INSILICO - VOLUNTARY ANNOUNCEMENT INSILICO MEDICINE RECEIVES NMPA IND APPROVAL FOR ISM8969/HT-001, THE BLOOD-BRAIN-BARRIER-PENETRANT NLRP3 INHIBITOR CO-DEVELOPED WITH HYGTIA THERAPEUTICS
INSILICO - VOLUNTARY ANNOUNCEMENT
INSILICO MEDICINE RECEIVES NMPA IND APPROVAL FOR ISM8969/HT-001, THE BLOOD-BRAIN-BARRIER-PENETRANT NLRP3 INHIBITOR CO-DEVELOPED WITH HYGTIA THERAPEUTICS
INSILICO MEDICINE
InSilico Medicine Cayman TopCo
英矽智能
(Incorporated in the Cayman Islands with limited liability)
(Stock code: 3696)
VOLUNTARY ANNOUNCEMENT
INSILICO MEDICINE RECEIVES NMPA IND APPROVAL FOR
ISM8969/HT-001, THE BLOOD-BRAIN-BARRIER-PENETRANT
NLRP3 INHIBITOR
CO-DEVELOPED WITH HYGTIA THERAPEUTICS
This announcement is made by InSilico Medicine Cayman TopCo (the "Company", together with its subsidiaries, the "Group" or "Insilico Medicine") on a voluntary basis to inform the shareholders and potential investors of the Company about the latest business updates of the Group.
The board of directors of the Company (the "Board") is pleased to announce that, ISM8969/HT- 001, an innovative oral NLRP3 inhibitor co-developed with Hygtia Therapeutics Co., Ltd ("Hygtia Therapeutics"), has received Investigational New Drug (IND) approval from the National Medical Products Administration (NMPA) of China for the treatment of Parkinson's disease. Following the announcement of first-in-human dosing in Australia under the Phase I study in June 2026, this approval marks the official launch of parallel clinical evaluations in China and Australia.
The clinical trial aims to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ISM8969/HT-001 in healthy subjects and preliminary efficacy of ISM8969/HT-001 in patients with Parkinson's disease, establishing a foundation for its subsequent clinical development.
In preclinical evaluation studies, ISM8969/HT-001 exhibited a balanced druggability profile, with promising in vitro activity and safety, favorable in vivo PK/PD profile, as well as efficacy against inflammation in multiple mouse disease models, including acute inflammatory disease and chronic disease models. Compared with other clinically advanced peripherally restricted NLRP3 inhibitors, ISM8969/HT-001 is blood-brain-barrier (BBB)-penetrant and can access the central nervous system, enabling potential treatment of neuroinflammation-related diseases.
About ISM8969/HT-001
ISM8969/HT-001 is an orally available, BBB-penetrant NLRP3 inhibitor discovered using Insilico Medicine's generative AI platform Chemistry42, which has demonstrated strong efficacy, favorable safety, and robust BBB-penetration profile in preclinical studies.
Since its nomination as a Preclinical Candidate Compounds in December 2024, ISM8969/HT- 001 has rapidly advanced through clinical development: receiving the IND clearance from the U.S. Food and Drug Administration and announcing a co-development partnership with Hygtia Therapeutics in January 2026; completing first-in-human dosing in Australia of Phase I clinical study in June 2026 as its first clinical milestone; and receiving IND approval from China's NMPA in July 2026.
Forward Looking Statement
There is no assurance that any forward-looking statements regarding the business development of the Group in this announcement or any of the matters set out herein are attainable, will actually occur or will be realized or are complete or accurate. The financial and other data relating to the Group as disclosed in this announcement has also not been audited or reviewed by its auditors. Shareholders and/or potential investors of the Company are advised to exercise caution when dealing in the shares of the Company and not to place any excessive reliance on the information disclosed herein. Any shareholder or potential investor who is in doubt is advised to seek advice from professional advisors.
By order of the Board
InSilico Medicine Cayman TopCo
Mr. Aleksandrs Zavoronkovs, Ph.D.
Chairman, Executive Director, CEO and CBO
Hong Kong, August 3, 2026