Delving into the Latest Updates on Etanercept biosimilar (Hisun Bio Pharmaceutical Co., Ltd.) with Synapse

Overview

Basic Info

Drug Type

Biosimilar, Fusion protein

Synonyms

Recombinant Human Tumor Necrosis Factor-α Receptor II(Hisun Bio Pharmaceutical), Recombinant Human Tumor Necrosis Factor-α Receptor II:IgG Fc Fusion Protein(Hisun Bio Pharmaceutical), Recombinant human type II tumor necrosis factor receptor-antibody fusion protein(Hisun Bio Pharmaceutical Co., Ltd.)

+ [3]

Target

LTα x TNF-α

Mechanism

LTα inhibitors(Tumor necrosis factor β inhibitors), TNF-α inhibitors(Tumor necrosis factor α inhibitors)

Therapeutic Areas

Immune System DiseasesInfectious DiseasesSkin and Musculoskeletal Diseases

Active Indication

Ankylosing SpondylitisPsoriasisRheumatoid Arthritis

Inactive Indication-

Originator Organization

Hisun Bio Pharmaceutical Co., Ltd.

Active Organization

Hisun Bio Pharmaceutical Co., Ltd.

BioRay Biopharmaceutical Co., Ltd.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date-

Regulation-

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Gene Sequence

Sequence Code 38320

The sequence is quoted from: *****

主要目的：比较注射用重组人II型肿瘤坏死因子受体-抗体融合蛋白水针和粉针两种剂型在男性健康受试者中单次皮下注射给药的药代动力学特征。次要目的：比较水针和粉针两种剂型在男性健康受试者中单次皮下注射给药的安全性。

[Translation]

Primary objective: To compare the pharmacokinetic characteristics of a single subcutaneous injection of recombinant human type II tumor necrosis factor receptor-antibody fusion protein for injection in male healthy subjects in the form of water injection and powder injection. Secondary objective: To compare the safety of a single subcutaneous injection ...

Start Date-

Sponsor / Collaborator

Hisun Bio Pharmaceutical Co., Ltd.

CTR20211375 / CompletedPhase 1

男性健康受试者皮下注射重组人 II 型肿瘤坏死因子受体-抗体融合蛋白的单中心、随机、开放、双周期两剂型交叉的药代动力学相似性 I 期临床试验

[Translation] A single-center, randomized, open-label, two-period, two-dose crossover pharmacokinetic similarity phase I clinical trial of subcutaneous injection of recombinant human type II tumor necrosis factor receptor-antibody fusion protein in healthy male subjects

评价粉针和水针两种剂型在男性健康受试者中皮下给药的药代动力学相似性

[Translation]

To evaluate the pharmacokinetic similarity of powder injection and water injection in male healthy subjects after subcutaneous administration

Start Date22 Jun 2021

Sponsor / Collaborator

Hisun Bio Pharmaceutical Co., Ltd.

100 Clinical Results associated with Etanercept biosimilar (Hisun Bio Pharmaceutical Co., Ltd.)

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100 Translational Medicine associated with Etanercept biosimilar (Hisun Bio Pharmaceutical Co., Ltd.)

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100 Patents (Medical) associated with Etanercept biosimilar (Hisun Bio Pharmaceutical Co., Ltd.)

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50

Literatures (Medical) associated with Etanercept biosimilar (Hisun Bio Pharmaceutical Co., Ltd.)

01 Jun 2024·Ecotoxicology and Environmental Safety

The role of PANoptosis in renal vascular endothelial cells: Implications for trichloroethylene-induced kidney injury

Article

Author: Xie, Haibo ; Liu, Zhibing ; Liang, Bo ; Zhang, Jiaxiang ; Zhu, Qixing ; Li, Hui ; Wu, Yonggui ; Wang, Lin ; Qin, Zhuohui

Trichloroethylene (TCE), a widely distributed environmental chemical contaminant, is extensively dispersed throughout the environment. Individuals who are exposed to TCE may manifest occupational medicamentose-like dermatitis due to trichloroethylene (OMDT). Renal impairment typically manifests in the initial phase of OMDT and is intricately linked to the disease progression and patient outcomes. Although recombinant human tumor necrosis factor-α receptor II fusion protein (rh TNFR:Fc) has been employed in the clinical management of OMDT, there was no substantial improvement in renal function observed in patients following one week of treatment. This study primarily examined the mechanism of TNFα- and IFNγ-induced endothelial cells (ECs) PANoptosis in TCE-induced kidney injury and hypothesized that the synergistic effect of TNFα and IFNγ could be the key factor affecting the efficacy of rh TNFR:Fc therapy in OMDT patients. A TCE-sensitized mouse model was utilized in this study to investigate the effects of TNFα and IFNγ neutralizing antibodies on renal vascular endothelial cell PANoptosis. The gene of interferon regulatory factor 1 (IRF1) in human umbilical vein endothelial cells (HUVEC) was silenced by using small interfering RNA (siRNA), and the cells were then treated with TNFα and IFNγ recombinant protein to investigate the mechanism of TNFα combined with IFNγ-induced PANoptosis in HUVEC. The findings indicated that mice sensitized to TCE exhibited increased levels of PANoptosis-related markers in renal endothelial cells, and treatment with TNFα and IFNγ neutralizing antibodies resulted in a significant reduction in PANoptosis and improvement in renal function. In vitro experiments demonstrated that silencing IRF1 could reverse TNFα and IFNγ-induced PANoptosis in endothelial cells. These results suggest that the efficacy of rh TNFR:Fc may be influenced by TNFα and IFNγ-mediated PANoptosis in kidney vascular endothelial cells. The joint application of TNFα and IFNγ neutralizing antibody represented a solid alternative to existing therapeutics.

01 Sep 2022·Clinical Pharmacology in Drug Development

Comparative Pharmacokinetics, Safety, and Immunogenicity Study of the Prefilled Syringe and Lyophilized Formulation of a Recombinant Human Tumor Necrosis Factor‐α Receptor II:lgG Fc Fusion Protein in Healthy Chinese Male Subjects

Article

Author: Chu, Nannan ; Qian, Zhenzhong ; Huang, Kai ; Shi, Yunfei ; Que, Linglin ; Qin, Wei ; Ding, Ying ; He, Qing

AbstractThis study aimed to compare the pharmacokinetics, safety, and immunogenicity of the prefilled syringe (PFS) with lyophilized (LYO) recombinant human tumor necrosis factor‐α receptor II:lgG Fc fusion protein (rhTNFR:Fc) in healthy Chinese male subjects. A single‐center, randomized, open‐label, 2‐period, crossover study was performed in healthy Chinese male subjects. Subjects were randomly assigned into 2 sequences and received a subcutaneous injection of 25 mg rhTNFR:Fc PFS or rhTNFR:Fc LYO (Anbainuo), with a 35‐day washout between the 2 periods. Blood samples were collected at specified time intervals, and then serum concentrations of rhTNFR:Fc were analyzed by enzyme‐linked immunosorbent assay. The maximum serum concentration, area under the concentration‐time curve (AUC) from time 0 to the last quantifiable concentration, and AUC from time 0 to infinity were all calculated and evaluated. Meanwhile, safety and immunogenicity were also assessed. A total of 82 subjects completed the study, and six subjects withdrew for various reasons. The 90%CIs for geometric mean ratios of maximum serum concentration, AUC from time 0 to the last quantifiable concentration, and AUC from time 0 to infinity were all within the equivalence range of 80% to 125%. Safety was comparable between the 2 formulations with low immunogenicity. rhTNFR:Fc PFS exhibited similar pharmacokinetic and safety profiles of rhTNFR:Fc LYO (Anbainuo) in healthy Chinese male subjects.

02 Jan 2021·Expert Opinion on Biological TherapyQ3 · MEDICINE

QL0902, a proposed etanercept biosimilar: pharmacokinetic and immunogenicity profile to its reference product in healthy Chinese male subjects

Q3 · MEDICINE

Article

Author: Huang, Jie ; Zeng, Yun ; Zhang, Ze-Yu ; Yang, Guo-Ping ; Huang, Zhi-Jun ; Ali, Saqib ; Cui, Chang ; Yang, Shuang

Objectives: To study the pharmacokinetics, safety and immunogenicity of Recombinant Human Tumor Necrosis Factor-α Receptor II: IgG Fc Fusion Protein for Injection (QL0902) and evaluate the pharmacokinetic similarity between QL0902 and reference Etanercept in healthy male subjects. Methods: A randomized, double-blinded, single-dose, two-period, two-sequence and crossover study was conducted in healthy males. Sixty-eight subjects were randomized at 1:1 ratio to receive a single 50-mg subcutaneous injection of QL0902 or reference Etanercept. The statistical analysis was conducted by SAS Enterprise Guide statistical software. Results: The main pharmacokinetic parameters of QL0902 were as follows: AUC_0-∞ was 461861.60 ± 126861.42 (h*ng/mL), AUC_0-t was 453304.68 ± 124424.94 (h*ng/mL), C_max was (2634.03 ± 833.82)ng/mL; The main pharmacokinetic parameters of reference Etanercept were as follows: AUC_0-∞ was 537977.72 ± 153295.70 (h*ng/mL), AUC_0-t was 528817.19 ± 150910.05 (h*ng/mL), C_max was (2874.21 ± 822.31) ng/mL. Conclusions: After a single subcutaneous injection of QL0902 and reference Etanercept, the 90% confidence intervals of the ratios of AUC_0-∞, AUC_0-t, C_max of healthy subjects were respectively 82.76% to 89.15%, 82.66% to 89.00%, 87.30% to 93.95%, which were between 80.00% and 125.00%. It indicts that their pharmacokinetic characteristics were similar. No serious adverse events occurred and the immunogenicity of QL0902 was lower. Trial Registration: The trial is registered at www.chictr.org.cn (ChiCTR1900023 437).

100 Deals associated with Etanercept biosimilar (Hisun Bio Pharmaceutical Co., Ltd.)

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R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Ankylosing Spondylitis	CN	Hisun Bio Pharmaceutical Co., Ltd.	-
Ankylosing Spondylitis	CN	BioRay Biopharmaceutical Co., Ltd.	-
Psoriasis	CN	Hisun Bio Pharmaceutical Co., Ltd.	-
Psoriasis	CN	BioRay Biopharmaceutical Co., Ltd.	-
Rheumatoid Arthritis	CN	Hisun Bio Pharmaceutical Co., Ltd.	-
Rheumatoid Arthritis	CN	BioRay Biopharmaceutical Co., Ltd.	-