HWHG(SH:600079) Shang Hai Zheng Quan Bao·2025-08-05 18:00Core Viewpoint - Humanwell Healthcare Group has received approval for clinical trials of HW241045 tablets, aimed at treating idiopathic pulmonary fibrosis, a condition for which no other drugs targeting the same pathway have been approved globally [1][2]. Group 1: Drug Approval Details - The drug name is HW241045 tablets, classified as a Class 1 chemical drug, and the application was submitted by Wuhan Humanwell Innovative Drug Research Center [1]. - The approval for clinical trials was granted by the National Medical Products Administration, allowing the drug to proceed with clinical research for idiopathic pulmonary fibrosis [1][2]. Group 2: Market Context - Currently, only two drugs, Nintedanib and Pirfenidone, are approved for treating idiopathic pulmonary fibrosis, with estimated sales in 2024 of approximately RMB 1.2 billion and RMB 670 million, respectively [2]. - The cumulative R&D investment in the HW241045 project by the innovative drug research center is around RMB 23 million [2]. Group 3: Next Steps and Considerations - Following the receipt of the clinical trial approval, the innovative drug research center will initiate the necessary clinical research activities and will submit trial data to the National Medical Products Administration upon completion [2]. - The lengthy and complex process of drug development, from research to market launch, is subject to various uncertainties, which investors should be aware of [2].