, realizing import substitution with higher-quality products and contributing to the health and beauty of the Chinese people.
