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]

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]

Core Viewpoint - The company, 英矽智能 (03696.HK), has initiated 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] Group 1: Clinical Trial Details - The BETHESDA trial is a multi-center, randomized, double-blind, placebo-controlled study [1] - The trial is led by Professor Chen Minhu, a prominent expert in gastroenterology from Sun Yat-sen University First Affiliated Hospital [1] - Approximately 80 patients with ulcerative colitis (UC) will be evaluated for the clinical application potential of Garutadustat (formerly ISM5411) [1] Group 2: Drug Development and Approval - Garutadustat has recently received official approval from the USAN Council for its generic name [1] - The drug is developed using the company's proprietary generative AI platform, Pharma.AI, and is characterized by its intestinal restriction [1] Group 3: Evaluation Metrics - The trial will assess safety, tolerability, and pharmacokinetic (PK) characteristics of Garutadustat [1] - Effectiveness signals will be explored through multiple indicators, including clinical remission/response, endoscopic examination, histopathology, and biomarkers [1]

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示概不就因本公告全部或任何部份內容而產生或因倚賴 該等內容而引致的任何損失承擔任何責任。 於本公告日期，本公司董事會包括執行董事Aleksandrs Zavoronkovs博士及任峰博 士，非執行董事陳侃博士、梁傳昕博士及施瓏先生，以及獨立非執行董事王勁松 博士、Denitsa Milanova博士及Roman Kyrychynskyi先生。 INSILICO MEDICINE InSilico Medicine Cayman TopCo 英矽智能 （於開曼群島註冊成立的有限公司） （股份代號：3696） 有關在名為BETHESDA的IIA期臨床試驗中完成 GARUTADUSTAT (ISM5411)首例受試者給藥之自願公告 本公告乃由英矽智能（「本公司」，連同其附屬公司統稱「本集團」）自願作出。 本公司謹此知會本公司股東及潛在投資者，隨附之新聞稿載述，本公司已在一項 名為BETHESDA的IIa期臨床試驗中完成其創新PHD抑制劑ISM5411的首例受試者 給藥。該創新候選藥物由本集團自有生成 ...