HENGRUI PHARMA (01276) has announced that its marketing authorization application for the HRG2010 capsule has been formally accepted by China's National Medical Products Administration (NMPA), following the receipt of the official "Acceptance Notification" from the regulatory body.
The HRG2010 capsule, a Class 2 innovative drug independently developed by the company, is a combination formulation of levodopa and the peripheral decarboxylase inhibitor carbidopa. By optimizing the release mechanism, the drug aims to achieve a rapid onset of action while ensuring sustained and stable efficacy over an extended period.
Currently, comparable products already available in both domestic and international markets primarily include carbidopa-levodopa extended-release tablets (marketed under the brand name Sinemet), as well as RYTARY® (IPX006) and CREXONT® (IPX203) manufactured by Amneal Pharmaceuticals LLC. According to data from the EvaluatePharma database, the combined global sales of these comparable products reached approximately $328 million in 2025.
As of the present date, the cumulative research and development investment for the HRG2010 capsule project has reached approximately RMB 84.2 million (unaudited).