Lead Product(s) : Hydronidone
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Gyre Completes Phase 3 Trial Evaluating F351 for CHB Liver Fibrosis
Details : F351 (hydronidone) is an analogue of Pirfenidone, which inhibits p38γ kinase and TGF-β1-induced excessive collagen synthesis HSCs, being developed for chronic hepatitis b associated liver fibrosis.
Product Name : F351
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
October 22, 2024
Lead Product(s) : Hydronidone
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Hydronidone
Therapeutic Area : Pulmonary/Respiratory Diseases
Study Phase : Phase III
Sponsor : Beijing Continent Pharmaceuticals
Deal Size : Undisclosed
Deal Type : Merger
Details : The combined company will more efficiently conduct clinical research and development of their promising pipeline of product candidates in organ fibrosis and inflammatory diseases, including F351 (hydronidone) for liver fibrosis.
Product Name : F351
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
October 30, 2023
Lead Product(s) : Hydronidone
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Phase III
Sponsor : Beijing Continent Pharmaceuticals
Deal Size : Undisclosed
Deal Type : Merger
Lead Product(s) : Hydronidone
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Study Phase : Phase III
Sponsor : Catalyst Biosciences
Deal Size : Undisclosed
Deal Type : Acquisition
Catalyst Biosciences Completes First Steps in Reverse Merger Plan
Details : F351 is a next-generation pirfenidone analog in Phase 3 clinical development for the treatment of HBV associated liver fibrosis in China and the combined company expects to file an IND in the US and commence Phase 2 studies in 2023.
Product Name : F351
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
December 27, 2022
Lead Product(s) : Hydronidone
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Highest Development Status : Phase III
Sponsor : Catalyst Biosciences
Deal Size : Undisclosed
Deal Type : Acquisition
Lead Product(s) : Hydronidone,Entecavir
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Study Phase : Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : F351 was generally well tolerated in this study. In patients treated with placebos, 60 mg/tid F351, 90 mg/tid F351, and 120 mg/tid F351, respectively.
Product Name : F351
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
August 17, 2020
Lead Product(s) : Hydronidone,Entecavir
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Highest Development Status : Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable