A Phase 2, Multiple Ascending Dose, Open-label, Proof-of-concept Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HM15136 (Efpegerglucagon) Treatment for 8 Weeks in Subjects Aged ≥2 Years With Congenital Hyperinsulinism (CHI)

This study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of HM15136 when used as add-on therapy in subjects with CHI with persistent hypoglycemia while on standard of care treatment (SoC). HM15136 will be administered once weekly in multiple doses to subjects in multiple age including pediatric to find appropriate exposure-response data.

开始日期2022-05-05

申办/合作机构

Hanmi Pharmaceutical Co., Ltd.

NCT04167553

/ Completed临床1期

A Phase 1, Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of HM15136(Efpegerglucagon) in Obese or Overweight Subjects With Comorbidities

The planned period of each cohort is 22 weeks including subject screening, treatments for 12 weeks, and follow up period.

开始日期2019-08-30

申办/合作机构

Hanmi Pharmaceutical Co., Ltd.

NCT04032782

/ Completed临床1期

A First-in-Human, Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HM15136(Efpegerglucagon) in Healthy Subjects

This is a double-blind, randomized, placebo controlled, single ascending dose (SAD) study to investigate the safety, tolerability, PK and PD of the SC administration of HM15136 in healthy subjects.
The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15136 or placebo in a ratio of 6:2 (6 active, 2 placebo).

开始日期2018-10-02

申办/合作机构

Hanmi Pharmaceutical Co., Ltd.

100 项与 Efpegerglucagon 相关的临床结果

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100 项与 Efpegerglucagon 相关的专利（医药）

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项与 Efpegerglucagon 相关的文献（医药）

2025-09-25·JCEM case reports

Treatment of Congenital Hyperinsulinism With a Novel, Long-acting Glucagon Analogue

Article

作者: Cannon, Molly ; De Leon, Diva D ; Mitteer, Lauren M ; Meline, Jessica

Abstract:

Congenital hyperinsulinism (HI) is a disorder of insulin regulation that results in hypoketotic hypoglycemia and is associated with a high risk of neurological sequalae from hypoglycemia-induced brain damage. There is only 1 Food and Drug Administration-approved drug for the treatment of HI, and up to 60% of patients do not respond to it; thus, there is a significant unmet need for new treatments. We report a case of a 29-year-old female with HI due to an activating glucokinase pathogenic variant, who was diagnosed as an adult and continued to have persistent hypoglycemia despite standard-of-care therapy. The patient was enrolled in the phase II clinical trial evaluating efpegerglucagon, a novel long-acting glucagon analog. She has continued treatment with efpegerglucagon through a single-patient Investigational New Drug Expanded Access Program and has demonstrated improved glycemic control throughout 10 months of treatment. Efpegerglucagon may be a viable treatment option or adjunct therapy for patients with HI who are unresponsive or partially responsive to currently available therapies.

2023-09-01·Diabetes, obesity & metabolism

Safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of the novel long‐acting glucagon analogue HM15136 in overweight and obese patients with co‐morbidities

Article

作者: Baek, Seungjae ; Byeon, JinHee ; Choi, Jaehyuk ; Shin, Wonjung ; Kang, Seohyun ; Hompesch, Marcus

Abstract:

Aim:

To evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of the novel long‐acting glucagon analogue HM15136 in overweight/obese patients with co‐morbidities, with and without type 2 diabetes (T2D).

Materials and Methods:

This was a phase 1, double‐blind, randomized, placebo‐controlled, two‐part trial with a 12‐week treatment period of once‐weekly subcutaneous HM15136 (0.02/0.04/0.06 mg/kg). Part 1 included patients with dyslipidaemia and/or hypertension and no T2D. Part 2 included patients with dyslipidaemia and/or hypertension plus T2D.

Results:

In part 1, 23/27 (85.2%) patients receiving HM15136 and all patients receiving placebo (9/9 [100%]) experienced a treatment‐emergent adverse event (TEAE). Five of 27 (18.5%) patients receiving HM15136 developed anti‐HM15136 antibodies. Dose‐dependent increases in mean HM15136 serum concentration and fasting plasma glucose (FPG) were observed, as were dose‐dependent weight reductions of 0.5%/2.3%/2.6% at doses of 0.02/0.04/0.06 mg/kg, respectively. In part 2, 8/12 (66.7%) patients receiving HM15136 and all patients receiving placebo (4/4 [100.0%]) reported a TEAE. Two (16.7%) patients developed anti‐HM15136 antibodies. Dose‐dependent increases in mean HM15136 serum concentration were observed. FPG of more than 200 mg/dL was reported in 4/9 (44.4%) and 2/3 (66.7%) patients receiving 0.02 and 0.06 mg/kg, respectively. The 0.06 mg/kg dose was not tolerated in part 2 because of hyperglycaemia. Patients receiving 0.02 mg/kg showed a 0.9% weight reduction. No serious TEAEs leading to discontinuation were reported in either study part.

Conclusions:

This study of HM15136 provides a preliminary safety and tolerability profile with initial insights into its efficacy profile.

2022-03-01·Diabetes, obesity & metabolism2区 · 医学

A double‐blind, placebo‐controlled, single‐ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of HM15136 , a novel long‐acting glucagon analogue, in healthy subjects

2区 · 医学

Article

作者: Cho, Young Min ; Hwang, Jun Gi ; Huh, Ki Young ; BAEK, Seungjae ; Lee, Nora ; Lee, Howard ; Shin, Wonjung ; Choi, JaeDuk

Abstract:

Aim:

To evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of HM15136, a novel long‐acting glucagon analogue under development, in healthy males and females presenting with no childbearing potential.

Materials and Methods:

A randomized, double‐blind, placebo‐controlled, single‐ascending dose study was conducted in 56 subjects who randomly received a single subcutaneous dose of HM15136 or its matching placebo at a ratio of 6:2 at 10, 20, 30, 50, 80, 100, and 120 μg/kg.

Results:

All adverse events were mild and transient. Neither serious adverse events nor discontinuation as a result of adverse events occurred. The most frequent adverse drug reaction was nausea (5.3%, only in the 100‐ and 120‐μg/kg groups). HM15136, particularly at doses of 50 μg/kg or higher, increased fasting blood glucose, with a maximum increase and area under the curve of 1.5 mmol/L at day 10 ( P = .006) and 166.3 day·mmol/L ( P = .022) at the dose of 80 μg/kg, while suppressing the secretion of endogenous glucagon, which continued until day 17. HM15136 also significantly reduced gluconeogenic and ketogenic amino acids. Compensatory changes in endogenous insulin and incretin hormones by HM15136 were not apparent. HM15136 was slowly but steadily absorbed and reached a peak concentration at 46‐68 hours after a single subcutaneous injection. HM15136 was eliminated with a terminal phase half‐life of 77.1‐101.1 hours.

Conclusions:

A single subcutaneous dose of HM15136 at 10‐120 μg/kg was safe and well tolerated. The long half‐life of HM15136, coupled with an increase in blood glucose for ~2 weeks, may warrant a weekly dosing regimen.

项与 Efpegerglucagon 相关的新闻（医药）

2025-11-10

·雪球

FGF21：从分子发现到临床成果，DR10624的故事

2025年11月9日，$华东医药(SZ000963)$控股子公司浙江道尔生物科技有限公司宣布，其全球首创（First-in-class）长效三重激动剂DR10624，在治疗重度高甘油三酯血症（SHTG）的Ⅱ期临床研究（DR10624-201研究）中取得重要成果，并在2025年美国心脏协会科学年会（AHA2025）上作为最新突破性研究在主会场开场报告中展示。这一突破不仅标志着中国心血管创新药物首次登上AHA主舞台，也意味着FGF21（成纤维细胞生长因子21）这一代谢调节分子正式从实验室走向临床。一、FGF21是什么？根据道尔生物官方发布信息，DR10624是全球首个靶向FGFR1c/Klothoβ（FGF21受体）、GLP-1R和GCGR的三靶点激动剂。其中，FGF21是其核心活性成分。FGF21是一种由肝脏、脂肪组织等分泌的内分泌因子，主要通过激活FGFR1c与β-Klotho复合物发挥作用。根据2025年AHA2025年会上李建平教授的报告，DR10624中的FGF21突变体具有如下功能：-增强脂质氧化；-抑制脂肪生成；-改善胰岛素敏感性；-减少肝脏脂质新生；-抑制食欲、减少摄食；-刺激胰岛素分泌。这些作用机制在DR10624的官方新闻稿中被明确描述为“从多个维度干预代谢调节”，并构成了其治疗代谢性疾病的基础。二、FGF21为何“怀才不遇”？——半衰期短是致命伤尽管FGF21在动物模型中表现惊艳，但其在人体临床应用中却屡屡受挫。根据华东医药官方资料及AHA2025发布内容，天然FGF21的半衰期仅为0.5至2小时，极易被蛋白酶降解，并且容易被肾脏快速清除。这种极短的药代动力学特性导致：-患者需每日多次注射，治疗依从性极差；-血药浓度波动大，难以维持稳定疗效；-临床使用受限，难以推广。此外，天然FGF21在长期高剂量使用下，可能引发骨代谢异常等副作用，进一步限制了其开发前景。因此，科学家面临的核心挑战是：如何让FGF21“长效化”且“安全化”？三、DR10624的结构设计DR10624是基于道尔生物MultipleBody®技术平台设计的。其结构组成为：“将N端靶向GLP-1R/GCGR的嵌合肽段与工程化改造的IgG1Fc融合，并在Fc的C末端融合重组的FGF21突变体。”这一设计使得DR10624具备以下特性：-三靶点协同作用：同时激活FGF21R、GLP-1R和GCGR；-靶点组合唯一性：全球尚无同类三靶点激动剂；-长效性：通过Fc融合技术延长半衰期；-稳定性：FGF21突变体去除蛋白酶切割位点，提升分子稳定性。四、临床数据——来自AHA2025主会场的官方报告在AHA2025年会上，北京大学第一医院副院长、心血管疾病研究所所长李建平教授作为主研人，首次公布了DR10624-201研究的临床数据。该研究为Ⅱ期临床试验，针对重度高甘油三酯血症（SHTG）患者。根据官方发布信息，关键数据如下：-主要疗效终点：“DR10624在治疗重度高甘油三酯血症的Ⅱ期临床研究中显示出显著疗效，甘油三酯水平显著下降。”-研究地位：“该研究作为最新突破性研究在主会场开场报告中正式展示。”-历史性突破：“李建平教授在本届AHA年会做开场报告，开创了中国心内科领域学者首次作为开场报告登陆AHA年度会议‘最新突破性研究’专场的先河。”虽然目前尚未公布完整的详细数据（如具体百分比、样本量、治疗周期等），但所有关键结论均来自华东医药官方发布及AHA2025年会公开报告内容，确保信息来源权威、可追溯。五、FGF21的临床意义——从机制到疾病治疗DR10624的成功，验证了FGF21作为代谢调节核心的临床潜力。根据官方描述，FGF21通过以下路径发挥作用：1.激活FGF21受体（FGFR1c/Klothoβ）：增强脂质氧化、抑制脂肪生成、改善胰岛素敏感性；2.激活GCGR：促进脂肪分解、增强肝脏脂肪酸氧化、减少肝脏脂质新生；3.激活GLP-1R：抑制食欲、减少摄食、刺激胰岛素分泌。这种多机制协同作用，使DR10624成为全球首个三靶点代谢调节剂，也为FGF21的临床应用提供了坚实证据。六、全球FGF21靶点药物研发格局——DR10624领跑，尚无药物上市尽管FGF21作为代谢调控分子的研究已有20余年，但截至目前（2025年11月），全球尚未有任何FGF21靶点药物正式获批上市。不过，多个候选药物正处于临床II期或III期阶段，竞争格局日趋清晰。1.DR10624（道尔生物，中国）-全球首个三靶点激动剂（FGF21R+GLP-1R+GCGR）；-已完成SHTG适应症II期临床，准备进入III期；-同时布局NASH、肥胖、2型糖尿病等适应症；-是当前全球进展最快、机制最复杂的FGF21类药物之一。2.Efruxifermin（AkeroTherapeutics，美国）-FGF21类似物，采用Fc融合技术；-在NASH患者中IIb期临床显示肝纤维化显著改善；-每周一次给药，已进入III期准备阶段。3.Pegbelfermin（BristolMyersSquibb，美国）-聚乙二醇化FGF21类似物；-曾获得FDA突破性疗法资格；-II期结果显示脂质代谢改善明显，III期临床筹备中。4.BOS-580（BostonPharmaceuticals，美国）-FGF21-Fc融合蛋白；-目前处于II期临床，适应症为NASH和肥胖；-每周一次给药，安全性良好。5.HM15136（HanmiPharmaceutical，韩国）-长效FGF21类似物；-I期已完成，II期推进中；-适应症聚焦于NASH和肥胖。七、结语：FGF21的临床时代正式开启DR10624的Ⅱ期临床成功，不仅是FGF21从基础研究走向临床转化的重要里程碑，也标志着中国原创新药在全球心血管领域的首次主场发声。随着Ⅲ期临床的推进，FGF21有望成为治疗高甘油三酯血症、NASH、肥胖及2型糖尿病等多种代谢疾病的核心药物。参考文献与信息来源：1.华东医药股份有限公司，《华东医药道尔生物全球首创三靶点激动剂DR10624在AHA2025发布Ⅱ期临床成果》，2025年11月9日官方发布；2.2025年美国心脏协会科学年会（AHA2025）主会场开场报告，李建平教授演讲内容；3.道尔生物MultipleBody®技术平台公开资料；4.AHA2025官网会议议程与摘要发布（网页链接）。

AHA会议临床结果临床1期临床2期寡核苷酸

2022-12-20

·PRNewswire

DelveInsight Estimates a Promising Picture of Obesity Pipeline Space Landscape as Key 100+ Pharma Companies Working in the Space

The prevalence of obesity has been rising since the past few years, which prompts the growing demand for treatment options. The increasing prevalence of Obesity and the growing research and development activities to develop novel therapies to treat obesity drive the market. The Companies developing the potential therapies in the last stage of development include Novo Nordisk, Eli Lilly and Company, Saniona, and several others. LAS VEGAS, Dec. 20, 2022 /PRNewswire/ -- DelveInsight's ' Obesity Pipeline Insight – 2022 ' report provides comprehensive global coverage of available, marketed, and pipeline obesity therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the obesity pipeline domain. Key Takeaways from the Obesity Pipeline Report DelveInsight's obesity pipeline report depicts a robust space with 100+ active players working to develop 130+ pipeline therapies for obesity treatment. Key obesity companies such as 180 Life Sciences, 9 meters, Aardvark Therapeutics, Adocia, Agentix, AgeX Therapeutics, Altimmune, Amgen, Antag Therapeutics, Aphaia Pharma, Aptorum Group, AstraZeneca, Bukwang Pharmaceutical, Caliway Biopharmaceutics Co Ltd, Can Fite Biopharma, Carmot Therapeutics, Inc., Cellivery Therapeutics Inc, CinFina Pharma, Clayton Biotech, Click Therapeutics, Corbus Pharma, DiscoveryBiomed Inc, Dong-A ST, Dongkook Pharmaceuticals, Eccogene, Elevian, Eli Lilly and Company, Empros Pharma, Enterin Inc., EraCal Therapeutics AG, ERX Pharmaceuticals, ERX Pharmaceuticals, Eternygen GmbH, Eurofarma, Gannex Pharma, Glaceum, Gmax Biopharm, GPER G-1 Development Group, LLC, Gubra Therapeutics, Hanmi Pharmaceutical, Hanmi Pharmaceuticals, Innovent Biologics, Jenrin Discovery, Jiangsu Hansoh Pharmaceutical, Kallyope, Kintai Therapeutics, Kriya Therapeutics, LG Life Sciences, Lipidio Pharmaceuticals, MakScientific, Nano Precision Medical, NeonMind Biosciences, Novartis, Novo Nordisk, NuSirt Biopharma, Otsuka Pharmaceutical Factory Inc, Pfizer, Raziel Therapeutics, Reata Pharmaceuticals, Regeneron Pharmaceuticals, Reviva Pharmaceuticals, Rivus Pharmaceuticals, Shionogi, SHIONOGI & Co., Ltd., Sigrid Therapeutics, SJT Molecular Research SL, Structure Therapeutics, Sun Pharmaceutical Industries, Techfields Pharma, Terns Pharmaceuticals, Tonix Pharmaceuticals, UGISense AG, Versanis Bio, Viking Therapeutics, YSOPIA Bioscience, Yuhan, Zealand Pharma, and others are evaluating new drugs for obesity to improve the treatment landscape. Promising obesity pipeline therapies in various stages of development include Semaglutide oral, Tirzepatide, Sibutramine/Topiramate, NNC0174-0833, Tesomet, SHR-20004, RZL-012, CT-868, PF-06882961, EMP-16, S-237648, LY3502970, ARD-101, NNC0165-1875, XW003, IBI362, TG103, Cotadutide, MBL949, PF-07081532, APHD-012, LY 3437943, HSG4112, Leucine/sildenafil, BI 456906, Pemvidutide, LY3841136, HM15136, GMA106, DD01, ZP8396, K833, NNC0480-0389, LB54640, CT-181, CB4211, CT-388, CIN-109, ERX-1000, DWP306001, SCO-094, S-309309, NO-13065, GDD3898, XW004, SCO-267, ASC41, AMG 133, LY3541105, AMG-786, HU6, BMS-963272, BI 1820237, Xla 1, Dapiglutide, PB-119, PB-718, AGTX-2004, ECC5004, Thermostem, XW017, HM 14320, TNX-2900, CF-102, XW 010, LR19020, LR19056, YH34160, NM-136, CIN 110, CIN 209, CIN 210, RSVI-301, PramExe, BC GlueExe, BC Pram GlueExe, AGEX BAT1, CLS-1, CRB-913, Tespria, AM 6545, LP-003, KT A522, JD5037, SJT4a, GL0034, TF0103, TERN-601, NEO-001, KTX 0200, ENT-03, Bimagrumab, VK2735, HUM-234, NPM 139, YHC2129, YHC2134, YHC1140, GSBR-2nd Gen, GSBR-3rd Gen, and others. In December 2022, Amgen announced new Phase I data from AMG 133. This first-in-human study was designed to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic effects of AMG 133 in people with obesity and without diabetes (NCT04478708). The MAD cohorts showed mean percent changes in body weight (BW), ranging from -7.2% at the lowest dose (140mg Q4W), to -14.5% at the highest dose (420mg Q4W) by day 85. A substantial degree of weight loss was maintained beyond the treatment period, which will be shared as part of the oral presentation. Most treatment-emergent adverse events (TEAEs) were mild and transient. The majority of the TEAEs were GI-related, with the most common being nausea and vomiting, most events resolved within 48 hours. In December 2022, Poolbeg Pharma, a clinical-stage infectious disease company, acquired the exclusive license from InsuCaps to use its proprietary microencapsulation and nanoencapsulation oral delivery technologies in metabolic syndrome-related diseases, including obesity, pre-diabetes, and diabetes. In November 2022, Rhythm Pharmaceuticals, Inc. announced that Great Britain's Medicines & Healthcare products Regulatory Agency (MHRA) has expanded the marketing authorization for IMCIVREE® (setmelanotide) to include the treatment of obesity and control of hunger associated with genetically confirmed Bardet-Biedl syndrome (BBS) in adult and pediatric patients 6 years of age and older. In November 2022, Reviva Pharmaceuticals Holdings, Inc. announced the issuance of a patent covering the composition of matter for RP1208 in Canada, adding to its existing protection in key markets around the world. The Canadian patent covers the compositions of novel phenylcycloalkylmethylamine derivatives and the use of the compositions for the treatment of obesity, related co-morbid conditions, and depression and related co-morbid conditions. In October 2022, Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) had granted Fast Track designation for the investigation of tirzepatide for the treatment of adults with obesity or overweight with weight-related comorbidities. In September 2022, Rivus Pharmaceuticals Inc. announced the completion of a USD 132 million Series B financing led by RA Capital Management with participation from Bain Capital Life Sciences, BB Biotech AG, and existing investors Longitude Capital, Medicxi, and RxCapital. This financing will further support the clinical advancement of lead candidate HU6, a first-in-class Controlled Metabolic Accelerator (CMA) designed to treat cardio-metabolic disease by addressing obesity, a primary driver of disease. In June 2022, LG Chem's new drug for treating genetic obesity received additional ODD (Orphan Drug Designation) from the US FDA. LG Chem announced on the 16th that the FDA recently granted ODD to ' LB54640' for the treatment of 'POMC (Proopiomelanocortin) deficiency.' In April 2022, Saniona announced that it paused the Phase IIb clinical trials testing Tesomet for people with Prader–Willi syndrome (PWS) and hypothalamic obesity (HO). The decision "is not related to the safety or efficacy of Tesomet and is entirely due to funding limitations. The company also announced a reprioritization and restructuring effort to immediately reduce operating expenses while maximizing cash resources. Request a sample and discover the recent advances in obesity drug treatment @ Obesity Pipeline Report The obesity pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage obesity drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the obesity clinical trial landscape. Obesity Overview Obesity is a chronic disease that causes abnormal or excessive fat accumulation or adipose tissue in the body, posing a health risk. It is caused by an imbalance between calories consumed and calories burned. The factors responsible for the causes of obesity include heredity, a sedentary lifestyle, excessive fat, sugar consumption (energy-dense meals), certain medications, and endocrine issues. Changes in the environment or society, as well as in behavior and culture, all directly impact. Obesity symptoms go beyond an increase in body fat. It can cause skin issues, shortness of breath, sleeping difficulties, and other symptoms. Some obesity symptoms have even been linked to an increased risk of developing certain diseases and disorders. In some cases, these can be life-threatening or even fatal. Find out more about drugs for obesity @ FDA-approved Obesity Drugs A snapshot of the Obesity Pipeline Drugs mentioned in the report: Learn more about the emerging obesity pipeline therapies @ Obesity Clinical Trials Obesity Therapeutics Assessment The obesity pipeline report proffers an integral view of obesity emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Obesity Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Oral, Parenteral, Intravenous, Subcutaneous, Topical Therapeutics Assessment By Molecule Type: Monoclonal Antibody, Peptides, Polymer, Small molecule, Gene therapy Therapeutics Assessment By Mechanism of Action: Glucagon like peptide 1 receptor agonists, Gastric inhibitory polypeptide receptor agonists, Beta 1 adrenergic receptor antagonists, Biogenic monoamine uptake inhibitors, Lipolysis modulators, Alpha-glucosidase inhibitors, Amylase inhibitors, Lipase inhibitors, Glucagon like peptide 1 receptor agonists, Glucagon receptor agonists, Islet amyloid polypeptide replacements Key Obesity Companies: 180 Life Sciences, 9 meters, Aardvark Therapeutics, Adocia, Agentix, AgeX Therapeutics, Altimmune, Amgen, Antag Therapeutics, Aphaia Pharma, Aptorum Group, AstraZeneca, Bukwang Pharmaceutical, Caliway Biopharmaceutics Co Ltd, Can Fite Biopharma, Carmot Therapeutics, Inc., Cellivery Therapeutics Inc, CinFina Pharma, Clayton Biotech, Click Therapeutics, Corbus Pharma, DiscoveryBiomed Inc, Dong-A ST, Dongkook Pharmaceuticals, Eccogene, Elevian, Eli Lilly and Company, Empros Pharma, Enterin Inc., EraCal Therapeutics AG, ERX Pharmaceuticals, ERX Pharmaceuticals, Eternygen GmbH, Eurofarma, Gannex Pharma, Glaceum, Gmax Biopharm, GPER G-1 Development Group, LLC, Gubra Therapeutics, Hanmi Pharmaceutical, Hanmi Pharmaceuticals, Innovent Biologics, Jenrin Discovery, Jiangsu Hansoh Pharmaceutical, Kallyope, Kintai Therapeutics, Kriya Therapeutics, LG Life Sciences, Lipidio Pharmaceuticals, MakScientific, Nano Precision Medical, NeonMind Biosciences, Novartis, Novo Nordisk, NuSirt Biopharma, Otsuka Pharmaceutical Factory Inc, Pfizer, Raziel Therapeutics, Reata Pharmaceuticals, Regeneron Pharmaceuticals, Reviva Pharmaceuticals, Rivus Pharmaceuticals, Shionogi, SHIONOGI & Co., Ltd., Sigrid Therapeutics, SJT Molecular Research SL, Structure Therapeutics, Sun Pharmaceutical Industries, Techfields Pharma, Terns Pharmaceuticals, Tonix Pharmaceuticals, UGISense AG, Versanis Bio, Viking Therapeutics, YSOPIA Bioscience, Yuhan, Zealand Pharma, and others. Key Obesity Pipeline Therapies: Semaglutide oral, Tirzepatide, Sibutramine/Topiramate, NNC0174-0833, Tesomet, SHR-20004, RZL-012, CT-868, PF-06882961, EMP-16, S-237648, LY3502970, ARD-101, NNC0165-1875, XW003, IBI362, TG103, Cotadutide, MBL949, PF-07081532, APHD-012, LY 3437943, HSG4112, Leucine/sildenafil, BI 456906, Pemvidutide, LY3841136, HM15136, GMA106, DD01, ZP8396, K833, NNC0480-0389, LB54640, CT-181, CB4211, CT-388, CIN-109, ERX-1000, DWP306001, SCO-094, S-309309, NO-13065, GDD3898, XW004, SCO-267, ASC41, AMG 133, LY3541105, AMG-786, HU6, BMS-963272, BI 1820237, Xla 1, Dapiglutide, PB-119, PB-718, AGTX-2004, ECC5004, Thermostem, XW017, HM 14320, TNX-2900, CF-102, XW 010, LR19020, LR19056, YH34160, NM-136, CIN 110, CIN 209, CIN 210, RSVI-301, PramExe, BC GlueExe, BC Pram GlueExe, AGEX BAT1, CLS-1, CRB-913, Tespria, AM 6545, LP-003, KT A522, JD5037, SJT4a, GL0034, TF0103, TERN-601, NEO-001, KTX 0200, ENT-03, Bimagrumab, VK2735, HUM-234, NPM 139, YHC2129, YHC2134, YHC1140, GSBR-2nd Gen, GSBR-3rd Gen, and others. Dive deep into rich insights for new drug for obesity treatment; visit @ Obesity Medications Table of Contents For further information on the obesity pipeline therapeutics, reach out @ Obesity Drug Treatment Related Reports Obesity Epidemiology Forecast Obesity Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology as well as the obesity epidemiology trends. Obesity Market Obesity Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key hypothalamic obesity companies, including Saniona, YSOPIA Bioscience, Innovent Biologics, Glaceum, Shionogi, Aardvark Therapeutics, among others. Hypothalamic Obesity Market Hypothalamic Obesity Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key hypothalamic obesity companies, including Altimmune, Saniona, YSOPIA Bioscience, Innovent Biologics, among others. Hypothalamic Obesity Pipeline Hypothalamic Obesity Pipeline Insight – 2022 report provides comprehensive insights about the pipeline landscape, including clinical and non-clinical stage products and the key hypothalamic obesity companies, including Altimmune, Saniona, YSOPIA Bioscience, Innovent Biologics, among others. HET Obesity/POMC Deficiency Obesity Pipeline HET Obesity/POMC Deficiency Obesity Pipeline Insight – 2022 report provides comprehensive insights about the pipeline landscape, including clinical and non-clinical stage products and the key HET obesity/POMC deficiency obesity companies, including Novo Nordisk, Eli Lilly, and Company, MedImmune, Boehringer Ingelheim, Raziel Therapeutics, among others. HET Obesity/POMC Deficiency Obesity Market HET Obesity/POMC Deficiency Obesity Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key HET obesity/POMC deficiency obesity companies, including Novo Nordisk, Eli Lilly, and Company, MedImmune, Boehringer Ingelheim, Raziel Therapeutics, among others. Other Trending Reports Goitre Market | Thymus Cancer Market | US Healthcare Outlook Report | Venous Stenosis Market | Negative Pressure Wound Therapy Systems Market | Metrorrhagia Market | Dysfunctional Uterine Bleeding Market | Hypereosinophilic Syndrome Market | Age-related Vision Dysfunction Market | Dental Lasers Market | CRISPR Therapies Pipeline Insight | Cell And Gene Therapy For Multiple Myeloma Market | Drug Hypersensitivity Market | Dysthymia Market | Persistent Depressive Disorder Market | Cancer Vaccines Market | Weight Loss/Weight Management (Obesity) Market | Food Allergy Market | Obsessive-Compulsive Disorder Market | Tumor Ablation Market | Physiotherapy Equipment Market | CAR-T Pipeline Insight | Anti-hypertension Market | Radiofrequency Ablation Devices Market | Global Messenger RNA (mRNA)-based Vaccines and Therapeutics Market | Gastro Intestinal Bleeding Market | Trastuzumab Biosimilars Insight | Varicose Veins Market | Germ Cell Tumor Market | Intracardiac Echocardiography Devices Market | India Healthcare Outlook Report | Crows Feet Market Insight | Seborrhoeic Dermatitis Market | Injectable Drug Delivery Devices Market | Structural Heart Devices Market | Substance (Drug) Abuse Market Related Healthcare Blogs Obesity: A Global Concern Weight Loss and Obesity Market Obesity Treatment Market Related Healthcare Services Healthcare Business Consulting Healthcare Competitive Intelligence Services Healthcare Asset Prioritization Services About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. 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临床1期孤儿药快速通道临床2期引进/卖出

2022-08-13

·药时代

【收藏】深度梳理国内外抗肥胖药物管线

‍‍正文共： 6000字 8图预计阅读时间： 8分钟来源：药渡撰文：杨哲编辑：丸子前段时间，饶毅与BGI于烨的“伪科学”之战再一次引发大众热议。也将“益生菌”产品推上了风口浪尖。与健康、减肥相挂钩的益生菌产品在近两年格外的火爆，反映了我国国内减肥药市场的庞大。根据《中国居民营养与慢性病状况报告（2020）年》与弗若斯特沙利文统计数据：中国成年居民的超重或肥胖人群占比已达50.7%，中国肥胖人口总数量预计在 2030 年达到 3.3 亿人。随着居民健康意识的提高，人们对于体重管理的需求也在不断增加。而我国抗肥胖药物（anti-obesity medications, AOMs）产业却处在十分尴尬的境地。目前我国CFDA批准上市的抗肥胖药物仅有奥利司它一款产品。国内生产奥利司他的厂商众多（图1），同质化竞争严重。同时奥利司他作为一种强效胰脂肪酶抑制剂，不良反应较多，减肥效果并不显著。随着国家对AOMs相关政策的放开，市场急需新型AOMs药物的入场。本文将对目前国内外主流抗肥胖药物产品管线及入局公司进行简要梳理。图1：国内奥利司他药物上市产品（来源：CFDA官网）1国外抗肥胖药物主要管线国外抗肥胖药物的发展较早，政策较为宽松。截至2021年，除奥利司他外，FDA还批准了其余6款具有抗肥胖功能的药物。但出于安全性及成熟性考虑，目前这些药物均未在中国获批用于抗肥胖治疗，6款AOMs药物列表整理如下：表1：目前FDA批准上市的减肥药物及其存在风险目前已上市的减肥药物均以抑制中枢神经食欲为主要方式。然而部分药物作用具体机理未知，药物安全性成问题，这也是目前国家迟迟不批准新的AOMs药物入局的根本原因。但随着部分药物使用的长期安全性得到验证以及全国肥胖人口的增多，目前我国的相关政策正在逐步放宽。其中，诺和诺德旗下的GLP-1受体激动剂系列药物最有希望突出重围。根据2021年柳叶刀杂志对目前已上市减肥药物临床试验数据的分析可知，芬特明-托吡酯（phentermine–topiramate）是目前上市药物中最有效的减肥药（体重减轻≥5%的优势比[OR] 8.02, 95% CI 5.24-12.27；体重减轻百分比的平均差[MD] -7.97, 95% CI -9.28~-6.66），其次是GLP-1受体激动剂（[OR] 6.33, 95% CI 5.0-8.0; [MD] -5.76, 95% CI -6.3~-5.21），但GLP-1受体激动剂相对芬特明-托吡酯诱发严重不良反应的几率更低，这证实了GLP-1受体激动剂在抗肥胖药物应用领域的强发展潜力。除上述成熟的抗肥胖药物产品外，目前国外药企也在迅速布局涵盖GLP-1受体激动剂在内的多种新型抗肥胖及减重产品，其主要入局公司如下：1Novo Nordisk目前诺和诺德主要还是围绕GLP-1受体激动剂进行抗肥胖药物开发，意在攻克GLP-1受体激动剂药物的长效性壁垒。其官网数据显示，目前诺和诺德共有四条AOMs管线处于临床开发阶段，如下图所示（图2）：图2：诺和诺德AOMs管线分布（来源：诺和诺德官网）Cagrisema及LA-GDF15均为长效GLP-1类似物。Cagrisema为长效amylin（胰淀素）类似物cagrilintide和长效GLP-1受体激动剂司美格鲁肽的双重复合制剂。其中，司美格鲁肽是目前诺和诺德公司的降糖王牌产品之一，仅2022年第一季度营业额便达到18.29亿美元。将其与cagrilintide这一能促进饱腹感的长效胰淀素类似物共同应用，意在加强司美格鲁肽的减重效果。目前该药物处于临床I期开发阶段，效果值得期待。CDE数据显示，诺和诺德于今年6月10日递交了Cagrisema国内临床试验申请，国内市场野心巨大。Oral Sema Obesity为口服型司美格鲁肽，也属于GLP-1受体激动剂，主要是改善司美格鲁肽注射剂患者依从性不好的缺陷。事实上，司美格鲁肽对于肥胖患者减重的实验结果十分惊艳。18年发表在柳叶刀杂志上的II期大规模实验结果显示，在受试的957名患者中， 0.1-0.4mg/天的司美格鲁肽注射量治疗组与安慰剂治疗组相比，受试者体重均产生了显著下降，减重效果强于0.3mg/天注射的利拉鲁肽治疗组。在第52周，司美格鲁肽0.4mg/天治疗组患者平均体重下降了16.3%（图3），且所有受试者均未产生任何不良反应。司美格鲁肽口服剂型的开发更利于其在抗肥胖药物市场的应用，真正做到“无痛减肥”，市场前景巨大。据悉，诺和诺德将在今年内于国内提交Oral Sema Obesity的上市申请。目前辉瑞制药也有口服小分子GLP-1受体激动剂药物正处于临床II期阶段。图3：司美格鲁肽的减重效果（来源：诺和诺德官网）除了GLP-1受体激动剂系列产品外，诺和诺德也布局了肽酪氨酸酪氨酸（PYY）类似物的药物管线开发，即PYY1875。肽酪氨酸酪氨酸（PYY）是神经肽Y（NPY）家族的成员，可抑制中枢神经，减少食欲，从而达到减轻体重的效果。PYY1875的安全性良好，目前已进入II期临床阶段。2Eli Lily GLP-1图4：礼来官网中对Trizepatide的报道在礼来官网最显著的位置，标注着Trizepatide三期临床的惊人效果。受试的的2539名志愿者在经过72周的治疗后，服用Trizepatide 5mg，10mg，15mg及安慰剂的患者体重分别下降了原始体重的16%，21.4%，22.5%及3.1%。在15mg Trizepatide治疗组中，有人在经历72周Trizepatide的治疗后体重竟减少了24千克，且无任何强烈的不良反应。Trizepatide的优异成效使其成为了目前抗肥胖药物市场的明日之星。Trizepatide是一种同时具有GIP（葡萄糖依赖性促胰岛素多肽）受体和GLP-1（胰高血糖素样肽-1）受体激动效果的新型药物。礼来利用将两种肠促胰岛素的作用整合到一个新的分子中的策略，补充了GLP-1受体激动剂作用效果，达到了1+1>2的惊艳疗效。与此同时，礼来更是借着Trizepatide的东风开启了肥胖患者关爱计划，意图深耕抗肥胖药物市场。目前礼来除了Trizepatide还在同时开发的AOMs临床管线如下图所示（图5）：图5：礼来的AOMs研发管线（来源：礼来官网）目前礼来处于I期临床的产品是一种长效胰淀素类似物。处于II期临床的GGG Tri-Agonist则是在Trizepatide的基础上，开发出的一种能同时激动GIP,GLP,GLP-1受体的三重激动剂，希望达到1+1+1>3的效果，重现Trizepatide的成功。同样处于II期开发阶段的GLP-1 Receptor NPA产品则是礼来最新研发的的化学小分子GLP-1受体激动剂。它能跨过大分子药物的吸收和代谢壁垒，适用于后期开发的更多剂型，如缓释制剂等等，有望解决目前GLP-1受体激动剂大多半衰期短的瓶颈，其临床结果同样值得期待。3韩美制药韩美制药是韩国的第一大制药公司，目前其在减肥药物研发方面有一款药物正处于临床前研发阶段，名为HM15136。HM15136是一种长效胰高血糖素类似物，通过非肽基柔性连接物（LAPSCOVERY）与人免疫球蛋白恒定区化学结合增强其体内半衰期。其利用的是胰高血糖素受体兴奋的生理效应（抑制食物摄入、增加能量消耗和改善脂质代谢）。在临床前研究中，观察到该药物显著的减肥效果和改善血脂状况。其具体原理如图6所示：图6：HM15136治疗肥胖的简要机理（来源：韩美制药官网）4Versanis bioVersanis bio是一家诺华背景的公司，于2021年成立，主攻肥胖治疗方向，其主要管线产品为Bimagrumab。Bimagrumab是一种独特的单抗，能靶向激活素II型受体（ActRII），通过与相关受体的结合，阻断包括激活素A和肌生长抑制素在内的激素的作用，刺激骨骼肌生长。在临床前实验中发现，Bimagrumab可以促进褐色脂肪细胞的分化和活性，促进机体燃烧能量。其机理可简要概括成在增肌的同时，完成了脂肪细胞的转化，是理想中的减肥产品。目前该产品已进入了II期临床阶段，在对于569名非糖尿病患者的随机临床试验中，最高剂量治疗组在24周减掉了14.6%的纯脂肪重量，在48周减掉了20.5%的纯脂肪重量，且肌肉重量增加了3.6%，而安慰剂组各项指标基本不变。该临床实验结果是十分惊人的，真正做到了只减脂肪并增加肌肉的效果，期待后续临床结果的披露。2国内抗肥胖药物主要管线相比于国外抗肥胖药物研究的繁荣，目前国内制药企业在AOMs领域主要集中于GLP-1受体激动剂药物的开发，尤其是在利拉鲁肽核心专利到期（化合物专利2017年已到期，晶体专利2022年到期），2022年1月21日CDE发布了《利拉鲁肽用于体重管理的临床试验设计指导原则》后，以华东医药为首的各国内厂商快速挤入利拉鲁肽仿制药及多靶点GLP-1受体激动剂药物研究赛道。1华东医药从华东医药官网上披露的其内分泌及肥胖药物研发管线中不难看出其对于GLP-1受体激动剂药物的前瞻性布局（图7）。其直接对标诺和诺德Saxenda的仿制药物利拉鲁肽注射液一骑绝尘，2022年第二季度便进入了上市申请阶段，有望成为国内第一家GLP-1受体激动剂抗肥胖药物的吃螃蟹玩家。同时其GLP-1相关创新性药物也层出不穷，TTP273作为全球创新小分子GLP-1受体激动剂，走的是First-in-class药物快速审批通道，已于2022年1季度完成II期临床试验的末例受试者出组。DR10624作为GLP-1R/GCGR/FGF21R靶点的多重激动剂，可用于2型糖尿病、肥胖和代谢综合征等疾病的治疗，已于2022年4月获批在新西兰开展I期临床试验。与此同时，由于诺和诺德司美格鲁肽的核心专利将于2026年到期，华东医药迅速布局了司美格鲁肽仿制药的临床试验申请，目前其IND已于2022年4月获得受理。华东医药在抗肥胖药物的产业布局之深可见一斑，是我国当之无愧的抗肥胖药物研发“卷中之王”。图7：华东医药内分泌及减肥药物研发管线（来源：华东医药官网）2爱美客截止2022年08月11日收盘，爱美客（300896）收盘价579.00元，可谓是中国的医美第一股，可看出投资者们对于中国大健康及医美市场的极高信心。从光大证券对爱美客的企业分析报告中可以了解到，目前爱美客在抗肥胖药物领域主要有布局有两款产品，一款是诺和诺德利拉鲁肽的仿制药，目前已经进入了I期临床阶段，一款是溶脂针产品去氧胆酸。去氧胆酸可溶解局部的脂肪细胞膜，导致脂肪细胞分解，从而达到去除脂肪的目的。目前全球范围内，已上市的去氧胆酸溶脂药物只有艾尔建旗下的 Kybella ，且适应症被严格限定于去除颏下脂肪（双下巴）。该款产品在 2015 年被 FDA 批准。当前，国内在研的溶脂针产品的企业仅有爱美客，科笛生物及南京诺瑞特生物三家。爱美客的溶脂针产品预计于2023年进入临床试验阶段。3上海仁会仁会生物的官网近日发布了其创新药贝那鲁肽的真实世界临床研究数据，其减重效果尤为振奋人心。贝那鲁肽是中国糖尿病领域第一个创新药，也是国内首个拥有自主知识产权的 GLP-1 受体激动剂，于 2017 年上市。对中国两家医院（唐山市迁安燕山医院、秦皇岛市中医医院）的 314 例 T2DM 患者数据进行分析，贝那鲁肽治疗3个月后患者体重平均降低10.05kg（图8），HbA1c 平均降低 2.87%。作为完全我国自研的创新药，其具备和人体完全同源的氨基酸序列，更加适合国人体质。贝那鲁肽已被收录入《中国II型糖尿病防治指南（2017年版）》中。作为临床常用GLP-1受体激动剂制剂，有望超过利拉鲁肽，成为国产减肥药物的后来居上者。目前其治疗肥胖适应症的临床试验已经进行到临床III期，药渡将关注其是否会在后期对贝那鲁肽进行长效性和口服制剂的开发。图8：贝那鲁肽的减重效果（来源：上海仁会生物官网）4恒瑞医药/信达生物/东阳光GLP-1受体激动剂等抗肥胖药物的火爆及国家政策的放开使得国内制药巨头们也加入抗肥胖药物研发大军。目前恒瑞医药，信达生物，东阳光均有一款GLP-1受体激动剂自研创新药进入临床阶段。恒瑞医药的诺利糖肽（HS-20004）目前已经进入了II期临床阶段，是一款经棕榈酸修饰的GLP-1类似物。通过氨基酸序列的改造，诺利糖肽既保证了生物学活性，又增强了抵抗DPP-IV酶解的能力。诺利糖肽结构中的棕榈酸还会与血清蛋白结合，延长其体内半衰期，达到长效作用的效果。而信达生物则选择了和礼来Trizepatide 1+1策略的相似研发方案，其GLP-1R/胰高血糖素受体（GCGR）双重激动剂mazdutide (研发代号：IBI362)目前也进入了II期临床。东阳光则是在寻找减肥新靶点的道路上另辟蹊径，其创新药物HEC88473是国内首个获批临床的GLP-1/FGF21双重激动剂，FGF21在与其体内受体结合后，能促进体细胞的脂肪酸代谢以及胰岛素敏感性，目前位于I期临床阶段。5甘李药业对于中国糖尿病患者来说，甘李药业绝不陌生。甘李药业于1998 年成立，是国内首家掌握产业化生产重组胰岛素类似物技术的企业，深耕于国内糖尿病胰岛素领域。甘李药业是国内首家实现三代胰岛素生产的糖尿病头部企业，突破了三代胰岛素由外企垄断的国内尴尬局面，据CDE官网数据显示，目前三代胰岛素中的门冬胰岛素仅有甘李药业一家国产企业于2020年获批上市。GLP-1受体激动剂药物的发现发展与糖尿病治疗密不可分，其研发初始治疗方向便是II型糖尿病。因此，深耕于糖尿病治疗领域的甘李药业也早早布局了GLP-1受体激动剂药物。其自主研发的长效GLP-1受体激动剂GZR18目前也进入了I期临床阶段，并已完成了首例受试者给药，预计给药每周一次。作为糖尿病治疗领域研发头部企业，手握中国众多糖尿病患者一手数据，其能否在GLP-1受体激动剂药物与胰岛素联合用药治疗肥胖的方案上做出新的尝试，为肥胖治疗提出国产化联合用药方案，突出重围，药渡将持续关注。3结语中国的减肥药物产业在经过了长久的沉寂之后，众多制药企业纷纷入局，究竟谁能脱颖而出，吃下国产减肥药物的第一口螃蟹，值得期待。而减肥药物的市场在GLP-1受体激动剂药物火爆之后，能否在肠脑轴，基因治疗，肠道菌群等研究中发现新的治疗靶点，则是众多研发者和制药企业们值得深思的方向。参考文献：1.Shi Qingyang,Wang Yang,Hao Qiukui et al. Pharmacotherapy for adults with overweight and obesity: a systematic review and network meta-analysis of randomised controlled trials.[J] .Lancet, 2022, 399: 259-269.2.Müller Timo D,Blüher Matthias,Tschöp Matthias H et al. Anti-obesity drug discovery: advances and challenges.[J] .Nat Rev Drug Discov, 2022, 21: 201-223.3.O'Leary Karen,An anti-obesity drug from the diabetes toolbox.[J] .Nat Med, 2022, 4.Geng Leiluo,Lam Karen S L,Xu Aimin,The therapeutic potential of FGF21 in metabolic diseases: from bench to clinic.[J] .Nat Rev Endocrinol, 2020, 16: 654-667.5.O'Neil Patrick M,Birkenfeld Andreas L,McGowan Barbara et al. Efficacy and safety of semaglutide compared with liraglutide and placebo for weight loss in patients with obesity: a randomised, double-blind, placebo and active controlled, dose-ranging, phase 2 trial.[J] .Lancet, 2018, 392: 637-649.6.光大证券，2022，《爱美客（300896）投资价值分析报告：医美赛道长期主义的践行者》。【备注】原文题目：不只奥利司他！深度梳理国内外抗肥胖药物管线版权声明/免责声明本文为授权转载文章，版权归拥有者。仅供感兴趣的个人谨慎参考，非商用，非医用、非投资用。欢迎朋友们批评指正！衷心感谢！文中图片、视频为授权正版作品，或来自微信公共图片库，或取自公司官网/网络根据CC0协议使用，版权归拥有者。任何问题，请与我们联系（电话：13651980212。微信：27674131。邮箱：contact@drugtimes.cn）。衷心感谢！推荐阅读又一个首款！FDA加快批准Enhertu（DS-8201）治疗HER2突变非小细胞肺癌患者药企们的「过冬」策略，裁员不尽兴，他还要收租...Aβ假说“被锤”后，离开4年的默沙东又被勾回来，买了一个连靶点都不知道的产品...54亿美金，买！歇了不到3个月的辉瑞，又开始溢价收购了...104家中国新药企业扬帆出海！ADC赛道喜讯频传！科伦博泰势头赶超老大哥石药 | 药时代出海系列对话RNA靶向新兴企业施能康（SynerK）：从Alnylam公司APOLLO-B的成功看RNAi药物的研发提前4个月！FDA批准ADC药物Enhertu（DS-8201）用于治疗「HER2低表达」乳腺癌患者，市场有望扩大5倍！接连7款药物试验失败！新药研发既要有毅力，更要有「及时止损」的智慧万字长文：从理论到生产，一文读懂mRNA-LNP制剂技术药时代第111期直播笔记 | 欧美儿童药物开发相关的法规和指导原则2022上半年成绩单出炉！勃林格殷格翰保持稳健增长，夯实研发管线！点击这里，欢聚药时代！

仿制药创新药小分子药物信使RNA专利到期

100 项与 Efpegerglucagon 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
先天性高胰岛素血症	临床2期	美国	Hanmi Pharmaceutical Co., Ltd.	2022-05-05
先天性高胰岛素血症	临床2期	德国	Hanmi Pharmaceutical Co., Ltd.	2022-05-05
先天性高胰岛素血症	临床2期	以色列	Hanmi Pharmaceutical Co., Ltd.	2022-05-05
先天性高胰岛素血症	临床2期	韩国	Hanmi Pharmaceutical Co., Ltd.	2022-05-05
先天性高胰岛素血症	临床2期	英国	Hanmi Pharmaceutical Co., Ltd.	2022-05-05
2型糖尿病	临床1期	美国	Hanmi Pharmaceutical Co., Ltd.	2019-08-30
肥胖	临床1期	美国	Hanmi Pharmaceutical Co., Ltd.	2019-08-30

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04167553 (PSUN305, CTgov)	临床1期	2型糖尿病 \| 肥胖	52	HM15136 (HM15136 0.02 mg/kg Part 1)	餘鏇鏇遞醖餘遞艱蓋鬱 = 願壓繭築壓衊網構壓鬱衊襯淵選觸觸醖衊簾衊 (襯遞餘網鬱廠衊鹽選鑰, 壓襯鑰積鏇顧淵鹹憲襯 ~ 襯艱糧積獵糧夢範齋鑰) 更多	-	2025-01-27
				HM15136 (HM15136 0.04 mg/kg Part 1)	餘鏇鏇遞醖餘遞艱蓋鬱 = 顧糧膚簾壓製願襯膚遞衊襯淵選觸觸醖衊簾衊 (襯遞餘網鬱廠衊鹽選鑰, 鹹襯壓繭鏇範廠製觸壓 ~ 願淵願積糧壓選淵鬱艱) 更多
NCT04732416 (ACHIEVE, ESPE2024)	临床2期	先天性高胰岛素血症	8	Efpegerglucagon 0.04 mg/kg (Cohort 1)	襯艱構齋獵艱鬱齋夢膚(膚願壓構廠顧餘壓積積) = Efpegerglucagon was safe and well tolerated, with no significant changes in vital signs, physical examinations, safety laboratory tests, or electrocardiograms. The most common adverse event was gastrointestinal disorders such as upper abdominal pain and diarrhea. Most of the adverse events were mild and moderate in severity. There were no adverse events leading to discontinuation of study treatment, adverse events of special interest, or death. 鹽壓餘醖糧艱觸顧衊淵 (膚簾鏇願遞鑰艱遞網簾 )	积极	2024-11-16
				Efpegerglucagon 0.06 mg/kg (Cohort 2)
NCT04167553 (PSUN305, ENDO2022)	临床1期	超重 \| 肥胖	36	HM15136 0.02 mg/kg	繭網淵膚顧蓋積膚鬱憲(壓餘簾選繭鑰夢醖構選) = The most frequent Treatment Related Adverse Event (TRAE) was injection site erythema (11.1%), the frequency of TRAEs was not dose dependent 願齋顧顧網鹹構衊蓋鏇 (簾積顧願衊窪觸憲餘願 ) 更多	积极	2022-11-01
				HM15136 0.04 mg/kg