Scientific Publications

R&D and Innovation

Driven by independent innovation, continuously building a differentiated R&D pipeline for metabolic and chronic diseases

Gan & Lee's research findings have been published in peer-reviewed scientific journals, including clinical studies, real-world studies, and other scientific research. Below is a selected list of publications, which can be searched and filtered by therapeutic area, target, and development stage.

Therapeutic area

Therapeutic area
Type 2 diabetes mellitus
Type 1 diabetes mellitus
Diabetes
Obesity/overweight

Target

Target
GLP-1
INSR
CDK4/6

Development Stage

Development Stage
Phase 3
Phase 2b
Phase 2
Phase 1b/2a
Phase 1b
Phase 1a
Phase 1
Preclinical
Review

Safety, tolerability, relative bioavailability, pharmacokinetics, and pharmacodynamics of single and multiple doses of the novel oral bofanglutide in healthy Chinese participants

Xiaohua Hao , Long Liu , Pu Li , Chunpu Lei , Yuanxu Tong , Junmin Dong , Xiaoyun Liu , Xiaoqiang Cheng , Jing Zhao , Xiao Min , Yining Zhang , Wei Chen

Bofanglutide Tablets (GZR18 Tablets)Type 2 diabetes mellitus

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Publication Date
July 15, 2026

Development Stage
Phase 1

Published in
Diabetes Research and Clinical Practice
Weekly and biweekly treatment with bofanglutide versus semaglutide in Chinese patients with type 2 diabetes: A phase 2b randomized clinical trial

Ming Liu, Zhifeng Cheng, Li Lu, Hanqing Cai, Jingyu Liu, Jinling Liu, Yueyue Zheng, Su Wang, Jing Zhao, Wei Yang, Tian Xie, Yue Li, Anshun He, Helena W Rodbard, Wei Chen

Bofanglutide (GZR18)Type 2 diabetes mellitus

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Publication Date
June 30, 2026

Development Stage
Phase 2b

Published in
Annals of Internal Medicine
Safety and efficacy of GZR18, a long-acting GLP-1 receptor agonist, in Chinese patients with type 2 diabetes: a randomized, double-blind, phase 1b/2a trial

Ming Liu, Xuhong Wang, Meizi Li, Enyue Yang, Aige Yang, Mingxia Yuan, Ruihua Dong, Guijun Qin, Ping Liu, Chengqian Li, Yu Cao, Jing Zhao, Liyuan Zhao, Wei Chen

Bofanglutide (GZR18)Type 2 diabetes mellitus

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Publication Date
June 19, 2026

Development Stage
Phase 1b/2a

Published in
Cell Reports Medicine
GZR18, a GLP-1 Analog with Once-weekly or Bi-weekly Dosing for Body Weight Management: A Randomized, Placebo-Controlled, Phase 1b/2a Trial

Linong Ji, Leili Gao, Ruihua Dong, Mingxia Yuan, Dong Zhao, Shuguang Pang, Jing Zhao, Liyuan Zhao, Wei Chen

Bofanglutide (GZR18)Obesity/overweight

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Publication Date
April 9, 2026

Development Stage
Phase 1b/2a

Published in
Cell Reports Medicine
Once-weekly insulin GZR4 versus once-daily insulin degludec in Chinese people with type 2 diabetes: a multicenter, open-label, randomized, phase 2 trial

Liming Chen, Xiaolin Dong, Qiumei Zhang, Huihui Wang, Hongyan Zhu , Zhifeng Cheng, Xiangqun Deng, Guang Wang , Jingyun Zhang, Xuerong Liu , Jing Zhao , Chunyue Hao, Tian Xie , Anshun He, Yue Li,Wei Chen

Insulin ludefen (GZR4)Type 2 diabetes mellitus

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Publication Date
March 14, 2026

Development Stage
Phase 2

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

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

Bofanglutide (GZR18)Obesity/overweight

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Publication Date
February 27, 2026

Development Stage
Phase 2b

Published in
Signal Transduction and Targeted Therapy
Pharmacokinetic Properties of Insulin GZR4 After Subcutaneous Administration in the Thigh, Abdomen or Upper Arm in Healthy Participants

Long Liu, Junmin Dong, Yuanxu Tong, Pu Li,Xiaoyun Liu, Xiaoqiang Cheng, Yingjuan Zhang,Chunpu Lei, Fang Cheng, Jing Zhao, Wei Zhao, Wei Chen, Xiaohua Hao

Insulin ludefen (GZR4)Type 2 diabetes mellitus

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Publication Date
January 8, 2026

Development Stage
Phase 1

Published in
Diabetes, Obesity and Metabolism
A phase 1b, randomized, open-label study of once-weekly insulin GZR4 in patients with type 2 diabetes mellitus

Xuhong Wang, Ye Hu, Chengyong Tang, Chenghu Huang , Fengxue Guo , Wei Chen

Insulin ludefen (GZR4)Type 2 diabetes mellitus

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Publication Date
December 18, 2025

Development Stage
Phase 1b

Published in
Diabetes Research and Clinical Practice
GZR101, a Novel Premixed Insulin for the Treatment of Diabetes Mellitus

Wei Chen, Cheng Cui, Wancai Xing, Yining Zhang, Anshun He, Yue Wang, Yan Huang, Nannan Zhai, Qimin Shi, Fangkai Xue, Yongchun Wang, Jun Zhang, Dongli Yu, Tian Xie, Yue Li, Zhong-Ru Gan

GZR101Diabetes mellitus

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Publication Date
June 18, 2025

Development Stage
Preclinical

Published in
Naunyn-schmiedebergs Archives Of Pharmacology
The safety, tolerability, pharmacokinetics and pharmacodynamics of GZR18 in healthy American and Chinese adult subjects

Yue Liu , Wei Chen , Xuemei He , Anshun He , Liyuan Zhao , Tian Xie , Yue Li , Jing Zhao , Allen Hunt , Aixin Shi , Zhong-Ru Gan

Bofanglutide (GZR18)Type 2 diabetes mellitusObesity/overweight

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Publication Date
March 3, 2025

Development Stage
Phase 1

Published in
Diabetes, Obesity and Metabolism
Safety, tolerability, pharmacokinetics and pharmacodynamics of GZR4, a novel once-weekly basal insulin, in healthy participants: A randomized trial

Chengyong Tang, Rui Su, Lei Wan, Mingxue Zhu, Junliang Pu, Chunyue Hao, Jing Zhao, Anshun He, Tian Xie, Yue Li , Wei Chen, Zhong-Ru Gan

Insulin ludefen (GZR4)Type 2 diabetes mellitus

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Publication Date
February 11, 2025

Development Stage
Phase 1a

Published in
Diabetes, Obesity and Metabolism
A comparative evaluation of bioequivalence of Gan & Lee glargine U300 and Toujeo® in Chinese healthy male participants

Xiaoli Li, Anshun He, Bingyan Liu, Rongfang Shan, Juan Zhu, Xiaoyue Li, Tian Xie, Yue Li, Mengmeng Chen, He Su, Chaoyang Zhang, Lufeng Li, Dongmei Cheng, Juan Chen, Ying Wang, Yue Su, Yuanyuan Xu, Zhuoran Li, Huan Zhou, Wei Chen, Yuanyuan Liu

DiabetesGlargine 300

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Publication Date
August 7, 2024

Development Stage
Phase 1

Published in
Frontiers in Endocrinology
Immunogenicity, Efficacy, and Safety of Biosimilar Insulin Glargine (Gan & Lee Glargine) Compared With Originator Insulin Glargine (Lantus) in Patients With Type 1 Diabetes After 26 Weeks Treatment

Elena A. Christofides, Andrzej Stankiewicz,Douglas Denham , Diego Bellido MD 4, Edward Franek, Samer Nakhle, Monika Łukaszewic,John Reed, Victoria Cózar-León,Christine Kosch Dipl-Med 10,Piotr Karaś, David Fitz-Patrick, Yehuda Handelsman,Mark Warren , Priscilla Hollander,David Huffman, Philip Raskin,Tamás Oroszlán, Michael Lillestol, Fernando Ovalle

BasalinType 1 diabetes mellitus

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Publication Date
June 12, 2024

Development Stage
Phase 3

Published in
Endocrine Practice
Immunogenicity, efficacy, and safety of biosimilar insulin glargine (Gan & Lee glargine) compared with originator insulin glargine (Lantus®) in patients with type 2 diabetes after 26 weeks' treatment: A randomized open label study

Elena A Christofides, Orlando Puente, Paul Norwood, Douglas Denham, Hiralal Maheshwari, Michael Lillestol, Terence Hart, Samer Nakhle, Anurekha Chadha, David Fitz-Patrick, Danny Sugimoto, Joseph Soufer, Douglas Young, Mark Warren, David Huffman, John Reed, Harold Bays, Samir Arora, Barbara Rizzardi, Raymond Tidman, Marc Rendell, Kimball A Johnson

BasalinType 2 diabetes mellitus

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Publication Date
April 1, 2024

Development Stage
Phase 3

Published in
Diabetes, Obesity and Metabolism
Pharmacokinetic and pharmacodynamic bioequivalence of Gan & Lee insulin analogues aspart (rapilin®), lispro (prandilin®) and glargine (basalin®) with EU- und US-sourced reference insulins

Wei Chen, Jia Lu, Leona Plum-Mörschel, Grit Andersen, Eric Zijlstra, Anshun He, Tian Xie, Longling Li, Chunyue Hao, Zhongru Gan, Tim Heise

BasalinPrandilinRapilinDiabetes mellitus

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Publication Date
September 21, 2023

Development Stage
Phase 1

Published in
Diabetes, Obesity and Metabolism
Current Status of Weekly Insulin Analogs and Their Pharmacokinetic/Pharmacodynamic Evaluation by the Euglycemic Clamp Technique

Na An, Xuhong Wang, Anshun He, Wei Chen

Insulin ludefen (GZR4)Diabetes mellitus

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Publication Date
July 13, 2023

Development Stage
Review

Published in
Clinical Pharmacology In Drug Development
Investigational cyclin-dependent kinase 4/6 inhibitor GLR2007 demonstrates activity against isocitrate dehydrogenase wild-type glioblastoma and other solid tumors in mice xenograft models

Lei Yin, Zhenglin Yao, Yue Wang, Michelle Mazuranic

GLR2007

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Publication Date
August 11, 2022

Development Stage
Preclinical

Published in
Frontiers in Oncology
Comparative efficacy and safety of two insulin aspart formulations (Rapilin and NovoRapid) when combined with metformin, for patients with diabetes mellitus: a multicenter, randomized, open-label, controlled clinical trial

Jun Yao, Xiaohui Guo, Li Sun, Ping Han, Xiaofeng Lv, Xiuzhen Zhang, Zhaohui Mo, Wenying Yang, Lihui Zhang, Zhanjian Wang, Lvyun Zhu, Quanmin Li, Tao Yang, Wenbo Wang, Yaoming Xue, Yongquan Shi, Juming Lu, Yongde Peng, Fan Zhang, Dewen Yan, Damei Wang, Xuefeng Yu

RapilinDiabetes mellitus

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Publication Date
July 22, 2022

Development Stage
Phase 3

Published in
Current Medical Research and Opinion.
GZR18, a novel long-acting GLP-1 analog, demonstrated positive in vitro and in vivo pharmacokinetic and pharmacodynamic characteristics in animal models

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

Bofanglutide (GZR18)Type 2 diabetes mellitusObesity/overweight

View Article

Publication Date
June 16, 2022

Development Stage
Preclinical

Published in
European Journal of Pharmacology

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