更新于：2024-09-06
Tocilizumab biosimilar (Zhejiang Hisun)
托珠单抗生物类似药（浙江海正）
更新于：2024-09-06
概要
基本信息
药物类型 生物类似药、单克隆抗体 |
别名 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.） + [4] |
靶点 |
作用机制 IL-6RA拮抗剂(白细胞介素-6受体α亚基拮抗剂) |
非在研适应症- |
原研机构 |
非在研机构- |
最高研发阶段批准上市 |
首次获批日期 中国 (2024-06-25), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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序列信息
Sequence Code 12264H
当前序列信息引自: *****
Sequence Code 12270L
当前序列信息引自: *****
关联
6
项与 托珠单抗生物类似药（浙江海正） 相关的临床试验A single-arm, open, multicenter Phase IIa clinical study to evaluate the efficacy and safety of recombinant humanized anti-interleukin-6 receptor monoclonal antibody injection in patients with idiopathic multicenter Castleman's disease (iMCD)
A Randomized Controlled, Double-blind, Phase III, Multicenter Clinical Study of HS628 Versus Actemra® in Combination With Methotrexate as Therapy in Patients With Moderate to Severe Rheumatoid Arthritis
治疗中重度类风湿关节炎的安全性、有效性和免疫原性的III期临床试验
100 项与 托珠单抗生物类似药（浙江海正） 相关的临床结果
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100 项与 托珠单抗生物类似药（浙江海正） 相关的转化医学
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100 项与 托珠单抗生物类似药（浙江海正） 相关的专利（医药）
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11
项与 托珠单抗生物类似药（浙江海正） 相关的文献（医药）2023-09-01Clinical and translational science
A phase I study comparing the pharmacokinetics and safety of HS628 (tocilizumab biosimilar) and reference tocilizumab in healthy male subjects.
Article
作者: Wu, Qingqing ; Qian, Hongjie ; Cheng, Jie ; Liang, Liyu ; Chen, Qian ; Wang, Wei ; Gui, Yuzhou ; Zhu, Huijuan ; Jia, Jingying ; Yu, Chen ; Ou, Meixian
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 AUC0-t , AUC0-∞ , and Cmax 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.
2023-03-01Journal of neuro-ophthalmology : the official journal of the North American Neuro-Ophthalmology Society
The Role of Tocilizumab in Glucocorticoid Resistant Giant Cell Arteritis: A Case Series and Literature Review
Review
作者: Hassall, Mark ; Tan, Yiran ; Stretton, Brandon ; Simon, Sumu
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.
2023-02-01Expert opinion on investigational drugs
Pharmacokinetics, pharmacodynamics, safety, and immunogenicity of Gerilimzumab (GB224), a recombinant humanized interleukin-6 monoclonal antibody, in healthy Chinese adults: A randomized controlled dose–escalation study
Article
作者: Song, Haifeng ; Dong, Wenliang ; Yan, Diqin ; Wang, Simin ; Lv, Jie ; Chen, Liming ; Hu, Dingyuan ; Sun, Yunjuan ; Wang, Jiaxue ; Fang, Yi ; Liu, Gang ; Wang, Qian ; Gu, Qun ; Zheng, Qingshan ; Niu, Suping
OBJECTIVES:
This study aimed to investigate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of Gerilimzumab (GB224), a recombinant humanized IgG1λ monoclonal antibody against interleukin-6, in healthy Chinese adults.
METHODS:
Fifty-eight subjects were randomly assigned to receive a single subcutaneous dose of 2, 5, 10, 15, 20, 30 mg GB224 or placebo. Safety assessments were performed, and blood samples were collected for PK, PD, and immunogenicity analyses during a follow-up of 112 days.
RESULTS:
The most frequent adverse event was decreased fibrinogen (43.1%). GB224 was absorbed relatively fast with a median Tmax of 48 h (24-168 h) but eliminated slowly with a long mean half-life (839.38-981.63 h). Dose proportionality was shown to be in the dose range of 10-30 mg. A dose-dependent increase in serum interleukin-6 concentration from baseline was observed in the subjects receiving GB224. Only two subjects tested positive for antidrug antibodies after administration of GB224.
CONCLUSION:
GB224 had a well-tolerated safety profile, desirable PK, and a low immunogenicity following a single-dose subcutaneous administration in healthy Chinese subjects. These findings warrant further investigation.
100 项与 托珠单抗生物类似药（浙江海正） 相关的药物交易
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 细胞因子释放综合征 | 中国 | 2024-06-25 | |
| 类风湿关节炎 | 中国 | 2024-06-25 | |
| 全身型幼年特发性关节炎 | 中国 | 2024-06-25 |
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