Top 5 Target	Count

IL-12 x IL-23	1
IL-6RA(Interleukin-6 receptor alpha subunit)	1
IL-17A(Interleukin 17A)	1
CTLA4(Cytotoxic T-Lymphocyte-Associated Antigen 4)	1
IL-31R(Interleukin 31 receptor)	1

Drugs associated with Qyuns Therapeutics Co., Ltd.

QX002N

Target

IL-17A

Mechanism

IL-17A inhibitors

Active Org.

Qyuns Therapeutics Co., Ltd.Startup

Originator Org.

Qyuns Therapeutics Co., Ltd.Startup

Active Indication

Ankylosing Spondylitis

Inactive Indication

Lupus Nephritis

Drug Highest PhasePhase 3

First Approval Ctry. / Loc.-

First Approval Date-

QX-005N

Target

IL-4Rα

Mechanism

IL-4Rα inhibitors

Active Org.

Qyuns Therapeutics Co., Ltd.Startup

Originator Org.

Qyuns Therapeutics Co., Ltd.Startup

Active Indication

prurigo nodularis [+5]

Inactive Indication-

Drug Highest PhasePhase 3

First Approval Ctry. / Loc.-

First Approval Date-

QX-004N

Target

IL-23p19

Mechanism

IL-23p19 inhibitors

Active Org.

Qyuns Therapeutics Co., Ltd.Startup

Originator Org.

Qyuns Therapeutics Co., Ltd.Startup

Active Indication

Plaque psoriasis [+1]

Inactive Indication-

Drug Highest PhasePhase 2

First Approval Ctry. / Loc.-

First Approval Date-

Clinical Trials associated with Qyuns Therapeutics Co., Ltd.

CTR20242416 / RecruitingPhase 2

一项评价皮下注射JKN24011治疗中、重度慢性阻塞性肺疾病（COPD）有效性、安全性的随机、双盲、安慰剂对照Ⅱ期临床研究

[Translation] A randomized, double-blind, placebo-controlled phase II clinical study to evaluate the efficacy and safety of subcutaneous injection of JKN24011 in the treatment of moderate to severe chronic obstructive pulmonary disease (COPD)

主要目的：评价不同剂量JKN24011治疗中、重度COPD患者的有效性。次要目的：评价不同剂量JKN24011在中、重度COPD患者中的安全性、免疫原性、药代动力学(PK)/药效动力学(PD)特征。

[Translation]

Primary objective: To evaluate the effectiveness of different doses of JKN24011 in the treatment of patients with moderate to severe COPD. Secondary objective: To evaluate the safety, immunogenicity, and pharmacokinetic (PK)/pharmacodynamic (PD) characteristics of different doses of JKN24011 in patients with moderate to severe COPD.

Start Date18 Jul 2024

Sponsor / Collaborator

Qyuns Therapeutics Co., Ltd.Startup

CTR20241726 / RecruitingPhase 1

一项在健康受试者中评估QX013N安全性和耐受性、药代动力学特征、免疫原性、药效学特征的单中心、随机、双盲、安慰剂对照的单次给药剂量递增的Ⅰ期临床研究

[Translation] A single-center, randomized, double-blind, placebo-controlled, single-dose ascending phase I clinical study to evaluate the safety and tolerability, pharmacokinetic characteristics, immunogenicity, and pharmacodynamic characteristics of QX013N in healthy subjects

主要研究目的：评价QX013N 单次给药在健康人体的安全性和耐受性。次要研究目的：评价QX013N 单次给药在健康人体的药代动力学（PK）特征，以及皮下给药与静脉给药相比下的绝对生物利用度；评价QX013N单次给药在健康人体的免疫原性特征。

[Translation]

Primary study objectives: To evaluate the safety and tolerability of a single dose of QX013N in healthy humans. Secondary study objectives: To evaluate the pharmacokinetic (PK) characteristics of a single dose of QX013N in healthy humans, as well as the absolute bioavailability of subcutaneous administration compared with intravenous administration; to evaluate the immunogenicity characteristics of a single dose of QX013N in healthy humans.

Start Date14 Jun 2024

Sponsor / Collaborator

Qyuns Therapeutics Co., Ltd.Startup

CTR20241178 / RecruitingPhase 2

一项评价QX005N在中国中度至重度特应性皮炎青少年受试者中的安全性、药代动力学和有效性的临床研究

[Translation] A clinical study evaluating the safety, pharmacokinetics and efficacy of QX005N in Chinese adolescent subjects with moderate to severe atopic dermatitis

主要研究目的评估QX005N在中重度AD青少年受试者中的安全性和耐受性评估QX005N在中重度AD青少年受试者中的药代动力学（PK）特征次要研究目的评估QX005N在中重度AD青少年受试者中的有效性评估QX005N的免疫原性探索性目的评估QX005N在中重度AD青少年受试者中的药效学（PD）特征

[Translation]

Primary study objectives Evaluate the safety and tolerability of QX005N in adolescent subjects with moderate to severe AD Evaluate the pharmacokinetic (PK) characteristics of QX005N in adolescent subjects with moderate to severe AD Secondary study objectives Evaluate the efficacy of QX005N in adolescent subjects with moderate to severe AD Evaluate the immunogenicity of QX005N Exploratory objectives Evaluate the pharmacodynamic (PD) characteristics of QX005N in adolescent subjects with moderate to severe AD

Start Date06 Jun 2024

Sponsor / Collaborator

Qyuns Therapeutics Co., Ltd.Startup

100 Clinical Results associated with Qyuns Therapeutics Co., Ltd.

0 Patents (Medical) associated with Qyuns Therapeutics Co., Ltd.

Literatures (Medical) associated with Qyuns Therapeutics Co., Ltd.

01 Dec 2024·International Immunopharmacology

Development of a novel humanized anti-TSLP monoclonal antibody, QX008N, and exploration of combination therapy of anti-TSLP antibody and anti-IL-4R antibody

Article

Author: Qiu, Jiwan ; Sun, Qiuping ; Kong, Yong ; Liu, Yuzhi ; Wang, Xiaomu ; Shi, Gaoyong ; Qiu, Tianquan ; Chen, Wei ; Zhang, Juan ; Chen, Tao

BACKGROUNDSevere asthma is a complex and chronic respiratory disease, and current conventional treatments are not effective in controlling the patients' condition. Thymic stromal lymphopoietin (TSLP) is a key regulatory factor in the initiation and maintenance of asthma. Thus, blocking TSLP during allergic inflammation emerges as a promising therapeutic approach; however, novel anti-TSLP therapies remain to be developed. Furthermore, the importance of other signaling molecules, such as IL-4 and IL-13, should be considered. Moreover, to the best of our knowledge, the inhibitory effect of binding upstream and downstream signaling molecules has not been assessed.PURPOSEThis study aimed to develop a novel, humanized anti-TSLP antibody and explore the enhancement in its efficacy when combined with anti-IL-4R antibodies to treat asthma.RESULTSQX008N, derived from a rabbit antibody platform, exhibits a high affinity for TSLP and superior efficacy in blocking TSLP-induced signaling pathways and inflammation in vitro compared with Tezepelumab. In a cynomolgus monkey asthma model, QX008N ameliorated lung function and reduced the levels of eosinophils and IgE. Moreover, the coadministration of QX008N with anti-IL-4R antibodies enhanced the inhibition of inflammatory mediator production triggered via costimulation in vitro. In mouse asthma models, the simultaneous blockade of TSLP and IL-4R using anti-TL4R and anti-TSLP surrogates surpassed the efficacy of monotherapy. To the best of our knowledge, the therapeutic effect of a combination of anti-TSLP and IL-4R antibodies in an asthma model has not yet been reported.CONCLUSIONThese results furnish comprehensive preclinical evidence for QX008N as an innovative anti-TSLP therapeutic agent and provide a preliminary rationale for the development of combination therapies that simultaneously target the TSLP and IL-4R signaling pathways.

01 Nov 2021·Protein Expression and PurificationQ4 · BIOLOGY

Generation and characterization of a humanized anti-IL-17A rabbit monoclonal antibody

Q4 · BIOLOGY

Article

Author: Qiu, Zhihua ; Wu, Yiliang ; Qiao, Huaiyao ; Wu, Meijuan ; Qiu, Jiwan ; Li, Wang ; Kong, Yong ; Chen, Tao ; Chen, Wei ; Zhou, Yi

Interleukin-17A (IL-17A) produced by Th17 cells, contributes to the pathogenesis of various autoimmune diseases by stimulating the release of cytokines and chemokines and its regulation. Anti-IL-17A antibody which blocks the function of IL-17A has been proved to be an effective treatment of autoimmune disease. The aim of our study was to generate a potential humanized anti-IL-17A therapeutic monoclonal antibody (mAb) through a comprehensive panel of in vitro and in vivo biological activity studies, as well as physicochemical characterization. HZD37-5, a humanized monoclonal antibody specifically recognizing N78 loci of IL-17A, binds to human and rhesus monkeys, blocks IL-17 induced signal transduction and the release of IL-6, IL-8, CXCL-1 and G-GSF. In an in vivo efficacy mouse model, HZD37-5 significantly inhibited human IL-17A induced-keratinocyte chemoattractant (KC) secretion in a dose-dependent manner. The pharmacokinetics (PK) study result of HZD37-5 in rhesus monkeys indicated that HZD37-5 had favorable PK characteristics with limited distribution (78.0-78.8 ml/kg), slow elimination (5.00-6.45 ml/day/kg), long half-life (9.1-10.7 days) and high bioavailability (103%) following a single IV or SC dose at 1.5 mg/kg. These findings provided a comprehensive preclinical characterization of HZD37-5 and supported that it may be developed as a potential therapeutic for the treatment of autoimmune diseases, including psoriasis, psoriatic arthritis, axial spondyloarthritis, etc.

Safety, Pharmacokinetics, Preliminary Efficacy, Pharmacodynamics, and Immunogenicity of QX002N, an Anti-IL-17A Monoclonal Antibody, after Short-term Treatment of Active Ankylosing Spondylitis

Author: Fang, Min ; Mai, Jiajia ; Ding, Yanhua ; Li, Qianqian ; Zhang, Hong ; Li, Xiaojiao ; Chen, Hong ; Wu, Min

Abstract

Objectives To investigate the safety, pharmacokinetics, preliminary efficacy, pharmacodynamics, and immunogenicity of QX002N, an interleukin-17A monoclonal antibody, in Chinese patients with active ankylosing spondylitis (AS). Methods In this phase 1b, double-blind, placebo-controlled, multiple ascending dose study, eligible patients with active AS were randomized into three dose (40, 80, or 160 mg) cohorts, with a 4:1 ratio in each cohort to subcutaneously receive either QX002N or a placebo once every 2 weeks with six doses in total. All patients were followed for 14 weeks (98 days) after the last dose. The primary endpoints were the safety and pharmacokinetics of QX002N, and the secondary endpoints included its preliminary efficacy, pharmacodynamics, and immunogenicity. Results Thirty patients (n = 10 in each cohort) were included, with 24 receiving QX002N and 6 receiving a placebo. A total of 85 adverse drug reactions, predominantly Grade 1–2, were identified in 20 out of 24 patients (83.3%) who took QX002N. The exposure to QX002N increased proportionally with the dose escalating from 40 mg to 160 mg. Patients taking 160 mg QX002N achieved higher response rates (ASAS20: 87.6% at Week 8 [Day 56]); ASAS40: 50.0% at Week 12 [Day 78]), than those taking 40-mg or 80-mg QX002N. An increase in interleukin-17A and a decrease in interleukin-6 levels in the serum, with decreases in the erythrocyte sedimentation rate and high-sensitivity C-reactive protein levels, were observed. Anti-drug antibodies were detected in only one of 24 patients taking QX002N. Conclusions Subcutaneous administration of QX002N demonstrates a favorable safety profile, with linear PK characteristics. Promising clinical responses in pharmacodynamics and preliminary efficacy have been observed. Immunogenicity does not appear to be a concern. Trial Registration This study was registered with Chinadrugtrials.org.cn (CTR20201277)

News (Medical) associated with Qyuns Therapeutics Co., Ltd.

18 Jun 2021

·www.globenewswire.com

Axial Spondyloarthritis Pipeline: Drug Pipeline, Regulatory Events and Clinical Trials in the Spotlight| Insights by DelveInsight

Los Angeles, June 17, 2021 (GLOBE NEWSWIRE) -- Axial Spondyloarthritis Pipeline: Drug Pipeline, Regulatory Events and Clinical Trials in the Spotlight| Insights by DelveInsight The report offers the most up-to-date information on Axial Spondyloarthritis pipeline products being developed by notable companies such as Pfizer, Suzhou Zelgen Biopharmaceuticals, Clover Biopharmaceuticals, FunPep Co Ltd., Kinevant Sciences, Izana Bioscience, Mycenax Biotech, and UCB Biopharma, among others. DelveInsight’s ‘Axial Spondyloarthritis (axSpA) Pipeline Insights’ report offers exhaustive coverage of the emerging therapies in different stages of development from pre-clinical till late-stage, along with dormant, inactive, and abandoned therapeutic agents. Some of the important takeaways from the Axial Spondyloarthritis Pipeline report: Request for Sample to know more about the therapies expected to make grab the maximum patient pool @ Axial Spondyloarthritis Emerging Therapies and Forecast The Axial Spondyloarthritis Pipeline reports lay down a thorough coverage of the ongoing clinical trials, collaborations taking place in the domain, recent happenings in the Axial Spondyloarthritis pipeline space, and growth prospects across the Axial Spondyloarthritis domain. Axial Spondyloarthritis: Overview Axial Spondyloarthritis is a chronic, inflammatory rheumatic disease that affects primarily the axial joints leading to severe pain, stiffness, and fatigue. It starts with an early inflammatory phase in which there is no structural damage in the sacroiliac joints (non-radiographic disease) progressing to later stages in which structural damage is visible on X‑ray scans of the sacroiliac joints as erosions, sclerosis, or bony bridges (radiographic disease; also known as Ankylosing Spondylitis). Discover more about the disease, treatments, and pipeline therapies @ axSpA Pipeline Assessment Axial Spondyloarthritis Pipeline Drugs Request for Sample to know more @ Axial Spondyloarthritis Pipeline Analysis, Key Companies, and Futuristic Trends Axial Spondyloarthritis Therapeutics Assessment The Axial Spondyloarthritis Pipeline report presents a kaleidoscopic view of the axSpA emerging novel therapies segmented by Stage, Product Type, Route of Administration (RoA), Molecule Type, Target, and Mechanism of Action. By Product Type By Stage By Molecule Type By Route of Administration By Mechanism of Action By Targets For rich insights into merging therapies and assessment, visit Axial Spondyloarthritis Pipeline: Emerging Novel Therapies Scope of the Axial Spondyloarthritis Pipeline Report Coverage: GlobalKey Players: Izana Bioscience, UCB, Sun Pharma Global, Akeso Biopharma, Kinevant Sciences, Jiangsu Hengrui Medicine Co., Suzhou Zelgen Biopharmaceuticals, Clover Biopharmaceuticals, Mycenax Biotech, Boehringer Ingelheim, and Qyuns Therapeutics among others.Key Axial Spondyloarthritis Pipeline Therapies: Namilumab , Bimekizumab, Tofacitinib, Tildrakizumab, AK-111, NDI 031232, Gimsilumab, QX002N, SHR-0302, Jaktinib, SCB-808, FPP003, KIN-1901, ENIA11, BI 730357, and QX002N among others. Discover more about the report offerings @ axSpA Emerging Therapies, Treatments, and Ongoing Clinical Trials Table of Contents Get in touch with our Business executive for Regulatory Analysis, Licensing Services, and Consulting Solutions Related Reports Axial Spondyloarthritis MarketDelveInsight's "Axial Spondyloarthritis Market Insights, Epidemiology, and Market Forecast-2030" report. Non-Radiographic Axial Spondyloarthritis MarketDelveInsight's "Non-Radiographic Axial Spondyloarthritis (nr-AxSpA) Market Insights, Epidemiology, and Market Forecast-2030" report. Spondylolisthesis Market InsightsDelveInsight's “Spondylolisthesis Market Insights, Epidemiology, and Market Forecast-2030" report. Ankylosing Spondylitis MarketDelveInsight’s ‘Ankylosing Spondylitis Market Insights, Epidemiology, and Market Forecast–2030’ report. Global Kinase Inhibitor In Autoimmune Diseases MarketDelveInsight’s ‘Global Kinase Inhibitor in Autoimmune Diseases Market Insights and Market Forecast – 2030’ report. Adenosine Deaminase Severe Combined Immunodeficiency MarketDelveInsight's "Adenosine Deaminase-Severe Combined Immunodeficiency Market Insights, Epidemiology, and Market Forecast-2030" report. Adult-Onset Still Disease MarketDelveInsight’s “Adult-onset Still’s Disease Market Insights, Epidemiology, and Market Forecast – 2030” report. Browse through our posts ABSSSI Pipeline Analysis Parkinson's Disease Risk FactorsWearable Healthcare Devices Market About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve. For more insights, visit Pharma, Healthcare, and Biotech News

Collaborate

100 Deals associated with Qyuns Therapeutics Co., Ltd.

100 Translational Medicine associated with Qyuns Therapeutics Co., Ltd.

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Pipeline

Pipeline Snapshot as of 26 Nov 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Discovery

Preclinical

IND Approval

Phase 1 Clinical

Phase 2 Clinical

Phase 3 Clinical

NDA/BLA

Other

Current Projects

Drug(Targets)	Indications	Global Highest Phase

Ustekinumab Biosimilar(Jiangsu Quanxin Biomedical Co Ltd) ( IL-12 x IL-23 )	Plaque psoriasis More	NDA/BLA
QX-005N ( IL-4Rα )	Dermatitis, Atopic More	Phase 3
QX002N ( IL-17A )	Ankylosing Spondylitis More	Phase 3
Tocilizumab Biosimilar(Jiangsu Quanxin Biomedical Co Ltd) ( IL-6RA )	Rheumatoid Arthritis More	Phase 2
QX-004N ( IL-23p19 )	Plaque psoriasis More	Phase 2

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