HRS-7535 片是一种新型口服小分子胰高血糖素样肽-1 受体(GLP-1R)激动剂，可以通过激活人的 GLP- 1R，促进胰腺的胰岛素分泌和降低胰高血糖素分泌并抑制胃排空，还可以通过影响中枢增强饱腹感和 抑制食欲，直接减少能量的摄入。临床前数据显示 HRS-7535 可显著改善动物慢性肾脏病(CKD)症状。 全球范围内尚无口服小分子 GLP-1R 激动剂上市。截至目前，HRS-7535 片相关项目累计研发投入约 36,940 万元(未经审计)。 智通财经APP讯，恒瑞医药(01276)发布公告，近日，江苏恒瑞医药股份有限公司(以下简称"公司")子公 司山东盛迪医药有限公司收到国家药品监督管理局(以下简称"国家药监局")核准签发关于 HRS-7535 片 的《药物临床试验批准通知书》，将于近期开展临床试验。 ...

Core Viewpoint - The company has initiated clinical trials for its oral small molecule GLP-1 receptor agonist ASC30, targeting type 2 diabetes and obesity, with significant data expected by Q3 2026 [1][3]. Group 1: Clinical Trials and Results - The company announced the completion of the first dosing of ASC30 in a 13-week Phase II study for type 2 diabetes in the U.S., with top-line data anticipated in Q3 2026 [1]. - A recent 13-week Phase II study for ASC30 in treating obesity involved 125 participants, showing statistically significant and clinically meaningful weight loss of 5.4%, 7.0%, and 7.7% for daily doses of 20 mg, 40 mg, and 60 mg respectively [2]. - The overall discontinuation rate due to adverse events in the obesity study was reported at 4.8%, indicating a favorable safety profile [2]. Group 2: Strategic Implications - The expansion of ASC30's clinical development into the diabetes treatment market is viewed as a logical strategic move, providing an opportunity to establish ASC30 as a best-in-class oral therapy option for patients [3].

Group 1 - The core focus of the news is the progress of Ascletis Pharma's oral small molecule GLP-1 receptor agonist ASC30, which is undergoing clinical trials for the treatment of type 2 diabetes and obesity [1][2][3] - The Phase II study for ASC30 in treating type 2 diabetes has commenced dosing the first batch of participants, with top-line data expected in Q3 2026 [1] - A recent Phase II study for ASC30 in treating obesity involved 125 participants and demonstrated statistically significant weight loss of 5.4%, 7.0%, and 7.7% for doses of 20mg, 40mg, and 60mg respectively, with a dose-dependent effect [2] Group 2 - ASC30 is the first and only small molecule GLP-1 receptor agonist in clinical research that can be administered both orally once daily and via subcutaneous injection monthly to quarterly [2] - The overall discontinuation rate due to adverse events in the obesity study was 4.8%, indicating a favorable safety profile [2] - The CEO of Ascletis Pharma highlighted the strategic expansion of ASC30's clinical development into the large diabetes treatment market, emphasizing the potential for ASC30 to offer a best-in-class oral therapy option [3]

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） 歌禮已於近期完成一項評估ASC30治療肥胖症的13周II期研究(NCT07002905)。 該研究在美國多個中心開展，共入組125例肥胖受試者或伴有至少一種體重相關 合併症的超重受試者。在第13周的主要終點上，每日一次20毫克、40毫克和60毫 克ASC30片分別實現了5.4%、7.0%和7.7%的經安慰劑校正後平均體重下降，體 重下降具有統計學顯著性、臨床意義且呈劑量依賴性。未觀察到減重平台期。每 周滴定直至目標劑量的ASC30的嘔吐發生率約為已公布的每周滴定的orforglipron 中觀察到的嘔吐發生率的一半。每周滴定的ASC30的胃腸道耐受性與已公布的 orforglipron在III期ATTAIN-1研究中每四周滴定(titrated every four weeks)的結果 相當。在ASC30用於治 ...

Group 1 - Jiangsu Hengrui Medicine Co., Ltd. has received approval from the National Medical Products Administration (NMPA) for clinical trials of HRS-7535 tablets, which are intended for the treatment of hypertension combined with overweight or obesity [1][2] - HRS-7535 is a novel oral small molecule GLP-1 receptor agonist that promotes insulin secretion and reduces glucagon secretion, while also enhancing satiety and suppressing appetite, making it suitable for treating type 2 diabetes and weight loss [2] - The total R&D investment for HRS-7535 has reached approximately 36.94 million yuan [2] Group 2 - The company's subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., has had its injectable SHR-1826 included in the list of breakthrough therapy drugs by the NMPA [5][6] - SHR-1826 is a therapeutic biological product targeting c-Met, intended for the treatment of locally advanced or metastatic non-squamous non-small cell lung cancer in patients who have failed at least one line of systemic therapy [6][7] - The total R&D investment for SHR-1826 has reached approximately 12.55 million yuan [7]

Core Viewpoint - Heng Rui Medicine (01276) has received approval from the National Medical Products Administration for clinical trials of HRS-7535 tablets, aimed at treating hypertension combined with overweight or obesity [1] Group 1: Clinical Trial Approval - The clinical trial approval notice for HRS-7535 was issued on October 27, 2025, confirming that the drug meets the registration requirements [1] - The drug is a novel oral small molecule GLP-1 receptor agonist, which promotes insulin secretion and reduces glucagon secretion while enhancing satiety and suppressing appetite [1] Group 2: Market Potential - HRS-7535 is intended for the treatment of Type 2 Diabetes Mellitus (T2DM) and weight loss, with no oral small molecule GLP-1 receptor agonists currently available in the global market [1] - The total research and development investment for HRS-7535 has reached approximately 369.4 million yuan [1]

Core Viewpoint - Heng Rui Medicine (600276.SH) announced that its subsidiary, Shandong Shengdi Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration for the clinical trial of HRS-7535 tablets, which will be conducted soon. The drug is intended for the treatment of hypertension combined with overweight or obesity [2] Group 1: Product Development - HRS-7535 tablets are a novel oral small molecule GLP-1 receptor agonist that activates human GLP-1 receptors to promote insulin secretion from the pancreas, reduce glucagon secretion, and inhibit gastric emptying [2] - The drug also enhances satiety and suppresses appetite through central mechanisms, directly reducing energy intake, making it suitable for treating type 2 diabetes (T2DM) and weight loss [2] - There are currently no oral small molecule GLP-1 receptor agonists available on the global market [2] Group 2: Financial Investment - The cumulative research and development investment for the HRS-7535 project has reached approximately 36.94 million yuan [2]

Core Viewpoint - Heng Rui Medicine (600276.SH) announced that its subsidiary, Shandong Shengdi Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the clinical trial of HRS-7535 tablets, which will be conducted soon. The indication for this product is intended for the treatment of hypertension combined with overweight or obesity [1] Group 1 - HRS-7535 tablets are a novel oral small molecule GLP-1 receptor agonist that promotes insulin secretion from the pancreas and reduces glucagon secretion while inhibiting gastric emptying through the activation of human GLP-1R [1] - The drug also enhances satiety and suppresses appetite through central mechanisms, directly reducing energy intake, making it suitable for the treatment of type 2 diabetes (T2DM) and weight loss [1] - There are currently no oral small molecule GLP-1 receptor agonists available in the global market [1] Group 2 - The cumulative research and development investment for HRS-7535 tablets has reached approximately 369.4 million yuan [1]

Core Viewpoint - Heng Rui Medicine (600276.SH) has received approval from the National Medical Products Administration for clinical trials of HRS-7535 tablets, a new oral small molecule GLP-1 receptor agonist aimed at treating type 2 diabetes and weight loss [1]. Company Summary - The subsidiary Shandong Shengdi Pharmaceutical Co., Ltd. of Heng Rui Medicine is set to initiate clinical trials for HRS-7535 tablets shortly [1]. - HRS-7535 functions by activating GLP-1 receptors to promote insulin secretion from the pancreas, reduce glucagon secretion, and inhibit gastric emptying [1]. - The drug also enhances satiety and suppresses appetite through central mechanisms, leading to a direct reduction in energy intake [1]. Industry Summary - The development of GLP-1 receptor agonists is significant in the treatment landscape for type 2 diabetes (T2DM) and obesity, addressing both metabolic control and weight management [1].

Core Viewpoint - Heng Rui Medicine (600276.SH) has received approval from the National Medical Products Administration for clinical trials of HRS-7535 tablets, a new oral small molecule GLP-1 receptor agonist aimed at treating type 2 diabetes and weight loss [1]. Group 1: Product Development - The clinical trial approval for HRS-7535 tablets will allow the company to initiate trials in the near future [1]. - HRS-7535 functions by activating GLP-1 receptors, which promotes insulin secretion from the pancreas, reduces glucagon secretion, and inhibits gastric emptying [1]. - The drug also enhances satiety and suppresses appetite through central mechanisms, leading to reduced energy intake [1]. Group 2: Market Implications - The introduction of HRS-7535 could provide a new treatment option for type 2 diabetes (T2DM) patients, addressing both glycemic control and weight management [1].