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].

Core Viewpoint - The article highlights the positive topline results of ASC50 from a Phase I clinical trial conducted in the United States, indicating its potential as a leading oral small molecule IL-17 inhibitor [1] Group 1: Clinical Trial Results - ASC50 was evaluated in a randomized, double-blind, placebo-controlled Phase I trial involving 46 healthy subjects [1] - The trial assessed the safety, tolerability, pharmacokinetics, and targeted binding characteristics of IL-17A [1] - Subjects received single doses of ASC50 at varying levels: 10 mg, 30 mg, 100 mg, 200 mg, 400 mg, or 600 mg, compared to a matching placebo [1] Group 2: Company Insights - The CEO of the company expressed encouragement from the data, highlighting ASC50's favorable safety profile and differentiated pharmacokinetic characteristics [1] - ASC50 is noted as the first oral small molecule candidate developed using Artificial Intelligence-assisted Structure-Based Drug Discovery (AISBDD) technology in the immunology field [1] - The findings underscore ASC50's potential as a best-in-class oral small molecule IL-17 inhibitor [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 ...

每经AI快讯，港股医药股普遍下挫。截至发稿，歌礼制药-B(01672.HK)跌11.02%，报12.92港元；圣诺 医药-B(02257.HK)跌8.27%，报8.32港元；和铂医药-B(02142.HK)跌7.29%，报12.46港元；荣昌生物 (09995.HK)跌4.87%，报75.15港元。 ...

Group 1 - The pharmaceutical sector is experiencing a general decline, with notable drops in stock prices for companies such as Genscript Biotech (down 11.02% to HKD 12.92), Sanofi (down 8.27% to HKD 8.32), and others [1] - Haitong International's research report indicates that the recent pullback in the pharmaceutical sector is primarily due to seasonal factors affecting liquidity, particularly the year-end accounting by southbound funds [1] - The report highlights a decreasing proportion of holdings in leading pharmaceutical stocks within the Hong Kong Stock Connect, such as Innovent Biologics and China National Pharmaceutical Group [1] Group 2 - Despite the short-term challenges, the report maintains a positive long-term outlook for the innovative drug industry chain, particularly for companies with strong fundamentals and successful overseas clinical progress [1] - The focus is on companies with strong earnings certainty in internet healthcare, CXO/research services, and leading biotech and pharmaceutical firms that have established external collaborations [1]

Core Viewpoint - The pharmaceutical sector is experiencing a general decline, with significant drops in stock prices for various companies, attributed to seasonal factors affecting liquidity and southbound fund flows [1] Group 1: Market Performance - Major pharmaceutical stocks have seen substantial declines, with Gilead Sciences-B (01672) down 11.02% to HKD 12.92, Sanofi-B (02257) down 8.27% to HKD 8.32, and Hengrui Medicine-B (02142) down 7.29% to HKD 12.46 [1] - Overall, the Hong Kong pharmaceutical sector has performed weakly, influenced by seasonal factors such as year-end fund settlement [1] Group 2: Analyst Insights - Haitong International's report indicates that the pharmaceutical sector is under short-term pressure due to liquidity issues, but maintains a positive long-term outlook on the innovative drug industry chain [1] - The report highlights a continuous decline in the Hong Kong Stock Connect holdings of leading pharmaceutical stocks, such as Innovent Biologics and China National Pharmaceutical Group [1] Group 3: Long-term Opportunities - The firm expresses confidence in the long-term prospects of internet healthcare, CXO/research service leaders, and top biotech and pharmaceutical companies that have established external collaborations and are making progress in overseas clinical trials [1]

港股生物技术板块持续走低，歌礼制药(01672.HK)跌超8%，圣诺医药(02257.HK)跌超6%，百济神州 (06160.HK)、复宏汉霖(02696.HK)等跟跌。 本文源自：金融界AI电报 ...

每经AI快讯，12月15日，港股生物技术板块持续走低，歌礼制药跌超8%，圣诺医药跌超6%，百济神 州、复宏汉霖等跟跌。 ...

Group 1: Hong Kong Stock Market Analysis - The Hang Seng Index opened down by 1%, while the Hang Seng Tech Index fell by 1.34%. The assisted reproductive concept stocks, such as Jinxin Fertility, rose by approximately 3%, while the pharmaceutical sector saw declines, with Genscript Biotech dropping over 5% [1] - Guotai Junan Securities believes that the Hong Kong stock market is more sensitive to external risks, particularly with the uncertain future path of the Federal Reserve's interest rate cuts and the upcoming peak of lock-up stock releases in December, which may lead to liquidity shocks. They suggest potential rebound points in mid to late December and early January [1] - Everbright Securities indicates that compared to previous bull markets, the current index still has significant upside potential. However, under the government's guidance for a "slow bull" market, the duration of the bull market may be more important than the magnitude of the increase. In the short term, the market may lack strong catalysts and could experience a period of consolidation [1] - Guosen Securities states that the short-term adjustment of the Hong Kong stock market may open up space for a market rise in 2026. They note that in November, net inflows from southbound funds into the Hong Kong market exceeded 110 billion RMB, reflecting strong liquidity and a willingness to accumulate positions at low levels. They predict that the Hong Kong stock market could operate between 30,000 and 32,000 points in 2026 [1] Group 2: Ice and Snow Economy - Ping An Securities highlights that the ice and snow economy has become a new growth point in the economy, encompassing ice and snow sports, tourism, equipment, and culture. It features a long industrial chain, significant diversion effects, and high social benefits, becoming an important force in promoting regional economic and social development [2] - The increasing popularity of ice and snow sports and the sustained heat of ice and snow tourism are transforming "cold resources" into a "hot economy," leading to rapid growth in the ice and snow industry. Companies with marginal improvements in ice and snow sports brands and stable dividend-paying leading enterprises are recommended for investment [2]