A Phase 2, Multicenter, Randomised, Paralleled, Placebo-controlled (Double-blind) and Active Drug-controlled (Open) Study to Investigate Efficacy and Safety of HEC88473 Injection in Subjects With Type 2 Diabetes Mellitus

This is a multicenter, randomized, parallel, placebo- and active comparator-controlled phase 2 trial to evaluate the efficacy, safety, pharmacokinetics and immunogenicity in subjects with T2DM.
Patients treated with diet and exercise alone, or in combination with stable metformin monotherapy (≥1500 mg/day or maximum tolerated dose ≥1000 mg/ day.), will be enrolled. Approximately 225 participants will be randomized. The study includes four stages: screening period (up to 2 weeks), lead-in period (2 weeks), treatment period (12 weeks) and safety follow-up period (3 weeks after treatment).

Start Date10 Dec 2023

Sponsor / Collaborator

Dongguan HEC Biopharmaceutical R&D Co., Ltd.

CTR20230605

/ CompletedPhase 3

比较德谷门冬双胰岛素注射液（22011）与德谷门冬双胰岛素注射液（诺和佳）治疗2型糖尿病患者的有效性和安全性的多中心、随机、开放、阳性对照的III期研究

[Translation] A multicenter, randomized, open-label, positive-controlled phase III study comparing the efficacy and safety of degludec and insulin aspart injection (22011) and degludec and insulin aspart injection (Novoga) in the treatment of patients with type 2 diabetes

验证德谷门冬双胰岛素注射液（22011）在2型糖尿病患者中疗效非劣于诺和佳

[Translation]

Verify that Degludec insulin aspart injection (22011) is non-inferior to Novartis in patients with type 2 diabetes

Start Date19 Jun 2023

Sponsor / Collaborator

Dongguan HEC Biopharmaceutical R&D Co., Ltd.

[+1]

CTR20230678

/ CompletedPhase 1

一项在健康受试者中比较德谷门冬双胰岛素注射液（22011）与德谷门冬双胰岛素注射液（诺和佳®）药代动力学和药效学特征的I期临床研究

[Translation] A Phase I clinical study comparing the pharmacokinetic and pharmacodynamic characteristics of degludec and insulin aspart injection (22011) and degludec and insulin aspart injection (Truoga®) in healthy subjects

以诺和诺德公司研发的德谷门冬双胰岛素注射液（诺和佳®）为对照药品，评价单剂量皮下注射东莞市东阳光生物药研发有限公司提供的德谷门冬双胰岛素注射液（22011）在健康受试者中的药代动力学（PK）和药效学（PD）特征，进而评价德谷门冬双胰岛素注射液（22011）和诺和佳®的生物等效性

[Translation]

To evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of a single subcutaneous injection of insulin degludec (22011) provided by Dongguan Sunshine Biopharmaceuticals R&D Co., Ltd. in healthy subjects, using insulin degludec (22011) developed by Novo Nordisk as the control drug, and then to evaluate the bioequivalence of insulin degludec (22011) and insulin degludec (22011).

Start Date08 Jun 2023

Sponsor / Collaborator

Dongguan HEC Biopharmaceutical R&D Co., Ltd.

[+1]

100 Clinical Results associated with Dongguan HEC Biopharmaceutical R&D Co., Ltd.

0 Patents (Medical) associated with Dongguan HEC Biopharmaceutical R&D Co., Ltd.

Literatures (Medical) associated with Dongguan HEC Biopharmaceutical R&D Co., Ltd.

01 May 2025·BioDrugs

First-in-Human Study on Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Escalating Doses of HEC88473, a Novel Dual GLP-1 and FGF21 Receptor Agonist in Healthy and Obese Chinese Subjects

Article

Author: Zhang, Hong ; Guo, Lingfeng ; Li, Qianqian ; Xie, Can ; Ding, Yanhua ; Li, Jing ; Chen, Hong ; Yan, Jiangyu

BACKGROUNDHEC88473 is a novel long-acting dual agonist of glucagon-like peptide 1 (GLP-1) and fibroblast growth factor 21 (FGF21) receptors. It is a Fc fusion protein containing a fibroblast growth factor 21 and a GLP-1 moiety, fused to the N-terminal and C-terminal of the Fc fragment, respectively.OBJECTIVESThis study aimed to evaluate the clinical safety, tolerability, pharmacokinetics, and pharmacodynamics of HEC88473.METHODSThe clinical safety, tolerability, pharmacokinetics, and preliminary pharmacodynamics of HEC88473 (0.5-62.9 mg) were evaluated in a phase I, single-ascending dose trial with healthy and obese subjects. Serum glucose, lipid, and adiponectin levels were evaluated.RESULTSHEC88473 was slowly absorbed and metabolized into Fc-GLP-1 and Fc-FGF21 after dosing. In healthy participants, the median times to observed maximum serum concentration of HEC88473, Fc-GLP-1, and Fc-FGF21 were all in the range of 12.00-14.00 h, and their geomean half-lives were 16.2-22.6, 66.5-119.5, and 28.4-41.6 h, respectively. Their systemic exposure increased slightly more than proportionally to the dose. In healthy subjects, serum glucose decreased from baseline (day 1) in the oral glucose tolerance test at days 3 and 7 after HEC88473 administration with doses ≥ 5.1 mg, and the largest reduction occured in the 47.6-mg dose group, which was -1.829 mmol/L after baseline and placebo adjustment. At doses of ≥ 10.2 mg, adiponectin levels showed an upward trend with the dose and treatment time, and the average percentage increase of adiponectin from baseline was up to 90.71% in the 62.9-mg dose group. At doses of ≥ 17.0 mg, triglyceride levels showed a significant reduction from baseline in a certain dose-dependent manner, and the average percentage of triglyceride decrease from baseline was up to - 43.01% in the 62.9-mg dose group. HEC88473 was well tolerated, with the majority of treatment-related adverse events being gastrointestinal disorders of mild severity.CONCLUSIONSHEC88473 is well tolerated in healthy and obese subjects, and it shows glucose-lowering and lipid-lowering efficacies. The data support further clinical evaluations of HEC88473 for the treatment of metabolic diseases.CLINICAL TRIAL REGISTRATIONThis study was registered at ClinicalTrials.gov (registration number: NCT05943886).

01 Jan 2025·Drug Delivery and Translational Research

Microneedle patch with pure drug tips for delivery of liraglutide: pharmacokinetics in rats and minipigs

Article

Author: Lin, Hongbing ; Xia, Dengning ; Chen, Yu ; Hu, Jingwen ; Liu, Jinbin ; Yu, Zhiyan ; Yu, Jianghong ; Hong, Juan ; Hou, Yulin

Transdermal delivery of peptide drugs is almost impossible with conventional penetration enhancers because of epidermal barrier function. Microneedle (MN) patches can bypass the epidermal barrier and have been developed for trans- and intradermal delivery of peptide drugs and vaccines. However, dissolving MN patches are limited by low drug loading capacities due to their small size and admixture of drug and water-soluble excipients. Furthermore, few in vivo pharmacokinetic studies, especially in large animals such as pigs, have been performed to assess post-application systemic drug exposure. Here, we developed a dissolving MN patch with pure liraglutide at the needle tips. The MN patch could load up to 2.21 ± 0.14 mg of liraglutide in a patch size of 0.9 cm², which was nearly two orders of magnitude higher than that obtained with conventional MN patches of the same size. Raman imaging confirmed that liraglutide was localized at the MN tips. The MN had sufficient mechanical strength to penetrate the epidermis and could deliver up to 0.93 ± 0.04 mg of liraglutide into skin with a dosing variability of less than 6.8%. The MN patch delivery enabled faster absorption of liraglutide than that provided by subcutaneous (S.C.) injection, and achieved relative bioavailability of 69.8% and 46.3% compared to S.C. injection in rats and minipigs, respectively. The MN patch also exhibited similar patterns of anti-hyperglycemic effect in diabetic rats and individual variability in pharmacokinetic parameters as S.C. injection. The liraglutide MN application was well tolerated; no skin irritation was observed in minipigs except for mild erythema occurring within 4 h after once daily administration for 7 days at the same site. Our preclinical study suggests that MN patch with pure drug needle tips might offer a safe and effective alternative to S.C. injection for administration of liraglutide.

01 Dec 2024·Journal of Hepatology

Safety and efficacy of GLP-1/FGF21 dual agonist HEC88473 in MASLD and T2DM: A randomized, double-blind, placebo-controlled study

Article

Author: Xie, Can ; Ding, Yanhua ; Peng, Yuyu ; Li, Xiaojiao ; Yan, Jiangyu ; Li, Xiaoping ; Wang, Guixia ; He, Qingwei ; Chen, Hong ; Zhang, Hong ; Guo, Linfeng ; Luo, Lin ; Xiang, Lin ; Zhuang, Yulei ; Lv, Guoyue ; Li, Qianqian

BACKGROUND & AIMSGlucagon-like peptide-1 (GLP-1) and fibroblast growth factor 21 (FGF21) are key regulators of glucose and lipid metabolism. In the present study, we assessed the safety and efficacy of a novel GLP-1/FGF21 dual agonist HEC88473 for the treatment of metabolic dysfunction-associated steatotic liver disease (MASLD) combined with type 2 diabetes mellitus (T2DM).METHODSThis was a randomized, double-blind, placebo-controlled, multiple-ascending-dose phase Ib/IIa trial. Sixty patients with MASLD and T2DM were randomized (10:2) to receive HEC88473 (5.1, 15.3, 30.6, 45.9, or 68.0 mg) or placebo via weekly subcutaneous injection for 5 weeks.RESULTSAfter 5 weeks of treatment with HEC88473, MRI-proton density fat fraction (MRI-PDFF) was reduced in a dose-proportional manner. The largest relative mean change reached -47.21% (p = 0.0143) in the 30.6 mg cohort, compared with -15.05% in the placebo group, with a higher proportion of >30% relative reductions in patients with baseline PDFF >8%. The 5-week treatment with HEC88473 significantly reduced levels of HbA1c (glycated hemoglobin), as well as fasting and postprandial glucose levels. The largest mean change in HbA1c was -1.10% in the 68.0 mg cohort, compared with -0.31% in the placebo group. Improvement was also observed in participants' lipid profiles. Most adverse events were mild to moderate in severity. The most frequently reported adverse events were gastrointestinal disorders (n = 29, 48.3%).CONCLUSIONSHerein, we report the clinical safety and proof-of-concept data for the GLP-1/FGF21 dual agonist HEC88473. A 5-week treatment with HEC88473 was generally safe and well tolerated, with multiple positive effects observed, including reduced liver fat, and improved glycemic control, insulin resistance and lipid metabolism, together indicating comprehensive improvement in metabolic syndrome.IMPACT AND IMPLICATIONSIn this randomized, double-blind, placebo-controlled phase Ib/IIa study, we assessed clinical safety, pharmacodynamic and pharmacokinetic data of the GLP-1/FGF21 dual agonist HEC88473 in patients with MASLD (metabolic dysfunction-associated steatotic liver disease) and T2DM (type 2 diabetes mellitus). HEC88473 was generally safe and well tolerated. The GLP-1/FGF21 dual agonist significantly reduced the hepatic fat fraction assessed using MRI-proton density fat fraction, and improved glycemic control and lipid profiles with only 5 weeks' treatment, leading to comprehensive improvement in metabolic syndrome. The present results suggest that HEC88473 could be a promising treatment option in this patient population.CLINICAL TRIAL NUMBERChinese Drug Trial Identifier (http://www.chinadrugtrials.org.cn/index.html): CTR20211088.CLINICALTRIALSGOV: NCT05943886.

100 Deals associated with Dongguan HEC Biopharmaceutical R&D Co., Ltd.

100 Translational Medicine associated with Dongguan HEC Biopharmaceutical R&D Co., Ltd.

Corporation Tree

Boost your research with our corporation tree data.

view full example data

Pipeline

Pipeline Snapshot as of 08 May 2025

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

IND Approval

Other

Current Projects

Drug(Targets)	Indications	Global Highest Phase

HEC-007 ( GCGR x GIPR x GLP-1R )	Diabetes Mellitus, Type 2 More	IND Approval
HEC-88473 ( FGF21R x GLP-1R )	Baritosis More	Pending

Deal

Boost your decision using our deal data.

view full example data

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Profit

Explore the financial positions of over 360K organizations with Synapse.

view full example data

Grant & Funding(NIH)

Access more than 2 million grant and funding information to elevate your research journey.

view full example data

Investment

Gain insights on the latest company investments from start-ups to established corporations.

view full example data

Financing

Unearth financing trends to validate and advance investment opportunities.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis

Dongguan HEC Biopharmaceutical R&D Co., Ltd.

Overview

Related

Corporation Tree

Pipeline

Pipeline Snapshot as of 08 May 2025

Current Projects

Deal

Translational Medicine

Profit

Grant & Funding(NIH)

Investment

Financing