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分內容所產生或因依 賴該等內容而引致的任何損失承擔任何責任。 Ascletis Pharma Inc. 歌禮製藥有限公司 （於開曼群島註冊成立的有限公司） （股份代號：1672） 自願性公告 歌禮選定新一代每月一次皮下注射GLP-1R/GIPR/GCGR 三靶點激動劑多肽ASC37進行臨床開發 本公告乃歌禮製藥有限公司（「本公司」或「歌禮」，連同其附屬公司稱為「本集 團」）自願作出，以使本公司股東及潛在投資者了解本集團的最新業務發展。 本公司董事（「董事」）會（「董事會」）宣布其已選定新一代每月一次皮下給藥的 GLP-1R/GIPR/GCGR[1]三靶點激動劑多肽ASC37注射劑作為臨床開發候選藥物。 歌禮預計將於2026年第二季度向美國食品藥品監督管理局(FDA)遞交ASC37注射 劑治療肥胖症的新藥臨床試驗申請(IND)。 ASC37是一款利用歌禮基於結構的AI輔助藥物發現（Artificial Intelligence-assisted Structure- ...

Core Viewpoint - The article highlights the positive topline results of ASC50, a novel oral small molecule IL-17 inhibitor developed by the company, from a Phase I clinical trial in the United States, indicating its potential as a best-in-class treatment for psoriasis and other autoimmune diseases [1][2][3] Group 1: Clinical Trial Results - ASC50 demonstrated a favorable safety profile and tolerability in a randomized, double-blind, placebo-controlled Phase I trial involving 46 healthy subjects [1] - The elimination half-lives of ASC50 after single oral doses of 10 mg, 30 mg, 100 mg, 200 mg, 400 mg, and 600 mg were 43, 89, 91, 87, 104, and 85 hours respectively, supporting the potential for once-daily or possibly once-weekly dosing [1][2] - ASC50 exhibited significant target engagement, with elevated plasma IL-17A levels persisting up to 7 days post-administration at higher doses [2] Group 2: Pharmacokinetics and Comparison - ASC50 showed dose-proportional pharmacokinetic characteristics across the 10 mg to 600 mg dosing range [2] - In head-to-head studies with LY4100511, ASC50 demonstrated higher absolute oral bioavailability, greater drug exposure, longer half-life, and lower clearance rates [2] Group 3: Future Development and Market Potential - Based on the positive safety, tolerability, pharmacokinetics, and significant target engagement, ASC50 is advancing to the next phase of clinical development in patients with mild to moderate plaque psoriasis [2] - ASC50 is a new chemical entity (NCE) with patent protection in the U.S. and globally until 2043, excluding potential patent extensions, indicating strong commercial value [3] - The company emphasizes the encouraging data and the differentiated pharmacokinetic profile of ASC50, positioning it as a potential best-in-class oral small molecule IL-17 inhibitor [3]

Core Viewpoint - The announcement by the company regarding the positive topline results of the ASC50 Phase I clinical trial in the U.S. indicates significant advancements in the development of ASC50 as a targeted treatment for autoimmune and inflammatory diseases, particularly psoriasis [1][3]. Group 1: Clinical Trial Results - ASC50 demonstrated a favorable safety and tolerability profile in the single ascending dose (SAD) study, with all adverse events reported as mild (Grade 1) and of short duration, and no serious adverse events (SAEs) reported [2]. - The elimination half-lives of ASC50 after single oral doses of 10 mg, 30 mg, 100 mg, 200 mg, 400 mg, and 600 mg were 43, 89, 91, 87, 104, and 85 hours respectively, supporting the potential for once-daily or possibly once-weekly dosing [2]. - ASC50 exhibited significant targeted binding effects, with elevated plasma IL-17A levels persisting up to 7 days post-administration at higher doses [2]. Group 2: Pharmacokinetics and Comparison - The pharmacokinetic characteristics of ASC50 were found to be dose proportional across the 10 mg to 600 mg dosing range [2]. - In head-to-head studies with LY4100511, ASC50 showed higher absolute oral bioavailability, greater drug exposure, longer half-life, and lower clearance rates [2]. Group 3: Future Development and Market Potential - Based on the positive safety, tolerability, pharmacokinetics, and significant binding effects, ASC50 has progressed to the next phase of clinical development in patients with mild to moderate plaque psoriasis [3]. - ASC50 is a novel chemical entity (NCE) with U.S. and global compound patent protection until 2043, excluding potential patent extensions, indicating strong commercial value in the market [3]. - The company emphasizes the potential of ASC50 as a best-in-class oral small molecule IL-17 inhibitor, developed using AI-assisted structure-based drug discovery technology [3].

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分內容所產生或因依 賴該等內容而引致的任何損失承擔任何責任。 Ascletis Pharma Inc. 歌禮製藥有限公司 （於開曼群島註冊成立的有限公司） （股份代號：1672） 自願性公告 歌禮宣布有望成為同類最佳口服小分子IL-17抑制劑ASC50美國I期研究 取得積極的頂線結果 本公告乃歌禮製藥有限公司（「本公司」或「歌禮」，連同其附屬公司稱為「本集 團」）自願作出，以使本公司股東及潛在投資者了解本集團的最新業務發展。 本公司董事（「董事」）會（「董事會」）宣布，ASC50在美國開展的一項隨機、雙 盲、安慰劑對照的I期臨床試驗(NCT07024602)取得積極頂線結果，該試驗是在健 康受試者中進行的單劑量遞增(SAD)研究，旨在評估ASC50的安全性、耐受性、 藥代動力學及外周循環的白細胞介素-17A(IL-17A)靶向結合特徵。46名健康受試 者接受了10毫克、30毫克、100毫克、200毫克、400毫克或600毫克ASC50，或匹 配的安慰劑給藥。該研究 ...

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分內容所產生或因依 賴該等內容而引致的任何損失承擔任何責任。 Ascletis Pharma Inc. 歌禮製藥有限公司 （於開曼群島註冊成立的有限公司） （股份代號：1672） 自願性公告 歌禮選定其首款口服GLP-1R/GIPR/GCGR三靶點激動劑 多肽ASC37進行臨床開發 本公告乃歌禮製藥有限公司（「本公司」或「歌禮」，連同其附屬公司稱為「本集 團」）自願作出，以使本公司股東及潛在投資者了解本集團的最新業務發展。 本公司董事（「董事」）會（「董事會」）宣布已選定其首款口服GLP-1R/GIPR/GCGR[1] 三靶點激動劑多肽ASC37口服片作為臨床開發候選藥物。歌禮預計將於2026年第 二季度向美國食品藥品監督管理局(FDA)遞交ASC37口服片治療肥胖症的新藥臨 床試驗申請(IND)。 1 － 在非人靈長類動物的頭對頭研究中，通過利用歌禮口服多肽遞送增強技術 (POTENT)，ASC37口服片的平均絕對口服生物利用度達4.2%，分別約為採 用口服SN ...

Core Viewpoint - The announcement highlights the promising efficacy and safety characteristics of the diverse obesity pipeline of the company, showcasing its proprietary AI-assisted drug discovery and ultra-long-acting drug development platforms [1] Group 1: Clinical Research Updates - The company presented multiple reports at the 2025 ObesityWeek in Atlanta, Georgia, including a complete analysis of the ASC30 oral tablet Phase Ib study and the ASC30 monthly injection Phase Ib study [1] - Additionally, the company reported on preclinical studies involving ASC31 and ASC47 combination therapy [1] Group 2: Strategic Focus - The CEO emphasized the ongoing clinical development of ASC30, ASC31, and ASC47 while maintaining close consultations with strategic partners to better meet the treatment needs of global obesity patients [1]

Core Insights - The company has selected ASC36 as a promising monthly subcutaneous injection amylin receptor agonist for clinical development, with plans to submit an IND to the FDA by Q2 2026 [1] Group 1: Product Development - ASC36 is developed using the company's AI-assisted structure-based drug discovery and ultra-long-acting platform technologies, achieving a longer apparent half-life and higher bioavailability per milligram of peptide [1] - The optimized characteristics of ASC36 support monthly subcutaneous administration with an injection volume not exceeding 1 milliliter, leading to cost advantages in manufacturing [1] Group 2: Clinical Research - In head-to-head studies with non-human primates, ASC36 demonstrated an average observed half-life of approximately 15 days, three times longer than petrelintide, indicating potential for monthly dosing in humans [2] - In diet-induced obesity rat studies, ASC36 resulted in a weight reduction of 10.01%, compared to 5.25% for petrelintide, representing a 91% relative improvement in weight loss efficacy [2]

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分內容所產生或因依 賴該等內容而引致的任何損失承擔任何責任。 Ascletis Pharma Inc. 歌禮製藥有限公司 （於開曼群島註冊成立的有限公司） （股份代號：1672） 自願性公告 歌禮選定同類最佳每月一次皮下注射胰淀素受體激動劑 ASC36進入臨床開發階段 本公告乃歌禮製藥有限公司（「本公司」或「歌禮」，連同其附屬公司稱為「本集 團」）自願作出，以使本公司股東及潛在投資者了解本集團的最新業務發展。 本公司董事（「董事」）會（「董事會」）宣佈，已選定一款有望成為同類最佳每月一 次皮下注射胰淀素(amylin)受體激動劑ASC36作為臨床開發候選藥物。歌禮預計 將於2026年第二季度向美國食品藥品監督管理局(FDA)遞交ASC36治療肥胖症的 新藥臨床試驗申請(IND)。 | 組別 | 給藥方案 | 相對基線的 | 較petrelintide的 | | --- | --- | --- | --- | | | | 總體重變化 | 減重效果相對提升 | | 服 ...