BEIJING—The Center for Drug Evaluation (CDE) in China has accepted the market filing for a long-acting erythropoietin (EPO) product, rhEPO-Fc, developed by Shandong Buchang Pharmaceuticals Co., Ltd (SHA: 603858), for review. The product is intended for the treatment of anemia associated with chronic kidney disease (CKD).
Anemia is a common complication in over half of the patients with CKD, and erythropoiesis-stimulating agents (ESA) along with iron supplements are traditionally used for its treatment. The market for ESA products includes both short-acting and long-acting EPOs. Short-acting EPOs available include Espo from Kyowa Kirin/Amgen, Espogen from LG Chem, and 宁红欣 from Huaxin Bio. Long-acting EPOs on the market comprise Roche’s 罗可曼, Mircera (methoxy polyethylene glycol-epoetin beta), Nesp (darbepoetin alfa) from Kyowa Kirin, and Shengluolai (pegmolesatide) from Hansoh Pharma.
Buchang Pharma’s rhEPO-Fc is a contender in the long-acting EPO segment, aiming to provide a more sustainable treatment option for CKD-associated anemia. The acceptance of its filing for review by the CDE marks a significant step forward in the drug’s path to potential market approval, offering hope for patients seeking more effective anemia management solutions. -Fineline Info & Tech
