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

Overview

Basic Info

Drug Type

Biosimilar, Monoclonal antibody

Synonyms

Recombinant chimeric anti-TNFα antibody(Zhejiang Hisun Pharmaceutical Co., Ltd.), 重组人鼠嵌合抗肿瘤坏死因子α单抗 (海正药业)

+ [2]

Target

TNF-α

Mechanism

TNF-α inhibitors(Tumor necrosis factor α inhibitors)

Therapeutic Areas

Immune System DiseasesInfectious DiseasesDigestive System Disorders+ [1]

Active Indication

Ankylosing SpondylitisColitis, UlcerativePediatric Crohn's Disease+ [1]

Inactive Indication

Plaque psoriasis

Originator Organization

Hisun Bio Pharmaceutical Co., Ltd.

Active Organization

Hisun Bio Pharmaceutical Co., Ltd.

Inactive Organization

Zhejiang Hisun Pharmaceutical Co., Ltd.

Drug Highest PhaseApproved

First Approval Date

CN (28 Sep 2021),

Ankylosing SpondylitisColitis, UlcerativePediatric Crohn's Disease+ [1]

Regulation-

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Gene Sequence

Sequence Code 69035L

The sequence is quoted from: *****

Sequence Code 69038H

The sequence is quoted from: *****

主要目的：比较注射用重组人鼠嵌合抗肿瘤坏死因子-α单克隆抗体（HS626）与原研药类克®治疗慢性中重度斑块型银屑病患者中的有效性次要目的：评价注射用重组人鼠嵌合抗肿瘤坏死因子-α单克隆抗体（HS626）与原研药类克®治疗慢性中重度斑块型银屑病患者中的安全性、免疫原性和药代动力学特征。

[Translation]

Primary objective: To compare the effectiveness of injectable recombinant human-mouse chimeric anti-tumor necrosis factor-α monoclonal antibody (HS626) and the original drug Remicade® in the treatment of patients with chronic moderate to severe plaque psoriasis. Secondary objective: To evaluate the safety, immunogenicity and pharmacokinetic characteristics of injectable recombinant human-mouse chimeric anti-tumor necrosis factor-α monoclonal antibody (HS626) and the original drug Remicade® in the treatment of patients with chronic moderate to severe plaque psoriasis.

Start Date25 May 2018

Sponsor / Collaborator

Zhejiang Hisun Pharmaceutical Co., Ltd.

[+1]

CTR20170280 / CompletedPhase 1

比较男性健康受试者单次静脉输注HS626与类克的随机、双盲、平行对照的药代动力学和安全性相似性的I期试验

[Translation] A randomized, double-blind, parallel-controlled phase I trial comparing the pharmacokinetics and safety of a single intravenous infusion of HS626 and levofloxacin in healthy male subjects

主要目的：评价HS626与类克在男性健康受试者中单次静脉输注的药代动力学相似性。次要目的：评价HS626与类克在男性健康受试者中单次静脉输注的药代动力学特征；评价HS626与类克在男性健康受试者中单次静脉输注的安全性；评价HS626与类克在男性健康受试者中单次静脉输注的免疫原性。

[Translation]

Primary objective: To evaluate the pharmacokinetic similarity of HS626 and Remicade after a single intravenous infusion in male healthy subjects. Secondary objectives: To evaluate the pharmacokinetic characteristics of HS626 and Remicade after a single intravenous infusion in male healthy subjects; To evaluate the safety of HS626 and Remicade after a single intravenous infusion in male healthy subjects; To evaluate the immunogenicity of HS626 and Remicade after a single intravenous infusion in male healthy subjects.

Start Date02 May 2017

Sponsor / Collaborator

Zhejiang Hisun Pharmaceutical Co., Ltd.

[+1]

100 Clinical Results associated with Infliximab Biosimilar(Hisun Bio Pharmaceutical Co., Ltd.)

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100 Translational Medicine associated with Infliximab Biosimilar(Hisun Bio Pharmaceutical Co., Ltd.)

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100 Patents (Medical) associated with Infliximab Biosimilar(Hisun Bio Pharmaceutical Co., Ltd.)

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10

Literatures (Medical) associated with Infliximab Biosimilar(Hisun Bio Pharmaceutical Co., Ltd.)

01 Mar 2022·American Journal of Ophthalmology Case Reports

Infliximab recovers central cone dysfunction with normal fundus in a patient with ulcerative colitis

Author: Hirakata, Toshiaki ; Chiba-Mayumi, Miyako ; Yamaguchi, Masahiro ; Murakami, Akira

PURPOSETo report the efficacy of anti-tumor necrosis factor α (anti-TNFα) on autoimmune-mediated macular cone dysfunction in a Japanese woman with ulcerative colitis (UC).OBSERVATIONSA 41-year-old woman presented with bilateral visual acuity loss and photophobia. She suffered from UC, and had been treated with prednisolone and 5-aminosalicylate since age 37. Although fundus photographs and optic coherence tomography images were unremarkable, electroretinograms (ERGs) were abnormal. A full-field electroretinogram (full-field ERG) revealed mildly decreased cone responses and oscillatory potential responses bilaterally. Importantly, focal-macular ERG (fmERG) and a multifocal electroretinogram (mfERG) revealed severe macular cone dysfunction in both eyes. Infliximab, a chimeric monoclonal anti-TNFα antibody, was administrated to treat recurrent abdominal symptoms and continued at 8-week intervals. Almost 6 months after infliximab therapy, the mfERG response (especially in the central retina), the fmERG response, and visual acuity recovered bilaterally. Abdominal symptoms also improved after infliximab therapy.CONCLUSIONS AND IMPORTANCEBilateral cone dysfunction with normal fundus were observed in a UC patient, resulting in loss of visual acuity and photophobia. This retinopathy may have been caused by an autoimmune mechanism, such as an autoimmune retinopathy or acute zonal occult outer retinopathy, which is most identifiable by ERG changes. This is the first report demonstrating the efficacy of infliximab in autoimmune retinal dysfunction.

01 Jan 2021·Journal of Chromatography BQ3 · MEDICINE

Isolation and characterization of charge variants of infliximab biosimilar HS626

Q3 · MEDICINE

Article

Author: Hu, Feng ; Shi, Yang ; Yuan, Jun-Jie ; Wang, Hai-Bin ; Wu, Zhen-Hua ; Zhang, Hai-Tao ; Hu, Chuan-Qin ; Gao, Dong ; Fang, Wei-Jie ; Huang, Xiao-Dong

Charge variants are the most commonly observed sources of heterogeneity in the routine manufacturing of monoclonal antibodies. To gain further insight into the structural foundation of charge heterogeneity and its influence on biological functions, an infliximab biosimilar HS626 from a biopharmaceutical facility was isolated by semipreparative cation exchange chromatography (CEX) to obtain fractions of acidic and basic charge variants and determine the main species. It was assessed again by CEX to ensure purities. Through a series of structural and physicochemical characterizations, we concluded that the acidic variants were caused by fragments, Met oxidation, Asn deamidation, higher levels of sialylation and galactosylation of N-linked glycans, and less high mannose. The basic variants resulted mainly from aggregates, fragments, and Met oxidation. Through further analysis of antigen binding affinity, cell death inhibitory activity, ADCC, and CDC, as well as FcRn, FcγRIIIa, and C1q affinity, we demonstrated that the charge heterogeneity did not affect biological functions. This research enhances the understanding of charge variants, which are usually effective components that should not be intentionally reduced unless biological functions are affected.

01 May 2012·Pharmacoepidemiology and Drug SafetyQ4 · MEDICINE

Comparative safety of infliximab and etanercept on the risk of serious infections: does the association vary by patient characteristics?

Q4 · MEDICINE

Article

Author: Grijalva, Carlos G. ; Toh, Sengwee ; Chen, Lang ; Herrinton, Lisa J. ; Harrold, Leslie R. ; Li, Lingling ; Bayliss, Elizabeth A. ; Curtis, Jeffrey R. ; Liu, Liyan

ABSTRACTPurposeInfliximab, a chimeric monoclonal anti‐TNFα antibody, has been found to increase the risk of serious infections compared with the TNF receptor fusion protein etanercept in some studies. It is unclear whether the risk varies by patient characteristics. We conducted a study to address this question.MethodsWe identified members of Kaiser Permanente Northern California who initiated infliximab (n = 793) or etanercept (n = 2692) in 1997–2007. Using a Cox model, we estimated the propensity‐score‐adjusted hazard ratio (HR) and 95% confidence interval (CI) of serious infections requiring hospitalization or opportunistic infections comparing infliximab initiators to etanercept initiators. We tested whether the adjusted HR differed by age, sex, race/ethnicity, body mass index, and smoking status.ResultsThe crude incidence rate of serious infections per 100 person‐years was 5.4 (95%CI: 3.8, 7.5) in patients <65 years and 16.0 (95%CI: 10.4, 23.4) in patients ≥65 years during the first 3 months following treatment initiation. Compared with etanercept, the adjusted HR during this period was elevated for infliximab in patients <65 years (HR: 3.01; 95%CI: 1.49, 6.07), but not in those ≥65 years (HR 0.94; 95%CI: 0.41, 2.13). Findings did not suggest that the HR varied by the other patient characteristics examined.ConclusionsAn increased risk of serious infections associated with infliximab relative to etanercept did not appear to be modified by patients' sex, race/ethnicity, body mass index, or smoking status. There was an indication that the increased risk might be limited to patients <65 years. Additional studies are warranted to verify or refute this finding. Copyright © 2012 John Wiley & Sons, Ltd.

100 Deals associated with Infliximab Biosimilar(Hisun Bio Pharmaceutical Co., Ltd.)

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External Link

KEGG	Wiki	ATC	Drug Bank
D02598	-	-	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Ankylosing Spondylitis	CN	Hisun Bio Pharmaceutical Co., Ltd.	28 Sep 2021
Colitis, Ulcerative	CN	Hisun Bio Pharmaceutical Co., Ltd.	28 Sep 2021
Pediatric Crohn's Disease	CN	Hisun Bio Pharmaceutical Co., Ltd.	28 Sep 2021
Psoriasis	CN	Hisun Bio Pharmaceutical Co., Ltd.	28 Sep 2021