Delving into the Latest Updates on Tocilizumab biosimilar (Zhejiang Hisun) with Synapse

Overview

Basic Info

Drug Type

Biosimilar, Monoclonal antibody

Synonyms

Recombinant humanized monoclonal antibody against interleukin-6 receptor(Zhejiang Hisun), Tocilizumab Biosimilar (Zhejiang Hisun Pharmaceutical Co., Ltd.), 托珠单抗生物类似药（Zhejiang Hisun Pharmaceutical Co., Ltd.）

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Target

IL-6RA

Mechanism

IL-6RA antagonists(Interleukin-6 receptor alpha subunit antagonists)

Therapeutic Areas

Immune System DiseasesSkin and Musculoskeletal DiseasesOther Diseases

Active Indication

Cytokine Release SyndromeRheumatoid ArthritisSystemic onset juvenile chronic arthritis

Inactive Indication-

Originator Organization

Zhejiang Hisun Pharmaceutical Co., Ltd.

Active Organization

Hisun Bio Pharmaceutical Co., Ltd.

Inactive Organization

Zhejiang Hisun Pharmaceutical Co., Ltd.

Drug Highest PhaseApproved

First Approval Date

CN (25 Jun 2024),

Cytokine Release SyndromeRheumatoid ArthritisSystemic onset juvenile chronic arthritis

Regulation-

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Gene Sequence

Sequence Code 12264H

The sequence is quoted from: *****

Sequence Code 12270L

The sequence is quoted from: *****

This is a multi-center, randomized, double-blind, parallel-group study to evaluate the efficacy and safety of intravenous HS628 in combination with MTX versus Actemra in combination with MTX, in participants with moderate to severe active rheumatoid arthritis (RA) who have inadequate response to current MTX therapy. The study comprises a 24-week treatment phase, followed by a 4-week safety observation period.

Start Date28 Dec 2020

Sponsor / Collaborator

Zhejiang Hisun Pharmaceutical Co., Ltd.

100 Clinical Results associated with Tocilizumab biosimilar (Zhejiang Hisun)

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100 Translational Medicine associated with Tocilizumab biosimilar (Zhejiang Hisun)

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100 Patents (Medical) associated with Tocilizumab biosimilar (Zhejiang Hisun)

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12

Literatures (Medical) associated with Tocilizumab biosimilar (Zhejiang Hisun)

01 Jan 2024·Journal of Investigative Medicine High Impact Case Reports

Tocilizumab Treatment in a Patient of Refractory Anti-EJ Positive ASyS: A Case Report

Article

Author: Wanlong, Wu ; Xiaodong, Wang ; Shuhui, Sun ; Jia, Li ; Shuang, Ye ; Jiajia, Jin

Anti-synthetase syndrome (ASyS) is an autoimmune disease characterized by the presence of autoantibodies to aminoacyl-tRNA synthetases accompanied with various organ involvements, including the lung, joints, and skin. The ASyS-related interstitial lung disease (ILD) can be seen in the vast majority of patients. The extent of lung involvement has a significant impact on patient prognosis; the occurrence of rapid-progressive ILD could prominently increase mortality. The mainstay of treatment is prednisone in combination with conventional synthetic disease-modifying anti-rheumatic drugs or some biologic disease-modifying anti-rheumatic drugs (DMARDs). Tocilizumab (TCZ), a recombinant humanized anti-interleukin (IL)-6 receptor monoclonal antibody, has also been used to treat some systemic autoimmune rheumatic diseases associated with ILD. Although the most recent American College of Rheumatology (ACR) Guideline for the Treatment of Interstitial Lung Disease conditionally recommends against the use of TCZ as a treatment option for people with idiopathic inflammatory myopathy (IIM)-ILD progression despite initial ILD treatment, the treatment effect of TCZ in ASyS patients remains obscure, particularly for refractory cases with anti-non-Jo1 antibodies. This report describes a case of Chinese ASyS patients with anti-EJ-positive antibodies who presented with typical proximal muscle weakness, elevated creatine kinase, and ILD with non-specific interstitial pneumonia (NSIP) pattern, along with typical skin involvement such as mechanic’s hand. The patients were resistant to various treatments, including rituximab (RTX), but benefited from TCZ. In this case, TCZ shows good therapeutic efficacy in a fatal acute exacerbation of ILD with a hyperinflammatory status, resulting in a relative remission of the disease flare and full preservation of lung function with a positive long-term treatment outcome.

01 Sep 2023·Clinical and translational science

A phase I study comparing the pharmacokinetics and safety of HS628 (tocilizumab biosimilar) and reference tocilizumab in healthy male subjects.

Article

Author: Wang, Wei ; Ou, Meixian ; Liang, Liyu ; Jia, Jingying ; Cheng, Jie ; Yu, Chen ; Gui, Yuzhou ; Zhu, Huijuan ; Qian, Hongjie ; Chen, Qian ; Wu, Qingqing

This study aimed to evaluate the pharmacokinetic (PK) similarity of the proposed biosimilar HS628 compared with the reference tocilizumab (Actemra®) and also to demonstrate similar safety and immunogenicity profiles in healthy Chinese male subjects. Eighty eligible subjects were randomized into two treatment groups in a 1:1 ratio to receive a single intravenous infusion of HS628 or tocilizumab at 4 mg/kg over 60 min. Blood samples were collected at the scheduled time points for PK and immunogenicity analysis. PK biosimilarity was determined using the standard bioequivalence criteria 80%-125%. A total of 77 subjects received the study drug and completed the study. The main PK parameters were similar for the test and reference groups. The ratio of geometric least-squares means (GMR) and its 90% CIs for AUC_0-t , AUC_0-∞ , and C_max between the test group and reference group were 1.06 (1.00-1.12), 1.07 (1.00-1.14), and 1.04 (0.99-1.10), respectively, which were fully within the predefined bioequivalent range of 80%-125%. The incidence of treatment-emergent adverse events (TEAEs) was similar for HS628 and tocilizumab (p > 0.05). The most common TEAEs were decreased fibrinogen, decreased neutrophils, pharyngalgia, oral ulcer, decreased leukocytes, and increased erythrocyte sedimentation rate. The results of the present study provide strong evidence to support the PK similarity and bioequivalence of HS628 and tocilizumab. The safety and immunogenicity profiles of HS628 were also shown to be similar to those of the reference tocilizumab.

01 Mar 2023·Journal of Neuro-Ophthalmology

The Role of Tocilizumab in Glucocorticoid Resistant Giant Cell Arteritis: A Case Series and Literature Review

Review

Author: Simon, Sumu ; Tan, Yiran ; Stretton, Brandon ; Hassall, Mark

Background:Glucocorticoid-resistant giant cell arteritis (GCA) describes a subgroup of patients whose visual acuity further declines despite immediate administration of high-dose intravenous glucocorticoids. Tocilizumab, a recombinant humanized anti-interleukin-6 receptor monoclonal antibody may be used as “rescue” therapy in these cases but requires more research.Methods:We present a literature review on tocilizumab as rescue therapy and a retrospective case series of 5 consecutive glucocorticoid (GC) resistant, temporal artery biopsy (TAB) negative patients.Results:The use of tocilizumab as rescue therapy for GC-resistant GCA is limited to 3 case reports. Two cases saw visual acuity improvement in the newly affected contralateral eye after 8 mg/kg of intravenous tocilizumab (from 6/60 to 6/15 in one case and hand motion to 6/6 in another). The third described stabilization and prevention of further best-corrected visual acuity (BCVA) decline. All 5 of our patients presented with acute monocular vision loss. BCVA ranged from 6/12 to light perception (LP). All patients were promptly commenced on 1 g intravenous methylprednisolone daily. Weekly 162 mg of subcutaneous tocilizumab was commenced once contralateral eye involvement was noted. Tocilizumab resulted in bilateral BCVA gains in 2 cases, recovery of the contralateral eye in one, and no effect in the remaining 2 cases. BCVA recovery was no light perception to 6/6 after 6 weeks of tocilizumab. Tocilizumab had no effect in cases with severe vision loss and high C-reactive protein on presentation.Conclusions:We agree with existing hypothesis that tocilizumab likely prevents a “pending” central retinal artery occlusion by maintaining retinal vasculature perfusion. Our case series suggests that there is a role for tocilizumab as “rescue” therapy for GC-resistant GCA, where vision loss would otherwise be imminent.

100 Deals associated with Tocilizumab biosimilar (Zhejiang Hisun)

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Cytokine Release Syndrome	CN	Hisun Bio Pharmaceutical Co., Ltd.	25 Jun 2024
Rheumatoid Arthritis	CN	Hisun Bio Pharmaceutical Co., Ltd.	25 Jun 2024
Systemic onset juvenile chronic arthritis	CN	Hisun Bio Pharmaceutical Co., Ltd.	25 Jun 2024

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Rheumatoid Arthritis	Discovery	CN	Zhejiang Hisun Pharmaceutical Co., Ltd.	28 Dec 2020
Systemic onset juvenile chronic arthritis	Discovery	CN	Zhejiang Hisun Pharmaceutical Co., Ltd.	23 May 2019

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


CTR20190620 (Pubmed) Manual	Phase 1	Systemic onset juvenile chronic arthritis \| Rheumatoid Arthritis	77	HS628 4 mg/kg	(eldnrofyjc): Ratio = 1.06 (90% CI, 1.00 - 1.12) View more	Positive	18 Jul 2023
				Actemra 4 mg/kg