Insilico Medicine Doses First Patient in GENESIS-IPF-3, the World's First Phase III Trial of a Generative AI-Driven Innovative Drug

Insilico Medicine ("Insilico," HKEX: 3696), a clinical-stage biotechnology company powered by generative AI, today announced that it has dosed the first patient with Rentosertib (known as ISM001-055 / INS018_055) in GENESIS-IPF-3, a Phase III clinical trial (NCT07687459, CTR20262475) at Peking Union Medical College Hospital, while Shanghai Pulmonary Hospital has also enrolled its first patient on the same day.

The Phase III clinical trial is a prospective, multi-center, randomized, double-blind, placebo-controlled, parallel-group study designed to systematically evaluate the efficacy and safety of once-daily Rentosertib administered over 52 weeks. The study is led by Professor Zuojun Xu of Peking Union Medical College Hospital, Chinese Academy of Medical Sciences as the Leading Principal Investigator (Leading PI), with Academician Nanshan Zhong of the Chinese Academy of Engineering, a renowned expert in respiratory medicine, and President Chang Chen of Shanghai Pulmonary Hospital serving as Co-Leading Principal Investigators (Co-Leading PIs).

As Leading PI of the study, Professor Zuojun Xu from Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, commented: "TNIK, the target driven by AI, had never previously been linked to fibrosis. This perhaps indicates that AI is carving out a path distinct from traditional research paradigms in target discovery for complex diseases. Dosing the first patient marks another key clinical milestone for Rentosertib; after preliminary findings in the 12 week duration phase IIa study showed promising results, including improvements in lung function among patients with idiopathic pulmonary fibrosis (IPF). This Phase III study is designed to validate the phase IIa study findings in a larger cohort of idiopathic pulmonary fibrosis patients treated for a longer duration of 52 weeks. From initiating Phase III to obtaining final regulatory approval, it will take three to four years under favorable conditions. We look forward to Rentosertib achieving its primary endpoints and successfully securing market approval to benefit IPF patients."

Till today, Insilico has published multiple peer-reviewed papers to document the milestones of Rentosertib along the R&D journey, all the way from target identification to Phase IIa positive results. In 2024, a Nature Biotechnology publication demonstrated the AI-driven early discovery process of Rentosertib. In 2025, a Nature Medicine study reported Phase IIa results of Rentosertib, demonstrating a promising dose-dependent efficacy trend. Most recently, in 2026, a Nature Biotechnology study revealed a consistent reduction in biological age after Rentosertib dosage, across six independent biological aging clocks.

Insilico's dual-purpose therapeutic strategy is also proving its viability as a sustainable commercial model. Recently, Insilico reported total revenue of approximately $106 million in the first half of 2026, a 287% year-over-year increase, and achieved its first profitable half-year since listing, with an adjusted net profit exceeding $51 million. This milestone was driven by a series of out-licensing, co-development, and R&D collaborations with global partners, including Eli Lilly, Servier, Takeda, SK Biopharmaceuticals, Qilu Pharmaceutical, Hygtia Therapeutics, CMS, and Tenacia.