INSILICO(03696.HK): Phase III Clinical Trial of Rentosertib for Idiopathic Pulmonary Fibrosis Officially Launched

NewTimeSpace News: InSilico Medicine Cayman TopCo issued a voluntary announcement dated 8 July 2026. Rentosertib (ISM001-055), independently developed by the Company, has officially commenced its Phase III clinical trial, with relevant information registered on both the Center for Drug Evaluation (CDE) platform of NMPA and ClinicalTrials.gov.

This is a prospective, randomised, double-blind, placebo-controlled, parallel-group Phase III study designed to assess the efficacy and safety of once-daily oral administration over a continuous 52-week treatment period. A total of 320 subjects are expected to be recruited across 47 clinical centres nationwide.Primary endpoint: Annual rate of decline in forced vital capacity (FVC) within 52 weeksSecondary endpoints: Time to first disease progression, changes in diffusing capacity of the lung for carbon monoxide (DLco), quality-of-life questionnaires and other multi-dimensional indicators

Rentosertib is a potential first-in-class TNIK small-molecule inhibitor, discovered and developed powered by the Group’s proprietary generative AI drug discovery platform Pharma.AI. It was granted U.S. FDA Orphan Drug Designation in February 2023 and included in NMPA’s Breakthrough Therapy Designation list in May 2025 for the treatment of idiopathic pulmonary fibrosis (IPF).