Core Viewpoint - Company has received approval for clinical trials of HW241045, a drug aimed at treating idiopathic pulmonary fibrosis, marking a significant step in its research and development efforts [1][2]. Group 1: Drug Approval Details - The drug HW241045 is classified as a Class 1 chemical drug and is intended for domestic production and clinical trials [1]. - The approval was granted by the National Medical Products Administration of China, allowing the company to proceed with clinical trials for the specified indication [1][2]. Group 2: Market Context - Currently, there are no other drugs targeting the same mechanism as HW241045 approved globally, with only two existing treatments, Nintedanib and Pirfenidone, available for idiopathic pulmonary fibrosis [2]. - Sales figures for Nintedanib and Pirfenidone in China for 2024 are projected to be approximately RMB 1.2 billion and RMB 670 million, respectively [2]. Group 3: R&D Investment - The cumulative R&D investment for the HW241045 project by the company's innovation drug research center is approximately RMB 23 million [2]. - The company is required to initiate clinical research activities following the receipt of the clinical trial approval and will submit trial data to the regulatory authority upon completion [2].
人福医药集团股份公司 关于HW241045片获得药物临床试验批准通知书的公告