Jiangsu Hengrui Pharmaceuticals (01276): The drug marketing authorization application for HRG2010 capsules has been accepted.

Jiangsu Hengrui Pharmaceuticals (01276) announced that it has recently received the "Acceptance Notification" issued by the National Medical Products Administration, indicating that the application for the market approval of the HRG2010 capsules has been accepted by the National Medical Products Administration. HRG2010 capsules are a Class 2 new drug independently developed by the company, consisting of a compound formulation of levodopa and the peripheral decarboxylase inhibitor carbidopa. The formulation aims to achieve rapid onset, lasting effect, and stable efficacy through an optimized release mechanism. Similar products that have been launched both domestically and internationally mainly include carbidopa/levodopa extended-release tablets (brand name: Xining), RYTARY (IPX006) by Amneal Pharmaceuticals LLC, and CREXONT (IPX203). According to the EvaluatePharma database, the total global sales of these similar products are projected to be approximately $328 million by 2025. As of now, the cumulative research and development investment in the HRG2010 capsule project has reached approximately 84.2 million yuan (unaudited).