Single-Arm, Open, Multi-Center Phase II Clinical Trial of the Efficacy, Safety, Pharmacokinetics, and Immunogenicity of GR1803 Injection in Patients With Relapsed/Refractory Multiple Myeloma Complicated by Extramedullary Plasmacytoma

All subjects will receive GR1803 injection until intolerable toxicity or investigator-assessed disease progression occurs (except in cases of disease progression due to discontinuation of the drug as a result of an adverse event) or until the subject has been administered the drug for 2 years or until the subject withdraws consent or until the investigator determines that the subject needs to be discontinued.

Start Date24 Apr 2025

Sponsor / Collaborator

Zhixiang (Shanghai) Medical Technology Co., Ltd.

CTR20251242

/ Active, not recruitingPhase 1

GR1802 注射液在健康受试者中单次给药的随机、开放、平行入组的安全性、药代动力学、免疫原性临床试验

[Translation] A randomized, open, parallel-group clinical trial of the safety, pharmacokinetics, and immunogenicity of GR1802 injection in healthy subjects after a single dose

主要目的：在健康受试者中，比较皮下注射 150mg 规格的 GR1802 注射液注射两次和300mg 规格的 GR1802 注射液注射一次的注射部位反应。次要目的：比较 GR1802 注射液不同规格在健康受试者中单次皮下给药的其他安全性特征；比较 GR1802 注射液不同规格在健康受试者中单次皮下给药的药代动力学特征；比较 GR1802 注射液不同规格在健康受试者中单次皮下给药的免疫原性。

[Translation]

Primary objective: To compare the injection site reactions of two subcutaneous injections of 150mg GR1802 injection and one subcutaneous injection of 300mg GR1802 injection in healthy subjects. Secondary objectives: To compare other safety characteristics of single subcutaneous administration of different strengths of GR1802 injection in healthy subjects; To compare the pharmacokinetic characteristics of single subcutaneous administration of different strengths of GR1802 injection in healthy subjects; To compare the immunogenicity of single subcutaneous administration of different strengths of GR1802 injection in healthy subjects.

Start Date16 Apr 2025

Sponsor / Collaborator

Chongqing Genrix Biopharmaceutical Co., Ltd.

[+1]

CTR20244828

/ RecruitingPhase 1

GR1802注射液在青少年/儿童中、重度特应性皮炎患者中多次皮下注射给药的耐受性、安全性、药代动力学、多中心、单臂、开放Ⅰb/Ⅱa期临床试验

[Translation] A multicenter, single-arm, open-label Phase Ib/IIa clinical trial of the tolerability, safety, and pharmacokinetics of multiple subcutaneous injections of GR1802 injection in adolescents/children with moderate to severe atopic dermatitis

主要目的：评价GR1802注射液在中、重度特应性皮炎青少年/儿童患者中多次皮下注射的耐受性和安全性特征。次要目的：评价GR1802注射液在中、重度特应性皮炎青少年/儿童患者中多次皮下注射的药代动力学特征；评价GR1802注射液在中、重度特应性皮炎青少年/儿童患者中多次皮下注射的初步疗效；评价GR1802注射液在中、重度特应性皮炎青少年/儿童患者中多次皮下注射的免疫原性；评价中、重度特应性皮炎青少年/儿童患者中皮下注射GR1802注射液疗效预测的生物标志物。

[Translation]

Primary objective: To evaluate the tolerability and safety of GR1802 injection after multiple subcutaneous injections in adolescents/children with moderate to severe atopic dermatitis. Secondary objectives: To evaluate the pharmacokinetic characteristics of GR1802 injection after multiple subcutaneous injections in adolescents/children with moderate to severe atopic dermatitis; To evaluate the preliminary efficacy of GR1802 injection after multiple subcutaneous injections in adolescents/children with moderate to severe atopic dermatitis; To evaluate the immunogenicity of GR1802 injection after multiple subcutaneous injections in adolescents/children with moderate to severe atopic dermatitis; To evaluate the biomarkers predicting the efficacy of subcutaneous GR1802 injection in adolescents/children with moderate to severe atopic dermatitis.

Start Date23 Mar 2025

Sponsor / Collaborator

Chongqing Genrix Biopharmaceutical Co., Ltd.

100 Clinical Results associated with Chongqing Genrix Biopharmaceutical Co., Ltd.

0 Patents (Medical) associated with Chongqing Genrix Biopharmaceutical Co., Ltd.

Literatures (Medical) associated with Chongqing Genrix Biopharmaceutical Co., Ltd.

01 May 2025·JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY

Efficacy and safety of GR1802 in uncontrolled chronic rhinosinusitis with nasal polyps: Placebo-controlled phase 2 trial

Article

Author: Piao, Yingshi ; Zhang, Luo ; Wan, Lijia ; Guan, Bing ; Yu, Hongmeng ; Zheng, Ming ; Yang, Yucheng ; He, Gang ; Tang, Jun ; Quan, Fang ; Wang, Chengshuo ; Zhang, Xiaowen ; Song, Xicheng ; Li, Xuezhong ; Lan, Feng ; Xu, Yu ; Wang, Wei ; Chen, Jianjun ; Du, Yuxiao ; Liu, Wen ; Ye, Jing ; Xu, Zhendong ; Wu, Di

BACKGROUND:

Anti-IL-4 receptor subunit alpha (IL-4Rα) treatments can effectively treat eosinophilic chronic rhinosinusitis with nasal polyps (ECRSwNP). However, their impact on the overall population of patients with uncontrolled CRSwNP remains unclear.

OBJECTIVES:

We evaluated the safety and efficacy of GR1802, a novel anti-IL-4Rα monoclonal antibody, in patients with uncontrolled CRSwNP.

METHODS:

Seventy patients with uncontrolled CRSwNP were randomized (1:1) to receive either GR1802 (300 mg with an initial doubled dose) or placebo every 2 weeks. Primary end points were the changes from baseline in nasal polyp score and nasal congestion score at week 16. Secondary end points mainly included change from baseline in Total Nasal Symptom Score (TNSS), 22-item Sino-Nasal Outcome Test (SNOT-22) score, and Lund-Mackay score. Efficacy (exploratory) was also analyzed in ECRSwNP and non-ECRSwNP subgroups. Safety was evaluated throughout the study.

RESULTS:

In uncontrolled CRSwNP participants, GR1802 significantly improved nasal polyp score and nasal congestion score compared with placebo, with least squares mean differences of -2.1 (95% confidence interval, -2.6, -1.5) and -0.8 (95% confidence interval, -1.1, -0.4), respectively. Participants treated with GR1802 had significantly decreased TNSS, SNOT-22 score, and Lund-Mackay score. The subgroup analysis demonstrated that GR1802 improved the symptoms and quality of life in both ECRSwNP and non-ECRSwNP participants, as evidenced by changes in nasal polyp score, University of Pennsylvania Smell Identification Test score, and Lund-Mackay score. Treatment-related adverse events occurred in 19.4% of the GR1802 group and 17.6% of the placebo group.

CONCLUSION:

GR1802 is well tolerated and effective in treating the overall population with uncontrolled CRSwNP.

01 Feb 2025·EXPERT OPINION ON INVESTIGATIONAL DRUGS

Tolerability, safety, and pharmacokinetics of GR1603 injection in healthy subjects: a randomized, double-blind, placebo-controlled single-dose escalation clinical trial

Article

Author: Huang, Xin ; Ye, Ling ; Wang, Wei ; Yang, Xiaoyan ; Yang, Shuang ; Cui, Chang ; Yang, Guoping ; Huang, Jie ; Hong, Xiang ; Wu, Qian

BACKGROUND:

GR1603 is a monoclonal antibody targeting the type I interferon receptor. The aim of this study was to evaluate the safety, tolerability, pharmacokinetics, immunogenicity and pharmacodynamics of GR1603 in healthy volunteers.

METHODS:

Healthy adults (≥18 years old) were enrolled in a placebo control, dose-escalation Phase I clinical trial receiving a single injectable dose of GR1603. Follow-up was 12 weeks. Adverse event (AE) profiles, vital signs, and blood samples were collected for assessment of safety, PK, and expression of type I interferon inducible genes.

RESULTS:

Of the 46 subjects, 44 completed treatment. In the experimental group of 34 subjects (mean age 26.6 years), 30 experienced treatment-emergent adverse events (TEAEs), with a total of 102 occurrences, resulting in an incidence rate of 88.2%. The most commonly reported drug-related AEs were upper respiratory tract infection (17.6%), all of which were ≤ grade 2. GR1603 exhibits non-linear PK in the dose range of 0.1 mg/kg to 9 mg/kg. All samples were negative for anti-drug antibodies before and after dosing. The degrees of IFN gene signature were significantly inhibited in the higher dose groups.

CONCLUSION:

The safety/tolerability, PK and exploratory metrics observed in this study support further clinical development of GR1603.

CLINICAL TRIAL REGISTRATION:

www.chictr.org.cn/searchproj.html identifier is ChiCTR2100045628.

01 Jan 2025·JOURNAL OF CLINICAL PHARMACOLOGY

Population Pharmacokinetics of Xeligekimab: An Anti‐IL‐17A Monoclonal Antibody, in Patients with Moderate to Severe Plaque Psoriasis

Article

Author: Liu, Hongxia ; Zheng, Qingshan ; Wang, Wei ; Meng, Qingheng ; Xu, Ling ; Zhang, Lingxiao ; Shi, Haiyang

Abstract:

Xeligekimab, a recombinant fully human IgG4 monoclonal antibody, has been strategically developed to target IL‐17A and is presently in the developmental phase for treating moderate to severe plaque psoriasis. This study aims to investigate the pharmacokinetic profile of Xeligekimab, utilizing data derived from clinical trials specifically conducted in Chinese patients. The study conducted a population pharmacokinetic (PopPK) analysis involving 614 patients with plaque psoriasis. Examined covariates encompassed demographics, baseline laboratory tests, anti‐drug antibodies (ADA), injection site, and disease‐related baseline characteristics. Model evaluation utilized goodness‐of‐fit, prediction‐corrected visual prediction check, and bootstrap methods. The clinical significance of covariates statistically associated with Xeligekimab was assessed through simulation analysis. The PopPK model of Xeligekimab demonstrated characteristics of a two‐compartment model with first‐order absorption and linear elimination. Inter‐individual variability (IIV) was estimated for clearance and volume of distribution. For a typical plaque psoriasis patient, the estimated values for absorption rate constant (Ka), apparent clearance (CL/F), central compartment volume (Vc/F), peripheral compartment volume (Vp/F), and inter‐compartmental clearance (Q/F) was 0.225 per day, 2.223 L/day, 4.02 L, 4.13 L, and 1.11 L/day, respectively. The estimated IIV for CL/F and Vc/F was 25.8% and 49.8%, respectively. The elimination half‐life (t1/2) was approximately 28.5 days. CL/F was significantly influenced by factors such as body weight, age, gender, and baseline total protein. Vc/F was significantly influenced by body weight, age, gender, and baseline albumin. However, the clinical relevance of these covariate effects on exposure parameters was determined to be limited.

News (Medical) associated with Chongqing Genrix Biopharmaceutical Co., Ltd.

06 Nov 2024

·www.prnewswire.com

Severe Asthma Clinical Trial Pipeline Appears Robust With 40+ Key Pharma Companies Actively Working in the Therapeutics Segment | DelveInsight

The severe asthma market is fueled by the rising prevalence of the condition, particularly in urban areas, alongside the emergence of innovative therapies like biologics targeting IgE and cytokine modulators. A growing demand for personalized medicine enhances treatment efficacy and patient compliance. Government initiatives and increased awareness improve access to care, while advancements in inhaler technology boost medication adherence. Collaborative efforts in R&D are also vital for driving innovation in asthma treatments. LAS VEGAS, Nov. 6, 2024 /PRNewswire/ -- DelveInsight's ' Severe Asthma Pipeline Insight 2024 ' report provides comprehensive global coverage of pipeline severe asthma therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the severe asthma pipeline domain. Key Takeaways from the Severe Asthma Pipeline Report DelveInsight's severe asthma pipeline report depicts a robust space with 40+ active players working to develop 50+ pipeline therapies for severe asthma treatment. Key severe asthma companies such as Kinaset Therapeutics, Bio-Thera Solutions, CSPC ZhongQi Pharmaceutical Technology, AB Science, GlaxoSmithKline, Oneness Biotech, Biosion, Lanier Biotherapeutics, Kymera Therapeutics, Suzhou Connect Biopharmaceuticals, Upstream Bio, Teva Branded Pharmaceutical Industries, Sanofi, Jiangsu Hengrui Medicine, AstraZeneca, Advagene Biopharma, Genrix (Shanghai) Biopharmaceuticals, and others are evaluating new severe asthma drugs to improve the treatment landscape. Promising severe asthma pipeline therapies such as KN-002, BAT2606, CM326, Masitinib, GSK3511294, FB 704A, BSI-045B, LNR 125.38, KT 621, CBP-201, Verekitug, TEV'248, Rilzabrutinib, SHR-1905, Atuliflapon, AD17002, GR1802, and others are under different phases of severe asthma clinical trials. In September 2024, Kinaset Therapeutics announced two oral presentations and a late-breaking poster presentation at the 2024 European Respiratory Society (ERS) Congress. The presentations demonstrate the potential of Kinaset's lead clinical candidate, frevecitinib ( KN-002), to treat all patients with moderate to severe asthma and patients with COPD. In May 2024, GSK announced positive headline results from the phase III clinical trials SWIFT-1 and SWIFT-2, which assessed the efficacy and safety of depemokimab versus placebo in adults and adolescents with severe asthma with type 2 inflammation characterized by blood eosinophil count. In April 2024, Twenty-five abstracts across approved and investigational medicines will be presented at this year's American Thoracic Society (ATS) International Conference. Notable data presentations for Sanofi's immunology pipeline include the first presentation of phase IIb moderate to severe asthma data for rilzabrutinib. In October 2023, Upstream Bio announced positive interim results in its Phase Ib clinical study of UPB-101, a thymic stromal lymphopoietin receptor (TSLPR) inhibitor. The Phase Ib study is a randomized, double-blinded, placebo-controlled multiple ascending dose (MAD) study with subcutaneous (SC) administration conducted in asthma patients. In October 2023, Aiolos Bio with an asthma drug in clinical trials, announced that it raised $245 million in Series A funding. Atlas Venture, Bain Capital Life Sciences, Forbion Capital Partners and Sofinnova Investments led the round, with additional investment from RA Capital Management Request a sample and discover the recent advances in severe asthma treatment drugs @ Severe Asthma Pipeline Report The severe asthma pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage severe asthma drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the severe asthma clinical trial landscape. Severe Asthma Overview Severe asthma is a chronic respiratory condition characterized by persistent symptoms that are difficult to control, even with high-dose medications. Unlike milder forms of asthma, severe asthma can significantly impair the quality of life and may result in frequent exacerbations requiring hospitalization. The exact cause of severe asthma is not entirely clear, but it often arises from a combination of genetic and environmental factors. These may include respiratory infections, allergens (pollen, mold, dust mites), pollutants (tobacco smoke, air pollution), occupational irritants, and lifestyle factors such as obesity and stress. Severe asthma can also develop in people whose milder asthma is not well-controlled over time. Diagnosis of severe asthma begins with a comprehensive medical history, physical examination, and pulmonary function tests like spirometry to assess lung function. Doctors may also order additional tests, such as chest X-rays, blood tests, and allergy tests to identify triggers. A key factor in diagnosing severe asthma is the persistence of symptoms despite the optimal use of standard asthma treatments. Managing severe asthma typically requires a multifaceted approach. Inhaled corticosteroids and long-acting bronchodilators are the mainstays of treatment. For those who do not respond to these medications, biologic therapies (such as omalizumab, mepolizumab, or dupilumab) may be prescribed to target specific pathways involved in the inflammatory response. In addition, patients with severe asthma may benefit from lifestyle modifications, including weight management, avoiding triggers, and pulmonary rehabilitation. In extreme cases, systemic corticosteroids may be necessary, although long-term use can have serious side effects. Find out more about severe asthma treatment drugs @ Drugs for Severe Asthma Treatment A snapshot of the severe asthma Pipeline Drugs mentioned in the report: Learn more about the emerging severe asthma pipeline therapies @ Severe Asthma Clinical Trials Severe Asthma Therapeutics Assessment The severe asthma pipeline report proffers an integral view of the severe asthma emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Severe Asthma Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Oral, Intravenous, Subcutaneous, Parenteral, Topical Therapeutics Assessment By Molecule Type: Recombinant fusion proteins, Small molecule, Monoclonal antibody, Peptide, Polymer, Gene therapy Therapeutics Assessment By Mechanism of Action: Interleukin 5 receptor antagonists, Thymic stromal lymphopoietin inhibitors, Thymic stromal lymphopoietin inhibitors, Thymic stromal lymphopoietin modulators, Interleukin 6 inhibitors, STAT6 transcription factor degraders, Interleukin 4 receptor alpha subunit antagonists Key Severe Asthma Companies: Kinaset Therapeutics, Bio-Thera Solutions, CSPC ZhongQi Pharmaceutical Technology, AB Science, GlaxoSmithKline, Oneness Biotech, Biosion, Lanier Biotherapeutics, Kymera Therapeutics, Suzhou Connect Biopharmaceuticals, Upstream Bio, Teva Branded Pharmaceutical Industries, Sanofi, Jiangsu Hengrui Medicine, AstraZeneca, Advagene Biopharma, Genrix (Shanghai) Biopharmaceuticals, and others. Key Severe Asthma Pipeline Therapies: KN-002, BAT2606, CM326, Masitinib, GSK3511294, FB 704A, BSI-045B, LNR 125.38, KT 621, CBP-201, Verekitug, TEV'248, Rilzabrutinib, SHR-1905, Atuliflapon, AD17002, GR1802, and others. Dive deep into rich insights for new drugs for severe asthma treatment, visit @ Severe Asthma Drugs Table of Contents For further information on the severe asthma pipeline therapeutics, reach out @ Severe Asthma Treatment Drugs Related Reports Severe Asthma Market Severe Asthma Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key severe asthma companies including AstraZeneca plc, GlaxoSmithKline plc, Sanofi S.A., Novartis AG, Roche Holding AG, Teva Pharmaceutical Industries Ltd., Merck & Co., Inc., Boehringer Ingelheim International GmbH, Regeneron Pharmaceuticals, Inc., Johnson & Johnson, Pfizer Inc., Bristol Myers Squibb, Eli Lilly and Company, Vertex Pharmaceuticals Incorporated, Amgen Inc., AbbVie Inc., Genentech, Inc., Gilead Sciences, Inc., Biogen Inc., CSL Limited, among others. Asthma Market Asthma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key asthma companies including GlaxoSmithKline, 4D Pharma plc, AstraZeneca, Suzhou Connect Biopharmaceuticals, Avillion, Pearl Therapeutics, ARS Pharmaceuticals, Sinomab, Avalo Therapeutics, Kymab, Sanofi, Cumberland Pharmaceuticals, Genentech, Inc. , among others. Asthma Pipeline Asthma Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, including clinical and non-clinical stage products, and the key asthma companies, including Jiangsu Hengrui Medicine, GlaxoSmithKline, Immunotek SL, AB Science, EMS, Avalo Therapeutics, Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd., ARS Pharmaceuticals, Sanofi, Zura Bio Ltd., AstraZeneca, EURRUS Biotech GmbH, T-Balance Therapeutics GmbH, Gossamer Bio, Aldeyra Therapeutics, Inc., Trio Medicines, Janssen Research & Development, Arrowhead Pharmaceuticals, Hoffman-La-Roche, GlaxoSmithKline, Biohaven Pharmaceutical, TAK-Circulator Co., Shanghai Hengrui Pharmaceutical, among others. Acute Respiratory Distress Syndrome Market Acute Respiratory Distress Syndrome Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key ARDS companies, including MediciNova, Edesa Biotech, Light Chain Biosciences, Boehringer Ingelheim, Genentech, Windtree Therapeutics, Biomarck Pharmaceuticals, Athersys, Healios, Direct Biologics, Biohaven Pharmaceutical, Arch Biopartners, APEPTICO Forschung und Entwicklung GmbH, Staidson (Beijing) Biopharmaceuticals, Veru, Mesoblast Limited, Avalo Therapeutics, Pluristem Therapeutics, ILTOO Pharma, among others. 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 . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 2Phase 3Phase 1

100 Deals associated with Chongqing Genrix Biopharmaceutical Co., Ltd.

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Pipeline

Pipeline Snapshot as of 15 Aug 2025

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

Phase 1

Phase 2

Phase 3

NDA/BLA

Approved

Other

Current Projects

Drug(Targets)	Indications	Global Highest Phase

Silevimig ( RABV-G )	Rabies More	NDA/BLA
Telikibart ( IL-4Rα )	Chronic rhinosinusitis with nasal polyps More	Phase 3
Vecantoxatag ( Tetanus toxin )	Tetanus More	Phase 3
Velinotamig ( BCMA x CD3 )	Extramedullary Plasmacytoma More	Phase 2
Xeligekimab ( IL-17A )	Lupus Nephritis More	Phase 2

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