Luye Pharma Group (HKG: 2186), a leading pharmaceutical company based in China, has announced a market approval filing with the Japanese regulatory authorities for its rivastigmine twice-weekly transdermal patch, LY03013. The company is seeking marketing authorization for the drug to treat symptoms of mild-to-moderate Alzheimer’s disease (AD).
Developed on Luye’s proprietary transdermal patch platform, LY03013 is an innovative modified version of the established Alzheimer’s therapy, rivastigmine. In December 2022, Luye entered into a licensing agreement with TOWA Precision Industries Limited, granting the Japanese company exclusive rights to develop and commercialize LY03013 in Japan. This filing is backed by the positive interim analysis results from a Phase III clinical study in AD-related dementia conducted in Japan, which successfully met its primary endpoint.- Flcube.com
