一项在健康受试者中评价苏帕鲁肽注射液对地高辛片或盐酸二甲双胍片药代动力学影响的单中心、开放、固定序列临床研究。主要目的 1.在健康受试者中，评价多次皮下注射苏帕鲁肽注射液对单次口服地高辛片药代动力学的影响。 2.在健康受试者中，评价多次皮下注射苏帕鲁肽注射液对多次口服盐酸二甲双胍片药代动力学的影响。次要目的 1.在健康受试者中，评价多次皮下注射苏帕鲁肽注射液后单次口服地高辛片的安全性。 2.在健康受试者中，评价多次皮下注射苏帕鲁肽注射液后多次口服盐酸二甲双胍片的安全性。

开始日期2023-03-20

申办/合作机构

广州银诺医药集团股份有限公司

[+1]

NCT05694221 / Completed临床1期

A Single-centre, Open Labeled, Fixed-sequence Study to Evaluate the Effect of Supaglutide on Digoxin or Metformin Pharmacokinetics

This is a study of a drug drug interaction between Supaglutide and Digoxin or Metformin.

开始日期2023-03-20

申办/合作机构

上海银诺医药技术有限公司

[+1]

100 项与苏帕鲁肽相关的临床结果

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100 项与苏帕鲁肽相关的转化医学

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100 项与苏帕鲁肽相关的专利（医药）

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项与苏帕鲁肽相关的文献（医药）

2022-08-01·European Journal of Pharmaceutical Sciences

Pharmacokinetic and pharmacodynamic studies of supaglutide in rats and monkeys

Article

作者: Wang, Zhihong ; Zhang, Li ; Ma, Anran ; Prud'homme, Gerald J ; Liao, Yijing ; Wang, Qinghua ; Liu, Lin ; Zhang, Na ; Zhou, Yue

We demonstrated recently that supaglutide, a novel GLP-1 mimetic generated by recombinant fusion protein techniques, exerted hypoglycemic effects in type 2 diabetes db/db mice and spontaneous diabetic monkeys. In this study, we investigated the pharmacokinetics and pharmacodynamics of supaglutide by single subcutaneous and intravenous injection(s) in rats and rhesus monkeys, as well as fourconsecutive subcutaneous injections in monkeys.We found the half-life (t1/2) of supaglutide was 39.7 h and 35.8 h at dosing 0.1 mg/kg upon subcutaneous or intravenous administration respectively, in rhesus monkeys. The plasma supaglutide peaked at 8-10 h, while the plasma drug exposure levels increased with the increase of dose, showing approximately a linear pharmacokinetic characteristic. The elimination kinetics (Ke) were found to be similar between subcutaneous (∼0.025 in rats and ∼0.018 in monkeys) and intravenous administration (0.021 in rats and 0.020 in monkeys), whereas the bioavailability was found to be 31.1% in rats and 63.9% in monkeys. In monkeys, a single dose injection of supaglutide markedly decreased the random blood glucose levels that reaching the maxima effects in 14-16 h, gradually recovered and returned to the baseline level approximately after 72 h. ¹²⁵I-supaglutide was found mainly distributed in the serum and organs rich in blood supply. Urine was found to be the primary excretion route of supaglutide, following by feces, but mostly not in bile.Our results show that supaglutide possess linear pharmacokinetic characteristics associated with prolonged hypoglycemic effects inanimals,suggestinga potential weekly dosing therapeutic reagent for the treatment of type 2 diabetes and metabolic diseases.

2021-02-01·Journal of Endocrinology3区 · 医学

Novel GLP-1 analog supaglutide improves glucose homeostasis in diabetic monkeys

3区 · 医学

Article

作者: Ma, Anran ; Zhao, Ying ; Li, Jia ; Cui, Qiaoli ; Zhou, Quanquan ; Zhang, Li ; Wang, Qinghua ; Liang, Yinan ; Wang, Zhihong ; Jiang, Yaojing ; Shao, Anna ; Tao, Weihong ; Yang, Zunyuan ; Liao, Yijing ; Zeng, Wen ; Yang, Zhenyan ; Huang, Xiaohang ; Wu, Minglin

Glucagon-like peptide 1 (GLP-1) is an insulinotropic hormone and plays an important role in regulating glucose homeostasis. GLP-1 has a short half-life (t1/2 < 2 min) due to degrading enzyme dipeptidyl peptidase-IV and rapid kidney clearance, which limits its clinical application as a therapeutic reagent. We demonstrated recently that supaglutide, a novel GLP-1 mimetic generated by recombinant fusion protein techniques, exerted hypoglycemic and β-cell trophic effects in type 2 diabetes db/db mice. In the present study, we examined supaglutide’s therapeutic efficacy and pharmacokinetics in diabetic rhesus monkeys. We found that a single subcutaneous injection of supaglutide of tested doses transiently and significantly reduced blood glucose levels in a dose-dependent fashion in the diabetic monkeys. During a 4-week intervention period, treatment of supaglutide of weekly dosing dose-dependently decreased fasting and random blood glucose levels. This was associated with significantly declined plasma fructosamine levels. The repeated administration of supaglutide remarkably also decreased body weight in a dose-dependent fashion accompanied by decreased food intake. Intravenous glucose tolerance test results showed that supaglutide improved glucose tolerance. The intervention also showed enhanced glucose-stimulated insulin secretion and improved lipid profile in diabetic rhesus monkeys. These results reveal that supaglutide exerts beneficial effects in regulating blood glucose and lipid homeostasis in diabetic rhesus monkeys.

Frontiers in Physiology2区 · 医学

Novel GLP-1 Analog Supaglutide Stimulates Insulin Secretion in Mouse and Human Islet Beta-Cells and Improves Glucose Homeostasis in Diabetic Mice

2区 · 医学

ArticleOA

作者: Zhang, Zhaoyun ; Zhang, Lina ; Wang, Liqian ; Feng, Ying ; Liu, Wenjuan ; Jin, Tianru ; Ren, Liwei ; Wang, Qinghua ; Leng, Ying ; Liao, Yijing ; Cui, Qiaoli ; Li, Yiming ; Yang, Yehong ; Sun, Wanwan ; Prud'homme, Gerald J

Glucagon-like peptide-1 (GLP-1), an incretin hormone plays an important role in regulating glucose homeostasis. The therapeutic use of native GLP-1 is inadequate due to its short in vivo half-life. We recently developed a novel GLP-1 mimetics supaglutide, and demonstrated that this formulation retained native GLP-1 biological activities and possessed long-lasting GLP-1 actions. In this study, we further examined its abilities in regulating blood glucose in diabetic mice. We found that supaglutide stimulated insulin secretion in both mouse and human islets in a dose-dependent fashion. Oral glucose tolerance test conducted in normal ICR mice showed that supaglutide significantly decreased postprandial glucose excursions in a dose-dependent fashion. In type 2 diabetic db/db mice, a single-dose injection of supaglutide significantly decreased blood glucose levels, and this efficacy was lasted for at least 72 h in a dose-dependent fashion. During a 4-weeks intervention course supaglutide (twice injections per week) dose-dependently and significantly decreased fasting and random blood glucose levels in hyperglycemic db/db mice. Supaglutide, at a dose of 1.2 mg/kg, significantly reduced serum fructosamine levels. This was associated with significant enlargement of beta-cell mass, increased pancreatic insulin content, and increased plasma insulin level. Notably, during the intervention course supaglutide significantly reduced body-weight gain in these obese diabetic mice, associated with reduced fat mass (but not the lean mass), improved lipid profile, i.e., declined serum triglyceride, and free fatty acid levels compared to the placebo control. These finding reveals that supaglutide exerts beneficial effects in regulating blood glucose and lipid homeostasis in diabetic db/db mice.

项与苏帕鲁肽相关的新闻（医药）

2024-09-19

·同写意

银诺医药：专注源头创新，探寻糖尿病标本兼治之法

突破性疗法

2024-06-24

·医药笔记

ADA2024：中国GLP-1产品竞相亮相

▎Armstrong 2024年6月21-24日，第84届美国糖尿病学会年会正在佛罗里达州奥兰多橙郡会议中心举办。来自中国药企的多GLP-1类产品在此次会议上竞相亮相，展示最新临床数据。双靶点是国产GLP-1焦点，信达生物披露玛仕度肽减重三期临床GLORY-1详细数据，4mg剂量组减重10.72%，6mg剂量组减重13.14%，同时显著降低心血管风险的相关参数，包括甘油三酯、血压、总胆固醇、LDL-C、ALT等。派格医药披露复方制剂PB-718（GLP-1+GCG）治疗肥胖1b/2a期临床，3个剂量组治疗12周减重4-6%。竞争最激烈的仍然是GLP-1/GIP双靶点激动剂，恒瑞医药、翰森制药、博瑞医药披露了相关管线最新临床数据。恒瑞医药HRS9537 6mg剂量组治疗12周减重16.7%。恒瑞医药还汇报了GLP-1/胰岛素复方制剂的最新临床数据。单靶点方面，甘李药业GZR18探索每周给药以及每两周一次给药，其中QW组治疗35周减重18.6%，Q2W组治疗35周减重13.5%。虽然是单靶点，但减重效果比替尔泊肽的历史数据更好。GZR18采用脂肪酸链修饰技术，但采用了更长的脂肪酸链，剂量方面更是爬坡到30mg，二期临床的剂量探索范围为2.3-24mg。先为达伊诺格鲁肽为cAMP偏向性GLP-1，此次报告了降糖三期临床的数据，此外还汇报了口服GLP-1，以及胰淀素受体激动剂的数据。质肽生物汇报了超长效GLP-1产品ZT002的一期临床数据，半衰期260-273小时。银诺医药汇报了苏帕鲁肽的一期临床数据。高天生物汇报了mRNA表达GLP-1（LNP递送，猴子体内试验）的临床前研究数据（下图）。总结 GLP-1赛道备受行业关注，中国企业也扮演重要角色，诚益生物小分子GLP-1以20亿美元授权给阿斯利康，恒瑞医药GLP-1产品组合以60亿美元授权给Hercules。随着临床数据不断披露，相信会有更多差异化的国产GLP-1产品达成出海合作。 Armstrong技术全梳理系列 GPRC5D靶点全梳理； CD40靶点全梳理； CD47靶点全梳理；补体靶向药物技术全梳理；补体药物：眼科治疗的重要方向； Claudin 6靶点全梳理； Claudin 18.2靶点全梳理；靶点冷暖，行业自知；中国大分子新药研发格局；被炮轰的“me too”；佐剂百年史；胰岛素百年传奇； CUSBEA：风雨四十载；中国新药研发的焦虑；中国生物医药企业的研发竞争；中国双抗竞争格局；中国ADC竞争格局；中国双抗技术全梳理；中国ADC技术全梳理； Ambrx技术全梳理； Vir Biotech技术全梳理； Immune-Onc技术全梳理；亘喜生物技术全梳理；康哲药业技术全梳理；科济药业技术全梳理；恺佧生物技术全梳理；同宜医药技术全梳理；百奥赛图技术全梳理；腾盛博药技术全梳理；创胜集团技术全梳理；永泰生物技术全梳理；中国抗体技术全梳理；德琪医药技术全梳理；德琪医药技术全梳理2.0；和铂医药技术全梳理；荣昌生物技术全梳理；再鼎医药技术全梳理；药明生物技术全梳理；恒瑞医药技术全梳理；豪森药业技术全梳理；正大天晴技术全梳理；吉凯基因技术全梳理；基石药业技术全梳理；百济神州技术全梳理；百济神州技术全梳理第2版；信达生物技术全梳理；信达生物技术全梳理第2版；中山康方技术全梳理；复宏汉霖技术全梳理；先声药业技术全梳理；君实生物技术全梳理；嘉和生物技术全梳理；志道生物技术全梳理；道尔生物技术全梳理；尚健生物技术全梳理；康宁杰瑞技术全梳理；科望医药技术全梳理；科望医药技术全梳理2.0；岸迈生物技术全梳理；礼进生物技术全梳理；康桥资本技术全梳理；余国良的抗体药布局；荃信生物技术全梳理；安源医药技术全梳理；三生国健技术全梳理；仁会生物技术全梳理；乐普生物技术全梳理；同润生物技术全梳理；宜明昂科技术全梳理；派格生物技术全梳理；迈威生物技术全梳理； Momenta技术全梳理； NGM技术全梳理；普米斯生物技术全梳理；普米斯生物技术全梳理2.0；三叶草生物技术全梳理；贝达药业抗体药全梳理；泽璟制药抗体药全梳理；恒瑞医药抗体药全梳理；齐鲁制药抗体药全梳理；石药集团抗体药全梳理；豪森药业抗体药全梳理；华海药业抗体药全梳理；科伦药业抗体药全梳理；百奥泰技术全梳理；凡恩世技术全梳理。

临床3期临床2期信使RNA临床1期引进/卖出

2024-06-21

·药时代

银诺医药在2024年美国糖尿病协会（ADA）科学年会展示研究成果

01 依苏帕格鲁肽α 于健康人群的药代动力学研究1 依苏帕格鲁肽α（原名苏帕鲁肽）为银诺医药首发管线，是一款新型人源化超长效 GLP-1 受体激动剂。已在T2D患者中完成了III期临床研究。近期，依苏帕格鲁肽α在非糖尿病受试者中的药代动力学 (PK)研究结果被第84届美国糖尿病协会（ADA）科学会议接收，在《Diabetes》杂志网站上发表。研究未发现依苏帕格鲁肽α与地高辛、二甲双胍存在具有临床意义的PK相互作用，依苏帕格鲁肽α可以与地高辛或二甲双胍联合使用，无需调整剂量。此外，依苏帕格鲁肽α在非糖尿病受试者中也呈现了明显的减重作用：给药4周后，A组（基线平均 BMI 24.44 kg/m2）和B组（基线平均 BMI 24.08 kg/m2）体重分别减少了5.4%和7.0%，所有受试者体重≥5%降幅比例达到71%，其中联合二甲双胍组体重≥5%降幅比例高达80%。共同给药的不良事件无明显增加，最常见的不良反应是胃肠道症状，大多为轻、中度且为一过性。 02 减重降腹防痴呆内脏脂肪是关键肥胖是世界卫生组织确定的十大慢性疾病之一，是多种代谢性疾病及心脑血管疾病的高危因素。更深入的研究发现：肥胖与日益突出的认知健康问题紧密相关。新加坡南洋理工大学Theresia Mina博士团队在《柳叶刀》子刊发表了一项基于8000多名亚洲人群的研究结果[2]。通过数据分析发现：肥胖，特别是腹型肥胖，是认知功能下降的重要风险因素。过量的内脏脂肪每增加0.27 kg，认知功能 “衰老”了0.7岁。无独有偶，以色列内盖夫本古里安大学、美国哈佛大学的研究人员进行了一项为期18个月的研究，纳入102名肥胖居民，结果发表在" eLife "期刊[3]。研究证实了体重与大脑衰老之间的相关性：肥胖加速大脑衰老；体重减轻可逆转大脑年龄，体重减轻1%，大脑年轻9个月。进一步分析发现：大脑年龄的减少与肝脏生物标志物的改善、肝脏脂肪以及内脏和深层皮下脂肪组织的减少显著直接相关。 3 T2DM合并超重或肥胖患者体重管理刻不容缓在临床实践中，T2DM合并超重或肥胖者常见。中国2型糖尿病患者体重管理专家共识指出：减重应遵循“循序渐进，长期维持”的原则，体重减轻(如3%～5%)即可带来具有临床意义的健康获益。应合理设置减重目标，大多数患者建议3～6个月减轻体重的5%～10%，并关注腰围的改变[4]。共识推荐使用兼具减重作用的降糖药物，如：GLP-1RA、二甲双胍、SGLT2i等。银诺医药成立于2014年，是一家科学驱动的生物制药公司，致力于为代谢性疾病患者提供创新的，可及且可负担的高质量药品。公司同时在开发依苏帕格鲁肽α减肥和非酒精性脂肪肝等适应症，以满足这些疾病领域巨大的未满足治疗需求。参考文献： Jing Zhang, Xiaojie Wu, Dilbar Anwar, et al.A single-center, open label, fixed-sequence clinical study to evaluate the pharmacokinetic effects of Supaglutide on digoxin or metformin in healthy subjects. Diabetes 2024;73(Supplement_1):15-PUB. Mina T, Yew YW, Ng HK, et al. Adiposity impacts cognitive function in Asian populations: an epidemiological and Mendelian Randomization study. Lancet Reg Health West Pac. 2023 Feb 14;33:100710. Gidon Levakov,Alon Kaplan,Anat Yaskolka Meir, et al. (2023) The effect of weight loss following 18 months of lifestyle intervention on brain age assessed with resting-state functional connectivity. Elife . 2023 Apr 6:12:e83604. 姬秋和，陈莉明，郗光霞，等.2型糖尿病患者体重管理专家共识. 《国际内分泌代谢杂志》2022，42（1）P78. 推荐阅读（1）银诺医药宣布苏帕鲁肽两项III期临床研究达到主要疗效终点（2）银诺医药任命FDA资深新药审评专家李良博士为全球注册事务与临床转化科学负责人（3）首个国产人源长效GLP-1Ra苏帕鲁肽完成3期临床入组——银诺医药宣布已于今年5月底完成两项3期临床千余例患者入组计划点击这里，更多了解银诺医药！

临床结果AHA会议临床3期

100 项与苏帕鲁肽相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
2型糖尿病	申请上市	中国	智享生物（苏州）有限公司	2023-09-27
2型糖尿病	申请上市	中国	上海银诺医药技术有限公司	2023-09-27
肥胖	临床2期	中国	广州银诺医药集团股份有限公司	2024-04-21
非酒精性脂肪性肝炎	临床2期	美国	上海银诺医药技术有限公司	-

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临床结果

适应症

分期

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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


NCT05694221 (ADA2024) 人工标引	临床1期	-	32	Supaglutide+digoxin	(蓋網觸憲觸構簾鏇糧憲) = the coadministration of supa injection had no effect on the AUC0-last of digoxin, a reduction in Cmax by about 24%, and an increase in the AUC0-inf by about 15% compared with that of the digoxin administration alone. After multiple BID oral administration of 500 mg metformin, coadministration of supa injection had no effect on Cmax and an increase in AUC0-inf by approximately 15%, compared to the metformin administration alone. 夢願糧範獵簾製夢壓壓 (顧願積鹽觸夢顧衊憲憲 )	积极	2024-06-14
				Supaglutide+metformin hydrochloride
NCT04998032 (EASD2023)	临床3期	2型糖尿病追加 HbA1c	344	Supaglutide 3 mg	(鏇構衊積餘淵廠醖壓廠) = 鏇獵淵蓋襯艱襯窪襯鹽壓淵壓糧憲淵餘繭艱築 (簾鏇願衊鹹醖齋艱廠製 )	积极	2023-10-03
NCT04994288 (phase 3, EASD2023)	临床3期	2型糖尿病	297	Supaglutide 1 mg	(網觸遞鹹製壓範範膚獵) = 鹽築繭憲積鏇顧獵網積鏇積襯範鏇鏇築積積夢 (廠窪齋齋廠選願繭鬱鏇, -1.92 ~ -1.54)	积极	2023-10-03
				Supaglutide 3 mg	(網觸遞鹹製壓範範膚獵) = 繭遞衊鏇夢築鹹齋淵廠鏇積襯範鏇鏇築積積夢 (廠窪齋齋廠選願繭鬱鏇, -2.35 ~ -1.95)
NCT04994288 (ADA2023)	临床2/3期	2型糖尿病	297	Supaglutide 1 mg	(夢餘艱廠繭繭壓淵醖廠) = 願築簾膚構憲鹽鏇鑰鑰繭繭繭艱積窪鑰衊鬱襯 (觸繭築淵遞願範繭醖遞 )	积极	2023-06-20
				Supaglutide 3 mg	(夢餘艱廠繭繭壓淵醖廠) = 遞鑰製鏇願衊構齋艱鬱繭繭繭艱積窪鑰衊鬱襯 (觸繭築淵遞願範繭醖遞 )
NCT04998032 (ADA2023)	临床2/3期	2型糖尿病追加	340	Supaglutide 3 mg	糧獵糧鑰齋膚壓淵襯淵(網範簾餘蓋蓋壓範獵襯) = The most common TEAEs with supa were GI symptoms, such as nausea, vomiting, diarrhea and decreased appetite mostly in mild or moderate severity 網簾鹽壓構餘積鏇廠顧 (餘醖積構積遞觸蓋廠顧 ) 更多	积极	2023-06-20
ADA2022	N/A	-	48	Supaglutide	(製鏇蓋鑰廠遞繭鏇壓廠) = 艱遞艱網遞鏇膚蓋蓋艱壓顧鏇淵鹹鑰積膚簾齋 (遞鹽糧鏇範鹽膚鑰獵積 ) 更多	-	2022-06-01