消息面上，歌礼制药公布，董事会已决定行使购回授权，并根据市况不时于公开市场购回股份，以使用 最多3亿港元的资金进行建议股份购回。东吴证券此前指出，公司下半年催化剂较多，多个重要临床数 据即将披露：根据临床试验进度和公司公告，该行预计2025年Q4将读出ASC30口服II期、ASC47的I期 及ASC50的I期顶线数据，2026年Q1将读出ASC30皮下注射II期顶线数据。同时公司预计未来6-9个月将 向FDA申报2-3个新管线的IND，包含双靶点多肽减重管线。 歌礼制药-B(01672)再涨超7%，截至发稿，涨6.8%，报11.62港元，成交额5646.13万港元。 ...

消息面上，歌礼制药公布，董事会已决定行使购回授权，并根据市况不时于公开市场购回股份，以使用 最多3亿港元的资金进行建议股份购回。东吴证券此前指出，公司下半年催化剂较多，多个重要临床数 据即将披露：根据临床试验进度和公司公告，该行预计2025年Q4将读出ASC30口服II期、ASC47的I期 及ASC50的I期顶线数据，2026年Q1将读出ASC30皮下注射II期顶线数据。同时公司预计未来6-9个月将 向FDA申报2-3个新管线的IND，包含双靶点多肽减重管线。 智通财经APP获悉，歌礼制药-B(01672)再涨超7%，截至发稿，涨6.8%，报11.62港元，成交额5646.13万 港元。 ...

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ASC47聯合司美格魯肽在肥胖受試者中 較司美格魯肽單藥減重效果相對提升高達56.2% 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，在第29天時，減重不減肌候選藥物 ASC47與司美格魯肽聯用在肥胖受試者（體重指數≥30 kg/m²）中較安慰劑與司美格 魯肽聯用（司美格魯肽單藥）減重效果相對提升高達56.2%。 ASC47-103研究(NCT06972992)是一項在美國開展的隨機、雙盲、安慰劑對照的 研究，旨在評估超長效皮下注射ASC47單次給藥與司美格魯肽（0.5毫克，每周一 次，給藥四次）聯用對比等量(volume-ma ...

Core Insights - Denifanstat (ASC40) has met all primary, key secondary, and secondary efficacy endpoints in treating moderate-to-severe acne compared to placebo [1][6][11] - The drug demonstrated a favorable safety and tolerability profile, with treatment-emergent adverse events (TEAEs) comparable to placebo [1][9] Efficacy Results - The Phase III clinical trial involved 480 patients, randomized into treatment and placebo groups, showing significant improvements in multiple efficacy endpoints after 4 weeks and 12 weeks of treatment [4][6] - Primary endpoints included a treatment success rate of 33.17% for denifanstat compared to 14.58% for placebo, with a p-value of <0.0001 [5][6] - Percent reductions from baseline to week 12 in total lesion count (TLC) and inflammatory lesion count (ILC) were 57.38% and 63.45% for denifanstat, respectively, both statistically significant [6][7] Safety Profile - The incidence of TEAEs was 58.6% for denifanstat and 56.3% for placebo, with most events being mild or moderate [9] - Notable TEAEs included 6.3% dry skin and 5.9% xerophthalmia in the denifanstat group, with no serious adverse events reported [9] Regulatory Progress - Ongoing pre-New Drug Application (NDA) consultation with the China National Medical Products Administration (NMPA) has yielded encouraging feedback, with plans to submit an NDA for denifanstat after consultation completion [2][11] Company Background - Ascletis Pharma Inc. is focused on developing and commercializing innovative therapeutics for metabolic diseases, utilizing advanced drug discovery platforms [13]

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]

Core Insights - Ascletis Pharma Inc. presented promising results for its oral small molecule GLP-1 receptor agonist ASC30, demonstrating significant body weight reduction in participants with obesity during a 28-day multiple ascending dose study [3][4][9] Group 1: Study Results - ASC30 achieved a 6.5% placebo-adjusted mean body weight reduction from baseline in MAD cohort 2 after 28 days of treatment [4] - In MAD cohort 1, ASC30 showed a 4.5% placebo-adjusted mean body weight reduction from baseline after the same treatment duration [4] - The study indicated no signs of a plateau effect at Day 29, suggesting continued efficacy [4] Group 2: Safety and Tolerability - ASC30 was found to be safe and well tolerated, with only mild to moderate gastrointestinal adverse events reported [2][6] - No serious adverse events were recorded, and there were no Grade 3 or higher adverse events observed [7] - The titration strategy from 2 mg to 5 mg in MAD cohort 1 resulted in zero incidence of vomiting, indicating an appropriate escalation pace [6] Group 3: Pharmacokinetics - Higher doses of ASC30 (20 mg and 40 mg) demonstrated a superior pharmacokinetic profile, with a positive correlation between the area under the curve (AUC) and body weight reduction [5] - The pharmacokinetic data showed that the maximum concentration (Cmax) for MAD cohort 2 was 397 ng/mL, compared to 272 ng/mL for MAD cohort 1 [5] Group 4: Future Outlook - The company anticipates reporting topline results from the 13-week Phase IIa study of ASC30 in the fourth quarter of this year [9] - ASC30 is positioned as a differentiated treatment option for obesity, with both oral and subcutaneous administration routes [10][11]

Core Viewpoint - The article highlights the positive market response to the announcement by Gilead Sciences-B (01672) regarding its long-acting subcutaneous formulation ASC30 for weight management, which shows a promising 75-day apparent half-life in obese subjects, indicating potential for quarterly dosing in the future [1] Company Developments - Gilead Sciences' stock rose over 4%, reaching HKD 11.63 with a trading volume of HKD 37.09 million following the announcement [1] - The ASC30 formulation is developed using Gilead's Ultra Long-Acting Pharmaceutical (ULAP) platform, showcasing the company's innovation in drug development for obesity management [1] Clinical Trials and Future Prospects - Gilead's major shareholder has committed to a voluntary lock-up, agreeing not to sell any shares before the release of three key clinical data points: 1. Topline data from the U.S. Phase I clinical study of ASC47 combined with semaglutide, expected by the end of September 2025 2. Topline data from the U.S. 13-week Phase IIa clinical study of ASC30 oral tablets in overweight or obese subjects, expected by December 2025 3. Topline data from the U.S. Phase I single ascending dose study of ASC50 in healthy subjects, expected by December 2025 [1]

Core Viewpoint - The stock of Gilead Sciences-B (01672) rose over 4% following the announcement of promising clinical data for its long-acting GLP-1R agonist ASC30, indicating potential for quarterly dosing in weight management [1] Group 1: Clinical Developments - Gilead announced that its small molecule GLP-1R agonist ASC30 has shown a 75-day apparent half-life in obese subjects, suggesting a long-term weight management solution [1] - The ASC30 formulation is developed using Gilead's Ultra Long-Acting Drug Development Platform (ULAP) [1] Group 2: Shareholder Commitments - Gilead's controlling shareholder has made a voluntary lock-up commitment, agreeing not to sell any shares before the release of three key clinical data points [1] - The three data points include: 1. Topline data from the U.S. Phase I clinical study of ASC47 combined with semaglutide, expected by the end of September 2025 [1] 2. Topline data from the U.S. 13-week Phase IIa clinical study of ASC30 oral tablets in overweight or obese subjects, expected by December 2025 [1] 3. Topline data from the U.S. Phase I single ascending dose study of ASC50 in healthy subjects, expected by December 2025 [1]

Investment Rating - The report maintains an investment rating of "Outperform the Market - A" [6] Core Insights - The report highlights the promising clinical data of BaiLi Tianheng's EGFR/HER3 dual antibody ADC, iza-bren, for treating EGFR mutation lung cancer, which shows potential for further clinical advancement [2][3][20][21][23] Summary by Sections Weekly New Drug Market Review - From September 8 to September 14, 2025, the top five gainers in the new drug sector were: - Saintno Pharmaceutical (+32.00%) - Junshengtai (+23.73%) - Canaan Bio (+20.43%) - Rongchang Bio (+16.52%) - Hengrui Medicine (+11.91%) - The top five losers were: - Basestone Pharmaceuticals (-18.90%) - Laika Pharmaceuticals (-18.12%) - Gilead Sciences (-16.93%) - Maiwei Bio (-14.41%) - Yifang Bio (-12.46%) [1][15] Recommended Stocks to Watch - The report suggests focusing on several potential catalysts in the sector, including academic conferences, business development realizations, and insurance negotiations. Key stocks to watch include: 1. Potential overseas licensed MNC heavyweights: - Differentiated GLP-1 assets: Zhongsheng Pharmaceutical, Gilead Sciences, Borui Pharmaceutical, Kangyuan Pharmaceutical - Upgraded PD-1 products: Kangfang Bio and other PD-1/VEGF assets, Innovent Biologics - Breakthroughs in autoimmune fields: Yifang Bio, China Antibody - Innovative target ADCs: Fuhong Hanlin, Shiyao Group 2. MNC-certified products with high overseas volume certainty: - Upgraded PD-1 products: Sanofi Pharmaceutical - GLP-1 assets: Lianbang Pharmaceutical - ADC assets: Kelong Botai, BaiLi Tianheng 3. Products likely to benefit from insurance negotiations and innovative drug directories [2][20] New Drug Industry Focus Analysis - At the recent 2025 World Lung Cancer Conference (WCLC), BaiLi Tianheng presented results from two studies on its EGFR×HER3 dual antibody ADC, iza-bren, showing excellent clinical data in both first-line and second-line treatments for advanced or metastatic EGFR mutation NSCLC. The results indicate a promising future for its application in relevant indications [2][20][21] New Drug Approval and Acceptance Status - No new drug or new indication applications were approved this week, but seven new drug or new indication applications were accepted [3][25] Clinical Application Approval and Acceptance Status - This week, 41 new drug clinical applications were approved, and 46 new drug clinical applications were accepted [9][28]