CAMBRIDGE, Mass., — Insilico Medicine (Insilico Medicine, HKEX: 03696), a clinical-stage biotechnology company powered by generative artificial intelligence (AI), announced that ISM4808, an AI-driven PHD inhibitor for chronic kidney disease (CKD)-related anemia previously out-licensed to TaiGen Biotechnology (TaiGen*-KY, 4157), has achieved its first milestone. Recently, TaiGen has successfully completed the enrollment and dosing of the first subject in the Phase I clinical trial.
The prevalence of CKD is steadily rising in the Greater China region. Anemia is one of the most common complications of CKD, affecting more than one in seven patients. ISM4808 is a potential best-in-class oral HIF-PHD inhibitor discovered with the support of Insilico Medicine’s generative chemistry platform, Chemistry42. Compared to traditional Erythropoiesis-Stimulating Agents (ESAs), ISM4808 stimulates the production of endogenous erythropoietin (EPO) and improves iron utilization. Its advantages, offering multiple advantages including improved iron use efficiency, avoidance of intravenous injections, and a favorable safety profile, with the potential to overcome limitations of existing treatment.
In December 2025, Insilico and TaiGen entered into a licensing agreement for the program. Under the agreement, TaiGen obtained exclusive rights to develop, commercialize, and sublicense ISM4808 in Greater China (including mainland China, Hong Kong, Macau, and Taiwan). Insilico Medicine is eligible to receive an upfront payment, development and sales-based milestone payments, as well as tiered royalties on net sales, with the total deal value reaching tens of millions of US dollars.
Since entering into the collaboration, TaiGen has efficiently initiated preparations for the Phase I clinical trial of this program. The Phase I clinical study is a randomized, double-blind, placebo-controlled trial comprising both single-ascending-dose (SAD) and multiple-ascending-dose (MAD) cohorts, designed to evaluate the safety, tolerability, and pharmacokinetic profile of ISM4808 in healthy adults.
Kuo-Lung Huang, Chairman of TaiGen Biotechnology, said, “ISM4808 is an important milestone in TaiGen’s drug development strategy. Within 3 months of in-licensing the program, our team completed the challenging process from regulatory preparation to first-subject enrollment and dosing, demonstrating TaiGen’s clinical development expertise. There remains significant unmet medical need in the CKD anemia market. We look forward to providing patients with a safer and more convenient oral treatment option through this novel mechanism, and we will continue to accelerate clinical progress to advance into the next stage of development as soon as possible.”
Feng Ren, PhD, Co-CEO and Chief Scientific Officer of Insilico Medicine, said, “We are deeply impressed by our partner TaiGen, who achieved clinical enrollment in less than three months after in-licensing the program. This highly efficient translational model—‘AI-enabled early discovery + professional clinical development’—greatly shortens the distance from concept to the clinic. We look forward to ISM4808 delivering strong outcomes in clinical trials and bringing a clinically differentiated new oral treatment option to the broader CKD anemia patient community. ISM4808 was initially discovered as a candidate drug targeting the PHD mechanism with the support of Chemistry42. Garutadustat, another drug candidate targeting the PHD discovered and optimized by Chemistry42, is being independently advanced by Insilico for the treatment of inflammatory bowel disease. The first patient dosing for its Phase II clinical trial was completed in January 2026.”
About Insilico Medicine
Insilico Medicine is a pioneering global biotechnology company dedicated to integrating artificial intelligence and automation technologies to accelerate drug discovery, drive innovation in the life sciences, and extend health longevity to people on the planet. The company was listed on the Main Board of the Hong Kong Stock Exchange on December 30, 2025, HKEX:3696.
By integrating AI and automation technologies and deep in-house drug discovery capabilities, Insilico is delivering innovative drug solutions for unmet needs including fibrosis, oncology, immunology, pain, and obesity and metabolic disorders. Additionally, Insilico extends the reach of Pharma.AI across diverse industries, such as advanced materials, agriculture, nutritional products and veterinary medicine. For more information, please visit www.insilico.com.