APRIL inhibitors(Tumor necrosis factor ligand superfamily member 13 inhibitors), BAFF inhibitors(B-cell-activating factor/B lymphocyte stimulator inhibitors), Immunomodulators

Therapeutic Areas

Immune System DiseasesSkin and Musculoskeletal DiseasesNeoplasms+ [6]

Active Indication

Rheumatoid ArthritisSystemic Lupus ErythematosusMyasthenia Gravis+ [9]

Inactive Indication-

Originator Organization

RemeGen Co., Ltd.

Active Organization

RemeGen Co., Ltd.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

China (09 Mar 2021),

Systemic Lupus Erythematosus

RegulationFast Track (United States), Orphan Drug (United States), Priority Review (China), Breakthrough Therapy (China), Conditional marketing approval (China)

Structure/Sequence

Sequence Code 616721115

Source: *****

Clinical Trials associated with Telitacicept

NCT06827587

/ Not yet recruitingNot ApplicableIIT

Efficacy, Safety, and PKPD Study of Efgartigimod Sequential Therapy with Telitacicept in Generalized Myasthenia Gravis (gMG): an Open-label, Randomized Controlled Trial

Title: The Efficacy, Safety, and PK/PD of Efgartigimod Followed by Telitacicept in Generalized Myasthenia Gravis: Protocol of a Randomized Controlled Trial Objective: This study aims to evaluate the efficacy, safety, and pharmacokinetics/pharmacodynamics (PK/PD) of efgartigimod followed by telitacicept in patients with generalized myasthenia gravis (gMG). Specifically, the trial seeks to determine the optimal treatment strategy for gMG by assessing the effect of sequential biologic therapy on disease management.
Study Design: This is a multi-center, open-label, randomized controlled trial involving 60 acetylcholine receptor antibody-positive gMG patients.

Start Date01 Feb 2025

Sponsor / Collaborator

The First Affiliated Hospital of Wenzhou Medical College

[+3]

NCT06375005

/ RecruitingPhase 2IIT

The Efficacy and Safety of Telitacicept in the Treatment of Early Diffuse Cutaneous Systemic Sclerosis: a Multicenter, Open-label, Randomized Controlled Study

This study is a prospective, open-label, randomized, controlled, multi-center clinical trial. The aim of this study is to investigate the efficacy and safety of Telitacicept in adults with early diffuse cutaneous systemic sclerosis (dcSSc), with Mycophenolate Mofetil (MMF) administered as a background treatment.

Start Date06 Jan 2025

Sponsor / Collaborator

Second Affiliated Hospital Zhejiang University College of

NCT06654596

/ RecruitingNot ApplicableIIT

A Multicenter, Randomized, Controlled Clinical Study on the Efficacy and Safety of Telitacicept in Patients with IgA Nephropathy

A study to evaluate efficacy and safety of telitacicept in the treatment of patients with primary IgA nephropathy at high risk of progression.

Start Date06 Dec 2024

Sponsor / Collaborator

Shanghai Changzheng Hospital

[+4]

100 Clinical Results associated with Telitacicept

100 Translational Medicine associated with Telitacicept

100 Patents (Medical) associated with Telitacicept

100

Literatures (Medical) associated with Telitacicept

31 Dec 2025·RENAL FAILURE

Efficacy and safety of telitacicept in IgA nephropathy: a real-world study

Article

Author: Qin, Wei ; Tan, Jiaxing ; Tang, Yi ; Wang, Siqing ; Qin, Aiya ; Yang, Dandan ; Dong, Lingqiu

BACKGROUND:

IgA nephropathy (IgAN) is the most common primary glomerular disease in the world, and specific therapeutic methods for IgAN are limited. Telitacicept is a humanized fusion protein composed of a transmembrane activator and calcium-modulating cyclophilin ligand interactor receptor and human IgG.

AIM:

To evaluate the efficacy and safety of telitacicept in adult patients with IgAN in a real-world study.

METHODS:

Biopsy-proven IgAN patients with 24-hour proteinuria greater than 0.5 g/d who received 240 mg telitacicept weekly were recruited for this study and 1:1:1 matched with patients who received supportive treatment only or immunosuppressive treatment by propensity score matching. The primary outcome was the change from baseline in 24-hour proteinuria over the 3-month follow-up.

RESULTS:

Twenty-one patients in each group were enrolled. Telitacicept reduced median proteinuria by 0.72 g/d (54.6%) from baseline, compared with a reduction of 0.18 g/d (20%) in the supportive treatment group and 1.12 g/d (72.1%) in the immunosuppressive treatment group. Preserved eGFR levels were observed in the telitacicept group, whereas eGFR levels decreased in the other two groups. No serious adverse events were observed in the telitacicept treatment group.

CONCLUSION:

Telitacicept may be an effective treatment for IgAN patients by reducing proteinuria and preserving eGFR, and showed a favorable safety profile.

01 May 2025·CLINICAL NEUROLOGY AND NEUROSURGERY

Effective treatment of immune mediated peripheral neuropathy with Ofatumumab - A case report

Article

Author: Hao, Yong ; Zhang, Ying ; Guan, Yangtai ; Yao, Xiaoying ; Jiang, Xianguo ; Zhu, Desheng ; Gao, Meichun ; Zhou, Xiajun ; Ding, Jie ; Lin, Yan

Recurrent immune-mediated peripheral neuropathy is a rare immune disorder that presents significant therapeutic challenges. Ofatumumab (OFA) is a fully humanized anti-CD20 monoclonal antibody with low immunogenicity. We report a patient with recurrent immune-mediated peripheral neuropathy who achieved sustained remission following OFA treatment after multiple relapses. Over a two-year period, the patient experienced over 20 episodes of bilateral upper and lower limb weakness. Furthermore, the patient was unresponsive to intravenous immunoglobulin, plasma exchange, corticosteroids, mycophenolate mofetil, and Telitacicept. Subcutaneous OFA administration resulted in marked reductions in CD19⁺ and CD20⁺ B-cell counts and a relapse-free period exceeding 20 months, with no adverse events observed. This case provides early evidence supporting OFA as a safe and effective alternative for recurrent immune-mediated peripheral neuropathy.

01 May 2025·INTERNATIONAL IMMUNOPHARMACOLOGY

Efficacy and safety of telitacicept in patients with class III–V lupus nephritis: A real-world retrospective cohort study

Article

Author: Teng, Yuwen ; Ma, Qiuling ; Dong, Wenbo ; Chen, Lin ; Wang, Ruiqiang ; Liu, Wenqing

OBJECTIVES:

This retrospective cohort study evaluated the efficacy and safety of telitacicept combined with standard therapy in class III-V lupus nephritis (LN).

METHODS:

We enrolled 146 patients with lupus nephritis confirmed by renal biopsy. Among them, 73 patients received treatment with telitacicept in combination with the standard therapy regimen, while the remainder were treated with the standard therapy alone. This analysis included class III/IV ± V or class V LN. Efficacy endpoints included cumulative complete renal response (CRR, 24hUTP < 0.5 g with stable renal function) and partial renal response (PRR, 50 % reduction in 24hUTP from baseline) at 6 months, 1 year, and the end of follow-up. Multivariate regression was used to assess baseline predictors of CRR. Safety was also evaluated.

RESULTS:

Compared with the control group, telitacicept showed remarkable efficacy in improving disease activity indicators such as serum albumin (ALB), complement levels, and 24-h urinary total protein (24hUTP), with a significant reduction in antibody positivity rates and immunoglobulin levels, alongside an improvement in anemia. By 6 months, the CRR rate in the telitacicept group reached 64.4 % (64.4 % vs 45.2 %, P = 0.020). At 1 year, the cumulative CRR was significantly higher in the telitacicept group compared to the control group (80.8 % vs 61.6 %; P = 0.010). During follow-up, the time to achieve CRR was significantly earlier in the telitacicept group (median 4.0 months, 95 %CI, 2.71-5.29) than in the control group (median 9.0 months, 95 %CI, 5.25-12.75) (LogRank P = 0.006). Moreover, subgroup analyses indicated better efficacy of telitacicept in patients with positive dsDNA antibodies (OR, 1.70, 95 %CI, 1.20-2.40, P for interaction = 0.031). Telitacicept dose reduction did not increase disease activity. Multivariate analysis showed that the use of telitacicept was a favorable factor for achieving CRR, and other predictors included BMI, eGFR, and 24hUTP. Compared with the standard treatment group, the risk of adverse renal outcome events in the telitacicept group was reduced by 53 %. The incidence of adverse events was similar between the two groups.

CONCLUSIONS:

This real-event study confirmed that the addition of telitacicept to standard therapy significantly boosted clinical remission rates and improved prognosis in patients with LN. It was also found that telitacicept may be more likely to achieve CRR in dsDNA antibody-positive patients. At baseline, the use of telitacicept, lower BMI and 24hUTP levels, and higher eGFR levels were associated with a greater likelihood of achieving CRR. In addition, for patients who achieve CRR and SLEDAI score ≤ 6, we advocate dose reduction of telitacicept after 6 months of treatment.

News (Medical) associated with Telitacicept

09 Apr 2025

·www.prnewswire.com

Remegen Announces Exciting Results of Telitacicept Phase 3 Clinical Trial for Patients with Generalized Myasthenia Gravis

YANTAI, China, April 8, 2025 /PRNewswire/ -- On April 8, 2025 (UTC-7), impressive results of the Phase 3 clinical trial (NCT05737160) evaluating the efficacy and safety of Telitacicept (synonym: RC18; brand name: 泰爱®) in patients with generalized myasthenia gravis (gMG) were presented during the Late-Breaking Science Session at the American Academy of Neurology (AAN) Annual Meeting 2025 in San Diego, CA. According to the presented data, among the participants in the Telitacicept 240 mg group, 98.1% of the patients demonstrated a ≥ 3-point reduction in Myasthenia Gravis Activities of Daily Living (MG-ADL) score and 87% of the patients demonstrated a ≥ 5-point reduction in Quantitative Myasthenia Gravis (QMG) score at Week 24. With the highest MG-ADL response rate among all drugs for gMG with phase 3 studies reported to date, Telitacicept will provide an important new treatment option gMG. Telitacicept is a novel fusion protein targeting both BlyS and APRIL independently designed and developed by RemeGen Co.,Ltd. ("RemeGen"). The multicenter, randomized, double-blind, placebo-controlled phase 3 clinical trial was conducted in China (NCT05737160) and led by Professor Jian Yin of Beijing Hospital. A total of 114 gMG patients with baseline MG-ADL score ≥6 and QMG score ≥8 were enrolled in the study, with 57 patients in the Telitacicept 240 mg group and the placebo group respectively. The study consisted of a 24-week double-blind treatment stage and an open-label treatment stage. The presented results herein were from the double-blind treatment study. The data showed that ‌Telitacicept‌ achieved ‌sustained and significant improvement‌ in clinical outcomes for patients with gMG, ‌with a favorable safety profile： Telitacicept demonstrated significant improvements‌ in MG-ADL and QMG scores after 4 weeks' treatment compared to placebo. At Week 24, change in MG-ADL was -5.74 and -0.91 with Telitacicept and placebo group, respectively. 98.1% and 12.0% of Telitacicept and placebo group patients had ≥3-point reduction in MG-ADL, respectively. The MG-ADL scale quantifies the impact of MG symptoms on daily life quality, focusing on patients' subjective experience and daily function. These data showed that patients treated with Telitacicept achieved ‌clinically meaningful improvement‌‌. At Week 24, change in QMG was -8.66 and -2.27 with Telitacicept and placebo group, respectively. 87.0% and 16.0% of Telitacicept and placebo group patients had ≥ 5-point reduction in QMG, respectively. The QMG score assesses the strength and endurance of the whole body muscle group, focusing on objective measurement. These data demonstrated that patients treated with Telitacicept‌ achieved ‌clinically meaningful reductions in disease severity. There is a strong correlation between MG-ADL and QMG in evaluating treatment response, and the combination of MG-ADL and QMG can comprehensively reflect the disease severity. Sustained improvement: MG-ADL and QMG scores continued to decline over time in the Telitacicept group, with peak improvement at the last reported observation, Week 24. Telitacicept was well tolerated during the treatment, with an overall adverse event (AE) incidence similar to that in the placebo group and an incidence of infection-related AEs lower than that in the placebo group (45.6% vs. 59.6%). The principal investigator Prof. Yin Jian of Beijing Hospital said "Telitacicept demonstrated rapid and significant clinical improvement in the phase 3 trial, and was well tolerated. Its dual-targeting mechanism not only inhibits abnormal B cells and plasma cells thoroughly and reduces the level of pathogenic antibodies, but also effectively slows down disease progression in the long term, and reduces steroid dosage as symptoms improve, providing a more precise, efficient, persistent, and safer option for gMG treatment." Dr. Jianmin Fang, CEO of RemeGen, said "The phase 3 data of Telitacicept for MG is clinically meaningful. There is a large unmet medical need in MG because the disease presents significant threat to patients' health and life-span. This breakthrough means that we have an new, effective treatment for MG as Telitacicept can significantly improve patients' symptoms and bring long term benefits to MG patients. We look forward to working with global experts and scholars to overcome more complex autoimmune diseases and benefit more patients." MG is an autoimmune disease caused by neuromuscular junction transmission disorders. It is characterized by fatigue and fluctuations in symptoms, long treatment cycles and high recurrence rate. More than 85% of patients develop to gMG within 24 months of onset. According to Frost & Sullivan report, there are about 1.2 million MG patients worldwide, including about 220,000 patients in China. At present, there is a great unmet medical demand. The newly disclosed "best-in-class" data mark a breakthrough achievement of Chinese innovative drugs in the field of neuroimmunology. Currently, the BLA of Telitacicept for the treatment of gMG has been accepted by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration, and it is expected to be approved in China in the second quarter of this year. Meanwhile, RemeGen is advancing a global multicenter Phase 3 trial of Telitacicept for the treatment of gMG, aiming to validate the efficacy and safety of Telitacicept in a wider patient population, and to provide a superior treatment option for gMG patients worldwide. SOURCE RemeGen Co., Ltd WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Clinical ResultDrug ApprovalPhase 2

08 Apr 2025

·www.prnewswire.com

Johnson & Johnson highlights new data that showcase the strength of nipocalimab, demonstrating long-term sustained disease control in adults living with generalized myasthenia gravis (gMG)

New compelling results demonstrate 18 months of both sustained reduction in immunoglobulin G antibodies and sustained improvement in gMG symptoms in pivotal Vivacity-MG3 study and open-label extension phase Up to 128 weeks and 180 patient years of follow-up in the open-label extensiona confirm a safety profile consistent with the Phase 3 Vivacity-MG3 study 45% of the patients receiving steroids at open-label extension baseline were able to decrease or discontinue their steroid use Additionally, the nipocalimab plus standard of care (SOC) group demonstrated four times greater odds of improving and maintaining the strength and function of different muscle groups as measured by QMGb response versus placebo plus SOC in the 24-week double blind phase of the study SPRING HOUSE, Pa., April 8, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced results from additional analyses of the Phase 3 Vivacity-MG3 double-blind study and the ongoing open-label extensiona (OLE), evaluating the long-term efficacy and safety of investigational nipocalimab in a broad population of antibody-positive (anti-AChR+, anti-MuSK+, anti-LRP4+) adults with generalized myasthenia gravis (gMG).1,2 Patients treated with nipocalimab plus standard of care (SOC) maintained improvements in their MG-ADLc and QMGb scores over 84 weeks with sustained reductions in total immunoglobulin G (IgG).1 These data are included in a presentation (Session 7 #022) and are among 12 abstracts that Johnson & Johnson will present at the American Academy of Neurology (AAN) 2025 Meeting in San Diego, California, which includes an oral presentation on QMG score improvements from the double-blind phase of the Phase 3 Vivacity-MG3 study. "The sustained disease control seen over 84 weeks for nipocalimab is a key result given the chronic course of generalized MG and the significant burden on people living with this condition," said Constantine Farmakidis M.D., Associate Professor of Neurology at University of Kansas Medical Centerd. "Overall, I am encouraged by these results that show improvement in disease control as measured by the MG-ADL and QMG scores across a broad population seropositive for AChR, MuSK, or LRP4 autoantibodies." Nipocalimab demonstrated a mean change in MG-ADL of -5.64 (p<0.001) from the double-blind baseline after 60 weeks in the OLE for study participants receiving nipocalimab and SOC, and -6.01 (p<0.001) mean change for study participants who transitioned from placebo and SOC to nipocalimab and SOC.1 In the antibody-positive population, 45% of patients receiving steroids at the OLE baseline were able to decrease or discontinue steroids at the time of this data cut by more than half of the baseline dose.1 Among these patients, the mean dose of prednisone decreased from 23 to 10 mg per day.1 Nipocalimab had a consistent and tolerable safety profile throughout the OLE phase.1 Additional findings from the Phase 3 Vivacity-MG3 double-blind study indicate that patients treated with nipocalimab plus SOC achieved statistically significant improvements in their QMG score by -4.9 versus placebo plus SOC (p<0.001) over weeks 22 and 24.2 Patients in the nipocalimab plus SOC treatment group were four times more likely to sustain symptom improvement at 20 weeks compared to the placebo plus SOC group, as measured by a three or greater point improvement on the QMG score.2 Results show significantly more patients treated with nipocalimab (36.4%,) versus placebo (10.5%, p<0.001) spent greater than 75% of study duration demonstrating improvements in the QMG score.2 A reduction of more than three points in the QMG score indicates a decrease in the severity of the patient's symptoms as a result of improvements in muscle strength, allowing patients to carry out important daily activities such as swallowing and chewing.3,4 "People living with generalized MG around the world endure daily challenges, such as difficulties swallowing, impaired speech and muscle weakness. They deserve additional, effective treatment options that help address these challenges and provide sustained disease control and stability over time," said Katie Abouzahr, M.D., Vice President, Autoantibody Portfolio and Maternal Fetal Immunology Disease Area Leader, Johnson & Johnson Innovative Medicine. "These positive data underscore our commitment to helping develop potential innovative therapeutic options for patients living with autoantibody diseases, including gMG." Editor's notes: ABOUT GENERALIZED MYASTHENIA GRAVIS (gMG) Myasthenia gravis (MG) is an autoantibody disease in which the immune system mistakenly makes antibodies (e.g., anti-acetylcholine receptor [AChR], anti-muscle-specific tyrosine kinase [MuSK] or anti-low density lipoprotein-related protein 4 [LRP4]), which target proteins at the neuromuscular junction, and can block or disrupt normal signaling from nerves to muscles, thus impairing or preventing muscle contraction.5,6,7 The disease impacts an estimated 700,000 people worldwide.5 The disease affects both men and women and occurs across all ages, racial and ethnic groups, but most frequently starts in young women and older men.8 Roughly 50 percent of individuals diagnosed with MG are women, and about one in five of those women are of child-bearing potential.9,10,11 Approximately 10 to 15% of new cases of MG are diagnosed in adolescents (12 – 17 years of age).12,13,14 Among juvenile MG patients, girls are affected more often than boys with over 65% of pediatric MG cases in the U.S. diagnosed in girls.15,16,17 Initial disease manifestations are usually ocular, but 85 percent of MG patients experience additional advancements to the disease manifestations – referred to as generalized myasthenia gravis (gMG). This is characterized by severe muscle weakness of the skeletal muscles and difficulties in speech and swallowing.18,19,20,21,22 Approximately 100,000 individuals in the U.S. are living with gMG.23 Vulnerable gMG populations, such as pediatric patients, have more limited therapeutic options.24 Currently, SOC treatments for adolescents with gMG are extrapolated from adult trials.14 Other than symptomatic treatments, there are no approved FcRn blockers for adolescents with gMG in the United States.14 ABOUT THE PHASE 3 VIVACITY-MG3 STUDY The Phase 3 Vivacity-MG3 study (NCT04951622) was specifically designed to measure sustained efficacy and safety with consistent dosing in this unpredictable chronic condition where unmet need remains high. Antibody positive or negative adult gMG patients with insufficient response (MG-ADL ≥6) to ongoing SOC therapy were identified and 199 patients, 153 of whom were antibody positive, enrolled in the 24-week double-blind placebo-controlled trial.25,26 Randomization was 1:1, nipocalimab plus current SOC (30 mg/kg IV loading dose followed by 15 mg/kg every two weeks) or placebo plus current SOC.25 Baseline demographics were balanced across arms (77 nipocalimab, 76 placebo).25 The primary endpoint of the study was mean change in MG-ADLb score from baseline over Weeks 22, 23 and 24 in antibody positive patients. A key secondary endpoint included change in QMG score. Long-term safety and efficacy were further assessed in an ongoing open-label extension (OLE) phase.26 ABOUT NIPOCALIMAB Nipocalimab is an investigational monoclonal antibody, designed to bind with high affinity to block FcRn and reduce levels of circulating immunoglobulin G (IgG) antibodies potentially without impact on other immune functions. This includes autoantibodies and alloantibodies that underlie multiple conditions across three key segments in the autoantibody space including Rare Autoantibody diseases, Maternal Fetal diseases mediated by maternal alloantibodies and Rheumatic diseases.26,27,28,29,30,31,32,33,34 Blockade of IgG binding to FcRn in the placenta is also believed to limit transplacental transfer of maternal alloantibodies to the fetus.35,36 The U.S. FDA and EMA have granted several key designations to nipocalimab including: U.S. FDA Fast Track designation in hemolytic disease of the fetus and newborn (HDFN) and warm autoimmune hemolytic anemia (wAIHA) in July 2019, gMG in December 2021 and fetal neonatal alloimmune thrombocytopenia (FNAIT) in March 2024 and Sjögren's disease (SjD) in March 2025 U.S. FDA Orphan drug status for wAIHA in December 2019, HDFN in June 2020, gMG in February 2021, chronic inflammatory demyelinating polyneuropathy (CIDP) in October 2021 and FNAIT in December 2023 U.S. FDA Breakthrough Therapy designation for HDFN in February 2024 and for Sjögren's disease in November 2024 U.S. FDA granted Priority Review in gMG in Q4 2024 EU EMA Orphan medicinal product designation for HDFN in October 2019 ABOUT JOHNSON & JOHNSON At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at or at Follow us at @JNJInnovMed. Janssen Research & Development, LLC and Janssen Biotech, Inc. are Johnson & Johnson companies. CAUTIONS CONCERNING FORWARD-LOOKING STATEMENTS This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of nipocalimab. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, Janssen Biotech, Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at , or on request from Johnson & Johnson. None of Janssen Research & Development, LLC, Janssen Biotech, Inc. nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments. 1 Antozzi, C et al., Long-Term Safety and Efficacy of Nipocalimab in Generalized Myasthenia Gravis: Vivacity-MG3 Open-Label Extension Phase Results. Abstract #022 for poster presentation at 2025 American Academy of Neurology Congress. April 2025. 2 Nowak R et al., Efficacy of Nipocalimab, a Novel Neonatal Fragment Crystallizable Receptor Blocker, as Measured using Quantitative Myasthenia Gravis Assessment: Findings from the Phase 3 Placebo-Controlled Vivacity-MG3 Study. Abstract #001 for oral presentation at 2025 American Academy of Neurology Congress. April 2025. 3 Wolfe GI Myasthenia gravis activities of daily living profile. Neurology. 1999;22;52(7):1487-9. doi: 10.1212/wnl.52.7.1487. 4 Yin J, et al. A multicenter, randomized, open-label, phase 2 clinical study of telitacicept in adult patients with generalized myasthenia gravis. Eur J Neurol. 2024 Aug;31(8):e16322. doi: 10.1111/ene.16322. 5 Chen J, Tian D-C, Zhang C, et al. Incidence, mortality, and economic burden of myasthenia gravis in China: A nationwide population-based study. The Lancet Regional Health - Western Pacific. 2020;5(100063). . 6 Bacci ED et al. Understanding side effects of therapy for myasthenia gravis and their impact on daily life. BMC Neurol. 2019;19(1):335. 7 Wiendl, H., et al., Guideline for the management of myasthenic syndromes. Therapeutic advances in neurological disorders, 16, 17562864231213240. . Last accessed: April 2025. 8 Bubuioc A, et al. The epidemiology of myasthenia gravis. Journal of Medicine & Life (2021). Jan-Mar;14(1):7-16. doi: 10.25122/jml-2020-0145. 9 Ye, Yun et al. Epidemiology of myasthenia gravis in the United States. Frontiers in neurology vol. 15 1339167. 16 Feb. 2024, doi:10.3389/fneur.2024.1339167. 10 Dresser, Laura et al. Myasthenia Gravis: Epidemiology, Pathophysiology and Clinical Manifestations. Journal of clinical medicine vol. 10,11 2235. 21 May. 2021, doi:10.3390/jcm10112235. 11 J&J. Data on file. 12 Evoli A, Batocchi AP, Bartoccioni E, Lino MM, Minisci C, Tonali P. Juvenile myasthenia gravis with prepubertal onset. Neuromuscul Disord. 1998 Dec;8(8):561-7. doi: 10.1016/s0960-8966(98)00077-7. 13 Evoli A. Acquired myasthenia gravis in childhood. Curr Opin Neurol. 2010 Oct;23(5):536-40. doi: 10.1097/WCO.0b013e32833c32af. 14 Finnis MF, Jayawant S. Juvenile myasthenia gravis: a paediatric perspective. Autoimmune Dis. 2011;2011:404101. doi: 10.4061/2011/404101. 15 Haliloglu G, Anlar B, Aysun S, Topcu M, Topaloglu H, Turanli G, Yalnizoglu D. Gender prevalence in childhood multiple sclerosis and myasthenia gravis. J Child Neurol. 2002 May;17(5):390-2. doi: 10.1177/088307380201700516. 16 Parr JR, Andrew MJ, Finnis M, Beeson D, Vincent A, Jayawant S. How common is childhood myasthenia? The UK incidence and prevalence of autoimmune and congenital myasthenia. Arch Dis Child. 2014 Jun;99(6):539-42. doi: 10.1136/archdischild-2013-304788. 17 Mansukhani SA, Bothun ED, Diehl NN, Mohney BG. Incidence and Ocular Features of Pediatric Myasthenias. Am J Ophthalmol. 2019 Apr;200:242-249. doi: 10.1016/j.ajo.2019.01.004. 18 National Institute of Neurological Disorders and Stoke. Myasthenia Gravis. Available at: . Last accessed: April 2025. 19 Bever, C.T., Jr, Aquino, A.V., Penn, A.S., Lovelace, R.E. and Rowland, L.P. (1983), Prognosis of ocular myasthenia. Ann Neurol., 14: 516-519. . 20 Kupersmith MJ, Latkany R, Homel P. Development of generalized disease at 2 years in patients with ocular myasthenia gravis. Arch Neurol. 2003 Feb;60(2):243-8. doi: 10.1001/archneur.60.2.243. PMID: 12580710. 21 Myasthenia gravis fact sheet. Retrieved April 2024 from . 22 Myasthenia Gravis: Treatment & Symptoms. (2021, April 7). Retrieved April 2024 from . 23 DRG EPI (2021) & Optum Claims Analysis Jan 2012-December 2020. 24 O'Connell K, Ramdas S, Palace J. Management of Juvenile Myasthenia Gravis. Front Neurol. 2020 Jul 24;11:743. doi: 10.3389/fneur.2020.00743. PMID: 32793107; PMCID: PMC7393473. 25 Antozzi, C et al., Nipocalimab in Generalized Myasthenia Gravis: Results from a Double-Blind, Placebo-Controlled, Randomized Phase 3 Study. Abstract at 2024 European Academy of Neurology Congress. June 2024. 26 ClinicalTrials.gov Identifier: NCT04951622. Available at: . Last accessed: April 2025. 27 ClinicalTrials.gov. NCT03842189. Available at: . Last accessed: April 2025. 28 ClinicalTrials.gov Identifier: NCT05327114. Available at: . Last accessed: April 2025. 29 ClinicalTrials.gov Identifier: NCT04119050. Available at: . Last accessed: April 2025. 30 ClinicalTrials.gov Identifier: NCT05379634. Available at: . Last accessed: April 2025. 31 ClinicalTrials.gov Identifier: NCT05912517. Available at: . Last accessed: April 2025. 32 ClinicalTrials.gov Identifier: NCT06028438. Available at: . Last accessed: April 2025. 33 ClinicalTrials.gov Identifier: NCT04968912. Available at: . Last accessed: April 2025. 34 ClinicalTrials.gov Identifier: NCT04882878. Available at: . Last accessed: April 2025. 35 Lobato G, Soncini CS. Relationship between obstetric history and Rh(D) alloimmunization severity. Arch Gynecol Obstet. 2008 Mar;277(3):245-8. DOI: 10.1007/s00404-007-0446-x. 36 Roy S, Nanovskaya T, Patrikeeva S, et al. M281, an anti-FcRn antibody, inhibits IgG transfer in a human ex vivo placental perfusion model. Am J Obstet Gynecol. 2019;220(5):498 e491-498 e499. SOURCE Johnson & Johnson 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 3Breakthrough TherapyFast Track

03 Dec 2024

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Lupus Nephritis Clinical Trial Pipeline Experiences Momentum: DelveInsight Estimates a Diverse Pipeline Comprising 30+ Companies Working in the Domain

The lupus nephritis market is poised for growth, driven by rising disease prevalence, advancements in therapeutics such as biologics and targeted therapies, and increased investment in R&D. Heightened awareness and robust support from governments and key industry players further create a dynamic environment for innovation and better patient outcomes. LAS VEGAS, Dec. 3, 2024 /PRNewswire/ -- DelveInsight's ' Lupus Nephritis Pipeline Insight 2024 ' report provides comprehensive global coverage of pipeline lupus nephritis therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the lupus nephritis pipeline domain. Key Takeaways from the Lupus Nephritis Pipeline Report DelveInsight's lupus nephritis pipeline report depicts a robust space with 30+ active players working to develop 35+ pipeline therapies for lupus nephritis treatment. Key lupus nephritis companies such as AstraZeneca, Hoffmann-La Roche, Novartis, Qilu Pharmaceutical, Vera Therapeutics, Conduit Pharmaceuticals, Amgen, Johnson & Johnson, BeiGene, RemeGen, Argenx, Kyverna Therapeutics, Cabaletta Bio, ImmPACT Bio, Alpine Immune Sciences, AlloSite Therapeutics, iCell Gene Therapeutics, Caribou Biosciences, Adicet Bio, Shenzhen Pregene Biopharma Co., Ltd., Resolve Therapeutics, BioAegis Therapeutics, Lepton Pharmaceuticals, Transcenta Holding, and others are evaluating new lupus nephritis drugs to improve the treatment landscape. Promising lupus nephritis pipeline therapies such as Anifrolumab, Obinutuzumab, Ianalumab, QLG1074, Atacicept, AZD1656, Daxdilimab, Nipocalimab, Zanubrutinib, Telitacicept, Efgartigimod alfa, KYV-101, CABA-201, IMPT-514, Povetacicept, ONT01, BCMA-CD19 cCAR T cells, CB-010, ADI-001, PRG-2311, RSLV-621, Recombinant human plasma gelsolin, LN-008, TST 008, and others are under different phases of lupus nephritis clinical trials. In November 2024, Adicet Bio announced that the first LN patient had been dosed in the Phase I clinical trial evaluating ADI-001 in autoimmune diseases. In November 2024, Kyverna Therapeutics announced that it would present updated clinical data from LN patients treated with KYV-101 in ongoing Kyverna-sponsored KYSA-1 and KYSA-3 Phase I/II studies and named patient treatments. In October 2024, Kezar Life Sciences suspended subject enrolment and patient dosing in the Phase II PALIZADE trial of zetomipzomib for active lupus nephritis. In June 2024, Nkarta announced the initiation of Ntrust-I, a multi-center clinical trial of NKX019 in lupus nephritis, with the first patient in screening. The company also announced the clearance by the U.S. Food and Drug Administration (FDA) of its second Investigational New Drug (IND) application for NKX019 in autoimmune disease. In June 2024, Adicet Bio announced that the US Food and Drug Administration (FDA) had granted Fast Track Designation to ADI-001 for the potential treatment of relapsed/refractory class III or class IV lupus nephritis. In April 2024, Caribou Biosciences announced that it had received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) for CB-010, an allogeneic anti-CD19 CAR-T cell therapy with a PD-1 knockout (KO), for the treatment of lupus nephritis (LN) and extrarenal lupus (ERL). The Phase 1, multicenter, open label GALLOP clinical trial of CB-010 in patients with LN and ERL is expected to initiate by year-end 2024. In March 2024, Artiva Therapeutics is looking to dose the first patient in a Phase I/II trial assessing its cell therapy AlloNK in lupus nephritis (LN). Request a sample and discover the recent advances in lupus nephritis treatment drugs @ Lupus Nephritis Pipeline Report The lupus nephritis pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage lupus nephritis drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the lupus nephritis clinical trial landscape. Lupus Nephritis Overview Lupus nephritis is a serious complication of systemic lupus erythematosus (SLE), an autoimmune disease that can affect multiple organ systems. In lupus nephritis, the immune system mistakenly attacks the kidneys, leading to inflammation and damage. The exact cause is not fully understood, but it is believed to involve a combination of genetic, hormonal, and environmental factors, including infections and exposure to certain drugs or UV light. Symptoms of lupus nephritis can vary but often include swelling in the legs and feet, high blood pressure, foamy urine, and in severe cases, hematuria. Patients may also experience fatigue, joint pain, and skin rashes, typical of lupus. Diagnosis usually involves a combination of blood tests, urinalysis, and imaging studies. A kidney biopsy may be necessary to evaluate the extent of kidney damage and guide treatment. Treatment for lupus nephritis aims to reduce inflammation and prevent kidney damage. It often involves corticosteroids and immunosuppressive medications such as mycophenolate mofetil or azathioprine. In severe cases, more aggressive treatments, including cyclophosphamide or biologic therapies like belimumab, may be utilized. Regular monitoring of kidney function and overall health is crucial for managing the disease effectively. Find out more about lupus nephritis treatment drugs @ Drugs for Lupus Nephritis Treatment A snapshot of the Lupus Nephritis Pipeline Drugs mentioned in the report: Learn more about the emerging lupus nephritis pipeline therapies @ Lupus Nephritis Clinical Trials Lupus Nephritis Therapeutics Assessment The lupus nephritis pipeline report proffers an integral view of the lupus nephritis emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Lupus Nephritis 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: Interferon alpha-beta receptor antagonists, Cell death inhibitors, Cell death stimulants, Antibody-dependent cell cytotoxicity, B-cell activation factor receptor antagonists, Glucokinase stimulants, Dendritic cell inhibitors, Complement factor D inhibitors, Complement C3 inhibitors, Proteasome inhibitors, Natural killer cell replacements, Immunologic cytotoxicity; T lymphocyte replacements Key Lupus Nephritis Companies: AstraZeneca, Hoffmann-La Roche, Novartis, Qilu Pharmaceutical, Vera Therapeutics, Conduit Pharmaceuticals, Amgen, Johnson & Johnson, BeiGene, RemeGen, Argenx, Kyverna Therapeutics, Cabaletta Bio, ImmPACT Bio, Alpine Immune Sciences, AlloSite Therapeutics, iCell Gene Therapeutics, Caribou Biosciences, Adicet Bio, Shenzhen Pregene Biopharma Co., Ltd., Resolve Therapeutics, BioAegis Therapeutics, Lepton Pharmaceuticals, Transcenta Holding, and others. Key Lupus Nephritis Pipeline Therapies: Anifrolumab, Obinutuzumab, Ianalumab, QLG1074, Atacicept, AZD1656, Daxdilimab, Nipocalimab, Zanubrutinib, Telitacicept, Efgartigimod alfa, KYV-101, CABA-201, IMPT-514, Povetacicept, ONT01, BCMA-CD19 cCAR T cells, CB-010, ADI-001, PRG-2311, RSLV-621, Recombinant human plasma gelsolin, LN-008, TST 008, and others. Dive deep into rich insights for new drugs for lupus nephritis treatment, visit @ Lupus Nephritis Drugs Table of Contents For further information on the lupus nephritis pipeline therapeutics, reach out @ Lupus Nephritis Treatment Drugs Related Reports Lupus Nephritis Epidemiology Lupus Nephritis Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical, and forecasted lupus nephritis 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, CABALETTA BIO, among others. Systemic Lupus Erythematosus Market Systemic Lupus Erythematosus 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 SLE companies, including Biogen, Novartis, MorphoSys, Idorsia Pharmaceuticals, Viatris, RemeGen, UCB Pharma, Genentech, Bristol Myers Squibb, AbbVie, among others. Systemic Lupus Erythematosus Pipeline Systemic Lupus Erythematosus Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key myasthenia gravis companies, including Yake Biotechnology, UCB, Sorrento Therapeutics, SinoMab Bioscience Ltd, Shanghai Junshi Biosciences, Sareum, Sanofi, Roche, Rheos Medicine, Resolve, Provention Bio, Pfizer, Novartis, Neovacs, Merck, Medsenic, Landos Biopharma, Kezar Life Sciences, Kangpu Biopharmaceuticals, Janssen Research & Development, Janssen, InnoCare, ImmuPharma, I-MAB Biopharma, ILTOO, Idorsia Pharmaceuticals, Horizon Therapeutics, Genovax, Exinda Thearapeutics, Equillium, Eli Lilly and Company, Eisai, Daiichi Sankyo Company, Corestem, Corbus Pharmaceuticals, Citryll BV, Chipscreen Biosciences, Carna Bioscience, Bristol-Myers Squibb, Brickell Biotech, Boston Pharmaceuticals, Biogen, Athos Therapeutics, Asahi Kasei Pharma, Aria Pharmaceuticals, Antengene Therapeutics, Amgen, Alpine Immune Sciences, Akeso Biopharma, AbbVie, 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

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Indication	Country/Location	Organization	Date
Rheumatoid Arthritis	China	RemeGen Co., Ltd.	16 Jul 2024
Systemic Lupus Erythematosus	China	RemeGen Co., Ltd.	09 Mar 2021

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Indication	Highest Phase	Country/Location	Organization	Date
Myasthenia Gravis	NDA/BLA	China	RemeGen Co., Ltd.	26 Oct 2024
Primary Sjögren's syndrome	Phase 3	China	RemeGen Co., Ltd.	03 Apr 2023
Lambert-Eaton Myasthenic Syndrome	Phase 3	China	RemeGen Co., Ltd.	28 Mar 2023
Glomerulonephritis, IGA	Phase 3	United States	RemeGen Co., Ltd.	18 Nov 2022
Neuromyelitis Optica	Phase 3	China	RemeGen Co., Ltd.	12 Jan 2018
Lupus Nephritis	Phase 2	China	RemeGen Co., Ltd.	17 Apr 2023
Multiple Sclerosis, Relapsing-Remitting	Phase 2	China	RemeGen Co., Ltd.	13 May 2021
Glomerulonephritis, Membranous	Phase 1	China	RemeGen Co., Ltd.	-
Nephrosis	IND Approval	China	RemeGen Co., Ltd.	22 Jul 2024
Immunoglobulin G4-Related Disease	IND Approval	China	RemeGen Co., Ltd.	17 Jun 2024

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06456580 (RemeMG, AAN2025) Manual	Phase 3	Myasthenia Gravis	114	Telitacicept 240 mg	lhqqccwyqa(iztidkmbgw) = ckqjllbkxs lzjjbepgyo (xochzctrod ) View more	Positive	05 Apr 2025
				Placebo	lhqqccwyqa(iztidkmbgw) = plcmrkaqsa lzjjbepgyo (xochzctrod ) View more
NEWS Manual	Not Applicable	Glomerulonephritis, IGA	-	Telitacicept	nnjkcjhlds(ydlvuvkerf) = hjfmbbfmvp elivmyaspf (dkadyytdlt ) View more	Positive	15 Nov 2024
				Supportive treatment	nnjkcjhlds(ydlvuvkerf) = invnvcmnyk elivmyaspf (dkadyytdlt ) View more
NCT02885610 (Pubmed \| Ann Rheum Dis) Manual	Phase 2	Systemic Lupus Erythematosus	249	Telitacicept 80 mg	svnbajnslm(ippsdyfxje) = nhadsspkpa nacbsijyvc (ipudfncfqe )	Positive	01 Apr 2024
				Telitacicept 160 mg	svnbajnslm(ippsdyfxje) = krfuctcsuh nacbsijyvc (ipudfncfqe )
NCT04078386 (Literature) Manual	Phase 2	Primary Sjögren's syndrome	42	telitacicept 160 mg	bqgdltzvrr(alvzlboeoj) = None lpbedzesbk (byzvngbpss ) View more	Positive	01 Mar 2024
				telitacicept 240 mg
NCT03016013 (ACR2023) Manual	Phase 3	Rheumatoid Arthritis	479	Telitacicept 160 mg	hgecqgkuek(aikyniikwk) = xtfyntiggt trskdnzuvi (tkhselwmnj ) View more	Positive	24 Oct 2023
				Placebo	hgecqgkuek(aikyniikwk) = lcueklzrnd trskdnzuvi (tkhselwmnj ) View more
NCT04078386 (Corporate Publications) Manual	Phase 2	Primary Sjögren's syndrome	42	placebo	numnhsadoi(soeqvxdyoe) = okwzprgrnh sageizsarf (iwbqsvqxvv, 4.55)	Positive	17 Jul 2023
				Telitacicept 160 mg	numnhsadoi(soeqvxdyoe) = dzvmphdtyg sageizsarf (iwbqsvqxvv, 2.73)
EULAR2023	Phase 3	Systemic Lupus Erythematosus ANA/anti-dsDNA \| C3 \| C4 ... View more	335	Telitacicept 160 mg	andwaabqoj(pkatawyptg) = esyhptkgzp yulgrtboed (mtyhrrwfme )	Positive	31 May 2023
				Placebo	andwaabqoj(pkatawyptg) = ubkxumphhx yulgrtboed (mtyhrrwfme )
Pubmed Manual	Not Applicable	Systemic Lupus Erythematosus	20	Telitacicept	xtxqcvbgja(rjzfmskabu) = fenuvrtsbp lpceipftpp (cktxjkmhhe ) View more	Positive	23 Nov 2022
NCT04302103 (Corporate Publications) Manual	Phase 2	Myasthenia Gravis	29	泰它西普 (160mg)	vnqgotgjbv(xoaooprxki) = lmbtabiywv shtqcwaiyr (fpwaipiyfj )	Positive	31 Oct 2022
				泰它西普 (240mg)	vnqgotgjbv(xoaooprxki) = nmyjuejfiy shtqcwaiyr (fpwaipiyfj )
NCT05306574 (Biospace) Manual	Phase 3	Systemic Lupus Erythematosus	335	Standard of Care+Telitacicept	hdxaqjzuwp(vnosdrkikr) = quqenjqvdd oxdgpfdxef (ueoyohalgu )	Positive	19 Sep 2022
				Standard of Care+Placebo	hdxaqjzuwp(vnosdrkikr) = dmggwnmvfm oxdgpfdxef (ueoyohalgu )

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