Hengrui Medicine’s HRG2101 Inhaler Wins NMPA Approval for IPF Clinical Trial

China’s Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has received approval from the National Medical Products Administration (NMPA) to conduct a clinical trial of its HRG2101 inhaler for idiopathic pulmonary fibrosis (IPF). The drug, with no similar marketed products in China, targets fibroblast activity and inflammatory pathways to address the progressive lung disease.

Drug Mechanism
HRG2101 works by inhibiting fibroblast biological activity through regulation of cytokines like TGF-β1, reducing cell proliferation and collagen synthesis. It also suppresses inflammatory mediators (e.g., TNF-α) and lipid peroxidation, offering anti-inflammatory and antioxidant effects. The mechanism positions it as a potential first-in-class therapy for IPF in China.

Development Context
Hengrui has invested RMB 11.54 million (USD 1.67 million) in HRG2101’s development to date. The NMPA approval marks a key milestone, advancing the drug toward clinical validation in IPF patients. The company plans to leverage its R&D expertise to accelerate trials and address unmet needs in fibrotic diseases.-Fineline Info & Tech

Insight, China's Pharmaceutical Industry