Market Performance - The Hong Kong stock market opened lower on January 30, with the Hang Seng Index dropping by 496.82 points, a decline of 1.78%, closing at 27,471.27 points [1] - The Hang Seng Tech Index fell by 104.83 points, down 1.79%, to 5,736.27 points, while the National Enterprises Index decreased by 2.08% to 9,354.3 points [1] - Major tech stocks experienced declines, with Alibaba down 2.71%, Tencent down 1.53%, and JD Group down 1.4% [1] Company Earnings Forecasts - Guoquan (02517.HK) expects revenue for 2025 to be approximately 7.75 billion to 7.85 billion yuan, a year-on-year increase of about 19.8% to 21.3%, with net profit projected at 443 million to 463 million yuan, up 83.7% to 92.0% [2] - Sunny Optical Technology (02382.HK) anticipates a net profit of 4.5886 billion to 4.7235 billion yuan for 2025, representing a year-on-year increase of approximately 70.0% to 75.0% [3] - Baidu (02315.HK) forecasts revenue of 1.369 billion to 1.389 billion yuan for 2025, with a net profit of 162 million to 182 million yuan, reflecting a significant increase of 384.26% to 443.88% [3] - Spring Medical (01858.HK) expects a net profit of 245 million to 288 million yuan for 2025, an increase of 96.01% to 130.41% [4] - Encounter Small Noodles (02408.HK) projects a net profit between 100 million to 115 million yuan for 2025, an increase of approximately 64.7% to 89.5% [5] - Macro Credit Development (09930.HK) issued a profit warning, expecting a decline in shareholder profit by 70% to 90% for 2025 [6] - Financial Street Securities (01476.HK) issued a profit alert, expecting a shareholder profit increase to approximately 327 million yuan for 2025 [7] Industry Insights - China Railway (00390.HK) recently won several major engineering contracts with a total bid amount of approximately 43.292 billion yuan [8] - New天绿色能源 (00956.HK) reported a cumulative power generation of 15.2104 million MWh for 2025, a year-on-year increase of 7.71% [9] - Huayi Pharmaceutical (01276.HK) received acceptance for a new indication application for its innovative drug, which may become a new treatment option for patients with unresectable liver cancer [9] - Citic Securities suggests focusing on three main lines in the short term: biomanufacturing, embodied intelligence, and 6G technology [11] - Guoyuan International believes that the Hong Kong stock market may continue to outperform the US market due to factors such as fiscal cliffs and geopolitical issues, benefiting from the low long-term valuation levels [12]

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 ...

Core Viewpoint - The company, Gilead Sciences-B (01672.HK), announced positive topline results from a Phase III open-label study of its first-in-class oral small molecule fatty acid synthase (FASN) inhibitor, denifasertib (ASC40), in patients with moderate to severe acne vulgaris [1] Group 1: Study Overview - The Phase III study was conducted in China and involved 240 patients with moderate to severe acne vulgaris [1] - The study aimed to evaluate the long-term safety of denifasertib (ASC40) over a 40-week treatment period, following a 12-week treatment with either denifasertib (ASC40) or placebo [1] Group 2: Safety and Tolerability - Key endpoints included the incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and the rate of discontinuation due to adverse events (AEs) [1] - Denifasertib (ASC40) demonstrated good safety and tolerability, with most adverse events being mild (Grade 1) or moderate (Grade 2) [1] - No Grade 3 or 4 adverse events or serious adverse events related to denifasertib (ASC40) were reported, and there were no reported deaths [1]

Core Insights - The company has announced positive topline results from a Phase III open-label study of its first-in-class oral small molecule FASN inhibitor, ASC40, for moderate to severe acne patients [1] - ASC40 demonstrated good safety and tolerability, with most adverse events being mild to moderate, and no severe adverse events reported [1] - The company has also achieved all primary and key secondary endpoints in a randomized, double-blind, placebo-controlled Phase III clinical study involving 480 patients [2] Group 1 - ASC40 was evaluated in a Phase III open-label study involving 240 moderate to severe acne patients, focusing on long-term safety [1] - The primary endpoints included the incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and the rate of discontinuation due to adverse events [1] - The study showed that there were no grade 3 or 4 adverse events related to ASC40, and no deaths were reported [1] Group 2 - The mechanism of action for ASC40 involves inhibiting de novo lipogenesis (DNL) in human sebocytes, directly reducing sebum production and inflammation [2] - Excessive sebum production is a major cause of acne, and ASC40's unique mechanism sets it apart from other acne treatments that do not address the root cause [2] - The company has obtained exclusive rights for ASC40 in Greater China from Sagimet Biosciences Inc. [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。 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]