Group 1 - The company believes its current stock price is undervalued and has decided to increase the share buyback fund from a maximum of HKD 300 million to HKD 500 million as of December 15, 2025 [1] - The increase in buyback funds is attributed to significant achievements, including a 13-week Phase II study in the US showing a weight reduction of up to 7.7% for the oral small molecule GLP-1 agonist ASC30 in overweight or obese subjects, with better gastrointestinal tolerance [1] - The selective small molecule agonist ASC47, targeting thyroid receptor β (THRβ), showed a weight reduction improvement of up to 56.2% when combined with semaglutide compared to semaglutide alone in obese subjects [1] Group 2 - The company’s financial position is stable, and the board believes the current trading price does not reflect its intrinsic value [2] - The updated share buyback proposal is expected to enhance the value of the shares and increase shareholder returns, reflecting the company's confidence in its long-term business prospects and growth potential [2] - As of October 2, 2025, the company has utilized approximately HKD 54.28 million (excluding expenses) to repurchase 4.586 million ordinary shares under the buyback authorization [2]

Group 1: Market Movements - Baoji Pharmaceutical-B (02659) surged over 3.2% amid its debut on the Hong Kong Stock Exchange, closing up 138.82% on its first day, with a market capitalization exceeding HKD 20 billion [1] - New Energy (01799) and Xinyi Solar (00968) saw declines of 3.01% and 3.67% respectively, as the photovoltaic sector faced weakness, with rumors of a 30 billion yuan investment for capacity storage by major companies [1] - Xpeng Motors-W (09868) and Li Auto-W (02015) dropped 4.88% and 2.67% respectively, following data from the China Association of Automobile Manufacturers indicating a month-on-month increase in production and sales [1] Group 2: Company-Specific News - Bolek Vision Cloud-B (02592) experienced a significant drop of nearly 15%, having previously doubled in price over 10 trading days, as it announced a new drug trial application to the FDA [2] - Hu Shang Ayi (02589) rose nearly 6% as Nayuki Tea expanded into the U.S. market, enhancing the international presence of Chinese tea brands [2] - Gold stocks fell sharply, with Zijin Mining (02899) and Shandong Gold (01787) declining by 4.29% and 4.94% respectively, following a report on the Bloomberg Commodity Index's upcoming rebalancing [2] Group 3: Cryptocurrency and Technology - Cryptocurrency ETFs faced significant declines, with notable drops in Bitcoin and Ethereum-related funds, as Bitcoin fell 3.3% from its record high, reflecting market pressures amid weak liquidity [3] - Oracle (ORCL.US) continued its downward trend, dropping 2.66% due to delays in delivering AI data centers for OpenAI, attributed to labor and material shortages [6] - Nvidia (NVDA.US) saw a slight increase of 0.73% after announcing the release of its third-generation language model, aimed at writing and programming tasks [6]

Core Viewpoint - Gilead Sciences-B (01672) shows a recovery of nearly 3%, with a current increase of 2.01% to HKD 13.2, and a trading volume of HKD 31.84 million [1] Group 1: Clinical Trial Results - On December 15, Gilead Sciences-B announced positive topline results from a randomized, double-blind, placebo-controlled Phase I clinical trial (NCT07024602) conducted in the United States [1] - The trial involved 46 healthy subjects who received single doses of ASC50 at varying strengths (10 mg, 30 mg, 100 mg, 200 mg, 400 mg, or 600 mg) or matching placebo [1] - The study aimed to evaluate the safety, tolerability, pharmacokinetics, and targeted binding characteristics of interleukin-17A (IL-17A) in peripheral circulation [1] Group 2: Product Information - ASC50 is an orally administered small molecule IL-17 targeted inhibitor developed by Gilead, which has been validated biologically and holds significant commercial value for various autoimmune and inflammatory diseases, including psoriasis [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 patent extensions) [1]

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]

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 Insights - Ascletis Pharma Inc. announced positive topline results from a Phase I clinical trial for ASC50, an oral small molecule inhibitor targeting IL-17, indicating favorable safety, tolerability, and pharmacokinetics [3][5][7] Group 1: Clinical Trial Results - The Phase I clinical trial was randomized, double-blind, and placebo-controlled, involving 46 healthy participants who received varying doses of ASC50 [3] - ASC50 demonstrated a dose-proportional pharmacokinetic profile from 10 mg to 600 mg, with an elimination half-life ranging from 43 to 104 hours depending on the dose [1][2][8] - All adverse events reported were mild and transient, with no serious adverse events or discontinuations noted during the study [8] Group 2: Target Engagement and Efficacy - Strong target engagement was observed with elevated plasma IL-17A levels persisting until day 7 for higher doses of ASC50 [1][8] - The drug showed higher absolute oral bioavailability and longer half-life compared to another IL-17 inhibitor currently in clinical development [8] Group 3: Future Development - Based on the positive results, ASC50 is advancing to the next phase of clinical development, focusing on multiple ascending doses in participants with mild to moderate plaque psoriasis [5] - ASC50 is positioned as a potential best-in-class oral small molecule IL-17 inhibitor, developed using Artificial Intelligence-assisted Structure-Based Drug Discovery technology [6][7]

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 ...

Core Viewpoint - The company, Gilead Sciences-B (01672), has seen a significant stock price increase of over 7%, currently trading at 11.62 HKD with a transaction volume of 56.46 million HKD, following the announcement of a share buyback plan using up to 300 million HKD [1] Group 1: Share Buyback Announcement - The board of directors has decided to exercise the buyback authorization and will repurchase shares in the open market based on market conditions [1] - The company plans to utilize a maximum of 300 million HKD for the proposed share buyback [1] Group 2: Clinical Data and Future Plans - Dongwu Securities has indicated that the company has multiple catalysts in the second half of the year, with several important clinical data releases expected [1] - The company is anticipated to report top-line data for ASC30 oral Phase II, ASC47 Phase I, and ASC50 Phase I by Q4 2025, and for ASC30 subcutaneous Phase II by Q1 2026 [1] - The company expects to submit 2-3 new IND applications to the FDA within the next 6-9 months, including a dual-target peptide weight loss pipeline [1]