复星医药（600196）(600196.SH)发布公告，2025年12月9日，公司控股子公司药友制药、复星医药产业 与辉瑞共同签订《许可协议》，(其中主要包括)由药友制药就口服小分子胰高血糖素样肽-1受体(GLP- 1R)激动剂(包括YP05002)及含有该活性成分的产品授予辉瑞于许可区域(即全球范围)及领域(人类、动物 所有适应症的治疗、诊断及预防)独家开发、使用、生产及商业化权利;就本次许可，药友制药将有权依 约获得(其中包括)不可退还的首付款1.5亿美元及基于许可产品临床、商业化进展获得开发里程碑付款至 多3.5亿美元。此外，基于许可产品的年度净销售额达成情况，由辉瑞向药友制药依约支付至多15.85亿 美元的销售里程碑款项。 YP05002为集团自主研发并拥有自主知识产权的口服小分子胰高血糖素样肽-1受体(GLP-1R)激动剂;其主 要通过激活人的GLP-1R，促进胰腺的胰岛素分泌和降低胰高血糖素分泌，在胃肠道抑制胃排空和肠道 的蠕动,并通过影响中枢抑制食欲减少能量的摄入等机制，用于治疗2型糖尿病、肥胖症及其相关疾病。 YP05002拟用于代谢领域相关疾病的治疗，潜在适应症包括但不限于长期体重管理、2型 ...

Group 1 - The core point of the news is that Fosun Pharma has signed a licensing agreement with Pfizer for the development and commercialization of the oral small molecule GLP-1 receptor agonist YP05002, granting Pfizer exclusive rights globally across various therapeutic areas [1][2] - Under the agreement, Fosun Pharma's subsidiary, YaoYao Pharmaceutical, will receive an upfront payment of $150 million and up to $350 million in milestone payments based on clinical and commercialization progress [1] - Additionally, Fosun Pharma could earn up to $1.585 billion in sales milestone payments based on the annual net sales performance of the licensed product [1] Group 2 - YP05002 is an oral small molecule GLP-1 receptor agonist developed by the company, aimed at treating type 2 diabetes, obesity, and related diseases by promoting insulin secretion and reducing glucagon secretion [2] - The potential indications for YP05002 include long-term weight management, type 2 diabetes, and metabolic dysfunction-related fatty liver disease (non-alcoholic steatohepatitis) [2]

智通财经APP讯，华领医药-B(02552)发布公告，第二代葡萄糖激酶激活剂(GKA)(HMS1005，前称为 HM-002-1005)在美国开展的多剂量递增(MAD) Ib期试验中，首名患者已成功给药。该研究为随机、双 盲、安慰剂对照研究，旨在评估多剂量递增的HMS1005在美国2型糖尿病(T2D)受试者中的安全性、耐 受性、药代动力学特征及药效学作用。在此研究中，亦将通过评估在空腹和进食状态下的PD标志物(包 括血糖、胰岛素、C肽、GLP-1及胰高血糖素等)，以及通过连续血糖监测仪(CGM)监测血糖波动，进一 步探究HMS1005的作用机制及效果。 此外，MAD Ib期研究成功完成后，公司拟寻求合作伙伴，为全球市场开发HMS1005。 HMS1005为一种物理化学性质有所改善的新型分子实体。其设计为缓释制剂以允许每天服药一次，为 患者带来更多便利并增加药物于肠道中的持续时间，从而增强患者GLP-1分泌不足的修复力。此前，公 司已成功完成并公布HMS1005在美国的单剂量递增研究结果，验证其对T2D及肥胖患者每日一次口服治 疗的可行性。 ...

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而產生或因依賴 該等內容而引致的任何損失承擔任何責任。 本公告由華領醫藥（「本公司」，連同其附屬公司統稱「本集團」）自願作出，以告知 股東及潛在投資者有關本公司的最新業務發展。 本公司董事（「董事」）會（「董事會」）欣然宣佈，第二代葡萄糖激酶激活劑 （「GKA」）（HMS1005，前稱為HM-002-1005）在美國開展的多劑量遞增（「MAD」） Ib期試驗中，首名患者已成功給藥。該研究為隨機、雙盲、安慰劑對照研究，旨 在評估多劑量遞增的HMS1005在美國2型糖尿病(T2D)受試者中的安全性、耐受 性、藥代動力學特徵及藥效學作用。在此研究中，亦將通過評估在空腹和進食狀 態下的PD標誌物（包括血糖、胰島素、C肽、GLP-1及胰高血糖素等），以及通過 連續血糖監測儀(CGM)監測血糖波動，進一步探究HMS1005的作用機制及效果。 HUA MEDICINE 華領醫藥 （於開曼群島註冊成立的有限公司） （股份代號：2552） 自願性公告 HMS1005為一種物理化 ...

Core Insights - The clinical trial HARMONY for HTD1801 in Type 2 Diabetes Mellitus (T2DM) patients has shown positive results, achieving its primary endpoint and outperforming Dapagliflozin in several key cardiovascular metabolic indicators [1][2] - HTD1801 targets the root causes of T2DM, providing comprehensive cardiovascular and metabolic benefits [1] Group 1: Clinical Trial Details - HARMONY is a randomized, double-blind, positive drug-controlled Phase III clinical study involving 369 participants, assessing the efficacy and safety of HTD1801 compared to Dapagliflozin in adults with T2DM who have inadequate blood sugar control after Metformin treatment [1] - The primary endpoint was the change in HbA1c from baseline after 24 weeks of treatment, with a non-inferiority margin of 0.4% [1] - HTD1801 achieved a least squares (LS) mean change in HbA1c of -1.12%, while the Dapagliflozin group had a change of -0.93%, showing a significant difference of -0.20% (95% CI: -0.37 to -0.03; P < 0.001) [1] Group 2: Secondary Endpoints and Safety - HTD1801 demonstrated superior results compared to Dapagliflozin in lowering LDL-C and non-HDL-C, with a significantly lower proportion of patients requiring additional or intensified statin therapy [2] - HTD1801 also showed a higher percentage of patients achieving the HbA1c < 7.0% control target and a greater reduction in Lp(a) levels [2] - The safety profile of HTD1801 is favorable, with a serious adverse event rate of 3.8% compared to 4.4% in the Dapagliflozin group, and the most common adverse events were mild to moderate gastrointestinal issues, with no severe hypoglycemic events reported [2] Group 3: Future Prospects - HTD1801's ability to simultaneously regulate metabolic and inflammatory pathways allows for a more precise targeting of the core pathological mechanisms of T2DM, potentially offering comprehensive clinical benefits for patients [2] - Following the positive results from the SYMPHONY-1 and SYMPHONY-2 trials, HARMONY marks the third successful Phase III trial for HTD1801, reinforcing its strong potential as a foundational treatment for cardiorenal metabolic diseases [2] - The company plans to initiate a New Drug Application (NDA) for HTD1801 within this year [2]

Core Insights - The clinical trial HARMONY for HTD1801 in Type 2 Diabetes Mellitus (T2DM) patients has shown positive results, achieving its primary endpoint and outperforming Dapagliflozin in several key cardiovascular metabolic indicators [1][2] - HTD1801 targets the root causes of T2DM, providing comprehensive cardiovascular metabolic benefits [1] Summary by Sections Clinical Trial Results - HARMONY is a randomized, double-blind, positive drug-controlled Phase III clinical study involving 369 participants, assessing the efficacy and safety of HTD1801 compared to Dapagliflozin in adults with T2DM who have inadequate blood sugar control after Metformin treatment [1] - The primary endpoint was the change in HbA1c from baseline after 24 weeks of treatment, with HTD1801 showing a least squares (LS) mean change of -1.12% compared to -0.93% for Dapagliflozin (LS mean difference: -0.20%; 95% CI: -0.37 to -0.03; P < 0.001) [1] - HTD1801 also achieved multiple secondary endpoints, demonstrating superior reductions in LDL-C and non-HDL-C compared to Dapagliflozin, with a significantly lower proportion of patients requiring additional or intensified statin therapy [1] Safety and Tolerability - HTD1801 exhibited good safety and tolerability, with a serious adverse event rate of 3.8% (compared to 4.4% in the Dapagliflozin group) [2] - The most common adverse events in the HTD1801 group were mild to moderate gastrointestinal issues, with no severe hypoglycemic events reported [2] Future Prospects - HTD1801's ability to simultaneously regulate metabolic and inflammatory pathways positions it as a promising foundational treatment for chronic kidney and metabolic diseases (CKM) [2] - Following the positive outcomes of the SYMPHONY-1 and SYMPHONY-2 trials, HARMONY marks the third successful Phase III trial for HTD1801, reinforcing its potential [2] - The company plans to initiate a New Drug Application (NDA) for HTD1801 within the year [2]

Core Insights - Junsheng Tai Pharmaceutical-B (02511.HK) announced positive results from the Phase III clinical trial (HARMONY) of HTD1801 in patients with Type 2 Diabetes Mellitus (T2DM), achieving the primary endpoint and outperforming Dapagliflozin in several key cardiovascular metabolic indicators [1][2] Group 1: Clinical Trial Results - HARMONY (NCT06415773) is a randomized, double-blind, positive drug-controlled Phase III clinical study involving 369 participants, aimed at evaluating the efficacy and safety of HTD1801 compared to Dapagliflozin in adult T2DM patients with inadequate blood sugar control after Metformin treatment [1] - The primary endpoint was the change in HbA1c from baseline after 24 weeks of treatment, with HTD1801 showing a least squares (LS) mean change of -1.12% compared to -0.93% for Dapagliflozin, resulting in a LS mean difference of -0.20% (95% CI: -0.37 to -0.03; P < 0.001) [1][2] Group 2: Secondary Endpoints and Safety - HTD1801 significantly outperformed Dapagliflozin in reducing LDL-C and non-HDL-C, with a lower proportion of patients requiring additional or intensified statin therapy compared to the Dapagliflozin group [2] - HTD1801 also showed superior improvement in multiple cardiovascular metabolic indicators, including a higher percentage of patients achieving the HbA1c < 7.0% control target and a greater reduction in Lp(a) levels [2] - The safety profile of HTD1801 was favorable, with a serious adverse event rate of 3.8% (compared to 4.4% for Dapagliflozin), and the most common adverse events were mild to moderate gastrointestinal issues, with no severe hypoglycemic events reported [2] Group 3: Future Prospects - Overall, HTD1801 targets the core pathological mechanisms of T2DM more precisely by simultaneously regulating metabolic and inflammatory pathways, potentially offering comprehensive clinical benefits for T2DM patients [2] - Following the positive results from the SYMPHONY-1 and SYMPHONY-2 trials, HARMONY marks the third successful Phase III trial for HTD1801, reinforcing its strong potential as a foundational treatment for cardiorenal metabolic diseases (CKM) [2] - Junsheng Tai Pharmaceutical plans to initiate a New Drug Application (NDA) for the HTD1801 project within this year [2]

整理 | GLP1减重宝典内容团队 此前发表在《Diabetes Obesity Metabolism》杂志上的一篇研究， 揭示了替尔泊肽对减重后体脂分布模式的显著影响。 肥胖与2型糖尿病之间有密切的联系，而肥胖的人发展为2型糖尿病的可能性是其他人的10倍。先前的研究表明,不同的体脂分布模式(内 脏脂肪、皮下脂肪和肝脏脂肪)与分离的心代谢风险分布有关,可用于鉴别肥胖中临床意义上的亚表型。肥胖症患者的脂肪主要是作为内 脏而不是皮下脂肪储存,他们患心脏病和相关并发症的风险更高。 这项研究基于 SURPASS-3 MRI 亚研究，利用磁共振成像（MRI）技术，评估了替尔泊肽治疗一年后糖尿病患者的体脂分布情况，并与 性别与体质指数（BMI）相似的UK Biobank成像研究的虚拟对照组（VCGs）进行对比。 经研究发现，在替尔泊肽与德谷胰岛素治疗2型糖尿病的比较中，SURPASS-3试验的患者在治疗前后具有内脏脂肪（z-VAT）、腹部皮下 脂肪（z-aSAT）和肝脂肪（z-LF）水平的显著变化， 相较于VCG组的患者，替尔泊肽组的治疗可引起显著的内脏和肝脂肪水平下降， 但皮下脂肪略有增加。 研究结果显示: 使用替尔泊 ...

Core Insights - The article discusses the revolutionary impact of GLP-1 receptor agonists, particularly semaglutide, in the treatment of obesity and related metabolic disorders, highlighting their effectiveness in appetite suppression and calorie intake reduction [6] - A new oral candidate drug, ATR-258, shows promising results in preclinical studies, demonstrating similar glucose control and weight loss effects as GLP-1 injections without the common side effects associated with GLP-1 drugs [7][9] - ATR-258 is designed to selectively activate β2 adrenergic receptors, enhancing muscle metabolism while minimizing cardiac side effects, representing a significant advancement in obesity and type 2 diabetes treatment options [11][12] Group 1: GLP-1 Receptor Agonists - GLP-1 receptor agonists, such as semaglutide, require weekly injections and are effective in treating obesity, type 2 diabetes, cardiovascular diseases, and sleep apnea [6] - These drugs have transformed obesity treatment by effectively suppressing appetite and reducing caloric intake [6] Group 2: ATR-258 Development - ATR-258, a β2 adrenergic receptor partial agonist, has shown excellent pharmacokinetics and tolerability in phase 1 clinical trials involving healthy volunteers and type 2 diabetes patients [9] - The drug aims to achieve "healthy weight loss" by reducing fat without losing muscle mass, which is crucial for patients with type 2 diabetes and obesity [11] - Atrogi AB plans to conduct larger phase 2 clinical trials to validate the positive effects observed in animal models for type 2 diabetes and obesity patients [12]

Core Viewpoint - Company received acceptance notification for drug registration applications for Dapagliflozin Metformin Extended-Release Tablets (I, II, III) from the National Medical Products Administration [1] Company Summary - Dapagliflozin Metformin Extended-Release Tablets are a fixed-dose combination formulation consisting of SGLT2 inhibitor Dapagliflozin and the biguanide drug Metformin [1] - The combination aims to provide comprehensive and effective blood glucose control for adult patients with type 2 diabetes [1] Industry Summary - The product is co-developed by Bristol-Myers Squibb Company and AstraZeneca AB [1] - As of the announcement date, eight domestic companies have received approval for similar products, excluding imported ones [1]