Core Insights - The company reported significant results from the Phase III study of denifanstat (ASC40) for the treatment of moderate to severe acne at the 2025 EADV annual meeting, indicating its potential clinical importance [1] - Denifanstat (ASC40) demonstrated statistically significant and clinically meaningful improvements compared to placebo across all primary and secondary endpoints, along with good safety and tolerability profiles [1] - The company is in communication with the National Medical Products Administration (NMPA) in China regarding the pre-New Drug Application (Pre-NDA) process, with positive feedback received [1] Group 1 - Denifanstat (ASC40) is an innovative therapy in the acne treatment field [1] - The company plans to submit a New Drug Application (NDA) for denifanstat (ASC40) for the treatment of moderate to severe acne after completing pre-NDA communications with NMPA [1] Group 2 - The company has obtained exclusive rights for denifanstat (ASC40) in Greater China from Sagimet Biosciences Inc. [2]

Core Viewpoint - The company announced the presentation of significant results from the Phase III study of denifanstat (ASC40) for the treatment of moderate to severe acne at the 2025 EADV annual meeting, highlighting its innovative mechanism and positive outcomes compared to placebo [1] Group 1: Clinical Research and Results - Denifanstat (ASC40) is positioned as an innovative therapy in the acne treatment field with potential clinical significance [1] - The Phase III study demonstrated statistically significant and clinically meaningful improvements in all primary and secondary endpoints compared to placebo, along with good safety and tolerability profiles [1] Group 2: Regulatory and Market Strategy - The company is in communication with the National Medical Products Administration (NMPA) in China regarding the pre-New Drug Application (Pre-NDA) for denifanstat (ASC40) [1] - Feedback from NMPA has been positive, and the company plans to submit a New Drug Application (NDA) for denifanstat (ASC40) for the treatment of moderate to severe acne following the completion of pre-application communications [1] Group 3: Licensing Agreement - The company has obtained exclusive rights for denifanstat (ASC40) in Greater China from Sagimet Biosciences Inc. [2]

Core Viewpoint - The company reported positive results from the Phase III study of denifanstat (ASC40) for the treatment of moderate to severe acne, demonstrating significant efficacy compared to placebo and good safety and tolerability profiles [1] Group 1: Study Results - Denifanstat (ASC40) achieved all primary, key secondary, and secondary efficacy endpoints in the intent-to-treat (ITT) analysis, showing significant improvement in moderate to severe acne compared to placebo [1] - The incidence of treatment-emergent adverse events (TEAEs) was comparable between the denifanstat (ASC40) group and the placebo group, at 58.6% versus 56.3% respectively [1] - Most TEAEs were mild (Grade 1) or moderate (Grade 2) [1] Group 2: Regulatory Communication - The company is in pre-New Drug Application (Pre-NDA) communication with the National Medical Products Administration (NMPA) in China regarding denifanstat (ASC40) [1] - Feedback from the NMPA has been positive, and the company plans to submit a New Drug Application (NDA) for denifanstat (ASC40) for the treatment of moderate to severe acne following the completion of pre-application communications [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 歌禮在2025年歐洲皮膚病與性病學會(EADV)年會最新突破性研究專場 報告了同類首創脂肪酸合成酶(FASN)抑制劑地尼法司他(ASC40) 治療痤瘡的III期研究結果 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」）宣佈，在2025年9月17日於法國巴黎舉 行的2025年歐洲皮膚病與性病學會(EADV)年會最新突破性研究專場上口頭 報告了地尼法司他（denifanstat，ASC40）治療中重度尋常性痤瘡的III期研究 (NCT06192264)結果。 口頭報告細節 標題：同類首創脂肪酸合成酶(FASN)抑制劑地尼法司他治療尋常性痤瘡達到所有 ...

Core Insights - The company reported results from its ASC30 oral small molecule GLP-1 receptor agonist study at the 61st EASD Annual Meeting, indicating promising weight loss outcomes in obese subjects [1][5] Study Results - The Ib phase MAD study was randomized, double-blind, and placebo-controlled, assessing the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of ASC30 in obese participants (BMI: 30-40 kg/m²) [1] - In MAD cohort 2, ASC30 showed a 6.5% average weight reduction after 28 days of treatment, while cohort 1 showed a 4.5% reduction, both adjusted for placebo [1] - No signs of weight loss plateau were observed by day 29 [1] Pharmacokinetics - ASC30 at 20 mg and 40 mg demonstrated superior oral PK characteristics at steady state, with a positive correlation between higher drug exposure (AUC) and significant weight loss [2] - Key PK metrics for MAD cohorts are summarized, showing differences in Tmax, Cmax, AUCo-24h, and half-life (T1/2) between the two cohorts [3] Safety and Tolerability - ASC30 exhibited good safety and tolerability, with only mild to moderate gastrointestinal adverse events reported [5] - No vomiting was reported in cohort 1, while cohort 2 experienced vomiting primarily during the 10 mg dose escalation week [5] - No serious adverse events (SAE) were reported, and liver enzymes remained stable throughout the study [5]

Core Viewpoint - The stock of Gilead Sciences-B (01672) rose over 5% following the announcement of positive results from its ASC30 oral GLP-1R agonist study, indicating significant weight loss and good safety profile [1] Company Summary - Gilead Sciences reported a 5.02% increase in stock price, reaching HKD 10.88, with a trading volume of HKD 92.59 million [1] - The company announced results from a 28-day multiple ascending dose study of ASC30, showing a maximum average weight loss of 6.5% compared to baseline after treatment [1] - ASC30 demonstrated superior efficacy due to higher oral drug exposure, with good safety and tolerability, experiencing only mild to moderate gastrointestinal adverse events [1] Industry Summary - Dongwu Securities highlighted that Gilead Sciences has several catalysts in the second half of the year, with multiple important clinical data releases expected [1] - The firm anticipates that by Q4 2025, Gilead will report top-line data for ASC30 oral Phase II, ASC47 Phase I, and ASC50 Phase I trials, with ASC30 subcutaneous Phase II data expected in Q1 2026 [1] - The company plans 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]

Core Viewpoint - The stock of Gilead Sciences-B (01672) increased by over 5%, currently trading at 10.88 HKD with a transaction volume of 92.59 million HKD, following the announcement of positive results from its ASC30 oral GLP-1R agonist study [1] Group 1: Clinical Trial Results - Gilead announced that at the 61st European Association for the Study of Diabetes (EASD) conference in Vienna, it reported results from its ASC30 oral GLP-1R agonist 28-day multiple dose escalation study [1] - The ASC30 oral tablet showed an average weight loss of up to 6.5% after 28 days of treatment, adjusted for placebo [1] - The efficacy of ASC30 is attributed to its higher oral drug exposure, with good safety and tolerability, experiencing only mild to moderate gastrointestinal adverse events [1] Group 2: Future Catalysts - Dongwu Securities noted that Gilead has several catalysts in the second half of the year, with multiple important clinical data expected to be disclosed [1] - The firm anticipates that by Q4 2025, Gilead will read out phase II topline data for ASC30 oral, phase I data for ASC47, and phase I data for ASC50, with phase II topline data for ASC30 subcutaneous expected in Q1 2026 [1] - The company plans to submit 2-3 new IND applications to the FDA for its pipeline, including a dual-target peptide weight loss program, within the next 6-9 months [1]

Group 1: Hong Kong Stock Market Highlights - NIO-SW (09866) rose over 9% ahead of the NIO Day 2025 event on September 20, where the new ES8 will be launched [1] - Home appliance stocks collectively increased, with Haier Smart Home (06690) up over 4%, Hisense Home Appliances (00921) nearly 3%, and Midea Group (00300) up nearly 1%, as retail sentiment improved with the arrival of the third batch of national subsidies in August [1] - Baidu Group (09888) surged over 16% following a strategic cooperation framework agreement signed with China Merchants Group in Shenzhen on September 15 [1] - Guofu Hydrogen Energy (02582) fell over 4% after signing a cooperation agreement with South Korea's Hylium Industries, focusing on hydrogen energy systems [1] - Aneng Logistics (09956) rose nearly 1% after Morgan Stanley issued its first research report on the company, giving it an "overweight" rating [1] - Lingbang Group (02230) increased over 10% after announcing the establishment of a new subsidiary, Medialink Japan, set to launch on August 8, 2025 [1] Group 2: Sector Performance - Hesai Technology (02525) declined nearly 2% despite a "buy" rating from CMB International, which raised revenue forecasts for 2026-2027 by about 2% and net profit forecasts by 6%-7% [2] - Gold stocks collectively fell, with Chifeng Jilong Gold Mining (06693) down over 4%, Lingbao Gold (03330) down over 4%, Zhaojin Mining (01818) down over 3%, and Zijin Mining (02899) down over 2%, influenced by the Federal Reserve's interest rate outlook and the performance of the Chinese stock market [2] - Cement stocks experienced a downturn, with Dongwu Cement (00695) down over 12%, Western Cement (02233) down over 2%, Huaxin Cement (06655) down over 1%, and Anhui Conch Cement (00914) down over 1%, as August cement production fell 6.2% year-on-year to 148 million tons, indicating weak demand in the off-season [2] - Gilead Sciences-B (01672) rose over 1% after reporting results from its ASC30 oral small molecule GLP-1R agonist study at the 61st European Association for the Study of Diabetes annual meeting [2] Group 3: US Stock Market Highlights - Webtoon (WBTN.US) surged 39.04% after Disney announced plans to acquire a 2% stake and collaborate on a digital platform for Disney comic content [3] - Tesla (TSLA.US) rose 2.82% as Elon Musk announced plans for a technical evaluation of the AI5 chip design and a meeting regarding AI/autonomous driving systems [3] - Oracle (ORCL.US) increased 1.49% amid reports that it may play a key role in a potential TikTok deal that would allow the platform to continue operating in the US [3] - Yum China (YUMC.US) rose 2.23% as Morgan Stanley highlighted its resilient earnings and stable shareholder returns, maintaining an "overweight" rating [3] - Taiwan Semiconductor Manufacturing Company (TSM.US) increased 0.57% as Nvidia considers adopting TSMC's advanced process for future production [3] - Micron Technology (MU.US) rose 0.67% with reports of a potential 30% price increase for storage products, leading several major firms to raise their target prices ahead of earnings [3] Group 4: Additional US Stock Highlights - Trip.com (TCOM.US) rose 3.32% after completing the acquisition of Key Travel, with reports of increased travel intentions among residents during the upcoming Mid-Autumn Festival and National Day holidays [4] - Pinduoduo (PDD.US) increased 1.31% as Goldman Sachs reported a recovery in GMV for its Temu platform, with monthly active users growing by 20% [4] - Novo Nordisk (NVO.US) rose 2.84% after announcing that its oral semaglutide has been approved by European regulators for reducing cardiovascular risks [4] - NetEase (NTES.US) increased 1.45% as Goldman Sachs noted strong performance driven by popular games and expected sales growth in Q3 [5] - Apple (AAPL.US) rose 0.61% as Goldman Sachs indicated strong pre-order demand for the iPhone 17, supporting an 8% growth forecast for iPhone revenue in Q4 [5]

Group 1 - US stock indices collectively declined overnight, while the China concept index surged by 1.76% [1] - Hong Kong's three major indices opened higher, with the Hang Seng Index rising by 0.44%, the National Index by 0.52%, and the Hang Seng Tech Index by 0.91% [1] - Major technology stocks in Hong Kong saw significant gains, with Baidu up nearly 7%, JD.com up 3%, and Alibaba up 2.74% [1] Group 2 - Biopharmaceutical stocks continued to perform well, with Baize Medical rising nearly 15%, and other companies like Rongchang Bio, WuXi AppTec, and Genscript also showing gains [1] - Various sectors including port and shipping stocks, autonomous driving concepts, tourism, semiconductor, and aviation stocks experienced upward movement [1] - Conversely, local Hong Kong bank stocks, nuclear power stocks, paper industry stocks, and gold stocks mostly declined [1] Group 3 - Alibaba's performance significantly influenced the Hong Kong market, with the Hong Kong Technology ETF (159747) and the Hang Seng Index ETF (513600) both rising over 1% [1] - The Hong Kong market has seen a four-day rally, surpassing the 26,000-point mark, with accelerated capital inflow into the Hang Seng Tech Index ETF (159742), which attracted over 800 million in the last 20 days [1] - Year-to-date, the Hang Seng Tech ETF and the Hang Seng Technology ETF from E Fund have both increased by over 28%, with net inflows exceeding 49 billion into the Hang Seng Technology ETF [1]

Core Viewpoint - The company reported positive results from its ASC30 oral GLP-1 receptor agonist in a 28-day multi-dose escalation study, indicating significant weight loss in obese subjects [1][5]. Group 1: Study Results - In MAD cohort 2, ASC30 showed a 6.5% average weight loss after 28 days of treatment, adjusted for placebo [1]. - In MAD cohort 1, ASC30 demonstrated a 4.5% average weight loss after 28 days of treatment, adjusted for placebo [1]. - No signs of weight loss plateau were observed by day 29 [1]. Group 2: Pharmacokinetics - ASC30 at 20 mg and 40 mg showed superior oral pharmacokinetic characteristics at steady state, with a positive correlation between higher AUC and significant weight loss [2]. - Key pharmacokinetic parameters for MAD cohorts are summarized, showing Tmax of 8 hours for both cohorts, with Cmax of 272±101 ng/mL for cohort 1 and 397±274 ng/mL for cohort 2 [3]. Group 3: Safety and Tolerability - ASC30 exhibited good safety and tolerability, with only mild to moderate gastrointestinal adverse events reported [5]. - No vomiting was reported in cohort 1, while cohort 2 experienced vomiting primarily during the 10 mg dose escalation week [5]. - No serious adverse events were reported, and liver enzymes remained stable throughout the treatment [5].