China-based Yifan Pharmaceutical Co., Ltd (SHE: 002019) has announced receiving market approval from the National Medical Products Administration (NMPA) for its in-licensed Category 5.1 drug Hyruan ONE (sodium hyaluronate), which is indicated for use in knee osteoarthritis.
Hyruan ONE: A Single-Dose Preparation for Knee Osteoarthritis
Hyruan ONE, originally developed by LG Chem, is a single-dose preparation specifically designed to treat knee osteoarthritis. First approved in South Korea in October 2013, the drug closely resembles the viscoelastic properties of normal adult joint synovial fluid. Its long retention time in the joint cavity following injection allows it to serve as a temporary replacement and supplement of joint fluid. Through viscoelastic complementary therapy, Hyruan ONE can restore the pathological joint histophysiology and rheology state, providing relief to patients suffering from knee osteoarthritis.
Yifan’s Licensing Deal and Responsibilities
Yifan struck a 10-year licensing deal with LG Chem in December 2017, securing exclusive rights to Hyruan ONE in China and Australia. Along with these rights, Yifan assumes the responsibilities for regulatory filing and conducting the necessary clinical trials to support the product’s market entry and success in these regions.-Fineline Info & Tech
