regulatory
confidence high
sentiment positive
materiality 0.65
Gyre subsidiary receives China NMPA IND approval for F230 in pulmonary arterial hypertension
GYRE THERAPEUTICS, INC.
- IND approved by CDE of China's NMPA for F230 tablets, a selective endothelin receptor antagonist for PAH.
- F230 originally licensed from Eisai through Gyre's indirect stockholder GNI Group Ltd.
- Preclinical data showed statistically significant reductions in mean pulmonary artery pressure and right ventricular systolic pressure.
- CEO Han Ying stated commitment to advancing F230 through clinical development for PAH; other indications also being explored.