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 A-share innovative drug and chemical pharmaceutical sectors experienced a strong surge, driven by the upcoming ESMO conference and the increasing visibility of Chinese pharmaceutical companies in global markets [1][4][5]. Group 1: Market Performance - Multiple stocks in the innovative drug sector saw significant gains, with Guangshentang rising over 17% and Shutaishen increasing by over 12% [1][2]. - The Hong Kong innovative drug concept also performed well, with WuXi AppTec rising over 7% [2][3]. Group 2: ESMO Conference Impact - The ESMO conference, scheduled from October 17 to 21, is expected to be a key catalyst for the innovative drug sector, showcasing significant clinical data and advancements from Chinese companies [4][5]. - The participation of Chinese pharmaceutical firms at ESMO is anticipated to enhance their global visibility and facilitate business development opportunities [5]. Group 3: Business Development and Collaborations - The ESMO conference is viewed as a critical event for potential business development collaborations, with previous high-value transactions indicating the growing global competitiveness of Chinese innovative drugs [5][6]. - The total transaction amount for Chinese innovative drugs reached $60.8 billion in the first half of 2025, reflecting a 129% year-on-year increase [5]. Group 4: R&D and Financial Performance - Recent advancements in R&D include the acceptance of a new drug application for a dual-target fusion protein by Rongchang Biopharmaceutical, marking a significant milestone in the treatment of primary IgA nephropathy [6]. - Companies like Luoxin Pharmaceutical are expected to report positive financial results, with projections indicating a turnaround from losses to profits due to strong market performance of their innovative drugs [6]. Group 5: Industry Outlook - Analysts express optimism regarding the innovative drug sector's sustainability, emphasizing the importance of clinical data, commercialization capabilities, and international expansion for future success [7]. - The trend of "innovation + internationalization" is expected to remain a core focus for the pharmaceutical industry, supported by favorable policies and improving global competitiveness [7].

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]

Policy Developments - Guizhou Province is advancing the monitoring of adverse reactions to medical institution formulations, highlighting issues such as insufficient awareness and inadequate responsibility among institutions [1] - Liaoning Province is implementing a tiered management system for outpatient medical insurance settlements at designated medical institutions starting next year, aiming to improve the efficiency of medical insurance fund usage [2] Drug and Device Approvals - GlaxoSmithKline announced that the NMPA has approved the use of its Shingrix vaccine for adults aged 18 and older with known diseases or treatments that increase the risk of shingles, addressing a significant health concern in China with approximately 6 million cases annually [2] - Shanghai Pharmaceuticals received FDA approval for its doxycycline capsules, primarily used for treating inflammatory lesions of rosacea, with projected sales of approximately $130 million in the U.S. for 2024 [3] - Gilead Sciences has completed pre-NDA communication with the NMPA regarding its new drug denifanstat for treating moderate to severe acne, planning to submit the application soon [4] - BD Medical's PleurX IPC system has been approved for clinical use in mainland China under the "Hong Kong and Macau Drug and Device Pass" policy [5] Capital Market Activities - Shanghai Guotou signed agreements with 10 general partners during the 2025 Shanghai International Biopharmaceutical Week, marking a significant step in building a comprehensive fund matrix for the biopharmaceutical industry [6][7] - Jinhai Biological announced plans to issue shares through a simplified procedure, which was approved by its board and supervisory board [8] Industry Events - Guangdong Province's Drug Inspection Institute has launched a new experimental zone for batch release, enhancing the province's capacity for vaccine quality assurance [9] Public Sentiment Alerts - Fosun Pharma announced the withdrawal of its registration application for dimethyl succinate for the treatment of non-small cell lung cancer, stating that this will not significantly impact current performance as they plan to improve the registration materials and resubmit [10]

Core Insights - The company has completed Pre-NDA communication with the National Medical Products Administration of China regarding denifanstat (ASC40) for the treatment of moderate to severe acne and plans to submit a New Drug Application soon [1][2] - Denifanstat (ASC40) has successfully met all primary, key secondary, and secondary efficacy endpoints in the Phase III study, showing significant improvement compared to placebo [2] - The safety profile of denifanstat (ASC40) is favorable, with all treatment-emergent adverse events being mild or moderate, and no severe adverse events reported [2] Company Developments - The company has completed Phase II (NCT05104125) and Phase III (NCT06192264) studies for denifanstat (ASC40) [1] - The results of the Phase III study were presented at the 2025 European Academy of Dermatology and Venereology (EADV) annual meeting in Paris on September 17, 2025 [2] - The company has obtained exclusive rights for denifanstat (ASC40) in Greater China from Sagimet Biosciences Inc. [2]

Core Insights - The company, Gilead Sciences-B (01672.HK), has recently completed pre-New Drug Application (Pre-NDA) communication with the National Medical Products Administration of China regarding denifanstat (ASC40) for the treatment of moderate to severe acne vulgaris [1][2] - Gilead plans to submit the New Drug Application shortly, following the completion of Phase II (NCT05104125) and Phase III studies (NCT06192264) for denifanstat [1] Group 1 - In the Phase III study, denifanstat (ASC40) achieved all primary, key secondary, and secondary efficacy endpoints, significantly improving moderate to severe acne vulgaris compared to placebo [2] - Denifanstat (ASC40) demonstrated 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 any serious adverse events (SAEs) associated with the treatment [2] Group 2 - Gilead reported the results of the Phase III study at the 2025 European Academy of Dermatology and Venereology (EADV) annual meeting held in Paris on September 17, 2025 [2] - The company has obtained exclusive rights for denifanstat (ASC40) in Greater China from Sagimet Biosciences Inc. (NASDAQ: SGMT) [2]