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+ [8]

Inactive Indication-

Originator Organization

RemeGen Co., Ltd.

Active Organization

RemeGen Co., Ltd.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

CN (09 Mar 2021),

Systemic Lupus Erythematosus

RegulationFast Track (US), Priority Review (CN), Breakthrough Therapy (CN), Conditional marketing approval (CN), Orphan Drug (US)

Gene Sequence

Sequence Code 616721115

Source: *****

Clinical Trials associated with Telitacicept

NCT06510283 / RecruitingPhase 2IIT

Efficacy and Safety of Taitacept in Treatment of Refractory or Recurrent Anti-NMDAR/anti-LGI1 Encephalitis

The main objective is to explore the efficacy and safety of Telitacicept in the treatment of refractory/recurrent anti-NMDAR and anti-LGI1 encephalitis.
Through this prospective, single-center, open-label clinical trial, we aim to investigate the effectiveness and safety of Telitacicept in refractory/recurrent anti-NMDAR and anti-LGI1 encephalitis by add-on therapy of Telitacicept combined with traditional treatment.

Start Date01 Dec 2024

Sponsor / Collaborator

Beijing Tongren Hospital

NCT06723548 / Not yet recruitingPhase 4IIT

The Efficacy and Safety of Telitacicept Combined With Low-dose Steroids in Patients With Refractory Myasthenia Gravis

This study is designed to explore the efficacy and safety of Telitacicept combined with low-dose steroids for the treatment of refractory MG, and to investigate related biomarkers such as immunoglobulins, BlyS/APRIL, and AChR-Ab titers, in order to clarify whether Telitacicept can rapidly and effectively help achieve MG treatment goals and assist in steroid reduction.

Start Date01 Dec 2024

Sponsor / Collaborator

First Affiliated Hospital of Wenzhou Medical University

NCT06654596 / Not yet 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 Date01 Nov 2024

Sponsor / Collaborator

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

[+7]

100 Clinical Results associated with Telitacicept

100 Translational Medicine associated with Telitacicept

100 Patents (Medical) associated with Telitacicept

Literatures (Medical) associated with Telitacicept

01 Nov 2024·Clinical Case Reports

Single‐dose telitacicept therapy for refractory idiopathic membranous nephropathy: A case series

Article

Author: Sun, Liping ; Zhang, Xinzhou ; Chen, Fuce

Key Clinical Message:

We report three cases of IMN from our center, where patients received a single dose of telitacicept after showing no response to conventional treatments. Although one case did not respond, the other two cases achieved complete or partial remission of proteinuria. These cases illustrates the telitacicept may offer new hope for the treatment of IMN.

Abstract:

Despite the variety of treatment options available, effective therapies for refractory membranous nephropathy remain lacking. Recently, some reports have suggested that telitacicept is a new therapeutic option. However, only a few published studies have documented the use of telitacicept for treating idiopathic membranous nephropathy (IMN). We present three cases of IMN from our center, where patients received a single dose of telitacicept after showing no response to conventional treatments, including glucocorticoids, tacrolimus, mycophenolate mofetil, cyclophosphamide, cyclosporine, and rituximab. Although one case did not respond, the other two cases achieved complete or partial remission of proteinuria. Thus, telitacicept may offer new hope for the treatment of refractory membranous nephropathy.

01 Nov 2024·Heliyon

Neuromyelitis optica spectrum disorder with ultra-longitudinally extensive transverse myelitis: A case report and literature review

Article

Author: Pan, Xin ; Xie, Lili ; Sui, Xiaowen ; Li, Furong ; Liu, Chang ; Zhao, Hongling ; Ma, Shubei

Background:

Neuromyelitis optica spectrum disorders (NMOSD) is characterized by inflammatory demyelinating events in the central nervous system (CNS), primarily affecting the spinal cord and optic nerve, with a significant influence of astrocytes. Longitudinal extensive transverse myelitis (LETM) is a distinct and relatively rare spinal cord syndrome, commonly associated with NMOSD.

Case presentation:

This report describes a unique case of myelitis in a patient diagnosed with NMOSD. The patient exhibited an uncommon manifestation of ultra- LETM (u-LETM), coexisting with connective tissue disorders including Sjögren's syndrome and autoimmune hepatitis-primary cholestatic cirrhosis. In the acute phase, high-dose methylprednisolone pulse therapy was administered in combination with intravenous human immunoglobulin, while prednisone was gradually tapered and discontinued upon stabilization of the patient's condition. Simultaneously, sequential disease-modifying therapy was initiated, starting with long-term oral administration of mycophenolate mofetil, followed by cyclophosphamide, telitacicept, and Inebilizumab. During follow-up visits conducted every three months, the patient showed gradual improvement, eventually achieving the ability to stand and walk independently.

Conclusions:

Early and comprehensive evaluation of autoimmune diseases is crucial in patients with NMOSD presenting with u-LETM as the initial symptom. Prompt treatment initiation, followed by disease-modifying therapy, is essential for improving patient prognosis.

01 Oct 2024·Clinical Kidney Journal

Efficacy and safety of telitacicept, a BLyS/APRIL dual inhibitor, in the treatment of IgA nephropathy: a retrospective case–control study

Article

Author: Ma, Jianfei ; Yao, Li ; Fan, Yi ; Wang, Meng

ABSTRACT:

Background:

Telitacicept, a B lymphocyte stimulator/A proliferation-inducing ligand dual-target fusion protein, has recently been used in autoimmune diseases. We assessed the efficacy and safety of telitacicept in immunoglobulin A nephropathy (IgAN) patients.

Methods:

This study included 42 IgAN patients who received telitacicept treatment, forming the ‘whole telitacicept group’. Among them, 20 patients who had not previously received corticosteroid (CS) therapy or immunosuppressive (IS) agents were categorized as the ‘newly treated telitacicept subgroup’. Additionally, 28 patients who were selected to match historical controls received conventional IS therapy (CS therapy with/without IS agents) and were classified as the ‘conventional IS group’. Telitacicept was partially used in combination with conventional IS therapy, including initial CS in different doses. Various indicators were compared at 4-week intervals up to 24 weeks among the three groups.

Results:

After 24 weeks of treatment, the 24-hour proteinuria decreased from 1.70 g [interquartile range (IQR) 1.05–2.58] to 0.21 g (IQR 0.39–0.13) (P = .043) in the newly treated telitacicept subgroup, from 1.78 g (IQR 0.97–2.82) to 0.44 g (IQR 1.48–0.16) (P = .001) in the conventional IS group and from 1.07 g (IQR 0.66–1.99) to 0.26 g (IQR 0.59–0.17) (P = .028) in the whole telitacicept group. The estimated glomerular filtration rate (eGFR) increased from 76.58 ± 30.26 ml/min/1.73 m2 to 80.30 ± 26.76 ml/min/1.73 m2 (P = .016) in the newly treated telitacicept subgroup, from 72.73 ± 33.41 ml/min/1.73 m2 to 84.08 ± 26.81 ml/min/1.73 m2 (P = .011) in the conventional IS group and from 70.10 ± 32.88 ml/min/1.73 m2 to 71.21 ± 31.49 ml/min/1.73 m2 (P = .065) in the whole telitacicept group. During follow-up periods, the efficacy rates of the three groups did not show statistically significant differences and no serious adverse events were observed.

Conclusions:

Telitacicept may be a safe and effective treatment for IgAN, offering reductions in proteinuria and increases in eGFR similar to conventional IS therapy. After a 24-week follow-up, the incidence of adverse events was lower for telitacicept than for conventional IS therapy.

News (Medical) associated with Telitacicept

03 Dec 2024

·www.prnewswire.com

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

IND

29 Oct 2024

·www.prnewswire.com

RemeGen Announces the Acceptance of the Marketing Application of Telitaccept for the Treatment of Myasthenia Gravis in China

YANTAI, China, Oct. 29, 2024 /PRNewswire/ -- RemeGen Co. Ltd. ("RemeGen" or "the Company") (9995.HK, 688331.SH), a commercial-stage biotechnology company, recently announced that the marketing application of Taicercept ® for the treatment of generalized myasthenia gravis (gMG) has been officially accepted by the Center for Drug Evaluation (CDE) of the China National Food and Drug Administration and has been included in the priority review and approval process. Myasthenia gravis (MG) is a rare chronic autoimmune disease that has been included in the First List of Rare Diseases in China. According to the Frost & Sullivan report, the global number of myasthenia gravis patients is expected to reach 1.5 million in 2025, and the number of patients in China is about 217,000. The disease involves immunoglobulin G (IgG) antibodies that disrupt synaptic transmission between nerves and muscles, leading to muscle weakness and, in severe cases, life threatening risks. More than 85% of patients develop generalized myasthenia gravis within 24 months of disease onset, characterized by extreme fatigue and significant difficulty with facial expression, speech, swallowing, and mobility. Currently, there is no satisfactory treatment for myasthenia gravis, and effective, safe and precise targeted biological agents have become a hot spot in the research and development of myasthenia gravis drugs. In recent years, B-cell targeted therapies have shown a good therapeutic prospect in myasthenia gravis treatment. Studies have found that compared with traditional immunotherapy, B-cell targeted therapies can significantly reduce the recurrence rate of myasthenia gravis, and the withdrawal rate is low. Teritacept is a dual target antibody fusion protein, which can target BLyS and APRIL at the same time, and directly attack the source of pathogenic antibodies -- B cells and plasma cells, thereby reducing the production of pathogenic antibodies and resulting in therapeutic effect. In August 2024, the company announced the completion of the domestic phase Ⅲ clinical trial of telitacept in the treatment of generalized myasthenia gravis. The results of the clinical study showed that telitacept can continuously and effectively improve the clinical status of patients with generalized myasthenia gravis. Internationally, the global multicenter phase Ⅲ clinical trial of gMG has achieved the first patient enrollment in the United States in August 2024. Telitacicept has been granted orphan drug and fast track status by the Food and Drug Administration (FDA) of the United States, and breakthrough therapy status by National Medical Products Administration (NMPA) of China. About Telitacicept (RC18) Telitacicept (RC18) is RemeGen's proprietary novel fusion protein for the treatment of autoimmune diseases. It is constructed with the extracellular domain of the human transmembrane activator and calcium modulator and cyclophilin ligand interactor (TACI) receptor and the fragment crystallizable (Fc) domain of human immunoglobulin G(IgG). Telitacicept targets two cell-signaling molecules critical for B-lymphocyte development: B-lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL), which allows it to effectively reduce B-cell mediated autoimmune responses that are implicated in several autoimmune diseases. It was granted complete marketing approval by China's National Medical Products Administration (NMPA) to treat systemic lupus erythematosus (SLE) in November 2023 and rheumatoid arthritis (RA) in July 2024. About RemeGen Co. Ltd. Founded in 2008, RemeGen (9995.HK, SHA: 688331) is a leading biopharmaceutical company in China committed to providing solutions to the unmet clinical needs of patients suffering from life-threatening illnesses. RemeGen has research laboratories and offices in China and the United States. The company is committed to discovering, developing, and commercializing innovative and differentiated biologic drugs of significant clinical value in the key therapeutic areas of autoimmune, oncology, and ophthalmic diseases. For more details, please visit: 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

Orphan DrugImmunotherapyClinical ResultFast TrackBreakthrough Therapy

06 Aug 2024

·www.prnewswire.com

First patient enrollment in the U.S. - A milestone for the global multi-center phase Ⅲ clinical trial of telitacicept for myasthenia gravis

YANTAI, China, Aug. 6, 2024 /PRNewswire/ -- RemeGen Co. Ltd. ("RemeGen" or "the Company") (9995.HK, SHA:688331), a commercial-stage biotechnology company, announced that the company's self-developed BLyS/APRIL dual targeting fusion protein innovative drug telitacicept has achieved the first patient enrollment in the United States for its global multi-center phase III clinical trial for the treatment of generalized myasthenia gravis (gMG). This milestone marks an important step in the worldwide clinical development of telitacicept, which will bring new hope to myasthenia gravis patients globally. Previously, telitacicept was granted orphan drug and fast track status for myasthenia gravis indication by the US Food and Drug Administration (FDA) and breakthrough therapy designation by the National Medical Products Administration (NMPA) of China. This global, multicenter, randomized, double-blind, placebo-controlled, phase III study aims to evaluate the efficacy and safety of telitacicept in the treatment of gMG. The trial plans to recruit 180 patients from multiple countries and regions around the world. Myasthenia gravis (MG) is a rare, chronic autoimmune disease that leads to impaired transmission at neuromuscular junctions, which can affect eye movement, swallowing, speech, general movement and respiratory function at varying degrees. According to the Frost & Sullivan report, the global number of myasthenia gravis patients is expected to reach 1.15 million in 2025, with about 70,000 in the United States and 22,000 in China. At present, the main treatment methods for myasthenia gravis include cholinesterase inhibitors, glucocorticoids and immunosuppressants. However, a substantial unmet medical need remains as there are many patients can not be effectively treated due to lack of efficacy, tolerability or contraindications of existing therapies. Telitacicept is a dual targeting antibody fusion protein that targets BLyS and APRIL at the same time, and directly attack the source of pathogenic antibodies -- B cells and plasma cells, thereby reducing the production of pathogenic antibodies and achieving its therapeutic purpose. Preliminary clinical studies have shown that telitacicept can continuously and effectively improve the clinical status of patients with generalized myasthenia gravis. Since its approval in China in March 2021, telitacicept has benefited more than 40,000 patients with excellent efficacy and safety. In China, in addition to the two approved indications of systemic lupus erythematosus and rheumatoid arthritis, telitacicept has the potential to be approved for myasthenia gravis, Sjogren's syndrome, IgA nephritis, and neuromyelitis optica in the coming years. About RemeGen Co. Ltd. Founded in 2008, RemeGen (9995.HK, SHA: 688331) is a leading biopharmaceutical company in China committed to providing solutions to the unmet clinical needs of patients suffering from life-threatening illnesses. RemeGen has research laboratories and offices throughout China and the United States. The company is committed to discovering, developing, and commercializing innovative and differentiated biologic drugs of significant clinical value in the key therapeutic areas of autoimmune, oncology, and ophthalmic diseases. For more details, please visit: About Telitacicept (RC18) Telitacicept (RC18) is RemeGen's proprietary novel fusion protein for the treatments of autoimmune diseases. It is constructed with the extracellular domain of the human transmembrane activator and calcium modulator and cyclophilin ligand interactor (TACI) receptor and the fragment crystallizable (Fc) domain of human immunoglobulin G(IgG). Telitacicept targets two cell-signaling molecules critical for B-lymphocyte development: B-lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL), which allows it to effectively reduce B-cell mediated autoimmune responses that are implicated in several autoimmune diseases. SOURCE RemeGen Co., Ltd

Phase 3Fast TrackOrphan DrugImmunotherapyDrug Approval

100 Deals associated with Telitacicept

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	L04AA	-

R&D Status

Approved

10 top approved records.

to view more data

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

Developing

10 top R&D records.

to view more data

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

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NEWS Manual	Not Applicable	Glomerulonephritis, IGA	-	Telitacicept	bzhcjkjwbg(soychpiigu) = cqczusyfwc gyloxfbtai (rykpfvosbz ) View more	Positive	15 Nov 2024
				Supportive treatment	bzhcjkjwbg(soychpiigu) = imdlewgqnl gyloxfbtai (rykpfvosbz ) View more
NCT02885610 (Pubmed \| Ann Rheum Dis) Manual	Phase 2	Systemic Lupus Erythematosus	249	Telitacicept 80 mg	fzygfjfiia(gxwhtzheyu) = nxrpanhwir traazsehju (keohmwjicr )	Positive	01 Apr 2024
				Telitacicept 160 mg	fzygfjfiia(gxwhtzheyu) = irxstcwgeu traazsehju (keohmwjicr )
NCT04078386 (Literature) Manual	Phase 2	Primary Sjögren's syndrome	42	telitacicept 160 mg	byczltohqz(vjpsdgcnle) = None dbbibvgrhg (qiiwgjblgb ) View more	Positive	01 Mar 2024
				telitacicept 240 mg
NCT03016013 (ACR2023) Manual	Phase 3	Rheumatoid Arthritis	479	Telitacicept 160 mg	ocyirmbaow(zwxolaurge) = iyokloxbxk aacmgoaibd (oodoqtnejk ) View more	Positive	24 Oct 2023
				Placebo	ocyirmbaow(zwxolaurge) = pyjmtpjdkg aacmgoaibd (oodoqtnejk ) View more
NCT04078386 (Corporate Publications) Manual	Phase 2	Primary Sjögren's syndrome	42	placebo	uhcameroge(hlouacugfp) = tcyicamlhi krslgzfyvl (lxcmsrmuxe, 4.55)	Positive	17 Jul 2023
				Telitacicept 160 mg	uhcameroge(hlouacugfp) = jottszzcer krslgzfyvl (lxcmsrmuxe, 2.73)
EULAR2023	Phase 3	Systemic Lupus Erythematosus ANA/anti-dsDNA \| C3 \| C4 ... View more	335	Telitacicept 160 mg	logpeaquop(oiyqmdgank) = rrkpkdvphx vhlsnfkodf (rikxvaxrwn )	Positive	31 May 2023
				Placebo	logpeaquop(oiyqmdgank) = bxfnbwknes vhlsnfkodf (rikxvaxrwn )
Pubmed Manual	Not Applicable	Systemic Lupus Erythematosus	20	Telitacicept	wjunvunphk(gzxprpnqzb) = jjkibdzrqs wzrbeywxzl (uaqemcbzkm ) View more	Positive	23 Nov 2022
NCT04302103 (Corporate Publications) Manual	Phase 2	Myasthenia Gravis	29	泰它西普 (160mg)	pqgnzekdes(tdvcgbefhg) = cjmjcofvaz upjicisgga (qauaaurxsq )	Positive	31 Oct 2022
				泰它西普 (240mg)	pqgnzekdes(tdvcgbefhg) = hgjtyvahye upjicisgga (qauaaurxsq )
NCT05306574 (Biospace) Manual	Phase 3	Systemic Lupus Erythematosus	335	Standard of Care+Telitacicept	mjjwtrpzmp(uzpoajsudj) = hotzyxazfy vvkqzzrdqu (ghidkdfutc )	Positive	19 Sep 2022
				Standard of Care+Placebo	mjjwtrpzmp(uzpoajsudj) = bdavgkrymh vvkqzzrdqu (ghidkdfutc )

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