甘李药业宣布在美国启动博方谷肽（GZR18）注射液针对超重或肥胖的二期临床研究，首例受试者已入组-动脉网

Gan & Lee Pharmaceuticals Announced First Participant Dosed in the US Phase 2 Clinical Study of Bofanglutide (GZR18) Injection for Overweight or Obesity

CISION 等信源发布 2025-03-10 23:26

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BEIJING

北京

and

和

BRIDGEWATER, N.J.

新泽西州布里奇沃特

，

March 10, 2025

2025年3月10日

/PRNewswire/ -- Gan & Lee Pharmaceuticals

/PRNewswire/ -- 甘李药业

(Gan & Lee, Shanghai Stock Exchange: 603087)

（甘李药业，上海证券交易所：603087）

announced that the first participant has been successfully dosed in a Phase 2 clinical trial of

宣布已在二期临床试验中成功给第一名参与者给药，

bofanglutide

播放lutide

(research code: GZR18) injection, a bi-weekly glucagon-like peptide-1 receptor agonist (

（研究代码：GZR18）注射剂，一种每两周一次的胰高血糖素样肽-1受体激动剂（

GLP-1

RA) independently developed by Gan & Lee, in the US participants with overweight or obesity.

甘李独立开发的RA，美国超重或肥胖参与者。

Notably, bofanglutide is the first GLP-1 receptor mono-agonist to undergo a head-to-head comparison with tirzepatide for evaluating the efficacy in body weight management globally.

值得注意的是，博方格鲁肽是全球首个与替尔泊肽进行头对头比较以评估其在体重管理方面疗效的GLP-1受体单激动剂。

This Phase 2 clinical trial (ClinicalTrials.gov registration number: NCT06737042) was designed to evaluate the efficacy and safety of

本项 2 期临床试验（ClinicalTrials.gov 注册号：NCT06737042）旨在评估

bofanglutide

播放格鲁肽

injection in US adults with overweight or obesity. The study plans to enroll 285 subjects,

在美国超重或肥胖的成年人中进行注射。该研究计划招募285名受试者，

who will be randomized to receive either 24 mg, 36 mg, or 48 mg of bofanglutide bi-weekly, 15 mg of tirzepatide once-weekly, or placebo. The primary endpoint is the percentage change in body weight from baseline at the end of the treatment.

谁将被随机分配接受每两周24毫克、36毫克或48毫克的博芳格鲁肽，每周一次15毫克的替尔扎帕肽，或安慰剂。主要终点是治疗结束时体重相对于基线的百分比变化。

Previously, a Phase 1 study (NCT06548997) of

此前，一项 1 期研究 (NCT06548997)

bofanglutide

播放格鲁肽

injection demonstrated good safety and tolerability in US subjects, along with promising glucose-lowering and weight-loss potential

注射剂在美国受试者中表现出良好的安全性和耐受性，同时具有降低血糖和减重的潜力。

[1]

。

The initiation of head-to-head clinical study for bofanglutide versus tirzepatide, marking a new phase in Gan & Lee's GLP-1 innovation.

甘李药业启动了博方谷肽与替尔泊肽的头对头临床研究，标志着其GLP-1创新药物研发进入新阶段。

This milestone underscores the company's ambition to challenge the

这一里程碑突显了该公司挑战的野心

leading GLP-1 therapy in the global market for weight management, aiming to provide a better treatment option for patients with overweight or obesity worldwide.

全球市场领先的体重管理GLP-1疗法，旨在为全球超重或肥胖患者提供更好的治疗选择。

Reference:

参考：

[1].Liu Y, Chen W, He X, He A, Zhao L, Xie T, Li Y, Zhao J, Hunt A, Shi A, Gan ZR. The safety, tolerability, pharmacokinetics and pharmacodynamics of GZR18 in healthy American and Chinese adult subjects. Diabetes Obes Metab. 2025 Mar 3. doi: 10.1111/dom.16285. Epub ahead of print. PMID: 40028667.

[1]. 刘洋，陈伟，何霞，何安，赵亮，谢涛，李勇，赵军，亨特，施安，甘志荣。GZR18在美国和中国健康成年受试者中的安全性、耐受性、药代动力学和药效学研究。《糖尿病、肥胖与代谢》。2025年3月3日。doi: 10.1111/dom.16285。在线提前发表。PMID: 40028667。

About Bofanglutide (GZR18)

关于博法鲁肽（GZR18）

Bofanglutide (R&D Code: GZR18) injection, developed by Gan & Lee Pharmaceuticals, is a bi-weekly

甘李药业研发的博法鲁肽（研发代码：GZR18）注射液，是一种双周

GLP-1

receptor agonist (RA) indicated for glycemic control in adults with type 2 diabetes and body weight management in overweight/obese individuals. As the potential first bi-weekly

受体激动剂（RA），用于控制2型糖尿病成人患者的血糖水平以及超重/肥胖人群的体重管理。作为潜在的首个双周用药

GLP-1

RA in the world, early clinical trials have demonstrated its efficacy in weight reduction comparable to or superior to marketed counterparts, with a safety and tolerability profile consistent with the established class of

在全球范围内，早期临床试验已证明其在减重方面的疗效与市场上现有的同类药物相当或更优，其安全性和耐受性特征与已确立的类别一致。

GLP-1

RAs, and significant reductions in both blood glucose levels and body weight.

RAs，以及血糖水平和体重的显著降低。

Forward-looking statements

前瞻性声明

Forward-looking statements are based on our expectations and assumptions as of the date of the statements. Actual results may differ materially from those expressed in these forward-looking statements due to a variety of factors, and we can give no assurance that such results will be achieved in the future.

前瞻性声明基于我们截至声明日期的预期和假设。由于各种因素，实际结果可能与这些前瞻性声明中表达的结果有重大差异，我们无法保证未来会实现这些结果。

We undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise..

我们不承担更新或修改任何前瞻性陈述的义务，无论这是由于新信息、未来事件或其他原因。

About Gan & Lee

关于甘李药业

Gan & Lee Pharmaceuticals developed the first Chinese domestic insulin analog. Currently, Gan & Lee has six core insulin products, including five insulin analog varieties: long-acting glargine injection (Basalin), fast-acting lispro injection (Prandilin

甘李药业研发出中国第一款国产胰岛素类似物，目前甘李药业已有六款核心胰岛素产品，包括五个胰岛素类似物品种：长效甘精注射液（长秀霖）、速效赖普注射液（速秀霖）。

™), fast-acting aspart injection (Rapilin), mixed protamine zinc lispro injection (25R) (Prandilin

™)，速效门冬胰岛素注射液（Rapilin），混合鱼精蛋白锌赖脯胰岛素注射液（25R）（Prandilin）

™25), aspart 30 injection (Rapilin30), and one human insulin injection - mixed protamine human insulin injection (30R) (Similin30). The company has two approved medical devices in China, namely reusable insulin injection pen (GanleePen), and disposable pen needle (GanleeFine)

™25）、门冬胰岛素30注射液（Rapilin30），以及一种重组人胰岛素注射液——精蛋白混合重组人胰岛素注射液（30R）（Similin30）。公司在中国有两种获批的医疗器械，即可重复使用的胰岛素注射笔（GanleePen）和一次性笔针（GanleeFine）。

。

In China's 2024 National Insulin-Specific Centralized Procurement, Gan & Lee Pharmaceuticals ranked

在中国2024年国家胰岛素专项集中采购中，甘李药业排名

first among all selected companies in terms of procurement demand for insulin analogs. The company is also making strides in international markets, with the disposable pen needle (GanleeFine) approved by the US Food and Drug Administration (FDA) in 2020 and received GMP inspection approval from the European Medicines Agency (EMA) in 2024.

在胰岛素类似物采购需求方面，位居所有入选公司之首。该公司在国际市场上也取得了进展，一次性笔针（GanleeFine）于2020年获得美国食品药品监督管理局（FDA）批准，并于2024年获得欧洲药品管理局（EMA）的GMP检查批准。

These achievements significantly boost Gan & Lee's competitiveness in both international and domestic markets.

这些成果显著提升了甘李药业在国际和国内市场的竞争力。

。

In the future, Gan & Lee will strive for comprehensive coverage in diabetes treatment. Moving forward with its mission to become a world-class pharmaceutical company, Gan & Lee will also actively develop new chemical entities and biological drugs, focusing on treatments for metabolic diseases, cardiovascular diseases, and other therapeutic areas..

未来，甘李药业将在糖尿病治疗领域努力实现全面覆盖。在朝着成为世界级药企的使命迈进的同时，甘李药业还将积极开发新的化学分子实体与生物药物，聚焦于代谢性疾病、心血管疾病等其他治疗领域。

SOURCE Gan & Lee Pharmaceuticals

来源：甘李药业

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