Core Insights - The company, Yingkui Intelligent (03696), has completed the first dosing of its innovative PHD inhibitor ISM5411 in a Phase IIa clinical trial named BETHESDA, aimed at treating inflammatory bowel disease (IBD) [1] - The generic name Garutadustat for ISM5411 has been officially approved by the USAN Council, indicating regulatory progress for the drug [1] - The ongoing multi-center, randomized, double-blind, placebo-controlled Phase IIa study will evaluate the clinical application potential of Garutadustat in approximately 80 patients with ulcerative colitis (UC), focusing on safety, tolerability, pharmacokinetics (PK), and efficacy signals through various multidimensional indicators [1] Company Developments - Yingkui Intelligent has entered into an external licensing collaboration with Taijing for another innovative candidate drug ISM4808, aimed at treating anemia related to chronic kidney disease (CKD), with a total collaboration value of tens of millions of dollars [2] - The collaboration aims to leverage Taijing's clinical and market expertise alongside Yingkui Intelligent's AI-driven drug development efficiency to address unmet medical needs [2] - The company has significantly enhanced early-stage new drug development efficiency through the integration of advanced AI and automation technologies, setting a benchmark for AI-driven drug development [2] - Compared to the traditional drug development cycle of approximately 4.5 years, Yingkui Intelligent's self-research projects from 2021 to 2024 have an average timeline of only 12-18 months from project initiation to PCC nomination, requiring the synthesis and testing of about 60-200 molecules per project [2]
英硅智能在名为BETHESDA的IIA期临床试验中完成 GARUTADUSTAT (ISM5411)首例受试者给药