Huadong Medicine (000963.SZ): Exclusive distributor product application for marketing authorization of injectable recombinant type A botulinum toxin received.

Huadong Medicine (000963.SZ) announced that on December 31, 2024, the company's exclusive distribution product, the injection of recombinant type A botulinum toxin (research code: YY001) for improving moderate to severe glabellar lines, has had its market approval application accepted by the National Medical Products Administration. It is reported that YY001 is the world's first and currently the only recombinant type A botulinum toxin product that has submitted a market approval application. YY001, without changing the protein activity, avoids the biological safety risks of using clostridium botulinum to produce botulinum toxin through traditional technology; through a full set of innovative production processes, the recombinant botulinum toxin produced has characteristics of high purity, high specific activity, and low immunogenicity, being regarded by the industry as a new generation of botulinum toxin. In addition to its medical aesthetics applications, YY001 has also entered phase II clinical trials for the treatment of adult upper limb muscle spasms (code-named YY001-002) in China in July 2024, making it the first to apply recombinant type A botulinum toxin in the medical field globally. The acceptance of the registration and market approval application for YY001 is based on a multicenter, randomized, double-blind, placebo and positive drug parallel controlled phase III clinical trial conducted in China. The results of the phase III clinical studies on a large population of YY001 showed that its efficacy, safety, and immunogenicity have all met the predetermined clinical trial endpoints, performing excellently compared to the control drug.