Global First! Innostat Bio's Recombinant Botulinum Toxin Type A Receives NMPA Filing Acceptance

Dec 31, 2024 16:49 CST Updated 16:49

MingMed

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On December 31, 2024, 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"), had independently developed and owned the global intellectual property rights for injectableMingMed's Recombinant Botulinum Toxin Type A YY001 Accepted by China's National Medical Products Administration for Marketing Authorization Application to Improve Moderate to Severe Glabellar Lines, marking that the world's first recombinant Type A botulinum toxin in the botulinum toxin field has officially entered the approval process for registration application.

Yifeng Capital's Kang Fund participated in MingMed's A+ round financing in 2021.

Basic Information of the Drug‍

Product Name:Injectable Recombinant Botulinum Toxin Type A

Application Items:Marketing Authorization for Domestically Produced Drugs

Indication for Application:Temporary improvement of moderate to severe glabellar lines in adults 65 years and younger caused by the activity of the corrugator and/or procerus muscles.

Applicant:Chongqing Yuyan Pharmaceutical Co., Ltd.

Application Number:CXSS2400144

About Recombinant Botulinum Toxin Type A YY001

Recombinant Botulinum Toxin Type A YY001 is the world's first and currently the only recombinant botulinum toxin type A product that has submitted an application for market approval.YY001 avoids the biosafety risks associated with traditional production methods using botulinum bacteria to produce botulinum toxin, without compromising protein activity. Through an entirely innovative manufacturing process, the recombinant botulinum toxin produced boasts high purity, high specific activity, and low immunogenicity, and is regarded as a new generation of botulinum toxin within the industry. Building on its application in medical aesthetics, YY001’s clinical research (codenamed YY001-002) for treating upper limb muscle spasticity in adults entered Phase II clinical trials in China in July 2024. This marks the world’s first application of recombinant Type A botulinum toxin in the medical field.

The acceptance of YY001's marketing application marks another significant milestone for Yuyan Pharmaceutical. Dr. Yang Wu, Chief Scientific Officer, noted: "As a major breakthrough in the traditional botulinum toxin production process via fermentation of Clostridium botulinum, the outstanding performance of Yuyan Pharmaceutical’s first recombinant Type A botulinum toxin product, YY001, in Phase III clinical trials demonstrates the success of recombinant botulinum toxin technology. Moreover, the world's first internationally high-standard recombinant botulinum toxin production line independently built by Yuyan Pharmaceutical provides strong assurance of both yield and quality for YY001's market launch." Liu Miao, Chairman and CEO of Yuyan Pharmaceutical, stated, "We are very pleased to see that the New Drug Application (NDA) for YY001 has been formally accepted by the Chinese regulatory authority, marking our transition from research and development of recombinant botulinum toxin into the era of commercialization. As an important product in minimally invasive aesthetics, botulinum toxin enjoys widespread market popularity. We look forward to the early market entry of YY001, our next-generation botulinum toxin product developed and manufactured by Yuyan Pharmaceutical, to meet consumers' growing demand for higher-quality and safer botulinum toxin products."

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 globally 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, tumor immunotherapy drugs, and pet immunotherapy drugs. Among these are multiple potential first-in-class innovative drugs, and our main products have entered the commercialization stage.

AboutChongqing 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. 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, replacing imported products with higher-quality domestic alternatives, contributing to the health and beauty of the Chinese population.