[Translation] A Phase I/IIa clinical trial to evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics, and preliminary efficacy of oral CGT-1881 tablets in healthy subjects and patients with non-Hodgkin lymphoma or multiple myeloma.

I期试验：主要评价健康受试者单次口服CGT-1881的安全性和耐受性以及高脂饮食对健康受试者单次口服CGT-1881的药代动力学和药效学特征的影响。 IIa期试验：主要评价NHL或MM患者单次口服CGT-1881的安全性、耐受性以及多次口服CGT-1881的安全性、耐受性和初步有效性。

[Translation]

Phase I trial: mainly evaluates the safety and tolerability of a single oral dose of CGT-1881 in healthy subjects and the effects of a high-fat diet on the pharmacokinetic and pharmacodynamic characteristics of a single oral dose of CGT-1881 in healthy subjects. Phase IIa trial: mainly evaluates the safety, tolerability of a single oral dose of CGT-1881 in patients with NHL or MM, as well as the safety, tolerability and preliminary efficacy of multiple oral doses of CGT-1881.

Start Date15 May 2023

Sponsor / Collaborator

CGeneTech (Suzhou, China) Co. Ltd.

CTR20220319 / RecruitingPhase 1

评价CGT-6321片在晚期实体瘤患者中的安全性、耐受性、药代动力学特征及有效性的多中心、开放、剂量递增与扩展的Ia/Ib期临床试验

[Translation] A multicenter, open-label, dose-escalation and expansion phase Ia/Ib clinical trial to evaluate the safety, tolerability, pharmacokinetic characteristics and efficacy of CGT-6321 tablets in patients with advanced solid tumors

主要目的：评价CGT-6321片在晚期实体瘤患者中的安全性和耐受性。次要目的：评价CGT-6321片在晚期实体瘤患者体内的药代动力学(PK)特征；初步评价CGT-6321片的抗肿瘤疗效。探索性目的：探索CGT-6321片的药效动力(PD)学特征，初步摸索具有疗效响应的实体瘤瘤种。

[Translation]

Primary objective: To evaluate the safety and tolerability of CGT-6321 tablets in patients with advanced solid tumors. Secondary objective: To evaluate the pharmacokinetic (PK) characteristics of CGT-6321 tablets in patients with advanced solid tumors; To preliminarily evaluate the anti-tumor efficacy of CGT-6321 tablets. Exploratory objective: To explore the pharmacodynamic (PD) characteristics of CGT-6321 tablets and preliminarily explore solid tumor types with therapeutic response.

Start Date27 Jun 2022

Sponsor / Collaborator

CGeneTech (Suzhou, China) Co. Ltd.

CTR20200163 / CompletedPhase 1

[14C]磷酸盛格列汀在中国成年男性健康志愿者体内的物质平衡与生物转化I期临床试验

[Translation] Phase I clinical trial of substance balance and biotransformation of [14C] senagliptin phosphate in healthy adult male volunteers in China

本试验旨在评价中国男性健康志愿者单剂量口服[14C]磷酸盛格列汀的物质平衡及生物转化途径。评价磷酸盛格列汀在人体内的药代动力学整体特征，为药物的合理使用提供参考。

[Translation]

This study aims to evaluate the material balance and biotransformation pathways of [14C] senolagliptin phosphate after a single oral dose in healthy Chinese male volunteers. The overall pharmacokinetic characteristics of senolagliptin phosphate in humans are evaluated to provide a reference for the rational use of the drug.

Start Date07 Jul 2020

Sponsor / Collaborator

CGeneTech (Suzhou, China) Co. Ltd.

100 Clinical Results associated with CGeneTech (Suzhou, China) Co. Ltd.

0 Patents (Medical) associated with CGeneTech (Suzhou, China) Co. Ltd.

Literatures (Medical) associated with CGeneTech (Suzhou, China) Co. Ltd.

01 Dec 2023·Diabetes, Obesity and Metabolism

Efficacy and safety of cetagliptin as monotherapy in patients with type 2 diabetes: A randomized, double‐blind, placebo‐controlled phase 3 trial

Article

Author: Ying, Changjiang ; Ji, Linong ; Wang, Tong ; Xie, Daosheng ; Gao, Leili ; Ding, Juping ; Wang, Kun ; Lu, Jinmiao ; Zhao, Wenhua ; Zhao, Jiahong ; Han, Jie ; Sun, Jiao ; Gao, Yunming ; Zheng, Xin ; Yu, Qiang

AbstractAimTo assess the efficacy and safety of the dipeptidyl peptidase‐4 inhibitor, cetagliptin, as monotherapy in Chinese patients with type 2 diabetes (T2D) and inadequate glycaemic control.Materials and MethodsIn total, 504 eligible patients with T2D were enrolled and randomized to cetagliptin 50 mg once daily, cetagliptin 100 mg once daily or placebo at a ratio of 2:2:1 for 24 weeks of double‐blind treatment, then all patients received cetagliptin 100 mg once daily for 28 weeks of open‐label treatment. The primary efficacy endpoint was the change in HbA1c level from baseline at week 24.ResultsAfter 24 weeks, HbA1c from baseline was significantly reduced with cetagliptin 50 mg (−1.08%) and cetagliptin 100 mg (−1.07%) compared with placebo (−0.35%). The placebo‐subtracted HbA1c reduction was −0.72% with cetagliptin 50 mg and 100 mg. Patients with a baseline HbA1c of 8.5% or higher had a greater HbA1c reduction with cetagliptin than those patients with a baseline HbA1c of less than 8.5%. Both doses studied led to a significantly higher proportion of patients (42.3% with 100 mg and 45.0% with 50 mg) achieving an HbA1c of less than 7.0% compared with placebo (12.9%). Cetagliptin also significantly lowered fasting plasma glucose and 2‐hour postmeal plasma glucose relative to placebo. The incidence of adverse experiences was similar between cetagliptin and placebo. No drug‐related hypoglycaemia was reported.ConclusionsCetagliptin monotherapy was effective and well tolerated in Chinese patients with T2D who had inadequate glycaemic control on exercise and diet.

01 Dec 2023·Diabetes, Obesity and Metabolism

A randomized, double‐blind, placebo controlled, phase 3 trial to evaluate the efficacy and safety of cetagliptin added to ongoing metformin therapy in patients with uncontrolled type 2 diabetes with metformin monotherapy

Article

Author: Ding, Juping ; Ji, Linong ; Wang, Tong ; Zhang, Lili ; Cheng, Zhifeng ; Xie, Daosheng ; Gao, Leili ; Li, Jifang ; Lu, Jinmiao ; Li, Ping ; Yan, Xiaoguang ; Zhao, Jiahong ; Tian, Junhang ; Yu, Qiang ; Bai, Jie

AbstractAimThis trial was designed to assess the efficacy and safety of cetagliptin added to metformin in Chinese patients with type 2 diabetes who had inadequate glycaemic control with metformin monotherapy.MethodsIn total, 446 patients with type 2 diabetes on metformin monotherapy were randomized to receive the addition of once‐daily cetagliptin 100 mg, cetagliptin 50 mg and placebo in a 2:2:1 ratio for 24‐week double‐blind treatment. At week 24, patients initially randomized to cetagliptin 50 mg and placebo were switched to cetagliptin 100 mg for 28 weeks open‐label treatment. The primary endpoint was the change in haemoglobin A1c (HbA1c) from baseline, and the efficacy analyses were based on an all‐patients‐treated population using an analysis of co‐variance.ResultsAfter 24 weeks, both add‐on therapies led to greater glycaemic control. Reductions in HbA1c from baseline were −1.17 ± 0.794%, −1.23 ± 0.896% in cetagliptin 100 mg and 50 mg plus metformin group, respectively. No difference was observed between the cetagliptin 100 mg and 50 mg plus metformin group. Patients with higher baseline HbA1c levels (≥8.5%) experienced greater reductions in HbA1c. A significantly greater proportion of patients achieved an HbA1c <7.0% with cetagliptin 100 mg (49.4%) and cetagliptin 50 mg (51.1%) plus metformin than metformin monotherapy (14.4%). Both combination therapies also improved the homeostasis model assessment β‐function index and decreased systolic blood pressure. There was no increased risk of adverse effects with combination therapy, and both combination therapies were generally well tolerated.ConclusionsThe addition of cetagliptin once daily to metformin was more efficacious and well tolerated than metformin monotherapy in Chinese patients with type 2 diabetes who had inadequate glycaemic control with metformin monotherapy.

04 May 2022·Xenobiotica

Disposition study of the novel dipeptidyl peptidase 4 inhibitor cetagliptin in rats

Article

Author: Lu, Jinmiao ; Hao, Yan ; Ding, Juping ; Yu, Qiang ; Zhang, Fuzhi ; Wang, Tong ; Pan, Huiping

Dipeptidyl peptidase-4 (DPP-4) inhibitor is a class of oral antihyperglycemic agents and therapeutic approach for type 2 diabetes. Cetagliptin is a novel oral and selective DPP-4 inhibitor and developed as a promising candidate for treatment of type 2 diabetes mellitus.This study aimed to evaluate the metabolism and excretion of cetagliptin in Sprague-Dawley (SD) rats, and to detect and identify metabolites of cetagliptin.The SD rats were administered with a single oral dose of 6 mg/kg with approximately 100 µCi of [¹⁴C] cetagliptin. The mean total recovery of radioactivity was 90.20% within 168h in SD rats excreta. Cetagliptin was the major radioactive component in SD rats plasma, urine and eliminated primarily by faecal excretion. The recovery of cetagliptin in urine and feces was 25.15% and 13.85% of the dose, respectively. Cetagliptin was well absorbed after oral administration in SD rats based on the total recovery of radioactivity in BDC SD rats bile and urine.Six major metabolites were observed and identified in SD rats, comprising 0.20 to 4.53% of total plasma AUC. These major metabolites were the hydroxylated, N-sulphate and N-carbamoyl glucuronic acid conjugates of the cetagliptin, two metabolites formed by glucuronide of a hydroxylated metabolite.

100 Deals associated with CGeneTech (Suzhou, China) Co. Ltd.

100 Translational Medicine associated with CGeneTech (Suzhou, China) Co. Ltd.

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Pipeline

Pipeline Snapshot as of 22 Nov 2024

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

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Cetagliptin Phosphate ( DPP-4 )	Diabetes Mellitus, Type 2 More	NDA/BLA
CGT-1881 ( CXCR4 )	Multiple Myeloma More	Phase 2 Clinical
CGT-9475 ( ALK )	Non-Small Cell Lung Cancer More	Phase 1
CGT-6321 ( FGFRs x VEGFR )	Advanced Malignant Solid Neoplasm More	Phase 1
Belinostat ( HDACs )	Peripheral T-cell lymphoma unspecified recurrent More	Phase 1

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