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 ...

智通财经APP讯，歌礼制药-B(01672)发布公告，由于合资格参与者根据公司于2019年6月6日采纳的购股 权计划行使购股权，公司于2025年9月18日发行普通股合计29.56万股。 ...

歌礼制药-B(01672)发布公告，由于合资格参与者根据公司于2019年6月6日采纳的购股权计划行使购股 权，公司于2025年9月18日发行普通股合计29.56万股。 ...

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 | | 佔有關事件前的現有已發 行股份（不包括庫存股 份）數目百分比 (註3) | 庫存股份數目 | | | | 於下列日期開始時的結存(註1) 2025年9月12日 | | 992,564,706 | | 5,78 ...

Core Viewpoint - The Trump administration is drafting an executive order that will impose three major restrictions on commercial transactions involving Chinese innovative drug patents or rights, focusing on national security reviews by the Committee on Foreign Investment in the United States (CFIUS) [1][2]. Summary by Sections Executive Order Details - The draft includes three main provisions: 1. Inclusion of Chinese innovative drug BD transactions in the CFIUS mandatory review list, ending the previous "low-risk automatic exemption" practice [2]. 2. FDA will implement "racial sensitivity supplementary reviews" for drugs relying on Chinese clinical data, requiring at least 20% comparative data from non-Asian populations [2]. 3. Establishment of a "key drug domestic production fund" to provide production subsidies for 15 categories of drugs, including antibiotics and acetaminophen, while implementing a "domestic priority" principle in federal procurement [2]. Market Reaction - The market reacted swiftly to the policy risks, with the Hong Kong innovative drug index (HK1105) dropping 3.82% on September 11, 2025, and the A-share innovative drug sector (BK1106) declining 2.17%, with over 80% of stocks in the sector experiencing pullbacks [3]. - The following day, the indices showed signs of recovery, indicating investors' responses to policy uncertainties and rational corrections [3]. Globalization Trends - Despite the geopolitical risks, the trend of Chinese innovative drugs going global remains intact, with total license-out transactions to Europe and the U.S. reaching $9.43 billion as of September 2025 [3]. - Major transactions include a $950 million licensing deal between BeiGene and Royalty Pharma, and a $6 billion global licensing agreement between 3SBio and Pfizer, highlighting a shift towards milestone payments and regional licensing [3]. Industry Challenges - The domestic market faces challenges, with annual growth in medical insurance fund spending (approximately 12%) lagging behind the growth in innovative drug R&D investment (approximately 25%) [4]. - The average reduction in medical negotiations remains high at 54%, and commercial health insurance coverage for innovative drugs is below 15%, creating a supply-demand imbalance that necessitates going global [4]. Risk Resilience Assessment - Goldman Sachs has categorized Chinese innovative drug companies into three risk resilience tiers based on their sensitivity to policy changes and operational capabilities [4][5]. - Companies with mature global layouts exhibit the strongest resilience, while those heavily reliant on domestic markets show the weakest resilience [5][10]. Strategic Defense Framework - A three-dimensional defense system is proposed to address risks associated with the executive order, focusing on transaction review, data compliance, and supply chain security [13]. - Strategies include conducting national security risk pre-assessments for transactions over $50 million and establishing partnerships with U.S. law firms to navigate regulatory challenges [14][15]. Conclusion - The construction of a quantifiable "risk resilience index" is essential for Chinese innovative drugs in the global 2.0 era, emphasizing the need for companies to embed policy hedging clauses in transaction structures and consider racial diversity data in clinical stages [23].

Core Viewpoint - The company reported significant results from its Phase III study of ASC40 for the treatment of moderate to severe acne, demonstrating substantial improvement compared to placebo [1] Group 1: Company Updates - The company presented its breakthrough research on ASC40 at the 2025 European Academy of Dermatology and Venereology (EADV) annual meeting in Paris [1] - ASC40 achieved all primary, key secondary, and secondary efficacy endpoints in the intention-to-treat (ITT) analysis [1] Group 2: Industry Context - The results indicate a promising advancement in the treatment options available for moderate to severe acne, potentially impacting the dermatology market [1]

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 in Paris, highlighting its innovative mechanism of action and clinical significance [1] - Denifanstat (ASC40) demonstrated statistically significant improvements in all primary and secondary endpoints compared to placebo, 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] Company Developments - The company has obtained exclusive rights for denifanstat (ASC40) in Greater China from Sagimet Biosciences Inc. [2]

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]