A Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of GZR18 Injection in Obese Subjects With Moderate to Severe Obstructive Sleep Apnea（OSA） Not Treated With Positive Airway Pressure（PAP）

This study is a multicenter, randomized, double-blind, parallel, placebo-controlled Phase III clinical trial evaluating the efficacy and safety of GZR18 injection in obese subjects with moderate to severe obstructive sleep apnea who are unable or unwilling to undergo positive airway pressure (PAP) therapy.

开始日期2026-04-27

申办/合作机构

甘李药业股份有限公司

NCT07501832

/ Not yet recruiting临床3期

A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of GZR18 Injection in Obese Subjects With Moderate to Severe Obstructive Sleep Apnea Receiving Positive Airway Pressure (PAP) Therapy

The study is a multicenter, randomized, double-blind, parallel-group, placebo-controlled Phase III clinical trial to evaluate the efficacy and safety of GZR18 injection in Chinese adult obese patients with moderate-to-severe obstructive sleep apnea (OSA) who are currently using positive airway pressure (PAP) therapy. This study will assess the impact of GZR18 on OSA-related symptoms, respiratory parameters, and quality of life compared to placebo.

开始日期2026-03-27

申办/合作机构

甘李药业股份有限公司

NCT07292441

/ Recruiting临床3期

A Multicenter Extension Study of the Phase 3 Clinical Study of GZR18 Injection for Weight Loss

This is a Phase 3 extension study conducted in subjects who have received GZR18 Injection once every 2 weeks (Q2W) for weight loss treatment for 52 weeks, aiming to explore the effect and safety of continuous injection of GZR18 Injection once every 4 weeks (Q4W) for 24 weeks on body weight.
In this study, it is planned to include subjects who have participated in the original study and completed the study contents of the original protocol. All subjects will maintain a regular diet and exercise lifestyle during the study.

开始日期2026-01-22

申办/合作机构

甘李药业股份有限公司

100 项与博凡格鲁肽相关的临床结果

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100 项与博凡格鲁肽相关的转化医学

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100 项与博凡格鲁肽相关的专利（医药）

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项与博凡格鲁肽相关的文献（医药）

2025-05-01·DIABETES OBESITY & METABOLISM

The safety, tolerability, pharmacokinetics and pharmacodynamics of GZR18 in healthy American and Chinese adult subjects

Article

作者: Zhong‐Ru Gan ; Yue Liu ; Anshun He ; Aixin Shi ; Yue Li ; Allen Hunt ; Liyuan Zhao ; Xuemei He ; Jing Zhao ; Tian Xie ; Wei Chen

Abstract:

Aims:

GZR18, a novel long‐acting GLP‐1 receptor agonist, has demonstrated substantial metabolic improvements in diabetic and obese animal models. The present studies aimed to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of the ascending dose of GZR18 in healthy American and Chinese subjects.

Materials and Methods:

In these phases 1, randomized, double‐blind, placebo‐controlled, sequential, dose‐escalation US and Chinese studies, healthy American and Chinese adults with similar age were enrolled to once‐weekly subcutaneous injection of GZR18 or placebo. The studies included three cohorts of male American subjects (cohorts US‐1–3) and six cohorts of Chinese subjects (cohorts CN‐1–6, male and female), each with a specified target dose of GZR18 ranging from 1 to 50 μg/kg (1–10 μg/kg for US study and 5–50 μg/kg for Chinese study). The primary endpoints were the safety and tolerability of GZR18. Blood samples were collected for PK and PD analysis of GZR18 before and after dosing. A population PK analysis of GZR18 was conducted to ascertain whether there are ethnic PK differences between American and Chinese adults.

Results:

The exposure of GZR18 was comparable between healthy American and Chinese subjects, with the geometric mean ratio between the two populations for AUC 0‐t and Cmax close to 1. A dose‐dependent increase in AUC 0–t and Cmax occurred in both populations. The median time to maximum plasma concentrations ( Tmax ) in American subjects ranged from 72 to 96 h, and the mean Tmax ranged from 60 to 72 h in Chinese subjects. The half‐life of GZR18 was approximately 7 days in both American and Chinese subjects. Evident body weight reduction was observed in GZR18 treatment groups in Chinese subjects (cohorts CN‐3–6 on Day 15, −1.25 to −1.86 kg; −1.88% to −3.11%). No deaths, serious adverse events or hypoglycaemia were reported. Decreased appetite and nausea were the most frequently reported treatment‐emergent adverse events, observed in Chinese study and mild in severity. The safety profile of GZR18 was generally consistent with the same class of drugs.

Conclusions:

GZR18 demonstrates good tolerability in healthy American and Chinese subjects. No ethnic differences were observed between healthy American and Chinese subjects. The safety, PK and PD profiles of GZR18 support its further clinical evaluation for glycaemic and body weight control.

2022-08-01·European journal of pharmacology

GZR18, a novel long-acting GLP-1 analog, demonstrated positive in vitro and in vivo pharmacokinetic and pharmacodynamic characteristics in animal models

Article

作者: Deng, Ying ; Chen, Wei ; Mazuranic, Michelle ; Qian, Yuzhen ; Wang, Yue ; He, Anshun ; Xue, Fangkai ; Peng, Xiaohong ; Zhang, Yining ; Wei, Bing ; Cui, Cheng ; Zhang, Man ; Xing, Wancai

GZR18 is a novel analog of glucagon-like peptide-1 (GLP-1). This study evaluates the pharmacology, pharmacokinetics, and efficacy of GZR18, and its potential for the treatment of Type 2 diabetes mellitus (T2DM). In vitro pharmacology and activity of GZR18 were characterized by a binding assay of GZR18 using human serum albumin (HSA), an activation assay in human GLP-1 receptor-expressing cell lines, and its effect on glucose-stimulated insulin secretion (GSIS) in primary mice islets. Pharmacokinetic profiling was performed in Sprague Dawley rats and cynomolgus monkeys, and efficacy evaluated using GZR18 single or repeated doses in db/db mice. GZR18 showed similar binding affinity for HSA and GLP-1 receptor compared with semaglutide and liraglutide. GZR18 increased GSIS, which was confirmed by dynamic islet perifusion and fluorescence imaging using PKZnR-5 for real-time detection. In cynomolgus monkeys, the average GZR18 maximal concentration was 527 nmol L^-1, the terminal half-life (T_1/2) was 61.3 h, and the time to maximum concentration was 14 h. Single-dose GZR18 lowered blood glucose levels and reduced body weight over 72 h in db/db mice. GZR18 successive administration (every three days for 33 days, i.e. 11 doses) lowered nonfasting and fasting blood glucose levels (p < 0.05 versus control) and glycated hemoglobin, following the 11th dose. Food and water consumption in db/db mice was lowered following repeated doses of GZR18 (p < 0.05 versus control), without a reduction in body weight. These results demonstrate the potential of GZR18 as a long-acting GLP-1 analog for the treatment of T2DM.

Signal Transduction and Targeted Therapy

Efficacy and safety of bofanglutide, a GLP-1 receptor agonist, in Chinese adults with overweight or obesity: a randomized, double-blind, placebo-controlled phase 2b trial

Article

作者: Zhao, Jing ; Chen, Wei ; Dong, Ruihua ; Zhang, Zhongtao ; Tian, Junhang ; Gao, Leili ; Zhao, Liyuan ; He, Anshun ; Ji, Linong ; Xie, Tian ; Shu, Hongyan ; Li, Yue

Abstract:

Bofanglutide is a novel biweekly (once every two weeks; Q2W) glucagon-like peptide-1 receptor agonist. We evaluated the efficacy and safety of bofanglutide in Chinese adults with overweight or obesity in a randomized, double-blind, placebo-controlled phase 2b trial (ClinicalTrials.gov, NCT06256562). Adults with overweight (body mass index [BMI] ≥24, <28 kg/m 2 ) and at least one weight-related comorbidity, or obesity (BMI ≥ 28 kg/m 2 ), were randomly assigned to five dose groups: 12 mg Q2W, 18 mg Q2W, 24 mg Q2W, 48 mg Q2W, and 24 mg once weekly (QW), with randomization to bofanglutide or placebo within each dose group. The primary endpoint was the percentage change in body weight from baseline to week 30. Between June 8, 2023, and June 5, 2024, 340 participants (185 [54.4%] male; mean age, 33.1 years; mean body weight, 95.6 kg; mean BMI, 33.2 kg/m²) were randomized into the following groups: bofanglutide 12 mg Q2W ( n = 52), 18 mg Q2W ( n = 53), 24 mg Q2W ( n = 52), 48 mg Q2W ( n = 64), 24 mg QW ( n = 53), or placebo ( n = 66). Overall, 286 participants (84.1%) completed the trial. The mean percentage change in body weight from baseline to week 30 ranged from −9.75% to −16.69% with bofanglutide, compared with −1.15% with placebo (all p < 0.001 versus placebo). Adverse events occurred in 98.9% (271/274) of the bofanglutide group versus 86.4% (57/66) of the placebo group and were mostly grade 1–2 gastrointestinal events (83.9% [230/274] with bofanglutide and 33.3% [22/66] with placebo). Bofanglutide is generally well tolerated and has a robust ability to reduce body weight.

260

项与博凡格鲁肽相关的新闻（医药）

2026-04-11

·BD随笔

2026年第十四周“药”闻，一起感觉行业回暖！

2026年第14周，国内医药给予我们带来很多好消息，有融资的，有医药上市的,资产转让授权，也有IPO相关，我们一起回顾总结一下：一、IPO及相关上市公司信息: 4月8号，靖因药业在港交所递交招股书，拟在香港主板挂牌上市。 4月5日，旺山旺水发布2025年财报，全年营业收从1千多万飙升至1.02亿元人民币，同比增幅高达762.9%，毛利率由29.5%飙升至79.0%。 4月8日，汇伦医药递交中国香港IPO招股书。公司在2023年、2024年、2025年营收分别为9.85亿、6.86亿、6.86亿元。二、收购、融资及交易： 4月9日，轩竹生物宣布与Boston Oncology就轩竹生物自主研发的两款1类创新药吡洛西利片及地罗阿克片达成独家授权许可及供货协议。根据双方正式签署的协议条款，Boston Oncology将获授独家许可，在中东及北非地区超20个国家开发、注册及商业化两款产品。轩竹生物将获得来自Boston Oncology支付的首付款和后续可能累计超过1亿美元的监管和商业里程碑付款，以及授权区域内销售总额的固定比例特许权使用费。 4月8日，甘李药业宣布与韩国头部药企JW Pharmaceutical签署独家许可协议，双方就甘李药业自主研发的博凡格鲁肽注射液在韩国的临床开发、注册申报及商业化开展合作。根据协议内容，JW制药将获得在韩国开发和商业化博凡格鲁肽注射液的独家权益。甘李药业将获得一次性、不可退还首付款500万美元，并可基于研发进展、监管审批及商业化等情况，收取总计7610万美元的里程碑付款，以及产品商业化后根据净销售额收取的分级特许权使用费；潜在交易总金额高达8110万美元。 4月8日，华海药业下属控股子公司华奥泰与 ALM 签署了合作开发与许可协议，根据本次新药BD协议，华奥泰有权从ALM获得总额不超过3.4亿美元的首付款、开发里程碑付款和商业化里程碑付款。 4月8日，上海科泽永欣生物科技有限公司宣布完成数千万元Pre-A轮融资。本轮融资由迪晟资本领投，老股东嘉乐资本继续追加投资。所筹资金将用于全资子公司安徽科泽永欣生物科技有限公司的生产基地建设。 4月10日，蔚程医药宣布完成5400万美元A轮融资。本轮融资由启明创投与一家知名产业基金联合领投，弘晖基金、一家知名投资基金、泰福资本共同积极参与投资，原有投资方杏泽资本持续追加投资。蔚程医药专注于肝外靶向小核酸药物研发，本轮融资资金将主要用于公司核心肝外递送技术平台的迭代优化、多条管线的临床推进，以及团队扩充与全球研发网络搭建。 4月10日，原启生物”宣布累计完成1.1亿美元的Pre-IPO轮融资。本轮融资由维梧资本、北京市医药健康产业投资基金、启明创投及一家全球领先的医疗基金共同领投，某国际主权基金、亦庄国投、鲁信创投、NGS（澳大利亚养老产业基金）、骊宸投资、瑞锋资本等知名机构跟投。原启生物作为细胞治疗药物领域的领军企业，原启生物始终致力于开发具有全球临床价值的CAR-T细胞疗法，并已在多条管线上取得了确证性的概念验证。三、医药上市相关 4月3日，CDE 官网显示上海海和药物研发的艾普美妥司他片上市申请获受理，艾普美妥司他用于治疗不可手术的局部晚期 / 转移性经治上皮样肉瘤。 4月3日，CDE 官网显示软膏明慧医药伊托法替布上市申请获受理，主要用于治疗青少年和成人轻至中度特应性皮炎。 4月8日，CDE 官网显示凌科药业研发的泽普昔替尼胶囊上市申请获受理，用于治疗重度特应性皮炎。新的适应症类风湿关节炎也在进行三期临床。 4月9日，CDE官网显示，映恩生物研发的注射用帕康曲妥珠单抗上市申请获受理，用于既往接受过曲妥珠单抗及紫杉烷治疗的 HER2 阳性不可切除或转移性乳腺癌。这是映恩生物首个申报上市的 ADC 产品。周末在家总结一下业界新闻，感受药界的变化，一起加油，行业慢慢会更好起来！

2026-04-10

·医联招募

【肥胖+打呼噜】睡眠呼吸暂停征：长效GLP-1RA制剂，减重+代谢改善，减轻夜间睡眠紊乱，最高补助10600元！

点击蓝字关注我们阻塞性睡眠呼吸暂停综合征（OSA）是一种睡觉时呼吸反复受阻的疾病，典型表现为打鼾、夜间憋醒、日间嗜睡。并会显著增加罹患高血压、冠心病、心律失常、脑卒中、2型糖尿病等多种并发症的风险。 GZR18（博凡格鲁肽）是甘李药业自主研发的长效GLP-1受体激动剂，有望成为全球首款GLP-1RA双周制剂。该药物于2026年3月获得国家药监局批准，开展针对治疗成人肥胖患者的中度至重度阻塞性睡眠呼吸暂停综合征临床项目。肥胖是OSA最重要且可逆的病因之一，GZR18治疗OSA的核心机制基于其强大的减重和代谢改善作用。通过生理性调节呼吸驱动与肌张力，有望从根源减轻夜间低氧与睡眠结构紊乱，并潜在降低心血管代谢合并症风险。全国多中心同步启动免费临床计划—— 试验组：GZR18注射液对照组：安慰剂 ✅ 免费使用研究相关药物，免费相关检查 ✅ 项目周期52周，预计到院访视18次 ✅ 交通补助/采血补助等共计10600元（具体以医院知情书为准） ✅ 入组标准：年龄18~65周岁，性别不限体重指数(BMI) ≥ 30 kg/㎡确诊为阻塞性睡眠呼吸暂停综合征（OSA），且多导睡眠监测（PSG）的AHI≥15次/小时不愿意或不适合接受呼吸机PAP治疗，且未计划在研究期间启用PAP治疗有打鼾、白天嗜睡等症状（Epworth嗜睡量表评分≥9）至少有一次饮食控制减肥不佳，且近12周内体重变化<5% ⛔ 排除标准：已知或疑似对胰高血糖素样肽-1受体激动剂（GLP-1 RA）类药物或其辅料过敏任何类型的糖尿病病史筛选前接受过或计划在研究期间接受手术或器械治疗肥胖疾病、药物或其他原因导致的继发性肥胖筛选时需要接受氧疗/辅助氧疗经研究者判断，认为不适合参与本研究的任何其他情况 ✍️报名参与：阻塞性睡眠呼吸暂停综合征诊断病历 6个月内多导睡眠监测报告 🏥 项目中心北京、广州、深圳、石家庄、长春、郑州、太原、成都、黄冈、南京、兰州、南阳、洛阳、重庆、宁波、惠州、淄博、济南、无锡、哈尔滨、宜昌。 🚀 仅需3步轻松申请 ① 扫码提交资料：病历+检查报告+用药记录 ② 专属顾问评估：1对1预筛评估入组资格 ③ 就近匹配三甲医院：全国多中心快速通道已开启！ 🔥转发帮助身边饱受困扰的病友，您的举手之劳可能会让急需治疗的病友及时获得免费用药机会！扫码关注｜YILIAN 了解更多｜ZHAOMU ▌ 严正声明：本文内容依据国家药品监督管理局（NMPA）临床试验备案信息及公开资料整理，所有项目均通过国家药监局审核备案，严格遵守《药物临床试验质量管理规范》。研究由全国三甲医院专业团队负责实施，全程接受药监部门及伦理委员会监管。 ▌ 费用说明：本项目为公益性临床研究，招募项目不收取任何费用，成功入组患者因试验产生的必要医疗费用将由申办方专项基金承担。 ▌ 隐私保障：您的个人信息及医疗数据将采用匿名编码系统加密管理，仅限授权团队用于医学研究评估，所有数据使用均需通过伦理审查。 ▌ 了解咨询：关注"医联招募"微信公众号获取更多项目详情，如果您本人或是亲友符合上述基本条件，想进一步了解，可扫描文末二维码进入咨询通道。

2026-04-10

·Pharmaceutical Technology

Gan & Lee and JW Pharmaceutical agree on bofanglutide commercialisation

Under the agreement, JW Pharmaceutical gains exclusive rights to develop and commercialise bofanglutide in South Korea. Credit: Gan & Lee Pharmaceuticals / PR Newswire. Gan & Lee Pharmaceuticals has entered an exclusive licence agreement with JW Pharmaceutical for the clinical development, regulatory approval, and commercialisation of bofanglutide injection in South Korea. Bofanglutide is a bi-weekly glucagon-like peptide-1 receptor agonist (GLP-1RA) discovered and developed by Gan & Lee. Under the agreement, JW Pharmaceutical gains exclusive rights to develop and commercialise the injection. Gan & Lee will leverage the strengths of JW Pharmaceutical in R&D to establish a commercial presence in South Korea’s metabolic disease market. Gan & Lee will receive a non-refundable upfront payment of $5m, with milestone payments up to $76.1m, dependent on research, regulatory, and commercialisation targets. The company will also obtain tiered royalties on net sales, bringing the total potential transaction value to $81.1m, excluding royalties. This marks the third overseas out-licensing deal for Bofanglutide, after similar agreements in India and Latin America. Bofanglutide has entered Phase III clinical research, targeting indications such as obesity/overweight, type 2 diabetes mellitus, and obstructive sleep apnoea. Data indicate that the injection reduces body weight and blood glucose levels while favourably affecting metabolic parameters, with a safety and tolerability profile similar to other GLP-1RA therapies. The bi-weekly dosing schedule minimises the annual number of injections by half compared to the standard once-weekly alternatives. Gan & Lee Pharmaceuticals chief business officer Dr Zhi Li said: “This partnership with JW Pharmaceutical marks another pivotal step in the globalisation strategy for bofanglutide. GLP-1 therapies are reshaping the global treatment landscape for metabolic diseases. “The convenience of Bofanglutide’s bi-weekly dosing and its compelling clinical benefits will help address the unmet medical needs of South Korean patients. With over 80 years of experience, JW brings deep development and commercial expertise in metabolic diseases—a key factor in our decision to partner with JW.”

引进/卖出临床3期

100 项与博凡格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
阻塞性睡眠呼吸暂停综合征	临床3期	中国	甘李药业股份有限公司	2026-03-27
低血糖	临床3期	中国	甘李药业股份有限公司	2025-01-16
2型糖尿病	临床3期	中国	甘李药业股份有限公司	2025-01-03
肥胖	临床3期	中国	甘李药业股份有限公司	2024-12-17

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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


CTR20240663 (NEWS)	临床1期	2型糖尿病	92	博凡格鲁肽片	鏇淵鹹鹽觸糧窪遞艱襯(選鹽窪醖壓憲廠壓遞艱) = 襯顧鹹網選獵襯窪築願衊鬱壓襯構蓋淵鬱醖窪 (壓襯壓顧淵鬱繭鏇鏇鹹 )	积极	2024-11-13
CTR20232069 (NEWS) 人工标引	临床2期	2型糖尿病	264	GZR18 (每两周给药一次)	鑰獵艱憲積艱簾醖鹽積(選築繭糧衊襯壓鏇襯顧) = 獵夢鹹蓋憲鏇廠鏇鬱憲觸艱願獵壓醖積積簾範 (觸觸積觸蓋鏇窪網鑰鹽 ) 更多	积极	2024-10-15
				GZR18 (12 mg)	鑰獵艱憲積艱簾醖鹽積(觸鏇顧蓋築膚鬱淵窪鑰) = 窪夢顧艱遞積鏇簾廠構鏇憲糧鬱遞艱遞糧膚齋 (夢襯繭鏇艱壓艱遞廠蓋 )
CTR20231695 (PRNewswire) 人工标引	临床2期	超重 \| 肥胖	-	GZR18 12 mg Q2W	鑰壓壓鑰鏇簾蓋淵鹽顧(夢廠顧簾鑰範鑰鏇遞願) = 顧顧膚壓憲範餘衊範壓遞廠醖構鏇醖選鑰艱窪 (選餘淵鹹壓齋鏇鬱構選 )	积极	2024-07-22
				GZR18 18 mg Q2W	鑰壓壓鑰鏇簾蓋淵鹽顧(夢廠顧簾鑰範鑰鏇遞願) = 願鏇鏇築範壓壓選獵襯遞廠醖構鏇醖選鑰艱窪 (選餘淵鹹壓齋鏇鬱構選 )
NCT06256536 (ADA2024) 人工标引	临床1/2期	肥胖	35	GZR18 30 mg QW	製顧齋積願範積衊憲鑰(選餘製築醖糧鹹獵鏇襯) = 鬱積鹹夢醖鹽鏇鬱壓醖觸獵範築鏇選窪鹽範範 (遞鹽蓋遞糧壓襯顧鏇選, -21.8 ~ -13.9) 更多	积极	2024-06-21
				GZR18 30 mg Q2W	製顧齋積願範積衊憲鑰(選餘製築醖糧鹹獵鏇襯) = 糧衊製簾窪蓋膚築網蓋觸獵範築鏇選窪鹽範範 (遞鹽蓋遞糧壓襯顧鏇選, -17.5 ~ -8.0) 更多
CTR20221509 (NEWS)	临床1/2期	2型糖尿病	-	博凡格鲁肽	鏇簾窪蓋鏇鏇遞顧鏇鹹(獵衊襯顧繭淵築廠鏇鑰) = Clinical results have reached the endpoint 糧淵淵鹽鬱繭願顧齋壓 (鑰鬱膚齋鬱餘餘蓋襯範 ) 更多	积极	2024-05-15
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