Core Viewpoint - The announcement from Gilead Sciences-B (01672) regarding positive results from the ASC50 clinical trial has led to a nearly 3% increase in stock price, reflecting investor optimism about the drug's potential in treating autoimmune diseases [1] Group 1: Clinical Trial Results - Gilead announced positive topline results from a Phase I clinical trial (NCT07024602) for ASC50, which was a randomized, double-blind, placebo-controlled study conducted in the United States [1] - The trial involved 46 healthy participants who received varying doses of ASC50 (10 mg, 30 mg, 100 mg, 200 mg, 400 mg, or 600 mg) or a matching placebo [1] - The study aimed to evaluate the safety, tolerability, pharmacokinetics, and targeted binding characteristics of ASC50 to interleukin-17A (IL-17A) [1] Group 2: Drug Information - ASC50 is an orally administered small molecule IL-17 targeted inhibitor developed by Gilead, which has shown biological validation and commercial potential in treating psoriasis and other autoimmune and inflammatory diseases [1] - ASC50 is classified as a new chemical entity (NCE) and is protected by patents in the U.S. and globally, with patent protection lasting until 2043, excluding potential extensions [1]

Market Overview - The Hong Kong stock market opened lower on December 16, with the Hang Seng Index down 0.32% at 25,547.92 points, the Hang Seng Tech Index down 0.56% at 5,467.76 points, and the State-Owned Enterprises Index down 0.35% at 8,886.24 points. The Red Chip Index increased by 0.11% to 4,129.18 points [1] Company News - China Shenhua (01088.HK) reported coal sales of 389.5 million tons for the first 11 months, a decrease of 7.7% year-on-year. November sales were 37 million tons, down 3.6% year-on-year [2] - China Metallurgical Group (01618.HK) signed new contracts worth RMB 958.13 billion in the first 11 months, an 8.6% decrease year-on-year, with overseas contracts amounting to RMB 75 billion, a 0.4% increase year-on-year [2] - China Eastern Airlines (00670.HK) saw a 6.51% year-on-year increase in passenger capacity in November, with passenger turnover up 10.35% and a seat occupancy rate of 87.37%, up 3.04 percentage points year-on-year [2] - China Southern Airlines (01055.HK) reported an 8.68% year-on-year increase in passenger capacity in November, with passenger turnover up 10.42% and a seat occupancy rate of 86.29%, up 1.36 percentage points year-on-year [2] - New China Life Insurance (01336.HK) reported cumulative original insurance premium income of RMB 188.85 billion for the first 11 months, a 16% year-on-year increase [3] - Hopson Development Holdings (00754.HK) reported total contract sales of approximately RMB 14.27 billion for the first 11 months, an 8.91% decrease year-on-year [4] - Kaisa Group (01813.HK) reported a pre-sale amount of RMB 511 million in November, a 21.4% decrease year-on-year [5] - Genscript Biotech (01672.HK) is expected to become a leading oral small molecule IL-17 inhibitor, with positive Phase I study results in the U.S. [5] - China Supply Chain Industry (03708.HK) signed a strategic cooperation framework agreement with Golden Energy regarding digital gold assets [6] - Times China Holdings (01233.HK) had a liquidation petition against the company withdrawn [7] - Botai Car Union (02889.HK) received a project designation notice from a leading domestic electric vehicle client [8] Institutional Insights - Dongwu Securities indicated that the Hong Kong stock market is at a rebound stage, with medium to long-term investment attractiveness. Despite some overseas risks being released, there are still potential risks ahead. The market has adjusted expectations for future interest rate cuts by the Federal Reserve, which may impact risk appetite for Hong Kong stocks [9] - Guohai Securities noted that the development of assisted driving functions is entering a new regulatory phase, with a clear path for standard implementation expected between 2025 and 2027. This will create market demand driven by policy compliance, particularly in areas like driver monitoring systems and data recording systems [9][10] - CITIC Securities highlighted that targeted radionuclide therapy (TRT) is a promising direction in targeted treatment, with significant investment and development activity in the nuclear medicine sector [10]

Company News - China Shenhua (01088.HK) reported coal sales of 389.5 million tons for the first 11 months, a decrease of 7.7% year-on-year. November sales were 37 million tons, down 3.6% year-on-year [1] - China Metallurgical Group (01618.HK) signed new contracts worth RMB 958.13 billion in the first 11 months, an 8.6% decrease year-on-year, with overseas contracts amounting to RMB 75 billion, a 0.4% increase year-on-year [1] - China Eastern Airlines (00670.HK) saw a 6.51% year-on-year increase in passenger capacity in November, with passenger turnover up 10.35% year-on-year and a seat load factor of 87.37%, up 3.04 percentage points year-on-year [1] - China Southern Airlines (01055.HK) reported an 8.68% year-on-year increase in passenger capacity in November, with passenger turnover up 10.42% year-on-year and a seat load factor of 86.29%, up 1.36 percentage points year-on-year [1] - New China Life Insurance (01336.HK) recorded cumulative original insurance premium income of RMB 188.85 billion for the first 11 months, a 16% year-on-year increase [1] - AOS Group (01161.HK) announced annual results for the year ending September 30, 2025, with revenue of approximately HKD 981 million, a decrease of 0.19% year-on-year, and a net profit of HKD 80.887 million, a 19% year-on-year increase [1] - Hopson Development Holdings (00754.HK) reported total contract sales of approximately RMB 14.27 billion for the first 11 months, an 8.91% decrease year-on-year [1] - Agile Group (01813.HK) had a pre-sale amount of RMB 511 million in November, a decrease of 21.4% year-on-year [1] - Galen Pharmaceuticals (01672.HK) is expected to become a best-in-class oral small molecule IL-17 inhibitor, with positive topline results from its Phase I study in the U.S. [1] - Bole Technology (02592.HK) submitted a new drug clinical trial application for CBT-199 to the U.S. FDA [1] - China Supply Chain Industry (03708.HK) signed a strategic cooperation framework agreement with Golden Energy regarding digital assets [1] - Times China Holdings (01233.HK) had its liquidation petition withdrawn [1] - Botai Car Union (02889.HK) received a first project designation notice from a leading domestic new energy vehicle client [1] Buyback Activities - Haijia Medical (06078.HK) plans to repurchase 10% of its issued shares, with a repurchase amount of no less than RMB 300 million [1] - Tencent Holdings (00700.HK) repurchased 1.051 million shares for HKD 636 million, with repurchase prices ranging from HKD 602.5 to HKD 608 [1] - Xiaomi Group (01810.HK) repurchased 7.2 million shares for HKD 302 million, with repurchase prices ranging from HKD 41.78 to HKD 42 [1] Share Cancellation - Pacific Shipping (02343.HK) canceled 23.739 million repurchased shares [2]

Investment Rating - The report rates the pharmaceutical industry as "stronger than the market" [8]. Core Insights - The pharmaceutical sector has shown a mixed performance recently, with the SW pharmaceutical index declining by 1.04%, underperforming the CSI 300 index, which decreased by 0.08% during the week of December 8 to December 14 [3]. - Key developments include positive results from Eli Lilly's GLP-1/GIP/GCG triagonist Retatrutide in its Phase III trial, achieving significant weight loss results of 26.4% and 28.7% in treatment groups compared to 2.1% in the placebo group [3]. - Wave Life Science's siRNA candidate WVE-007 demonstrated promising results in its Phase I trial, showing a 9.4% reduction in visceral fat and a 4.5% decrease in total body fat after 12 weeks, indicating a competitive edge in obesity treatment [3]. Summary by Sections Industry Performance - The pharmaceutical sector's performance has been volatile, with various sub-sectors showing differing results. CXO and innovative drugs have seen gains, while offline pharmacies and drug distribution have struggled [3]. Key Developments - Eli Lilly's Retatrutide trial results indicate a strong potential for weight loss treatment, with safety profiles consistent with other GLP-1 receptor agonists [3]. - WVE-007's mechanism of action offers a unique advantage in fat reduction while preserving muscle mass, with a potential for infrequent dosing [3]. Investment Opportunities - The report highlights the trend of Chinese innovative drug companies expanding globally, with a focus on ADCs, bispecific antibodies, small nucleic acids, and weight loss drugs as key investment areas for 2026 [3]. - Companies such as InnoCare Pharma, WuXi AppTec, and others are noted as potential investment targets due to their promising developments [3].

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 ...

Group 1 - Hong Kong pharmaceutical stocks experienced a general decline, with notable drops in share prices [1] - Gilead Sciences-B (01672.HK) fell by 11.02%, trading at HKD 12.92 [1] - Saint Noble Pharmaceuticals-B (02257.HK) decreased by 8.27%, with a price of HKD 8.32 [1] - Hengrui Medicine-B (02142.HK) saw a decline of 7.29%, priced at HKD 12.46 [1] - Rongchang Biopharmaceutical (09995.HK) dropped by 4.87%, now at HKD 75.15 [1]

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]