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.
Elevate Your Investing Strategy:
- Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence.
- Make smarter investment decisions with TipRanks' Smart Investor Picks, delivered to your inbox every week.
Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>>
Read More on GYRE:
- Gyre Therapeutics announces publication of protocol for Phase 3 trial on F351
- Gyre Therapeutics Reports Strong Turnaround in 2024 Earnings
- Impact of New U.S. Regulations on Gyre Therapeutics: Potential Delisting Risks and Investor Concerns
- Catalyst Biosciences Inc trading resumes
- Catalyst Biosciences Inc trading halted, volatility trading pause