Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for the launch of its drug, Paricalcitol Soft Capsules, which is aimed at treating secondary hyperparathyroidism in adults with chronic kidney disease stages 3-4 [1] Group 1: Drug Information - Drug Name: Paricalcitol Soft Capsules [1] - Dosage Form: Capsule [1] - Specifications: 1μg, 2μg [1] - Registration Classification: Class 3 Chemical Drug [1] - Prescription Status: Prescription Drug [1] - Approved Indication: Prevention and treatment of secondary hyperparathyroidism (SHPT) in adults with chronic kidney disease (CKD) stages 3-4 [1] Group 2: Clinical Significance - SHPT is a common and serious complication in CKD patients, which can occur early in CKD (glomerular filtration rate <80 mL/[min·1.73m²]) and worsens with declining kidney function [1] - Paricalcitol is a synthetic vitamin D analog that inhibits the secretion of parathyroid hormone (PTH) by binding to vitamin D receptors, thereby reducing serum PTH levels [1] Group 3: Development and Investment - The drug was developed by AbbVie and received FDA approval in May 2005, but has not been launched in China until now [1] - The company is the first generic drug manufacturer for this product in China, and the approval is considered equivalent to passing the consistency evaluation of generic drug quality and efficacy [1] - Cumulative R&D investment for the Paricalcitol Soft Capsules project is approximately 57.94 million yuan [1]