YY001注册上市许可申请的受理，是基于一项在中国进行的多中心、随机、双盲、安慰剂及阳性药平行对照的Ⅲ期临床试验。YY001在大规模人群的III期临床研究结果显示，其有效性、安全性和免疫原性都达到了既定的临床试验终点，与对照药相比表现优异。Huadong Medicine (000963.SZ) released an announcement, stating that on December 31, 2024, the company will exclusively distribute products related to...
According to the Zhitong Finance APP, Huadong Medicine (000963.SZ) announced that on December 31, 2024, the exclusive distribution product injectable ASSETREORGANIZATIONA botulinum toxin (Research Code: YY001) for the application of marketing authorization to improve moderate to severe glabellar lines has been accepted by the National Medical Products Administration.
It is reported that YY001 is the first and currently the only ASSETREORGANIZATIONA botulinum toxin product that has submitted a marketing application globally. YY001 avoids the biological safety risks associated with traditional production methods that use Clostridium botulinum to produce botulinum toxin, while maintaining protein activity; through a fully innovative designed production process, the produced recombinant botulinum toxin is characterized by high purity, high specific activity, and low immunogenicity, and is regarded by the industry as a new generation of botulinum toxin. Based on its application in medical aesthetics, clinical research for YY001 in treating adult upper limb muscle spasms (coded YY001-002) also entered the Phase II clinical trial stage in China in July 2024, and will be the first to apply the ASSETREORGANIZATIONA botulinum toxin in the medical field globally.
The acceptance of the registration application for YY001 is based on a multicenter, randomized, double-blind, placebo-controlled, and positive drug parallel-controlled Phase III clinical trial conducted in China. The results of the Phase III clinical study of YY001 in a large population showed that its efficacy, safety, and immunogenicity all reached the predetermined clinical trial endpoints, outperforming the control drug.