| 受理品种目录浏览 | 在审品种目录浏览 | | | | | --- | --- | --- | --- | --- | | 年 度: | 2026 > | 药品类型: | 実部 | > 申请类 | | 受理号: | 请输入受理号 | 药品名称: | 请输入药品名称 | 企业名: | | 序号 | 受理号 | 药品名称 | 药品类型 | 申请类型 | | 1 | JXHS2600014 | 奥氟格列隆片 | 化药 | 进口 | 智通财经APP获悉，1月10日，CDE网站显示，礼来(LLY.US)的小分子GLP-1R激动剂奥氟格列隆(Orforglipron)在华申报上市。此前，该药物在2025年11月被 纳入FDA特批药物名单，礼来已于2025年12月向FDA递交该药物用于减重的上市申请。 截至今日，奥氟格列隆已顺利完成7项III期研究，其中4项针对2型糖尿病人群(ACHIEVE-1、ACHIEVE-2、ACHIEVE-3、ACHIEVE-5)，2项针对肥胖或超重 人群(ATTAIN-1、ATTAIN-MAINTAIN)，1项针对伴2型糖尿病的肥胖或超重人群(ATTAIN-2)，相关结果也已披露。 ...

Core Viewpoint - The approval of the IND for ASC30 by the FDA marks a significant milestone for the company, potentially enhancing its market position in the diabetes treatment sector [1] Group 1: Company Developments - The stock price of Gilead Sciences-B (01672) increased by over 5%, reaching HKD 12.12 with a trading volume of HKD 2.7083 million [1] - On January 5, Gilead Sciences-B announced the FDA's approval for its oral small molecule GLP-1, ASC30, for a Phase II clinical trial in diabetic patients [1] - ASC30 is the first and only small molecule GLP-1 receptor agonist in clinical research that can be administered either orally once daily or via subcutaneous injection monthly to quarterly [1] Group 2: Clinical Trial Details - The Phase II study is a 13-week, randomized, double-blind, placebo-controlled, multi-center trial aimed at evaluating the efficacy, safety, and tolerability of ASC30 in Type 2 diabetes patients [1] - The primary endpoint of the Phase II study is the average change in glycated hemoglobin (HbA1c) from baseline at 13 weeks, comparing the treatment group to the placebo group [1]

歌礼制药-B(01672)公布，近期已获得美国食品药品监督管理局(FDA)对其口服小分子GLP-1，ASC30， 在糖尿病受试者中的II期研究的新药临床试验(IND)的批准。该II期研究是一项为期13周、随机、双盲、 安慰剂对照及多中心的研究，旨在评估ASC30在2型糖尿病受试者中的疗效、安全性和耐受性。 由歌礼自主研发的ASC30是首款也是唯一一款正在临床研究中的、既可每日一次口服也可每月一次至每 季度一次皮下注射的小分子GLP-1R完全偏向激动剂，用于肥胖症、糖尿病及其它代谢疾病的治疗。 "随着我们持续积累ASC30的相关研究数据，此项用于糖尿病治疗的II期研究的IND获批是歌礼的一项重 要里程碑，"歌礼创始人、董事会主席兼首席执行官吴劲梓博士表示，"此外，FDA对于我们的IND申请 的批准，为ASC30进军庞大的糖尿病治疗市场进行临床开发拓宽了道路。" 该II期研究的主要终点是至13周时，治疗组与安慰剂组相比，糖化血红蛋白(HbA1c)相对基线的平均变 化。次要终点包括：至13周时，治疗组与安慰剂组相比，空腹血糖相对基线的平均变化;至13周时，治 疗组与安慰剂组相比，体重相对基线的平均变化;以及安全性和 ...

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。 （於開曼群島註冊成立的有限公司） （股份代號：1672） 自願性公告 歌禮宣布其口服小分子GLP-1，ASC30，在糖尿病受試者中的 13周II期研究IND獲美國FDA批准 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，近期已獲得美國食品藥品監督管理局 (FDA)對其口服小分子GLP-1，ASC30，在糖尿病受試者中的II期研究的新藥臨床 試驗(IND)的批准。該II期研究是一項為期13周、隨機、雙盲、安慰劑對照及多中 心的研究，旨在評估ASC30在2型糖尿病受試者中的療效、安全性和耐受性。該II 期研究的主要終點是至13周時，治療組與安慰劑組相比，糖化血紅蛋白(HbA1c) 相對基線的平均變化。次要終點包括：至13周時，治療組與安慰劑組相比，空腹 血糖相對基線的 ...

Core Viewpoint - The completion of subject enrollment in the Phase IIa study for ASC30, a novel GLP-1 receptor agonist for obesity treatment, marks a significant milestone in the development of this innovative therapy [1] Company Summary - Songlei Pharmaceutical-B (01672.HK) has announced the completion of subject enrollment for its monthly subcutaneous depot formulation of the small molecule GLP-1 receptor agonist ASC30 in the United States [1] - The study involved 65 participants, all of whom are either obese or overweight individuals with at least one weight-related comorbidity [1] - The CEO of Songlei, Dr. Wu Jinzi, highlighted the importance of this milestone, indicating substantial progress in the development of ASC30 [1] Product Summary - ASC30 is the first and only small molecule GLP-1 receptor agonist that can be administered either orally once daily or via subcutaneous injection once a month to once a quarter [1] - The product is designed for both weight loss treatment and weight maintenance therapy, aimed at long-term weight management [1] - ASC30 features a prolonged apparent half-life of 46 days and a superior peak-to-trough ratio of approximately 1.5, positioning it as a promising monthly treatment option for obesity [1] - Topline data from the Phase IIa study is expected to be available in the first quarter of 2026 [1]

Core Viewpoint - The stock of Gilead Sciences-B (01672) rose over 5% in early trading, driven by the announcement of a voluntary lock-up commitment from the controlling shareholder, which will prevent the sale of shares until key clinical data is released [1] Group 1: Clinical Trials and Data - Gilead Sciences announced that the controlling shareholder will not sell any company shares before the release of three key clinical data points: 1. Top-line data from the U.S. Phase I clinical trial of ASC47 combined with semaglutide in obese subjects, expected by the end of September 2025 2. Top-line data from the U.S. 13-week Phase IIa clinical trial of ASC30 oral tablets in obese or overweight subjects, expected by December 2025 3. Top-line data from the U.S. Phase I single ascending dose study of ASC50 in healthy subjects, expected by December 2025 [1][1][1] Group 2: Drug Development and Potential - The company recently announced that the small molecule GLP-1R agonist ASC30 demonstrated an apparent half-life of 75 days in obese subjects, indicating the potential for developing a long-term weight management solution with quarterly dosing [1][1] - ASC30 is developed using Gilead's Ultra-Long-Acting Drug Development Platform (ULAP), and the company has multiple pipelines relying on this platform to develop long-acting formulations, which may meet various clinical needs [1][1]

Core Viewpoint - The company is set to present clinical data for ASC30, an oral small molecule GLP-1 receptor agonist, at the 61st European Association for the Study of Diabetes (EASD) annual meeting in Vienna, Austria, highlighting its potential as a differentiated treatment for obesity [1] Group 1: Clinical Research and Development - ASC30 is currently undergoing a 28-day multiple ascending dose study (NCT06680440) [1] - The drug is characterized as a new chemical entity (NCE) with unique properties that allow for both oral and subcutaneous administration [1] - The compound is protected by patents in the U.S. and globally, with patent protection lasting until 2044, excluding any extensions [1] Group 2: Company Leadership and Vision - Dr. Wu Jinzi, the founder, chairman, and CEO of the company, expressed confidence that the efficacy and safety data presented will position ASC30 as a promising option for obesity treatment [1]

Core Viewpoint - Songlei Pharmaceutical-B has announced the completion of the Phase IIa study for its small molecule oral GLP-1R agonist ASC30, targeting obesity or overweight subjects, indicating rapid clinical advancement in a competitive market [1][2]. Group 1: Clinical Progress - ASC30 is the first and only small molecule GLP-1R agonist developed by the company that can be administered either orally once daily or via subcutaneous injection once monthly. The company initiated the Phase IIa clinical trial in early July and enrolled 125 subjects in just over a month, showcasing high efficiency. The treatment period lasts for 13 weeks, with top-line data expected in Q4 2025. Currently, the fastest progress in the global small molecule GLP-1 development pipeline is by Eli Lilly with Orforglipron, which has submitted an FDA application, while Pfizer has abandoned its small molecule GLP-1 pipeline, placing ASC30 in a competitive catch-up position [1]. Group 2: Potential and Safety Profile - ASC30 demonstrates potential to become a Best in Class (BIC) treatment due to its safety profile and rapid weight loss capabilities. According to data presented at the ADA conference from the Phase I MAD study, the average weight loss after four weeks was 6.4%. No severe adverse reactions, such as hepatotoxicity, were observed, and treatment-emergent adverse events (TEAEs) were mild, with no vomiting reported at doses of 2mg and 5mg. This positions ASC30 favorably in the market [1]. Group 3: ASC47 Development - ASC47, another small molecule THRβ agonist developed by the company, is designed for monthly injection and is currently in clinical trials in combination with semaglutide for treating obesity. ASC47 targets adipose tissue and is expected to provide synergistic effects when used with GLP-1, helping to reduce muscle loss while enhancing weight loss efficacy. The design of ASC47 allows for convenient monthly administration alongside GLP-1 [2]. Group 4: Financial Forecast - The company anticipates increased overseas clinical investment, projecting R&D expenses of 415 million, 487 million, and 540 million yuan for 2025, 2026, and 2027, respectively. The net profit attributable to the parent company is forecasted to be -372 million, -467 million, and -562 million yuan for the same years. Given the rapid clinical progress of ASC30 and ASC47, the company is positioned to achieve Best in Class potential in the small molecule weight loss drug development space, leading to a "Buy" investment rating [2].