Insilico Medicine: ISM8969/HT-001 New Drug Clinical Trial Application accepted for review
On May 20, CDE issues an announcement that Insilico Medicine’s new drug clinical trial application for ISM8969/HT-001 tablets has been accepted for review. The drug received an FDA clinical trial approval in January this year. The acceptance of the domestic application means that ISM8969 will advance parallel clinical development in both China and the United States.
ISM8969 is an oral, novel NLRP3 inhibitor with blood-brain barrier penetration capabilities. Insilico Medicine discovers and optimizes it using Chemistry42, its proprietary generative chemistry engine. Chemistry42 covers all stages of drug design and discovery, optimizing key druggability parameters such as efficacy, safety, and blood-brain barrier penetration from the molecular design stage.
In December 2024, Insilico Medicine formally nominates ISM8969 as a preclinical candidate (PCC). From project initiation to PCC nomination, Insilico Medicine synthesizes only about 60–200 molecules, taking an average of 12–18 months. In contrast, traditional early drug discovery typically requires an average of 4.5 years. These figures clearly demonstrate the significant efficiency advantages of the AI-driven drug discovery model.
In January this year, Insilico Medicine enters into a co-development collaboration with Hygtia Therapeutics for ISM8969, with a total value exceeding HK$500 million. In February, it signs multiple project collaborations with CMS in the CNS and autoimmune disease areas, with each project eligible for up to tens of millions of Hong Kong dollars in R&D funding support. In March, it expands its CNS collaboration with YuanYi Bio, reaching a total transaction value of up to US$94.75 million.
Insilico Medicine’s dual-engine business model—in-house pipeline development plus platform licensing collaboration—is proving its commercial value. The in-house pipeline can realize value through out-licensing, while platform capabilities continue to generate revenue through deep collaborations with pharmaceutical companies. Currently, Insilico Medicine has established software licensing collaborations with over ten of the world’s top 20 pharmaceutical companies, and has achieved multiple BD transactions with global pharmaceutical companies for pipeline licensing.
