Yuyan Pharma's Recombinant Botulinum Toxin Type A (YY001-002) Becomes World’s First to Enter Clinical Trials for Medical Indication – Upper Limb Spasticity in Adults

Jul 24, 2024 17:10 CST Updated 17:10

MingMed

Innovative Drug Developer

Source of the article: Tan Mei Medical World

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Recently,MingMed Biotechnology Co., Ltd.(Abbreviation: "MingMed"") announced that its holding companyChongqing Yuyan Pharmaceutical Co., Ltd.(abbreviation: "Yuyan Pharmaceutical") independently developed, with global intellectual property rightsInjectable RecombinantType A Botulinum Toxin YY001-002 TheThe FirstIndications in the Medical Field——Adult Upper Limb Muscle SpasmsAlready obtainedApproved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA)Approval to Conduct Clinical Trials. This isFor the First Time GloballyApplication of Recombinant Botulinum Toxin Type A in the Medical Field。

Chief Scientific Officer of Chongqing Yuyan Pharmaceutical Co., Ltd.Dr. Yang WuIndicates that all clinical drugs this time are GMP-certified.Factory production: The company has achieved comprehensive technical breakthroughs in key areas such as plasmid construction, bacterial expansion, precise activation, and efficient purification.Built the world's first international high-standard production line。

Chairman and CEOLiu MiaoIt is emphasized that the clinical approval of YY001-002 represents a significant scientific breakthrough for Chongqing Yuyan Pharmaceutical Co., Ltd. in the field of serious medical treatment, and it is expected that this product will quickly serve a wide range of patients.

Chongqing Yuyan Pharmaceutical Co., Ltd. asThe World's FirstThe application of recombinant botulinum toxin type A toClinical Research in HumansAn innovative pharmaceutical company, its indication YY001-001 in the medical aesthetics field is used for "improving moderate to severe glabellar lines."All subjects in the Phase III clinical trial have been enrolled.Out of Group。Huadong MedicineMingMed Biotechnology Co., Ltd. and Chongqing Yuyan Pharmaceutical Co., Ltd. have the recombinant botulinum toxin type A product YY001 in the medical aesthetics indications field for mainland China, Hong Kong Special Administrative Region, and Macao Special Administrative Region.Exclusive commercialization rights, along with multiple preferential options。

# Product Introduction

YY001 is produced byNovel Recombinant Protein Production PathwayBotulinum toxin produced, aimed at addressing issues from the hostBotulinum ToxinBiosafety Issues in the Extraction of Natural Botulinum Toxin. The product hasHigh purity, good safety, and production scalabilityAmong various advantages. MingMed believes that the high purity of YY001 reduces the risk of immunogenicity associated with the introduction of exogenous proteins into the human body and can enhance the overall safety of YY001 administration.

According to the company's official website, the innovatively designed recombinant Type A botulinum toxin expresses similarities with natural Type A botulinum toxin.High-purity toxin protein with identical structure，The overall spatial structure is highly similar, with the distribution of the three functional areas being consistent.(The figure below) simultaneously meets the requirements for improving purity and ensuring safe production. High purity ensures that the recombinant protein hasHigh protein-specific activity,Less protein is used in clinical treatment, making it safer.; Preclinical pharmacodynamics and toxicology studies have validated the efficacy of the recombinant protein and provided comprehensive safety data.。

These studies supported the design of the YY001 clinical trial protocol in terms of safety and efficacy. The expression platform constructed through the recombinant botulinum toxin type A protein project,ForThe development of other types of botulinum toxins and chimeric botulinum toxins has laid an important foundation.。

In short,Recombinant Botulinum Toxin Type AYY001Without altering protein activity, it avoids the biosafety risks associated with traditional production methods of botulinum toxin, while incorporating its innovative triple filtration technology.The botulinum toxin developed has high purity, high specific activity, and a significantly improved response rate., regarded as a new generation of botulinum toxin in the industry.

# Product Market

Currently, botulinum toxin drugs approved by the pharmaceutical regulatory authority in ChinaOnly four products，Imported products from the United StatesBotox, Independently Developed Products in Lanzhou, ChinaHengli、British Royal Long-Lasting Botulinum ToxinJisuitAnd Korean lightweight luxury botulinum toxinLetibao。

In China,Botulinum toxin has a huge market size and is expected to maintain a rapid growth pace in the future.According to Frost & Sullivan, the market size of botulinum toxin products in China increased from RMB 19 billion in 2017 to RMB 46 billion in 2021, with a compound annual growth rate of 25.6%.The market size is expected to reach RMB 12.6 billion and RMB 39 billion in 2025 and 2030, respectively.

Not only is the market broad, but the application scope of botulinum toxin is equally vast.Can Achieve Dual Applications in Medicine + AestheticsBotulinum toxin was first approved by the FDA for the clinical treatment of strabismus and has now been widely used in clinical treatment fields such as neurology, rehabilitation, and urology. In China, with the extensive clinical application of botulinum toxin,Its range of applications and indications is also being gradually developed, expanding into other medical applications.. However, there are currently no recombinant Type A botulinum toxin products for medical use that have entered the clinical stage globally.YY001 isWorld's First Clinical Approval for Medical IndicationRecombinant Botulinum Toxin Type A, occupying a certain first-mover advantage。

November 14, 2023Huadong Medicine Announces the Introduction of YY001, reaching a long-term strategic cooperation with Chongqing Yuyan, and gaining priority rights in multiple matters. Sinclair Aesthetics, a wholly-owned subsidiary of Huadong Medicine, invested RMB 150 million to increase the capital of Chongqing Yuyan Pharmaceutical Co., Ltd. After the transaction, Sinclair Aesthetics will hold 4.2857% of Chongqing Yuyan's equity.

At the same time, Huadong Medicine acquired Chongqing Yuyan Pharmaceutical Co., Ltd.Recombinant Botulinum Toxin Type A YY001 ProductIn the medical aesthetics indications field in mainland China, Hong Kong Special Administrative Region, and Macao Special Administrative RegionExclusive Commercialization Rights. Meanwhile,Huadong Medicine also enjoys the following mattersRight of First Refusal: Development and commercialization rights of the product outside the authorized region;And has the right of first negotiation for the following matters: Any form of cooperation for other products with recombinant botulinum toxin type A YY001 as the active ingredient, including but not limited to development, registration, and commercialization rights; as well as promotional and sales cooperation for the product in indications beyond medical aesthetics.

# About MingMed

MingMed was founded in 2019 as a Chinese enterprise focused on independent innovation and the development of globally competitive drugs. The company has a research and development team composed of numerous top scientists and experts, as well as a scientific committee made up of globally influential scientists.Ophthalmic drugs, recombinant protein botulinum toxins, small molecule immunotherapeutics, and cell therapy fieldsThe company has more than ten products under development, the vast majority of which are breakthrough First-in-Class innovative drugs, and the main products have entered the clinical stage.。

# AboutChongqing Yuyan Pharmaceutical Co., Ltd.

Chongqing Yuyan Pharmaceutical Co., Ltd. was established in 2020 as a company controlled by MingMed Biotechnology Co., Ltd., and is committed toDeveloped and produced using recombinant protein technologyCommercialized Botulinum Toxin's pharmaceutical enterprises. 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. They have established a series of recombinant protein drug development platforms and successfully developedWorld's First Recombinant Botulinum Toxin Type A。

The company has currently built a production base of approximately12,000 square metersAt the same time, it plans to invest 1 billion yuan in the next five years to build Yuyan Pharmaceutical's global R&D center and industrialization base, fully demonstrating the company's "innovation capabilities" and "scientific confidence," breaking foreign monopolies, achieving import substitution, and promoting the development of Chongqing's large health industry cluster.

Editor-in-Chief | Zhao Qing Reviewed by | Yi He