Core Insights - The company has completed the first dosing of its innovative PHD inhibitor ISM5411 in a Phase IIa clinical trial named BETHESDA, which focuses on treating inflammatory bowel disease (IBD) [1] - The company has entered into a 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] Group 1 - The innovative candidate drug ISM5411, developed with the assistance of the company's proprietary AI platform Pharma.AI, has received the official generic name Garutadustat from the USAN Council [1] - The ongoing multi-center, randomized, double-blind, placebo-controlled Phase IIa clinical study will evaluate the clinical application potential of Garutadustat in approximately 80 patients with ulcerative colitis (UC), focusing on safety, tolerability, and pharmacokinetic (PK) characteristics [1] - The study will explore efficacy signals through various multidimensional indicators, including clinical remission/response, endoscopic examination, histopathology, and biomarkers [1] Group 2 - The collaboration with TaiJing aims to leverage clinical and market expertise alongside the company's AI-driven drug development efficiency to address unmet medical needs [2] - The integration of advanced AI and automation technologies has significantly enhanced early-stage new drug development efficiency, setting a benchmark for AI-driven drug development [2] - Compared to the traditional drug development cycle of approximately 4.5 years, the company'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(03696)在名为BETHESDA的IIA期临床试验中完成 GARUTADUSTAT (ISM5411)首例受试者给药