INSILICO (03696.HK): AI-Driven Candidate Rentosertib Completes First Patient Dosing in Phase III IPF Trial

On 10 September 2026, INSILICO (03696.HK) announced that its AI-driven candidate Rentosertib completed first patient dosing in the Phase III IPF trial GENESIS-IPF-3 at Peking Union Medical College Hospital and Shanghai Pulmonary Hospital on the same day. The 52-week study plans to enroll 320 subjects at 47 Chinese centers with annual FVC decline rate as primary endpoint, led by Professor Xu Zuojun, with Academician Zhong Nanshan and Chen Chang as co-lead investigators.

NewTimeSpace News: On 10 September 2026, InSilico Medicine (stock code: 03696) announced in a voluntary filing that Rentosertib (also known as ISM001-055/INS018_055), the company's lead AI-driven innovative candidate, has completed first patient enrollment and dosing in the Phase III trial GENESIS-IPF-3 in idiopathic pulmonary fibrosis (IPF). On the same day, Shanghai Pulmonary Hospital also completed first patient enrollment in the trial.

GENESIS-IPF-3 is a 52-week, prospective, randomized, multicenter, double-blind, placebo-controlled, parallel-group Phase III study planned to enroll 320 subjects across 47 clinical centers in China. The primary endpoint is the annual rate of decline in forced vital capacity (FVC) over 52 weeks, with the key secondary endpoint being the time to first disease progression event. The trial is led by Professor Xu Zuojun of Peking Union Medical College Hospital as principal investigator, with Chinese Academy of Engineering Academician Zhong Nanshan and Chen Chang, president of Shanghai Pulmonary Hospital, as co-principal investigators.

Rentosertib is a potential first-in-class small-molecule TNIK inhibitor discovered and developed with the company's proprietary generative AI platform Pharma.AI. Phase IIa results were published in Nature Medicine in June 2025. 

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