Delving into the Latest Updates on Recombinant humanized monoclonal antibody antiIL-1β(Sunshine Guojian Pharmaceutical) with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

Recombinant humanized monoclonal antibody antiIL-1β, 重组抗白介素1-β（IL-1β）人源化单克隆抗体

+ [2]

Target

IL-1β

Action

inhibitors

Mechanism

IL-1β inhibitors(Interleukin-1 beta inhibitors)

Therapeutic Areas

Immune System DiseasesCongenital DisordersEndocrinology and Metabolic Disease+ [2]

Active Indication

Arthritis, GoutyPrimary gout

Inactive Indication

Periodic Fever SyndromeSystemic onset juvenile chronic arthritis

Originator Organization-

Active Organization

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

3SBio, Inc.

Inactive Organization-

Drug Highest PhasePhase 3

First Approval Date-

Regulation-

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[Translation] A multicenter, randomized, open-label, active-controlled phase II clinical trial to evaluate the efficacy and safety of recombinant anti-interleukin-1β (IL-1β) humanized monoclonal antibody injection (SSGJ-613) in preventing acute attacks of gouty arthritis in gout subjects who are in the early stages of uric acid-lowering therapy

评价重组抗IL-1β人源化单克隆抗体注射液（SSGJ-613）在启动降尿酸治疗初期的中国痛风受试者中预防痛风性关节炎急性发作的有效性、安全性、免疫原性、PK特征等。

[Translation]

To evaluate the efficacy, safety, immunogenicity, and PK characteristics of recombinant anti-IL-1β humanized monoclonal antibody injection (SSGJ-613) in preventing acute attacks of gouty arthritis in Chinese gout subjects who are initially starting urate-lowering therapy.

Start Date28 Mar 2024

Sponsor / Collaborator

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

CTR20233982

/ RecruitingPhase 3

一项评价重组抗白介素1-β（IL-1β）人源化单克隆抗体注射液治疗中国急性痛风性关节炎受试者的有效性和安全性的多中心、随机、双盲双模拟、阳性对照的III期临床试验

[Translation] A multicenter, randomized, double-blind, double-dummy, positive-controlled phase III clinical trial to evaluate the efficacy and safety of recombinant anti-interleukin 1-β (IL-1β) humanized monoclonal antibody injection in the treatment of acute gouty arthritis in Chinese subjects

评价重组抗IL-1β人源化单克隆抗体注射液（SSGJ-613）治疗中国急性痛风性关节炎受试者的有效性、安全性、PK特征和免疫原性等。

[Translation]

To evaluate the efficacy, safety, PK characteristics and immunogenicity of recombinant anti-IL-1β humanized monoclonal antibody injection (SSGJ-613) in the treatment of acute gouty arthritis in Chinese subjects.

Start Date12 Jan 2024

Sponsor / Collaborator

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

100 Clinical Results associated with Recombinant humanized monoclonal antibody antiIL-1β(Sunshine Guojian Pharmaceutical)

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100 Translational Medicine associated with Recombinant humanized monoclonal antibody antiIL-1β(Sunshine Guojian Pharmaceutical)

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100 Patents (Medical) associated with Recombinant humanized monoclonal antibody antiIL-1β(Sunshine Guojian Pharmaceutical)

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2

Literatures (Medical) associated with Recombinant humanized monoclonal antibody antiIL-1β(Sunshine Guojian Pharmaceutical)

01 Feb 2002·Veterinary MicrobiologyQ2 · AGRICULTURAL & FORESTRY SCIENCE

Latent infection by bovine herpesvirus type-5 in experimentally infected rabbits: virus reactivation, shedding and recrudescence of neurological disease

Q2 · AGRICULTURAL & FORESTRY SCIENCE

Article

Author: R Weiblen ; J.-H Sur ; A Odeon ; C.F.C Scherer ; P.M Roehe ; L Caron ; E.F Flores ; L.F Irigoyen

Latent infection with bovine herpesvirus type-5 (BHV-5) was established in rabbits inoculated with two South American isolates (EVI-88 and 613) by intranasal or conjunctival routes. Nine rabbits (613, 8/27; EVI-88, 1/34) developed neurological disease and died during acute infection and other three (613, n=2; EVI-88, n=1) developed a delayed neurological disease, at days 34, 41 and 56 post-inoculation (p.i.). Between days 56 and 62 p.i., the remaining rabbits were submitted to five daily administrations of dexamethasone (Dx) to reactivate the infection. Twenty-five out of 44 rabbits (56.8%) shed virus in nasal or ocular secretions after Dx treatment. Virus shedding was first detected at day two post-Dx and lasted from one to 11 days. The highest frequencies of virus reactivation were observed in rabbits inoculated conjunctivally (10/15 versus 15/29); and among rabbits infected with isolate 613 (12/16 versus 13/28). Virus reactivation upon Dx treatment was accompanied by neurological disease in nine rabbits (20.4%), resulting in six deaths (13.6%). Virus in moderate titers and mild to moderate non-suppurative inflammatory changes in the brain characterized the neurological infection. Three other rabbits showed severe neurological signs followed by death after 31 to 54 days of Dx treatment. Virus, viral nucleic acids and inflammatory changes were detected in their brains. The late-onset neurological disease, after acute infection or Dx treatment, was probably a consequence of spontaneous virus reactivation. These results demonstrate that BHV-5 does establish a latent infection in rabbits and that clinical recrudescence may occur upon reactivation.

OncoTargets and TherapyQ4 · MEDICINE

Role of miR-613 as a tumor suppressor in glioma cells by targeting SOX9

Q4 · MEDICINE

ArticleOA

Author: Liu, Xuejuan ; Sun, Daju ; Sang, Qiuling

BACKGROUND AND OBJECTIVESMicroRNA-613 (miR-613), a novel cancer-related microRNA, has been shown to be responsible for the inhibition of tumor development and progression in various cancers. We aimed to investigate the biological function and regulatory mechanisms of miR-613 in gliomas.MATERIALS AND METHODSmiR-613 expression were detected by qRT-PCR assays in glioma tissues and cell lines. Cell Counting Kit-8 (CCK-8) assay, colony formation analysis, wound healing and transwell invasion assays were performed to evaluate cell proliferation, colony formation, migration and invasion abilities. Luciferase reporter assays, qRT-PCR and Western blot were performed to explore the potential targets of miR-613. Xenograft mice model was established to evaluate the effect of miR-613 in vivo.RESULTThe expression levels of miR-613 were significantly downregulated in the glioma tissues and cell lines, and the decreased level was significantly negatively associated with the overall disease-free survival of the patients. Functionally, ectopic expression of miR-613 in glioma cells suppressed the proliferation, colony formation, and migration and invasion of the cells. The sex-determining region Y-box 9 (SOX9) was identified as a direct functional target of miR-613, and its expression was inversely correlated with miR-613 expression in glioma tissues. Moreover, rescue of SOX9 could partially reverse the inhibitory effects of miR-613 on glioma cell proliferation, colony formation, migration, and invasion. Importantly, miR-613 also suppressed tumor growth in vivo by targeting SOX9.CONCLUSIONTaken together, these findings demonstrate that miR-613 functions as a tumor suppressor in glioma cells by directly targeting SOX9.

100 Deals associated with Recombinant humanized monoclonal antibody antiIL-1β(Sunshine Guojian Pharmaceutical)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Arthritis, Gouty	Phase 3	China	Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.	12 Jan 2024
Primary gout	Phase 3	-	Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.	01 Dec 2023
Periodic Fever Syndrome	Preclinical	China	Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.	13 Aug 2021
Systemic onset juvenile chronic arthritis	Preclinical	China	Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.	13 Aug 2021

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05588908 (EULAR2024) Manual	Phase 2	Gout Interleukin 1-β (IL-1β)	90	SSGJ-613 200mg	(emkykjjdob) = btoylsmaqo rlpvrrnmea (ylgeteihnl ) View more	Positive	05 Jun 2024
NCT05588908 (EULAR2024) Manual	Phase 2	Gout Interleukin 1-β (IL-1β)	90	SSGJ-613 300mg	(emkykjjdob) = ptnqfjiavu rlpvrrnmea (ylgeteihnl ) View more	Positive	05 Jun 2024
CTR20220967 (Corporate Publications) Manual	Phase 1/2	Primary gout	10	SSGJ-613	(xtlpxwsvnq) = anihlguffe nwlxclyndz (mxidskyxsr, 23.6)	Positive	25 Aug 2022

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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