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

RegulationConditional marketing approval (CN), Special Review Project (CN), Fast Track (US), Orphan Drug (US), Priority Review (CN), Breakthrough Therapy (CN)

Gene Sequence

Sequence Code 616721115

Source: *****

Clinical Trials associated with Telitacicept

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]

NCT06614985 / Not yet recruitingPhase 2IIT

The Efficacy and Safety of Treatment With Telitacicept in Primary Membranous Nephropathy

This is a multiple-center, prospective, open-label, positive drug controlled, randomized, clinical study to evaluate the safety and efficacy of Telitacicept in the treatment of primary membranous nephropathy.

Start Date20 Oct 2024

Sponsor / Collaborator

Wuhan University People's Hospital

NCT06677801 / Active, not recruitingPhase 4IIT

Changes of Immune Cell Subsets During the Treatment of Lupus with Telitacicept

This study is a single-center cohort study. Patients with SLE who met the inclusion criteria were treated with tetanercept 160 mg once a week for a total of 24 weeks, and the clinical and laboratory indicators were collected before treatment, at the 4th week, at the 12th week, and at the 24th week, and blood samples were collected for the detection of immune cell subsets.

Start Date11 Oct 2024

Sponsor / Collaborator

Second Affiliated Hospital Zhejiang University College of

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

Key Clinical MessageWe 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.AbstractDespite 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 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 ; Wang, Meng ; Fan, Yi ; Yao, Li

ABSTRACTBackgroundTelitacicept, 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.MethodsThis 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.ResultsAfter 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.ConclusionsTelitacicept 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.

01 Sep 2024·Journal of Autoimmunity

Telitacicept: A novel horizon in targeting autoimmunity and rheumatic diseases

Review

Author: Hao, Moujia ; Wu, Yang ; Chen, Junpeng ; Yan, Yexing ; Yu, Ganpeng ; Sun, Lingyun ; Li, Yuwei ; Zeng, Liuting ; Song, Tian ; Yang, Kailin

BLyS and APRIL have the capability to bind to B cells within the body, allowing these cells to evade elimination when they should naturally be removed. While BLyS primarily plays a role in B cell development and maturation, APRIL is linked to B cell activation and the secretion of antibodies. Thus, in theory, inhibiting BLyS or APRIL could diminish the population of aberrant B cells that contribute to SLE and reduce disease activity in patients. Telitacicept functions by binding to and neutralizing the activities of both BLyS and APRIL, thus hindering the maturation and survival of plasma cells and fully developed B cells. The design of telitacicept is distinctive; it is not a monoclonal antibody but a TACI-Fc fusion protein generated through recombinant DNA technology. This fusion involves merging gene segments of the TACI protein, which can target BLyS/APRIL simultaneously, with the Fc gene segment of the human IgG protein. The TACI-Fc fusion protein exhibits the combined characteristics of both proteins. Currently utilized for autoimmune disease treatment, telitacicept is undergoing clinical investigations globally to assess its efficacy in managing various autoimmune conditions. This review consolidates information on the mechanistic actions, dosing regimens, pharmacokinetics, efficacy, and safety profile of telitacicept-a dual-targeted biological agent. It integrates findings from prior experiments and pharmacokinetic analyses in the treatment of RA and SLE, striving to offer a comprehensive overview of telitacicept's research advancements.

News (Medical) associated with Telitacicept

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

21 May 2024

·www.biospace.com

RemeGen Completes Patient Enrollment in Two Phase III Clinical Trials Using Telitacicept for Treatment of IgA Nephropathy and Primary Sjögren's Syndrome

YANTAI, China, May 21, 2024 /PRNewswire/ -- RemeGen Co. Ltd. ("RemeGen" or "the Company") (9995.HK, 688331.SH), a commercial-stage biotechnology company, recently announced significant progress of Telitacicept (RC18), that two Phase III clinical trials in China for the treatment of IgA nephropathy and primary Sjögren's syndrome (pSS) have completed patient enrollments. Dr. Jianmin Fang, CEO of RemeGen, commented, "This marks further continued progress in RemeGen's research achievements for the treatment of these two diseases and we remain steadfastly committed to providing patients with more efficient and convenient treatment options. The smooth progress of these two clinical trials is an important milestone on the road to achieving this goal." IgA nephropathy is a kidney disease, for which there is currently no cure, caused by the build-up of a germ-fighting protein called immunoglobulin A (IgA) in the kidneys, causing inflammation that can make it harder for the kidneys to filter waste from the blood. A total of 318 patients were enrolled between June 2023 and May 2024 in the clinical study led by Professor Zhang Hong from Peking University First Hospital. It has been designed to evaluate the efficacy and safety of RemeGen's telitacicept in the treatment of patients with primary IgA nephropathy who are at risk of progression to end-stage kidney disease (ESKD). The study uses pre-filled injections which can provide patients with a more convenient administration method and simplified medication use compared with the approved lyophilized powder injection form of telitacicept for the treatment of systemic lupus erythematosus (SLE). Primary Sjögren's syndrome (pSS) is a common rheumatic disease characterized by autoimmune exocrinopathy that clinically manifests as dry eyes and mouth caused by glandular dysfunction as a result of autoimmune damage with multiple organ systems also at risk of being affected. Studies have shown that B-cells are key immune cells involved in the pathogenesis of pSS, and excessive activation of B-cells is a pathogenic indicator of pSS that has long been regarded as a key target for intervention. A total of 381 patients were enrolled between the end of 2022 and May 2024 in the clinical study led by Professor Zeng Xiaofeng from Peking Union Medical College Hospital. This study aims to evaluate the efficacy and safety of telitacicept in the treatment of patients with primary Sjögren's syndrome (pSS) with a primary endpoint of a change in the EULAR Sjögren's syndrome (SS) disease activity index (ESSDAI) score from baseline at week 24 of treatment. Telitacicept has previously displayed a significant clinical benefit in a randomized, double-blind, placebo-controlled Phase II clinical trial in the treatment of adult patients with pSS that can significantly improve ESSDAI scores and Multidimensional Fatigue Inventory (MFI-20), thereby reducing immunoglobulin levels in patients. 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 completed marketing approval by China's National Medical Products Administration (NMPA) to treat systemic lupus erythematosus (SLE) in November 2023. 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: View original content: SOURCE RemeGen Co., Ltd Company Codes: HongKong:9995, OTC-PINK:REGMY, Shanghai:688331

Phase 2Phase 3Drug ApprovalImmunotherapyClinical Result

100 Deals associated with Telitacicept

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	L04AA	-

R&D Status

Approved

10 top approved records.

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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
Systemic Lupus Erythematosus	Phase 3	PL	RemeGen Co., Ltd.	21 Apr 2022
Neuromyelitis Optica	Phase 3	CN	RemeGen Co., Ltd.	12 Jan 2018
Lupus Nephritis	Phase 2	CN	RemeGen Co., Ltd.	17 Apr 2023
Nephrosis	Phase 2	CN	RemeGen Co., Ltd.	23 Jun 2022
Nephrosis	Phase 2	US	RemeGen Co., Ltd.	23 Jun 2022
Multiple Sclerosis, Relapsing-Remitting	Phase 2	CN	RemeGen Co., Ltd.	13 May 2021
Glomerulonephritis, Membranous	Phase 1	CN	RemeGen Co., Ltd.	-

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02885610 (Pubmed \| Ann Rheum Dis) Manual	Phase 2	Systemic Lupus Erythematosus	249	Telitacicept 80 mg	(gftnfevdms) = tcxcpnpbwh wxyvnjxkzc (ujakiqxxpj )	Positive	01 Apr 2024
				Telitacicept 160 mg	(gftnfevdms) = cidyidsbyn wxyvnjxkzc (ujakiqxxpj )
NCT04078386 (Literature) Manual	Phase 2	Primary Sjögren's syndrome	42	telitacicept 160 mg	(mcvzusokwp) = None ivledniprw (vigztbwcxs ) View more	Positive	01 Mar 2024
				telitacicept 240 mg
NCT03016013 (ACR2023) Manual	Phase 3	Rheumatoid Arthritis	479	Telitacicept 160 mg	(bxdqnodcnr) = sbxgpcekjh abomkwfklt (ikqaedavpa ) View more	Positive	24 Oct 2023
				Placebo	(bxdqnodcnr) = wfdlpbydov abomkwfklt (ikqaedavpa ) View more
NCT04078386 (Corporate Publications) Manual	Phase 2	Primary Sjögren's syndrome	42	placebo	(cbyketkhci) = xjbfuzeuyw jdqkrogqtd (fhhnhbcwdj, 4.55)	Positive	17 Jul 2023
				Telitacicept 160 mg	(cbyketkhci) = uiwjjoiieu jdqkrogqtd (fhhnhbcwdj, 2.73)
EULAR2023	Phase 3	Systemic Lupus Erythematosus ANA/anti-dsDNA \| C3 \| C4 ... View more	335	Telitacicept 160 mg	(zdbnbbdtjt) = ylpuauvppg vltuhwhbjt (jhtdzgzsbp )	Positive	31 May 2023
				Placebo	(zdbnbbdtjt) = sooayqcram vltuhwhbjt (jhtdzgzsbp )
Pubmed Manual	Not Applicable	Systemic Lupus Erythematosus	20	Telitacicept	(wrnszbvmbq) = plsnezstof bguusfqbyn (rcanzwniel ) View more	Positive	23 Nov 2022
NCT04302103 (Corporate Publications) Manual	Phase 2	Myasthenia Gravis	29	泰它西普 (160mg)	(fzocnugexu) = bzmljjfili rdvqmmqsbl (fukelggnnq )	Positive	31 Oct 2022
				泰它西普 (240mg)	(fzocnugexu) = nwnjtgoexm rdvqmmqsbl (fukelggnnq )
NCT05306574 (Biospace) Manual	Phase 3	Systemic Lupus Erythematosus	335	Standard of Care+Telitacicept	(miwtqmlbwr) = yfnvskeqxh tllxybxosf (tdqikdygrk )	Positive	19 Sep 2022
				Standard of Care+Placebo	(miwtqmlbwr) = yxowcqbopg tllxybxosf (tdqikdygrk )

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