Core Viewpoint - The company, Gilead Sciences-B (01672), announced a share buyback plan, indicating confidence in its financial position and future prospects [1] Group 1 - The company will repurchase 100,000 shares at a total cost of HKD 948,700 [1] - The buyback price per share ranges from HKD 9.31 to HKD 9.60 [1] - The repurchase is scheduled for October 15, 2025 [1]

Core Viewpoint - The company, Gilead Sciences-B (01672), announced a share buyback plan, indicating confidence in its stock value and future prospects [1] Group 1 - The company will repurchase 100,000 shares at a total cost of HKD 948,700 [1] - The buyback price per share ranges from HKD 9.31 to HKD 9.60 [1] - The buyback is scheduled to take place on October 15, 2025 [1]

Core Viewpoint - The company, Gilead Sciences-B (01672.HK), announced a share buyback of 100,000 shares at a cost of HKD 949,000 on October 15 [1] Group 1 - The total expenditure for the share buyback was HKD 949,000 [1] - The number of shares repurchased was 100,000 [1]

FF305 翌日披露報表 (股份發行人 ── 已發行股份或庫存股份變動、股份購回及/或在場内出售庫存股份) 表格類別： 股票 狀態： 新提交 公司名稱： 歌禮製藥有限公司 呈交日期： 2025年10月15日 如上市發行人的已發行股份或庫存股份出現變動而須根據《香港聯合交易所有限公司（「香港聯交所」）證券上市規則》(「《主板上市規則》」)第13.25A條 / 《香港聯合交易所有限公司GEM證券 上市規則》(「《GEM上市規則》」)第17.27A條作出披露，必須填妥第一章節 。 | 第一章節 | | | | | | | | --- | --- | --- | --- | --- | --- | --- | | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | 於香港聯交所上市 | 是 | | | 證券代號 (如上市) | 01672 | 說明 | | | | | | A. 已發行股份或庫存股份變動 | | | | | | | | | | | 已發行股份（不包括庫存股份）變動 | 庫存股份變動 | 每股發行/出售價 (註4) | 已發行股份總數 | | 事件 | | 已發行股份（不包括庫存股份）數 目 | ...

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]

Group 1 - The stock of Gilead Sciences-B (01672.HK) has increased by over 4% as of October 15, reaching a price of 9.49 HKD [1] - The trading volume for Gilead Sciences-B is reported at 23.58 million HKD [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 [1] Group 1: New Drug Application - Gilead Sciences 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 [1] - The Pre-NDA communication took place from June 2025 to October 2025, with plans to submit the new drug application soon [1] Group 2: Clinical Development Candidates - Gilead Sciences has selected ASC35, a GLP-1R/GIPR dual agonist peptide, as a clinical development candidate, which is expected to be a best-in-class monthly subcutaneous injection [1] - The company plans to submit an Investigational New Drug (IND) application to the FDA for ASC35 in the second quarter of 2026, targeting obesity treatment [1] - ASC35 is being developed as both a monotherapy and combination therapy for treating cardiometabolic diseases, including obesity, diabetes, and metabolic dysfunction-related fatty liver disease (MASH) [1]

歌礼已完成地尼法司他(ASC40)治疗中重度寻常性痤疮的II期(NCT05104125)和III期研究 (NCT06192264)。 在该III期研究中，地尼法司他(ASC40)达到所有主要、关键次要及次要疗效终点(意向治疗集(ITT)分 析)，与安慰剂相比显著改善中重度寻常性痤疮。地尼法司他(ASC40)显示出了良好的安全性与耐受性特 征。所有与地尼法司他(ASC40)相关的治疗期间发生的不良事件(treatment-emergent adverse events， TEAE)均为轻度(1级)或中度(2级)。没有与地尼法司他(ASC40)相关的3级或4级TEAE，且没有与地尼法 司他(ASC40)相关的严重不良事件(SAE)。未有观察到与地尼法司他(ASC40)相关的永久性终止治疗或退 出试验的情况。 2025年9月17日，在法国巴黎举办的2025年欧洲皮肤病与性病学会(EADV)年会上，歌礼口头报告了该项 III期研究结果。 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。 歌礼制药-B(01672)发布公告，公司董事 ...

在该III期研究中，地尼法司他(ASC40)达到所有主要、关键次要及次要疗效终点(意向治疗集(ITT)分 析)，与安慰剂相比显着改善中重度寻常性痤疮。地尼法司他(ASC40)显示出了良好的安全性与耐受性特 徵。所有与地尼法司他(ASC40)相关的治疗期间发生的不良事件(treatment-emergent adverse events， TEAE)均为轻度(1级)或中度(2级)。没有与地尼法司他(ASC40)相关的3级或4级TEAE，且没有与地尼法 司他(ASC40)相关的严重不良事件(SAE)。未有观察到与地尼法司他(ASC40)相关的永久性终止治疗或退 出试验的情况。 格隆汇10月14日丨歌礼制药-B(01672.HK)宣布，已于近期与中国国家药品监督管理局就地尼法司他 (denifanstat，ASC40)治疗中重度寻常性痤疮完成新药上市申请前(Pre-NDA)沟通，并计划於近日递交新 药上市申请。该新药上市申请前(Pre-NDA)沟通自2025年6月开始，并于2025年10月结束。 歌礼已完成地尼法司他(ASC40)治疗中重度寻常性痤疮的II期(NCT05104125)和III期研究 (NCT0619 ...

Core Viewpoint - The company has completed pre-NDA communication with the National Medical Products Administration of China regarding the new drug application for denifanstat (ASC40) for the treatment of moderate to severe acne vulgaris, with plans to submit the application soon [1][2] Group 1: Drug Development Progress - Denifanstat (ASC40) has successfully completed Phase II (NCT05104125) and Phase III (NCT06192264) studies for treating moderate to severe acne vulgaris [1] - In the Phase III study, denifanstat (ASC40) met all primary, key secondary, and secondary efficacy endpoints, showing significant improvement compared to placebo [2] - The drug demonstrated good safety and tolerability, with all treatment-emergent adverse events (TEAEs) being mild (Grade 1) or moderate (Grade 2), and no Grade 3 or 4 TEAEs reported [2] Group 2: Licensing and Presentation - The company has obtained exclusive rights for denifanstat (ASC40) in Greater China 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 on September 17, 2025 [2]