Kelun Pharmaceutical secures NMPA approval for rotigotine patch

Sichuan Kelun Pharmaceutical Co., Ltd. has received drug registration approval from the National Medical Products Administration for its chemical drug, rotigotine patch. The approval covers two specifications: 2mg/24 hours (4.5mg/patch) and 4mg/24 hours (9mg/patch), classified as Class 4 chemical drugs for domestic production.

The rotigotine patch, originally developed by UCB Pharma, was imported into China in 2018. It is used as monotherapy for early-stage essential Parkinson's disease or in combination with levodopa for all stages. As the world's first transdermal patch for Parkinson's, it offers reduced blood concentration fluctuations and improved patient compliance compared to oral medications. Global sales for this product in 2024 were $330 million.

This domestic first-to-market approval enhances Kelun Pharmaceutical's competitiveness in the central nervous system therapeutic area, complementing its existing portfolio. The rotigotine patch is also the first approved product from the company's patch platform, with several other patch formulations currently under development.