This study will evaluate the efficacy, safety, pharmacokinetics(PK) ,pharmacodynamics and anti-drug antibodies（ADA） of MIL62 compared with cyclosporine in participants with primary membranous nephropathy (pMN).

Start Date02 Jun 2023

Sponsor / Collaborator

Beijing Mabworks Biotech Co., Ltd.

CTR20231574 / Active, not recruitingPhase 3

一项评价重组人源化单克隆抗体MIL62 注射液治疗原发性膜性肾病的有效性和安全性的多中心、随机、对照、开放的Ⅲ期研究

[Translation] A multicenter, randomized, controlled, open-label phase III study to evaluate the efficacy and safety of recombinant humanized monoclonal antibody MIL62 injection in the treatment of primary membranous nephropathy

评价和比较MIL62和环孢素治疗原发性膜性肾病受试者76周达到完全缓解（complete remission, CR）的比例。

[Translation]

To evaluate and compare the proportion of subjects with primary MN who achieved complete remission (CR) at week 76 between MIL62 and cyclosporine.

Start Date02 Jun 2023

Sponsor / Collaborator

Beijing Mabworks Biotech Co., Ltd.

NCT05796206 / RecruitingPhase 2/3

A Phase Ⅱ/Ⅲ Clinical Study to Evaluate the Safety and Efficacy of Recombinant Humanized Monoclonal Antibody MIL62 Injection in the Treatment of Systemic Lupus Erythematosus.

This study will evaluate the efficacy, safety, pharmacokinetics(PK) 、pharmacodynamics(PD) and ADA of MIL62 compared with placebo in participants with systemic lupus erythematosus.

Start Date26 May 2023

Sponsor / Collaborator

Beijing Mabworks Biotech Co., Ltd.

100 Clinical Results associated with Recombinant humanized monoclonal antibody MIL62 (Beijing InnoCare)

100 Translational Medicine associated with Recombinant humanized monoclonal antibody MIL62 (Beijing InnoCare)

100 Patents (Medical) associated with Recombinant humanized monoclonal antibody MIL62 (Beijing InnoCare)

Literatures (Medical) associated with Recombinant humanized monoclonal antibody MIL62 (Beijing InnoCare)

01 Jul 2024·EClinicalMedicine

Efficacy and safety of MIL62, a novel glycoengineered type Ⅱ anti-CD20 monoclonal antibody, combined with lenalidomide in patients with relapsed/refractory follicular lymphoma or marginal zone lymphoma: a multicentre, single-arm, phase 1b/2 trial

Article

Author: Bai, Ou ; Zhou, Keshu ; Xiang, Ying ; Shi, Yuankai ; Zhou, Hui ; Qin, Yan ; Wei, Min ; Jing, Hongmei ; Li, Zhenyu ; Song, Yongping ; Wang, Zhen ; Zang, Aimin ; Zhang, Huilai ; Wang, Zhao ; Liang, Jinjin

Background:

MIL62, a novel glycoengineered type Ⅱ anti-CD20 monoclonal antibody, with a nearly completely afucosylated N-glycans in Fc region, has demonstrated superior activity compared with rituximab and obinutuzumab in vitro and in vivo, respectively.

Methods:

This multicentre, single-arm, phase 1b/2 trial aimed to explore the efficacy, pharmacokinetics, and safety of MIL62 combined with lenalidomide in patients with relapsed/refractory (R/R) follicular lymphoma (FL) or marginal zone lymphoma (MZL). Eligible patients included those who had histopathologically confirmed CD20 positive FL (grade 1-3a) or MZL and failed to be treated with rituximab. Patients received intravenously infused MIL62 1000 mg (cycle 1: day 1, 15; cycles 2-8: day 1, cycles 10 and 12: day 1) combined with oral lenalidomide (once a day, days 2-22, the initial dose was 10 mg, and the maximum dose was 20 mg) for 12 cycles, 28 days as a cycle. The primary endpoint was objective response rate (ORR) assessed by investigator per Lugano 2014 criteria every 3 cycles. This study was registered in ClinicalTrials.gov (NCT04110301).

Findings:

Between November 22, 2019 and December 22, 2020, 54 patients were enrolled from 11 hospitals in China and received study treatment. Fifty patients were included in the efficacy analysis set, and 43 patients (86%, 95% CI: 73, 94) achieved objective response, meeting the pre-specified primary endpoint. Disease control rate was 96% (48/50, 95% CI: 86, 100), proportion of patients with duration of response (DoR) > 6 months was 77% (33/43). The median follow-up for survival was 12.3 months (IQR 12.0-12.6). The 1-year progression-free survival rate was 72% (95% CI: 57, 83), 9-month DoR rate was 74% (95% CI: 58, 85), and 1-year overall survival rate was 98% (95% CI: 85, 100). Most common TRAEs were neutropenia (93%, 50/54), leukopenia (85% 46/54), thrombocytopenia (61% 33/54), lymphopenia (32% 17/54), and alanine aminotransferase increased (20% 11/54).

Interpretation:

MIL62 combined with lenalidomide showed promising efficacy in patients with R/R FL and MZL. A multicentre, randomized, open-label, phase Ⅲ trial of MIL62 combined with lenalidomide versus lenalidomide in anti-CD20 monoclonal antibody refractory FL patients is ongoing (NCT04834024).

Funding:

Beijing Mabworks Biotech Co. Ltd, Beijing China and the National Science and Technology Major Project for Key New Drug Development (2017ZX09304015).

News (Medical) associated with Recombinant humanized monoclonal antibody MIL62 (Beijing InnoCare)

28 Nov 2024

·www.prnewswire.com

Follicular Lymphoma Clinical Trial Pipeline Appears Robust With 50+ Key Pharma Companies Actively Working in the Therapeutics Segment | DelveInsight

Advances in immunotherapy have ushered in a new era of treatment for follicular lymphoma (FL), particularly for patients who have experienced relapse after conventional chemotherapy regimens. This paradigm shift is characterized by the emergence of innovative therapies like CAR T-cell therapy and bispecific antibodies, which have demonstrated remarkable efficacy in targeting and eradicating lymphoma cells. CAR T-cell therapy represents a groundbreaking approach where a patient's own T-cells are genetically engineered to recognize and attack cancer cells. This personalized treatment has shown significant promise, especially for individuals who have undergone extensive previous therapies. One notable example is Axicabtagene ciloleucel (Yescarta), a CAR T-cell therapy approved for use in patients with relapsed or refractory follicular lymphoma. Clinical trials have highlighted its ability to induce durable remissions, with some patients experiencing long-term remission even after multiple prior therapies. LAS VEGAS, Nov. 28, 2024 /PRNewswire/ -- DelveInsight's ' Follicular Lymphoma Pipeline Insight 2024 ' report provides comprehensive global coverage of pipeline follicular lymphoma therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the follicular lymphoma pipeline domain. Key Takeaways from the Follicular Lymphoma Pipeline Report DelveInsight's follicular lymphoma pipeline report depicts a robust space with 50+ active players working to develop 55+ pipeline therapies for follicular lymphoma treatment. Key follicular lymphoma companies such as Chia Tai Tianqing Pharmaceutical Group, Incyte Corporation, Mabworks, Johnson & Johnson Innovative Medicine, Nektar Therapeutics, Xynomic Pharmaceuticals, Merck Sharp & Dohme, Jiangsu HengRui Medicine Co., Ltd., ADC Therapeutics, Bristol-Myers Squibb, Swedish Orphan Biovitrum, Zhejiang DTRM Biopharma, Immpact Bio, Galapagos, Immunitas Therapeutics, Enterome, CRISPR Therapeutics, CHO Pharma, Shanghai Blueray Biopharma, BeiGene, AstraZeneca, AVM Biotechnology, Mustang Bio, Merck, Pell Bio-Med Technology, Schrodinger Inc., Sana Biotechnology, Poseida Therapeutics, OncoNano Medicine, Inc., Nurix Therapeutics, Inc., NovalGen, Pfizer, Xencor, Wellington Zhaotai Therapies, MEI Pharma, Sutro Biopharma, Synthekine, Verismo Therapeutics, Vincerx Pharma, Novartis, Century Therapeutics, Newave Pharmaceuticals, Bio-Path Holdings, Affimed GmbH, Iksuda Therapeutics, Allogene Therapeutics, Adicet Bio, Carna Biosciences, Inc., BeiGene, Boryung Pharmaceutical, Accutar Biotechnology, Atara Biotherapeutics, AbbVie, InnoCare Pharma, NeoImmuneTech, and others are evaluating new follicular lymphoma drugs to improve the treatment landscape. Promising follicular lymphoma pipeline therapies such as Parsaclisib, TQ-B3525, Tafasitamab, MIL62, Ibrutinib, AZD0486, NKTR-255, Abexinostat, Acalabrutinib, Zilovertamab vedotin, SHR2554, Nivolumab, Loncastuximab tesirine, Golcadomide, Emapalumab, DTRM-555, Capivasertib, IMPT 314, GLPG5101, IMT-009, EO2463, CTX112, CHO-H01, BR1733, BGB-16673, BGB-10188, AZD5492, AVM0703, MB106, MK-1026, PL001, SGR-1505, SC291, SC262, P-CD19CD20-ALLO1, ONM 501, NX-5948, NX 2127, NVG-111, Mevrometostat, Plamotamab, WZTL-002, Voruciclib, STRO001, SYNCAR-001 + STK-009, SynKIR-310, VIP-152, VAY736, CNTY-101, LP-168, BP1002, IOA-244, IKS 03, ALLO-501, ADI-001, AS-1763, BGB-21447, BR101801, AC676, ATA3219, ABBV-319, ABBV-101, ICP-B02, ICP-B05, C-CAR039, Efineptakin Alfa, and others are under different phases of follicular lymphoma clinical trials. In August 2024, the company expects to file a supplemental Biologics License Application for tafasitamab for the treatment of patients with FL who have failed at least one prior systemic anti-CD20 immunotherapy or chemo-immunotherapy by the end of 2024 based on the positive Phase III results. In June 2024, a consortium of Eugene Private Equity and Korea Development Bank Private Equity announced that they would acquire 80% of South Korean vaccine maker Boryung Biopharma Co. for 320 billion won (USD 231 million). In February 2024, Incyte announced that it had entered into an asset purchase agreement with MorphoSys AG, which gives Incyte exclusive global rights for tafasitamab. Incyte will now recognize revenue and cost for all US commercialization and clinical development and MorphoSys will no longer be eligible to receive future milestone, profit split and royalty payments. In September 2023, OncoNano Medicine, Inc. announced a clinical trial supply agreement with Regeneron for the use of Libtayo (cemiplimab), a PD-1 inhibitor, in the combination stage of the first human trial of ONM-501, a dual-activating STING (STimulator of INterferon Genes) agonist and lead therapeutic development candidate. The ONM-501 first-in-human trial is a multicenter Phase Ia/b dose escalation and dose expansion study of intratumoral ONM-501 as monotherapy and in combination with Libtayo in patients with advanced solid tumors and lymphomas. OncoNano is the sponsor of the clinical trial, and Regeneron will supply cemiplimab. In May 2023, Janssen Pharmaceutical Companies of Johnson & Johnson announced that it had entered into a worldwide collaboration and license agreement with Cellular Biomedicine Group Inc. (CBMG) to develop, manufacture, and commercialize next-generation chimeric antigen receptor (CAR) T-cell therapies for the treatment of B-cell malignancies. Under the terms of the agreement, CBMG will grant Janssen a worldwide license to develop and commercialize the CAR-T assets, except in Greater China. Janssen and CBMG will negotiate an option for Janssen to commercialize the products in the Chinese territory. Janssen will make an upfront payment of USD 245 million that will be accounted for in the second quarter as a research and development expense. Additional future payments will be based upon achieving certain development, regulatory, and sales milestones, as well as tiered royalty payments on worldwide net trade sales, excluding Greater China. Request a sample and discover the recent advances in follicular lymphoma treatment drugs @ Follicular Lymphoma Pipeline Report The follicular lymphoma pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage follicular lymphoma drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the follicular lymphoma clinical trial landscape. Follicular Lymphoma Overview Follicular lymphoma is a common type of non-Hodgkin lymphoma (NHL) that originates from B-cells, a kind of white blood cell responsible for producing antibodies. This cancer is characterized by the growth of abnormal lymphoid follicles, which can disrupt normal lymphatic function. While the exact causes of follicular lymphoma are not fully understood, certain factors may increase the risk, including age (most commonly affecting adults over 60), a family history of lymphoma, and potential environmental factors such as exposure to pesticides or chemicals. Symptoms of follicular lymphoma can vary widely but may include painless swelling of lymph nodes in the neck, armpit, or groin, unexplained weight loss, night sweats, fatigue, and fever. Some patients may remain asymptomatic for extended periods, as this type of lymphoma can progress slowly. Diagnosis typically involves a combination of physical examinations, blood tests, imaging studies (like CT scans), and a biopsy of affected lymph nodes. The biopsy helps determine the subtype and stage of the lymphoma, which is crucial for planning treatment. Treatment for follicular lymphoma depends on the stage of the disease and the patient's overall health. Options may include watchful waiting for asymptomatic cases, chemotherapy, immunotherapy (such as monoclonal antibodies), and targeted therapies. In some cases, stem cell transplants may be considered for patients with more aggressive forms or those who do not respond to initial treatments. Given the indolent nature of follicular lymphoma, ongoing management, and regular monitoring are vital for achieving the best possible outcomes. Find out more about follicular lymphoma treatment drugs @ Drugs for Follicular Lymphoma Treatment A snapshot of the Follicular Lymphoma Pipeline Drugs mentioned in the report: Learn more about the emerging follicular lymphoma pipeline therapies @ Follicular Lymphoma Clinical Trials Follicular Lymphoma Therapeutics Assessment The follicular lymphoma pipeline report proffers an integral view of the follicular lymphoma emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Follicular Lymphoma 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: Intra-articular, Intraocular, Intrathecal, Intravenous, Oral, Parenteral, Subcutaneous, Topical, Transdermal Therapeutics Assessment By Molecule Type: Oligonucleotide, Peptide, Small molecule Therapeutics Assessment By Mechanism of Action: Phosphatidylinositol 3 kinase delta inhibitors, Phosphatidylinositol 3 kinase gamma inhibitors, Emt protein-tyrosine kinase inhibitors, Interleukin 15 receptor agonists, Histone deacetylase inhibitors, Rad51 recombinase inhibitors, Agammaglobulinaemia tyrosine kinase inhibitors, Apoptosis stimulants, Cell cycle inhibitors, Tubulin inhibitors, Tubulin polymerisation inhibitors, Enhancer of zeste homolog 2 protein inhibitors, Antibody-dependent cell cytotoxicity, Programmed cell death 1 receptor antagonists, T lymphocyte stimulants, Alkylating agents, DNA cross-linking agents Key Follicular Lymphoma Companies: Chia Tai Tianqing Pharmaceutical Group, Incyte Corporation, Mabworks, Johnson & Johnson Innovative Medicine, Nektar Therapeutics, Xynomic Pharmaceuticals, Merck Sharp & Dohme, Jiangsu HengRui Medicine Co., Ltd., ADC Therapeutics, Bristol-Myers Squibb, Swedish Orphan Biovitrum, Zhejiang DTRM Biopharma, Immpact Bio, Galapagos, Immunitas Therapeutics, Enterome, CRISPR Therapeutics, CHO Pharma, Shanghai Blueray Biopharma, BeiGene, AstraZeneca, AVM Biotechnology, Mustang Bio, Merck, Pell Bio-Med Technology, Schrodinger Inc., Sana Biotechnology, Poseida Therapeutics, OncoNano Medicine, Inc., Nurix Therapeutics, Inc., NovalGen, Pfizer, Xencor, Wellington Zhaotai Therapies, MEI Pharma, Sutro Biopharma, Synthekine, Verismo Therapeutics, Vincerx Pharma, Novartis, Century Therapeutics, Newave Pharmaceuticals, Bio-Path Holdings, Affimed GmbH, Iksuda Therapeutics, Allogene Therapeutics, Adicet Bio, Carna Biosciences, Inc., BeiGene, Boryung Pharmaceutical, Accutar Biotechnology, Atara Biotherapeutics, AbbVie, InnoCare Pharma, NeoImmuneTech, and others. Key Follicular Lymphoma Pipeline Therapies: Parsaclisib, TQ-B3525, Tafasitamab, MIL62, Ibrutinib, AZD0486, NKTR-255, Abexinostat, Acalabrutinib, Zilovertamab vedotin, SHR2554, Nivolumab, Loncastuximab tesirine, Golcadomide, Emapalumab, DTRM-555, Capivasertib, IMPT 314, GLPG5101, IMT-009, EO2463, CTX112, CHO-H01, BR1733, BGB-16673, BGB-10188, AZD5492, AVM0703, MB106, MK-1026, PL001, SGR-1505, SC291, SC262, P-CD19CD20-ALLO1, ONM 501, NX-5948, NX 2127, NVG-111, Mevrometostat, Plamotamab, WZTL-002, Voruciclib, STRO001, SYNCAR-001 + STK-009, SynKIR-310, VIP-152, VAY736, CNTY-101, LP-168, BP1002, IOA-244, IKS 03, ALLO-501, ADI-001, AS-1763, BGB-21447, BR101801, AC676, ATA3219, ABBV-319, ABBV-101, ICP-B02, ICP-B05, C-CAR039, Efineptakin Alfa, and others. Dive deep into rich insights for new drugs for follicular lymphoma treatment, visit @ Follicular Lymphoma Drugs Table of Contents For further information on the follicular lymphoma pipeline therapeutics, reach out @ Follicular Lymphoma Treatment Drugs Related Reports Follicular Lymphoma Market Follicular Lymphoma 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 follicular lymphoma companies including Epizyme, Eisai, Bayer Healthcare Pharmaceuticals, Verastem Oncology, Gilead Sciences, TG Therapeutics, Bristol-Myers-Squibb, Roche, Incyte Corporation, Bristol Myers Squibb, ADC Therapeutics, MorphoSys, Nordic Nanovector, AbbVie, Regeneron Pharmaceuticals, Janssen Research & Development, Novartis, MEI Pharma, and BeiGene, among others. Non-Hodgkin Lymphoma Market Non-Hodgkin Lymphoma Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key Non-Hodgkin lymphoma companies, including Roche, Pfizer, Amgen, Novartis, Teva Pharmaceuticals, Genentech, ACD Therapeutics, among others. Non-Hodgkin Lymphoma Pipeline Non-Hodgkin Lymphoma Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Non-Hodgkin lymphoma companies, including Novartis, AstraZeneca, Genentech, BioInvent, Genmab, SystImmune, Nordic Nanovector, Pacylex Pharmaceuticals, Artiva Biotherapeutics, Inc., Chipscreen Biosciences, Ltd., Timmune Biotech Inc., Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Gilead Sciences, Acerta Pharma BV, Adagene Inc, Conjupro Biotherapeutics, Inc., Rhizen Pharmaceuticals, Juventas Cell Therapy Ltd., Incyte Corporation, HUYA Bioscience International, SecuraBio, Genor Biopharma Co., Ltd., Kyowa Kirin Co., Ltd., Antengene Therapeutics Limited, Regeneron Pharmaceuticals, Jiangsu HengRui Medicine Co., Ltd., Xynomic Pharmaceuticals, Inc., BioTheryX, Inc., UWELL Biopharma, Kronos Bio, Bio-Thera Solutions, Spectrum Pharmaceuticals, Inc., Aptose Biosciences Inc., Miltenyi Biomedicine GmbH, Precision BioSciences, Inc., Teneobio, Inc., TCR2 Therapeutics, IGM Biosciences, Inc, among others. Diffuse Large B-cell Lymphoma Market Diffuse Large B-cell Lymphoma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key DLBCL companies, including AbbVie, Genmab, Merck, Roche, Xencor, Janssen, Denovo Biopharma, Calithera Biosciences IMV, Biogen, Autolus Therapeutics, Allogene Therapeutics, Novartis, Miltenyi Biomedicine, Regeneron Pharmaceuticals, Debiopharm, Seagen, Takeda, AstraZeneca, Gilead Sciences, 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

ImmunotherapyLicense out/inPhase 3VaccineCell Therapy

19 Nov 2024

·www.prnewswire.com

Systemic Lupus Erythematosus Clinical Trial Pipeline Gains Momentum as 120+ Key Companies at the Forefront | DelveInsight

Systemic Lupus Erythematosus (SLE) is a chronic autoimmune disease characterized by inflammation and tissue damage across multiple organ systems, such as the skin, joints, kidneys, heart, and brain. The incidence of autoimmune diseases, including SLE, has been increasing globally, with a significant impact on demand for targeted and effective therapies. LAS VEGAS, Nov. 19, 2024 /PRNewswire/ -- DelveInsight's ' Systemic Lupus Erythematosus Pipeline Insight 2024 ' report provides comprehensive global coverage of pipeline systemic lupus erythematosus therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the systemic lupus erythematosus pipeline domain. Key Takeaways from the Systemic Lupus Erythematosus Pipeline Report DelveInsight's systemic lupus erythematosus pipeline report depicts a robust space with 120+ active players working to develop 140+ pipeline therapies for systemic lupus erythematosus treatment. Key systemic lupus erythematosus companies such as Roche, ImmuPharma, UCB, Idorsia Pharmaceuticals, Biogen, AbbVie, Bristol-Myers Squibb, Vera Therapeutics, Beijing Mabworks Biotech Co., Ltd., BeiGene, Jiangsu Renocell Biotech Company, AstraZeneca, Pfizer, Red de Terapia Celular, Kira Pharmacenticals (US), LLC., Jemincare, Galapagos NV, Alumis, argenx, Gilead Sciences, Novartis, Zenas Biopharma, Horizon Therapeutics, Provention Bio, Janssen Research & Development, Eli Lilly and Company, Medsenic, Sanofi, Merck KGaA, Resolve Therapeutics, ILTOO, Janssen, Alpine Immune Sciences, Kezar Life Sciences, Neovacs, Kangpu Biopharmaceuticals, Cartesian Therapeutics, Apellis Pharmaceuticals, Inc., Alexion Pharmaceuticals, Inc., Q32 Bio Inc., Conduit Pharmaceuticals, Miltenyi Biomedicine GmbH, Kyverna Therapeutics, ImmPACT Bio, Genrix (Shanghai) Biopharmaceutical Co., Ltd., Gracell Biotechnologies (Shanghai) Co., Ltd., Cabaletta Bio, Tenet Medicines, Ascentage Pharma Group Inc., InnoCare, Eisai, Sorrento Therapeutics, Carna Bioscience, Yake Biotechnology, Equillium, Daiichi Sankyo Company, SinoMab Bioscience Ltd, Citryll BV, Sareum, Shanghai Junshi Biosciences, Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Millennium Pharmaceuticals, Inc., Takeda, Synthekine, Hangzhou Sumgen Biotech Co., Ltd., Sana Biotechnology, Hoffmann-La Roche, Guangdong Ruishun Biotech Co., Ltd, Shanghai Ming Ju Biotechnology Co., Ltd., Autolus Limited, Nkarta, Inc., Luminary Therapeutics, Kyowa Kirin Co., Ltd., Shanghai Ming Ju Biotechnology, IGM Biosciences, Inc., GlaxoSmithKline, Fate Therapeutics, Cugene Inc., Century Therapeutics, Inc., Cullinan Therapeutics Inc., Juno Therapeutics, Inc., EdiGene Inc., Atara Biotherapeutics, Annexon, Inc., Adicet Therapeutics, Bioray Laboratories, PersonGen BioTherapeutics (Suzhou) Co., Ltd., Juventas Cell Therapy Ltd., Nanjing Bioheng Biotech Co., Ltd., Pregene ShenZhen Biotechnology, Artiva Bio, KeyMed Biosciences, IASO, JW Therapeutics, ROME Therapeutics, Ventus Therapeutics, Allosite Therapeutics, iCell Gene Therapeutics, Caribou Biosciences, LongBio Pharma, Amytrx Therapeutics, Corestem, Eliem Therapeutics, SinoMab Bioscience Ltd., and others are evaluating new systemic lupus erythematosus drugs to improve the treatment landscape. Promising systemic lupus erythematosus pipeline therapies such as Obinutuzumab, Lupuzor (IPP-201101), Dapirolizumab pegol, Cenerimod, BIIB059, Upadacitinib, Deucravacitinib, Atacicept, MIL62, Zanubrutinib, RY_SW01 cell injection|Basic treatment, Ravulizumab, Rapcabtagene autoleucel, PF-06823859, Mesenchymal stem cells (MSC), KP104, JMKX000189, Iptacopan, GLPG3667, ESK-001, Elsubrutinib, Efgartigimod alfa, Edecesertib, Ianalumab, Obexelimab (XmAb5871), Daxdilimab (VIB7734), PRV-3279, Nipocalimab, ABBV 599, NKTR-358 (LY3471851), Arscimed, SAR441344, Enpatoran, RSLV-132, Aldesleukin, Daratumumab, Branebrutinib, BMS-986256, ALPN-101, KZR-616, IFNα kinoid, KPG 818, Descartes-08, CFZ533, APL-2, ALXN2050, ADX-097, AZD1656, MB-CART19.1, KYV-101, IMPT-514, GR1603, GC012F Injection, CABA-201, Budoprutug, APG-2575, ICP-022, E6742, ALPN-303, AC0058, Mosunetuzumab, AS-0871, CD19/BCMA CAR T-cells, PF-06835375, EQ001 (Itolizumab), DS-7011a, SM03, CIT-013, SDC-1801, UBP1213, TQB3702, TAK-079, TAK-007, SYNCAR-001, SG301, SC291, RO7507062, RJMty19 (CD19-CAR-DNT cells), Relma-cel, PIT565, Obecabtagene autoleucel (obe-cel), NKX019, LMY-920, KK4277, JWCAR201, Imvotamab, GSK4527363, GSK4347859, FT819, CUG252, CNTY-101, CLN-978, CC-97540, Belantamab, ATHENA CAR-T ATA3219, ANX009, ADI-001, BRL-301, T-cell injection targeting CD19 chimeric antigen receptor, CNCT19, RD06-04, PRG-2311, PRG-1801, AlloNK, CM313, CT103A, JWCAR 029, Research program: endogenous reverse transcriptase inhibitors, VENT 03, ONT01, BCMA-CD19 cCAR T cells, CB-010, LP-005, AMTX 100, CE211AT15, TN-119, SN1011, QX002N, RSLV-145, Recombinant human plasma gelsolin, LN-008, TST 008, IBL 100s, and others are under different phases of systemic lupus erythematosus clinical trials. In October 2024, the FDA approved the investigational new drug (IND) application for Cullinan Therapeutics' CLN-978 to treat systemic lupus erythematosus (SLE). In September 2024, Cartesian Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation to Descartes-08 for the treatment of juvenile dermatomyositis (JDM). In September 2024, Caribou Biosciences announced that the U.S. Food and Drug Administration (FDA) had granted fast-track designation to CAR T-cell therapy CB-010 for systemic lupus erythematosus (SLE). In September 2024, UCB and Biogen reported successful results from their Phase III clinical trial of the PHOENYCS GO study, which tested dapirolizumab pegol as a treatment for moderate-to-severe systemic lupus erythematosus. In August 2024, Conduit Pharmaceuticals announced they will be conducting a Phase IIa clinical trial to evaluate AZD1656 for the treatment of multiple autoimmune diseases, including systemic lupus erythematosus (SLE). In July 2024, the first individual received the therapy Descartes-08 to treat systemic lupus erythematosus. This therapy has been previously administered to patients with myasthenia gravis, a long-term autoimmune disorder characterized by muscle weakness. In February 2024, Idorsia Pharmaceuticals formed a major global research and development partnership with Viatris to advance and commercialize two Phase III assets, selatogrel and cenerimod, on a global scale. Request a sample and discover the recent advances in systemic lupus erythematosus treatment drugs @ Systemic Lupus Erythematosus Pipeline Report The systemic lupus erythematosus pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage systemic lupus erythematosus drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the systemic lupus erythematosus clinical trial landscape. Systemic Lupus Erythematosus Overview Systemic lupus erythematosus (SLE) is a chronic autoimmune disease in which the immune system mistakenly attacks healthy tissues in various parts of the body. The exact cause of SLE is unknown, but it is believed to result from a combination of genetic, environmental, and hormonal factors. Common triggers include infections, sunlight exposure, and certain medications. Women, particularly of childbearing age, are more commonly affected. Symptoms of SLE vary widely and can affect many organ systems, leading to a wide range of clinical presentations. Common symptoms include fatigue, joint pain, skin rashes, photosensitivity, and fever. More severe cases can affect the kidneys, heart, lungs, and central nervous system, potentially leading to life-threatening complications. Diagnosis of SLE is based on a combination of clinical features and laboratory tests. The antinuclear antibody (ANA) test is a common initial screening tool, but additional tests like anti-double stranded DNA (anti-dsDNA) and anti-Smith antibodies, as well as assessments of kidney and liver function, are often necessary. Diagnosis can be challenging because SLE symptoms often mimic those of other diseases. Treatment for SLE focuses on managing symptoms and preventing flares. Mild cases may be treated with nonsteroidal anti-inflammatory drugs (NSAIDs) and antimalarial drugs like hydroxychloroquine. More severe cases may require corticosteroids, immunosuppressive drugs such as azathioprine, methotrexate, or newer biologics like belimumab. Lifestyle modifications, such as avoiding excessive sun exposure and managing stress, are also essential in controlling the disease. Find out more about systemic lupus erythematosus treatment drugs @ Drugs for Systemic Lupus Erythematosus Treatment A snapshot of the Systemic Lupus Erythematosus Pipeline Drugs mentioned in the report: Learn more about the emerging systemic lupus erythematosus pipeline therapies @ Systemic Lupus Erythematosus Clinical Trials Systemic Lupus Erythematosus Therapeutics Assessment The systemic lupus erythematosus pipeline report proffers an integral view of the systemic lupus erythematosus emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Systemic Lupus Erythematosus 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: Intra-articular, Intraocular, Intrathecal, Intravenous, Ophthalmic, Oral, Parenteral, Subcutaneous, Topical, Transdermal Therapeutics Assessment By Molecule Type: Oligonucleotide, Peptide, Small molecule Therapeutics Assessment By Mechanism of Action: Antibody-dependent cell cytotoxicity, Cell death inhibitors, Cell death stimulants, Immunomodulators, CD40 ligand inhibitors, Sphingosine 1 phosphate receptor modulators, Calcineurin inhibitors, Immunosuppressants, Janus kinase 1 inhibitors, TYK2 kinase inhibitors, B cell activating factor inhibitors, Tumour necrosis factor ligand superfamily member 13 inhibitors Key Systemic Lupus Erythematosus Companies: Roche, ImmuPharma, UCB, Idorsia Pharmaceuticals, Biogen, AbbVie, Bristol-Myers Squibb, Vera Therapeutics, Beijing Mabworks Biotech Co., Ltd., BeiGene, Jiangsu Renocell Biotech Company, AstraZeneca, Pfizer, Red de Terapia Celular, Kira Pharmacenticals (US), LLC., Jemincare, Galapagos NV, Alumis, argenx, Gilead Sciences, Novartis, Zenas Biopharma, Horizon Therapeutics, Provention Bio, Janssen Research & Development, Eli Lilly and Company, Medsenic, Sanofi, Merck KGaA, Resolve Therapeutics, ILTOO, Janssen, Alpine Immune Sciences, Kezar Life Sciences, Neovacs, Kangpu Biopharmaceuticals, Cartesian Therapeutics, Apellis Pharmaceuticals, Inc., Alexion Pharmaceuticals, Inc., Q32 Bio Inc., Conduit Pharmaceuticals, Miltenyi Biomedicine GmbH, Kyverna Therapeutics, ImmPACT Bio, Genrix (Shanghai) Biopharmaceutical Co., Ltd., Gracell Biotechnologies (Shanghai) Co., Ltd., Cabaletta Bio, Tenet Medicines, Ascentage Pharma Group Inc., InnoCare, Eisai, Sorrento Therapeutics, Carna Bioscience, Yake Biotechnology, Equillium, Daiichi Sankyo Company, SinoMab Bioscience Ltd, Citryll BV, Sareum, Shanghai Junshi Biosciences, Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Millennium Pharmaceuticals, Inc., Takeda, Synthekine, Hangzhou Sumgen Biotech Co., Ltd., Sana Biotechnology, Hoffmann-La Roche, Guangdong Ruishun Biotech Co., Ltd, Shanghai Ming Ju Biotechnology Co., Ltd., Autolus Limited, Nkarta, Inc., Luminary Therapeutics, Kyowa Kirin Co., Ltd., Shanghai Ming Ju Biotechnology, IGM Biosciences, Inc., GlaxoSmithKline, Fate Therapeutics, Cugene Inc., Century Therapeutics, Inc., Cullinan Therapeutics Inc., Juno Therapeutics, Inc., EdiGene Inc., Atara Biotherapeutics, Annexon, Inc., Adicet Therapeutics, Bioray Laboratories, PersonGen BioTherapeutics (Suzhou) Co., Ltd., Juventas Cell Therapy Ltd., Nanjing Bioheng Biotech Co., Ltd., Pregene ShenZhen Biotechnology, Artiva Bio, KeyMed Biosciences, IASO, JW Therapeutics, ROME Therapeutics, Ventus Therapeutics, Allosite Therapeutics, iCell Gene Therapeutics, Caribou Biosciences, LongBio Pharma, Amytrx Therapeutics, Corestem, Eliem Therapeutics, SinoMab Bioscience Ltd., and others. Key Systemic Lupus Erythematosus Pipeline Therapies: Obinutuzumab, Lupuzor (IPP-201101), Dapirolizumab pegol, Cenerimod, BIIB059, Upadacitinib, Deucravacitinib, Atacicept, MIL62, Zanubrutinib, RY_SW01 cell injection|Basic treatment, Ravulizumab, Rapcabtagene autoleucel, PF-06823859, Mesenchymal stem cells (MSC), KP104, JMKX000189, Iptacopan, GLPG3667|Placebo, ESK-001, Elsubrutinib, Efgartigimod alfa, Edecesertib, Ianalumab, Obexelimab (XmAb5871), Daxdilimab (VIB7734), PRV-3279, Nipocalimab, ABBV 599, NKTR-358 (LY3471851), Arscimed, SAR441344, Enpatoran, RSLV-132, Aldesleukin, Daratumumab, Branebrutinib, BMS-986256, ALPN-101, KZR-616, IFNα kinoid, KPG 818, Descartes-08, CFZ533, APL-2, ALXN2050, ADX-097, AZD1656, MB-CART19.1, KYV-101, IMPT-514, GR1603, GC012F Injection, CABA-201, Budoprutug, APG-2575, ICP-022, E6742, ALPN-303, AC0058, Mosunetuzumab, AS-0871, CD19/BCMA CAR T-cells, PF-06835375, EQ001 (Itolizumab), DS-7011a, SM03, CIT-013, SDC-1801, UBP1213, TQB3702, TAK-079, TAK-007, SYNCAR-001, SG301, SC291, RO7507062, RJMty19 (CD19-CAR-DNT cells), Relma-cel, PIT565, Obecabtagene autoleucel (obe-cel), NKX019, LMY-920, KK4277, JWCAR201, Imvotamab, GSK4527363, GSK4347859, FT819, CUG252, CNTY-101, CLN-978, CC-97540, Belantamab, ATHENA CAR-T ATA3219, ANX009, ADI-001, BRL-301, T-cell injection targeting CD19 chimeric antigen receptor, CNCT19, RD06-04, PRG-2311, PRG-1801, AlloNK, CM313, CT103A, JWCAR 029, Research program: endogenous reverse transcriptase inhibitors, VENT 03, ONT01, BCMA-CD19 cCAR T cells, CB-010, LP-005, AMTX 100, CE211AT15, TN-119, SN1011, QX002N, RSLV-145, Recombinant human plasma gelsolin, LN-008, TST 008, IBL 100s, and others. Dive deep into rich insights for new drugs for systemic lupus erythematosus treatment, visit @ Systemic Lupus Erythematosus Drugs Table of Contents For further information on the systemic lupus erythematosus pipeline therapeutics, reach out @ Systemic Lupus Erythematosus Treatment Drugs Related Reports Systemic Lupus Erythematosus Market Systemic Lupus Erythematosus 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 SLE companies including Biogen, Novartis, MorphoSys, Idorsia Pharmaceuticals, Viatris, RemeGen, UCB Pharma, Genentech, Bristol Myers Squibb, AbbVie, among others. Systemic Lupus Erythematosus Epidemiology Systemic Lupus Erythematosus Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical, and forecasted SLE epidemiology in the 7MM. Lupus Nephritis Market Lupus Nephritis 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 lupus nephritis companies, including NOVARTIS, MORPHOSYS, ASTRAZENECA, ROCHE, KEZAR LIFE SCIENCES, ALEXION PHARMACEUTICALS, NOVARTIS, CABALETTA BIO, among others. Lupus Nephritis Pipeline Lupus Nephritis Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key lupus nephritis companies, including Inflection Biosciences, Equillium, Roche, Horizon Therapeutics, BeiGene, Janssen Research & Development, ImmPACT Bio, 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

Phase 3Phase 2Fast TrackCell Therapy

100 Deals associated with Recombinant humanized monoclonal antibody MIL62 (Beijing InnoCare)

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Indication	Highest Phase	Country/Location	Organization	Date
Idiopathic Membranous Glomerulonephritis	Phase 3	CN	Beijing Mabworks Biotech Co., Ltd.	02 Jun 2023
Systemic Lupus Erythematosus	Phase 3	CN	Beijing Mabworks Biotech Co., Ltd.	26 May 2023
Neuromyelitis Optica	Phase 3	CN	Beijing Mabworks Biotech Co., Ltd.	18 Aug 2022
Refractory Follicular Lymphoma	Phase 3	CN	Beijing Mabworks Biotech Co., Ltd.	02 Jun 2021
Refractory Marginal Zone Lymphoma	Phase 3	CN	Beijing Mabworks Biotech Co., Ltd.	02 Jun 2021
Lupus Nephritis	Phase 2	CN	Beijing Mabworks Biotech Co., Ltd.	26 Nov 2021
Myasthenia Gravis	Phase 2	CN	Beijing Mabworks Biotech Co., Ltd.	27 Sep 2021
B-cell lymphoma recurrent	Phase 2	CN	Beijing InnoCare Pharma Tech Co., Ltd.	28 Jul 2020
B-cell lymphoma refractory	Phase 2	CN	Beijing InnoCare Pharma Tech Co., Ltd.	28 Jul 2020
CD20 positive B-Cell Lymphoma	Phase 2	CN	Beijing InnoCare Pharma Tech Co., Ltd.	28 Jul 2020

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05398653 (NEWS) Manual	Phase 1/2	Glomerulonephritis, Membranous	-	MIL62	wptlmptkqp(yhmqodzqkg) = ejmkzqfyym echhrtgyvn (ynxmotumqg ) View more	Positive	23 Oct 2024
NCT05398653 (NEWS) Manual	Phase 1/2	Glomerulonephritis, Membranous	-	Cyclosporine	wptlmptkqp(yhmqodzqkg) = cwhgflhmnz echhrtgyvn (ynxmotumqg ) View more	Positive	23 Oct 2024
NCT04110301 (Pubmed) Manual	Phase 1/2	Follicular Lymphoma \| Marginal Zone B-Cell Lymphoma CD20 Positive	50	MIL62 + Lenalidomide	ufylmhgpyq(xyzuekfcdk) = avtzveamot xxcsngjden (qfupksmvjd, 73 - 94) View more	Positive	01 Jul 2024
NCT04304040 (ASH2022) Manual	Phase 1/2	B-cell lymphoma refractory	43	Orelabrutinib+MIL62	vmaoakzjky(fdyfjcehzw) = bfkzzckxcn cmbbxnqdsk (yhegveszrj ) View more	Positive	12 Dec 2022
CSCO2022	Phase 1/2	B-Cell Lymphoma	43	MIL62 注射液	dszlqngswx(exhxerxcxb) = MIL62输液反应发生率为11.6%, 均为 1-2级 aetogdstke (wdrmuygibr ) View more	-	21 Sep 2022
NCT04110301 (ASH 12021 \| ASH 22021) Manual	Phase 1/2	Refractory Follicular Lymphoma \| Marginal Zone B-Cell Lymphoma	54	Lenalidomide+MIL62	xddzmwpexq(ligejteppg) = vaqsqvpktn byeymmwdoi (jqgtchblxr ) View more	Positive	05 Nov 2021
NCT04110301 (ASH 12021 \| ASH 22021) Manual	Phase 1/2		54	refractory to rituximab	xddzmwpexq(ligejteppg) = gnpujnylfd byeymmwdoi (jqgtchblxr ) View more	Positive	05 Nov 2021
NCT04304040 (ESMO 12021 \| ESMO 22021) Manual	Phase 1/2	B-cell lymphoma refractory CD20 Positive	14	Orelabrutinib+MIL62	auqrlzwnwi(sciwlojlcg) = thrombocytopenia (5/14, 35.7%), infusion-related reaction (3/14, 21.4%) and hyperuricemia (3/14, 21.4%) opgzuypght (kszawtiaue )	Positive	16 Sep 2021
NCT04103905 (ESMO2020)	Phase 1	CD20 Positive B-Cell Non-Hodgkin Lymphoma	27	MIL62	voaursarhg(noxefpfqvr) = grade 1 infusion-related reaction was observed and experienced with 4 patients zksqwwzhvx (xpuhyrvddd ) View more	Positive	17 Sep 2020

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