1月30日，港股早盘低开低走，午前小幅反弹后再度震荡走低，截止午盘，恒生指数跌496.82点，跌幅 1.78%报27471.27点，恒生科技指数下跌104.83点，跌幅1.79%报5736.27点，国企指数跌2.08%，报 9354.3点，红筹指数跌2.01%，报4380.19点。 盘面上，大型科技股普遍走低，阿里巴巴跌2.71%，腾讯控股跌1.53%，京东集团跌1.4%，小米集团跌 2.73%，网易涨0.19%，美团跌0.76%，快手跌2.95%，哔哩哔哩跌1.01%； 舜宇光学科技(02382.HK)：预计2025年净利润45.886亿元至47.235亿元，同比增加约70.0%至75.0%。 百奥赛图-B(02315.HK)：预计2025年实现营业收入13.69亿元至13.89亿元，同比增加39.61%至41.65%； 净利润1.62亿元至人民币1.82亿元，同比增加384.26%到443.88%。 诺诚健华(09969.HK)：预计2025年实现营业总收入23.65亿元左右，同比增长134%左右。此外，预计首 次实现年度业绩扭亏为盈，实现净利润6.33亿元左右。 彩虹新能源(00438.HK)：预计20 ...

公司于2025年6月4日的公告中宣布地尼法司他(ASC40)在480例患者中开展的治疗中重度寻常性痤疮的 随机、双盲、安慰剂对照的III期临床研究(NCT06192264)达到所有主要、关键次要和次要终点。 歌礼制药-B(01672)发布公告，同类首创(first-in-class)、每日一次口服小分子脂肪酸合成酶(FASN)抑制剂 地尼法司他(ASC40)在中重度寻常性痤疮患者中的III期开放标签研究(NCT06248008)取得积极顶线结 果。 于近期完成的该第二项III期研究是一项在中国开展的开放标签的多中心研究，旨在评估地尼法司他 (ASC40)在240例中重度寻常性痤疮患者中的长期安全性。这240例患者均接受了40周的每日一次地尼法 司他(ASC40)治疗，且此前均接受过12周的地尼法司他(ASC40)或安慰剂治疗。主要终点包括治疗期间 发生的不良事件(treatment-emergent adverse event，TEAE)的发生率;严重不良事件(SAE)的发生率;及因不 良事件(AE)导致停药的发生率。地尼法司他(ASC40)显示出良好的安全性和耐受性特征。大部分治疗期 间发生的不良事件为轻度 ...

于近期完成的该第二项III期研究是一项在中国开展的开放标签的多中心研究，旨在评估地尼法司他 (ASC40)在240例中重度寻常性痤疮患者中的长期安全性。这240例患者均接受了40周的每日一次地尼法 司他(ASC40)治疗，且此前均接受过12周的地尼法司他(ASC40)或安慰剂治疗。主要终点包括：(1)治疗 期间发生的不良事件(treatment-emergent adverse event，TEAE)的发生率；(2)严重不良事件(SAE)的发生 率；及(3)因不良事件(AE)导致停药的发生率。地尼法司他(ASC40)显示出良好的安全性和耐受性特徵。 大部分治疗期间发生的不良事件为轻度(1级)和中度(2级)。没有与地尼法司他(ASC40)相关的3级或4级不 良事件，没有与地尼法司他(ASC40)相关的严重不良事件。未有报告死亡病例。 格隆汇1月29日丨歌礼制药-B(01672.HK)宣布，同类首创(first-in-class)、每日一次口服小分子脂肪酸合 成酶(FASN)抑制剂地尼法司他(ASC40)在中重度寻常性痤疮患者中的III期开放标签研究(NCT06248008) 取得积极顶线结果。 ...

智通财经APP讯，歌礼制药-B(01672)发布公告，同类首创(first-in-class)、每日一次口服小分子脂肪酸合 成酶(FASN)抑制剂地尼法司他(ASC40)在中重度寻常性痤疮患者中的III期开放标签研究(NCT06248008) 取得积极顶线结果。 公司于2025年6月4日的公告中宣布地尼法司他 (ASC40)在480例患者中开展的治疗中重度寻常性痤疮的 随机、双盲、安慰剂对照的III期临床研究(NCT06192264)达到所有主要、关键次要和次要终点。 地尼法司他(ASC40)治疗痤疮的作用机制是通过抑制人皮脂细胞的脂肪酸从头合成(DNL)，直接抑制皮 脂生成;和通过减少细胞因子分泌和Th17分化来抑制炎症。皮脂分泌过剩是导致痤疮的主要诱因之一， 地尼法司他(ASC40)独特的作用机制可直接减少皮脂分泌过剩，这使得地尼法司他(ASC40)独树一帜， 而其他大多数痤疮治疗药物并不针对痤疮的根本原因。 歌礼已从Sagimet Biosciences Inc.(纳斯达克股票代码：SGMT)获得地尼法司他 (ASC40)的大中华区独家 授权。 于近期完成的该第二项III期研究是一项在中国开展的开放标签 ...

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。 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，同類首創(first-in-class)、每日一次口服 小分子脂肪酸合成酶(FASN)抑制劑地尼法司他(ASC40)在中重度尋常性痤瘡患者 中的III期開放標籤研究(NCT06248008)取得積極頂線結果。 於近期完成的該第二項III期研究是一項在中國開展的開放標籤的多中心研究， 旨在評估地尼法司他(ASC40)在240例中重度尋常性痤瘡患者中的長期安全性。 這240例患者均接受了40周的每日一次地尼法司他(ASC40)治療，且此前均接受 過12周的地尼法司他(ASC40)或安慰劑治療。主要終點包括：(1)治療期間發生的 不良事件（treatment-emergent adverse event，TEAE）的發生率； ...

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]

Core Viewpoint - The company, Gilead Sciences (1672.HK), has announced that its novel FASN inhibitor, ASC40, for the treatment of acne has received acceptance for a new drug application by the National Medical Products Administration of China [1] Group 1: Clinical Trial Results - ASC40 demonstrated significant improvement in moderate to severe acne compared to placebo in a randomized, double-blind, placebo-controlled, multi-center Phase III clinical trial, achieving all primary, key secondary, and secondary efficacy endpoints [1] - The drug exhibited good safety and tolerability profiles [1]

Core Viewpoint - The announcement of the New Drug Application (NDA) acceptance for denifanstat (ASC40), a first-in-class oral small molecule fatty acid synthase (FASN) inhibitor for the treatment of moderate to severe acne, marks a significant milestone for the company in providing a potentially groundbreaking therapy for acne treatment [1][2]. Group 1 - The NDA for denifanstat (ASC40) has been accepted by the National Medical Products Administration (NMPA) of China [1]. - The company has completed Phase II (NCT05104125) and Phase III (NCT06192264) studies for denifanstat (ASC40) in treating moderate to severe acne [1]. - The Phase III study demonstrated that denifanstat (ASC40) achieved all primary, key secondary, and secondary efficacy endpoints, significantly improving moderate to severe acne compared to placebo [2]. Group 2 - Denifanstat (ASC40) exhibited good safety and tolerability, with all treatment-emergent adverse events (TEAEs) being mild (Grade 1) or moderate (Grade 2) [2]. - There were no Grade 3 or 4 TEAEs related to denifanstat (ASC40), nor were there any serious adverse events (SAEs) associated with the treatment [2]. - The company has received positive feedback from the NMPA following recent pre-NDA communications regarding the new drug application for denifanstat (ASC40) [2]. Group 3 - The company has obtained exclusive rights for denifanstat (ASC40) in the Greater China region from Sagimet Biosciences Inc. (NASDAQ: SGMT) [2]. - The results of the Phase III study were presented orally at the 2025 European Academy of Dermatology and Venereology (EADV) annual meeting held in Paris [2].

Core Viewpoint - The announcement of the acceptance of the New Drug Application (NDA) for the first-in-class oral small molecule fatty acid synthase (FASN) inhibitor, ASC40, by the National Medical Products Administration (NMPA) of China marks a significant milestone in providing a potential groundbreaking therapy for moderate to severe acne [1] Company Summary - The company, Gilead Sciences-B (01672.HK), is advancing its innovative treatment for moderate to severe acne with the drug ASC40, which is a first-in-class FASN inhibitor [1] - The CEO, Dr. Wu Jinzi, expressed excitement about the NDA acceptance, indicating that ASC40 is just one step away from commercialization [1]

Core Viewpoint - The company, Gilead Sciences-B (01672), has seen a stock increase of over 4% following the announcement of its new drug application progress for ASC40, aimed at treating moderate to severe acne, and the selection of ASC35 as a clinical development candidate for obesity treatment [1] Group 1: Drug Development Updates - Gilead has completed pre-New Drug Application (Pre-NDA) communication with the National Medical Products Administration of China regarding ASC40 for treating moderate to severe acne, with plans to submit the new drug application soon [1] - The Pre-NDA communication for ASC40 began in June 2025 and concluded in October 2025 [1] Group 2: Future Clinical Trials - Gilead has selected ASC35, a GLP-1R/GIPR dual agonist peptide, as a candidate for clinical development, expected to be submitted for an Investigational New Drug (IND) application to the FDA in the second quarter of 2026 [1] - ASC35 is being developed for use as a monotherapy and in combination therapy for treating cardiometabolic diseases, including obesity, diabetes, and metabolic dysfunction-related fatty liver disease (MASH) [1]