Gyre Therapeutics announces NMPA approval for trial on pirfenidone

Gyre Therapeutics (GYRE) announced that the National Medical Products Administration, NMPA, of the People’s Republic of China, PRC, has approved its clinical trial application for a potential new indication for pirfenidone in oncology-related pulmonary complications. The trial will evaluate pirfenidone capsules for the treatment of radiation-induced lung injury, with or without immune-related pneumonitis. This regulatory milestone marks the expansion of pirfenidone beyond its established role in idiopathic pulmonary fibrosis into the oncology supportive care space, offering a novel lung-protective strategy for cancer patients undergoing radiation therapy or immunotherapy. In accordance with the NMPA approval, Gyre intends to pursue an adaptive Phase 2/3 clinical trial design, combining dose exploration with efficacy confirmation, to efficiently evaluate pirfenidone’s potential in this new indication.