Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for the launch of Paricalcitol soft capsules, marking a significant milestone as the first domestic generic drug for this product [1] Group 1: Product Approval - The approval allows Heng Rui Medicine's subsidiary, Chengdu Shengdi Pharmaceutical Co., Ltd., to market Paricalcitol soft capsules in China [1] - Paricalcitol is a synthetic vitamin D analog that helps manage secondary hyperparathyroidism (SHPT) in chronic kidney disease (CKD) patients [1] Group 2: Market Context - SHPT is a common and serious complication in CKD patients, appearing early when the glomerular filtration rate is below 80 mL/[min·1.73m2] and worsening with declining kidney function [1] - The product was originally developed by AbbVie and received FDA approval in May 2005, but had not been launched in the domestic market until now [1] Group 3: Investment and Development - The total research and development investment for the Paricalcitol soft capsule project has reached approximately 57.94 million yuan [1] - The approval signifies that the product has passed the consistency evaluation of quality and efficacy for generic drugs in China [1]
恒瑞医药(01276):帕立骨化醇软胶囊获得药品注册批准