Insilico Medicine and Taiho Pharmaceutical Enter Pipeline Licensing Collaboration to Advance AI-Driven PHD Inhibitor Development and Commercialization for Anemia in Chronic Kidney Disease (CKD)

Insilico Medicine, a clinical-stage biotech company powered by generative artificial intelligence, and TaiGen Biotechnology, a market-driven drug discovery company, together with its wholly-owned Beijing subsidiary TaiGen Pharma (collectively referred to as "TaiGen"), today announced an exclusive pipeline out-licensing collaboration.

Under the terms of the agreement, TaiGen will obtain exclusive rights to develop, commercialize, and sublicense the PHD inhibitor ISM4808 in Greater China, including mainland China, Hong Kong, Macau, and Taiwan. In return, Insilico Medicine is eligible to receive an upfront payment, milestone payments based on development and sales achievements, and tiered royalties on net sales, with the total deal value reaching tens of millions of U.S. dollars.

Chronic kidney disease (CKD) causes over 1.5 million deaths annually, and more than one in seven patients with kidney disease suffer from anemia due to reduced erythropoietin (EPO) production and shortened red blood cell lifespan. However, anemia cannot be fully cured; current therapies primarily focus on symptomatic treatment, aiming to alleviate fatigue, shortness of breath, body pain, dizziness/fainting, and other symptoms to improve patients' quality of life.

ISM4808 was nominated in 2022 as a candidate PHD inhibitor with best-in-class potential. It targets the HIF-α pathway—a mechanism recognized by the Nobel Prize—enhancing red blood cell regeneration by inducing EPO and improving iron utilization for the treatment of anemia associated with chronic kidney disease. Notably, the novel structure of ISM4808 was enabled by Insilico Medicine's proprietary Chemistry42 platform, which completed the design, synthesis, and testing within just 12 months prior to candidate nomination. The discovery and development journey of the ISM4808 series was published in the Journal of Medicinal Chemistry in January 2024, highlighting the novelty and efficiency of Insilico Medicine's AI-driven drug discovery workflow.

In preclinical studies, ISM4808 demonstrated robust efficacy in both in vitro and in vivo experiments, with a lower effective dose confirmed in rat models of chronic kidney disease. Additionally, ISM4808 exhibited favorable oral druggability, characterized by excellent in vitro ADME properties, favorable pharmacokinetic (PK) profiles in animal models, a higher maximum tolerated dose, and a wider safety margin. The project received clinical trial authorization from China's Center for Drug Evaluation (CDE) in 2023.

Dr. Feng Ren, Co-CEO and Chief Scientific Officer of Insilico Medicine, said, "We are delighted to partner with TaiGen. Previously, empowered by our AI platforms, Insilico Medicine efficiently nominated two novel small-molecule PHD inhibitors for different indications. Among them, ISM5411, a candidate molecule for treating inflammatory bowel disease, has successfully completed two Phase I clinical trials under Insilico's leadership, demonstrating good safety and further strengthening our confidence in targeting the PHD mechanism. We are very pleased that ISM4808, another candidate from this target, will now be advanced by TaiGen, a partner with extensive R&D experience and strong commercialization capabilities. I believe TaiGen's robust drug development expertise and clinical resources will accelerate the progress of this program, bringing AI-driven therapies to patients with unmet clinical needs sooner."

Dr. Kuo-Lung Huang, Chairman of TaiGen Biotechnology, stated, "We are excited to establish this strategic partnership with Insilico Medicine. Their innovation driven by generative AI platforms is truly impressive. In mainland China alone, there are over one million dialysis patients, and the PHD inhibitor market is experiencing explosive growth, expanding from 50 million RMB to 2.45 billion RMB in just five years. Oral medications are gradually replacing traditional injectables to meet clinical demands for convenience and patient adherence. This licensing agreement perfectly aligns with our mission in innovative drug development, and TaiGen is committed to advancing the clinical development of this program."