Delving into the Latest Updates on Telitacicept with Synapse

Overview

Basic Info

Drug Type

Fc fusion protein

Synonyms

Tai'ai, 重组人B淋巴细胞刺激因子受体-抗体融合蛋白, RC-18

+ [4]

Target

APRIL x BAFF

Action

inhibitors, modulators

Mechanism

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+ [7]

Active Indication

Myasthenia GravisRheumatoid ArthritisSystemic Lupus Erythematosus+ [11]

Inactive Indication-

Originator Organization

RemeGen Co., Ltd.

Active Organization

RemeGen Co., Ltd.

Vor Biopharma, Inc.

Inactive Organization-

License Organization

Vor Biopharma, Inc.

RemeGen Co., Ltd.

Drug Highest PhaseApproved

First Approval Date

China (09 Mar 2021),

Systemic Lupus Erythematosus

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

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Structure/Sequence

Sequence Code 616721115

Source: *****

This clinical trial is a prospective, multicenter, non-randomized controlled study designed to evaluate the efficacy and safety of Telitacicept, a novel biologic agent, in treating pediatric IgA Nephropathy (IgAN) and IgA Vasculitis Nephritis (IgAVN). The study plans to enroll 124 children aged 5-18, divided into a test group (standard therapy + Telitacicept) and a control group (standard therapy alone), with a 24-week treatment period. The primary endpoint is the change in 24-hour urine protein levels at week 24, while secondary outcomes include UPCR (urine protein-to-creatinine ratio), eGFR, and drug safety.

Start Date01 Aug 2025

Sponsor / Collaborator

Nanjing Children's Hospital Ltd.

ChiCTR2500107996

/ Not yet recruitingNot ApplicableIIT

Efficacy and Safety of Telitacicept in Glucocorticoid Reduction in Patients with Stable Systemic Lupus Erythematosus (SLE) Receiving Standard Therapy: A Prospective, Multicenter, Single-Arm, Exploratory Clinical Trial

Start Date01 Aug 2025

Sponsor / Collaborator-

100 Clinical Results associated with Telitacicept

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100 Translational Medicine associated with Telitacicept

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100 Patents (Medical) associated with Telitacicept

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134

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.

16 Sep 2025·Zhonghua yi xue za zhi

[Efficacy of Telitacicept combined with low-dose mycophenolate mofetil in the treatment of moderate-to-severe systemic lupus erythematosus].

Article

Author: Zhang, G L ; Zhang, M Y ; Zhang, C Q ; Li, L N ; Li, D M ; Zhang, M

Objective: To evaluate the efficacy of Telitacicept combined with low-dose mycophenolate mofetil (MMF, 1 g/day) in patients with moderate-to-severe systemic lupus erythematosus (SLE). Methods: In this prospective, open-label, randomized controlled trial, 84 patients with active SLE [Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)≥10] were enrolled at Shanxi Provincial People's Hospital from June 2023 to June 2024. The participants were randomized to 2 groups with block randomization sequence: Telitacicept group (the patients were given subcutaneous Telitacicept 160 mg weekly+MMF 1 g/day+prednisone) and the MMF group (the patients were treated with MMF 2 g/day+prednisone). The primary endpoint was non-inferiority in SLEDAI-2K reduction at week 24 (margin Δ=2.0). The secondary endpoints included British Isles Lupus Assessment Group 2004 (BILAG-2004), Physician's Global Assessment (PGA), complement levels, glucocorticoid-tapering success rate (prednisone≤7.5 mg/d), and adverse events. Results: A total of 84 patients with moderate-to-severe SLE were enrolled, including 75 females (89.29%), with a mean age of (39.39±10.68) years. There were 43 cases in the Telitacicept group and 41 cases in the MMF group. The Telitacicept group demonstrated non-inferior SLEDAI-2K reduction [(14.77±5.28) vs (17.32±5.99) points, 95%CI of between-group difference:-1.92 to 0.43]. Compared to the MMF group, the Telitacicept group showed a significantly higher achievement rate of prednisone reduction to≤7.5 mg/d [83.72% (36/43) vs 63.41% (26/41), P=0.034], a lower incidence of infections [23.26% (10/43) vs 68.29% (28/41), P<0.001], and a lower anti-dsDNA level [(64.87±44.11) vs (111.92±34.08) U/ml, P=0.001]. In the lupus nephritis subgroup, the 12-week urinary protein remission rate (<0.5 g/24 h) was 90.48% (19/21) in the Telitacicept group, it was higher than that in the MMF group [73.91% (17/23)](P=0.042). The Telitacicept group showed a greater improvement in complement C3 level [(1.03±0.35) vs (0.89±0.29) g/L, P=0.063]. No intergroup differences in BILAG-2004, PGA, or joint symptoms improvement was found between the two groups (all P>0.05). Conclusion: Telitacicept plus low-dose MMF shows comparable efficacy to high-dose MMF for moderate-to-severe SLE, with superior glucocorticoid sparing and reduced infection risk.

05 Sep 2025·CLINICAL NEPHROLOGY

Peritoneal dialysis in neuropsychiatric systemic lupus erythematosus: A case report integrating proteomic insights into complement-mediated mechanisms

Article

Author: Deng, Qinyuan ; Wang, Xinyu ; Pu, Litian ; Yu, Manxia

BACKGROUND:

Neuropsychiatric systemic lupus erythematosus (NPSLE) is a severe SLE complication with limited therapeutic options. While plasma exchange is used, it carries cardiovascular risks and logistical barriers.

CASE REPORT:

We report a 42-year-old East Asian female with SLE who developed progressive edema, dyspnea, and seizures. Imaging and labs revealed cardiorenal dysfunction and neuroinflammatory signs. Peritoneal dialysis (PD) was initiated alongside immunosuppressive therapy (methylprednisolone, telitacicept, cyclophosphamide), leading to resolution of neuropsychiatric symptoms and improvement in renal and hematologic parameters. Proteomic findings: LC-MS/MS analysis of dialysate identified 518 proteins, with functional enrichment pointing to complement activation pathways. By day 4, levels of FCER2 (CD23) and C-reactive protein (CRP), both of which are associated with inflammation, were significantly downregulated, suggesting that PD may facilitate the removal of proinflammatory mediators.

CONCLUSION:

PD may serve as a dual-purpose therapy in NPSLE, offering renal support and modulating complement overactivation.

50

News (Medical) associated with Telitacicept

18 Sep 2025

·www.prnewswire.com

Results of China Phase III Clinical Study of Telitacicept for Generalized Myasthenia Gravis Selected for Oral Presentation at 2025 AANEM Annual Meeting

YANTAI, China, Sept. 17, 2025 /PRNewswire/ -- RemeGen (688331.SH/09995.HK) announced that the 48-week open-label extension (OLE) data from China Phase III clinical study of telitacicept (RC18, brand name: 泰爱®, a BLyS/APRIL dual-target fusion protein innovative drug independently developed by RemeGen) for the treatment of generalized myasthenia gravis (gMG) was selected as an oral presentation at the 2025 American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) Annual Meeting. The meeting will be held from October 29 to November 1, 2025, local time, at the Hilton San Francisco Union Square in California, USA. Oral Presentation Details Presentation Title: Efficacy and Safety of Telitacicept in Patients with Generalized Myasthenia Gravis: Results from a Phase 3 Study Session: MGFA. This session, invited by the Myasthenia Gravis Foundation of America (MGFA) Medical and Scientific Advisory Committee (MSAC), features clinical and scientific experts sharing current and future peer-reviewed research findings on myasthenia gravis (MG). Presentation Time: October 29, 2025, at 10:50 AM Pacific Standard Time (October 30, 1:50 AM Beijing Time). Previously, at the 2025 American Academy of Neurology (AAN) Annual Meeting held in March this year, RemeGen presented the 24-week data from the Phase III study of telitacicept for myasthenia gravis. The results showed that 98.1% of patients achieved an improvement of ≥3 points in the Myasthenia Gravis Activities of Daily Living (MG-ADL) score, and 87% of patients achieved an improvement of ≥5 points in the Quantitative Myasthenia Gravis (QMG) score. Among drugs that have completed Phase III clinical studies for generalized myasthenia gravis, telitacicept has demonstrated highest MG-ADL response rate. The complete 48-week data to be presented at the AANEM Annual Meeting should further highlight telitacicept's potential to become a best-in-class therapy in the field of myasthenia gravis. In June 2025, RemeGen out-licensed telitacicept to Vor Bio (Nasdaq: VOR) and Vor Bio is actively advancing the global multicenter Phase III clinical trial of telitacicept for generalized myasthenia gravis (gMG), with patient recruitment progressing smoothly in the United States, Europe, South America, and the Asia-Pacific region. About Telitacicept Telitacicept is the world's first and first-in-class injectable recombinant B-lymphocyte stimulator (BLyS)/A proliferation-inducing ligand (APRIL) dual-target fusion protein developed by RemeGen. It simultaneously inhibits the binding of BLyS and APRIL cytokines to their receptors on B cells, preventing abnormal differentiation and maturation of B cells, thereby treating autoimmune diseases. Telitacicept has been approved in China for the treatment of systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and generalized myasthenia gravis (gMG). About Vor Bio Vor Bio is a clinical-stage biotechnology company committed to the treatment of autoimmune diseases. The company focuses on rapidly advancing the Phase III clinical development and commercialization of the novel dual-target fusion protein telitacicept to meet the needs of patients with autoimmune diseases worldwide. For more information, please visit . About Generalized Myasthenia Gravis (gMG) gMG is a rare, chronic autoimmune disorder that disrupts communication between nerves and muscles, leading to muscle weakness that can affect mobility, vision, swallowing, and breathing. The disease is antibody-mediated, primarily by autoantibodies against the acetylcholine receptor (AChR) or muscle-specific kinase (MuSK), which interfere with neuromuscular transmission. Despite various treatment options, many patients continue to suffer from refractory symptoms or significant side effects. There is a significant unmet clinical need for new therapies that offer long-lasting efficacy, safety, and convenience. Currently, there are approximately 90,000 gMG patients in the US, 140,000 in Europe, and 29,000 in Japan. 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 Approval

29 Aug 2025

·www.fiercepharma.com

Fierce Pharma Asia—Ivonescimab's survival win; Fosun, Sitala's $670M deal; HutchMed's acting CEO

The first overall survival win for a PD-1xVEGF drug, Fosun Pharma's immune disease deal with Sitala Bio and Hutchmed's acting CEO appointment made our news this week. Akeso and Summit Therapeutics' PD-1xVEGF drug has delivered its first overall survival win in a phase 3 trial. Fosun Pharma out-licensed another immune disease candidate. Hutchmed's CEO took medical leave. And more.1. Akeso, Summit's PD-1xVEGF drug meets overall survival goal for the first time in a lung cancer trialFor the first time, Akeso and Summit Therapeutics’ ivonescimab has hit the overall survival goal in a phase 3 trial. The study, HARMONi-A, tested the PD-1xVEGF drug alongside chemo in patients with previously treated EGFR-mutated nonsquamous non-small cell lung cancer in China. The success of the trial increases the chances that its global version, HARMONi, could meet its overall survival goal, too, Evercore ISI analysts said.2. Sitala, backed by Forbion and OrbiMed, seals $670M deal for Fosun immune disease drugFosun Pharma has signed its second immune-related disease deal in about two weeks. For up to $670 million, the Chinese biopharma is granting Britain’s Sitala Bio ex-China rights to its drug coded FXS6837. Existing therapies for the candidate’s targeted indications generated $3.8 billion in global revenue last year, Fosun said, citing IQVIA data.3. Hutchmed names interim chief as CEO Weiguo Su takes medical leaveHutchmed CEO Weiguo Su, Ph.D., is taking a leave of absence due to health reasons, the company said Monday. The firm’s chief financial officer Johnny Cheng has been named acting CEO to oversee day-to-day operations and management of the company. “This has been a very difficult decision to make, but at this time my focus must be on my health,” Su said in a statement.4. Akeso scores twice in pair of phase 3 trials, teeing up regulatory submission in ChinaAkeso is more than just an oncology company. The company just recorded two positive phase 3 readouts for two of its inflammatory disease candidates. The two drugs, the anti-IL-17A agent gumokimab and the anti-IL-4Rα med manfidokimab, were successful in their respective Chinese trials in active ankylosing spondylitis and atopic dermatitis. Akeso is now planning regulatory submissions in China.5. RemeGen and Vor score again with telitacicept, this time in IgA nephropathyRemeGen’s telitacicept has pulled off another China phase 3 win. The IgA nephropathy study met its primary endpoint, linking the BLyS/APRIL dual-target agent to a 55% reduction in 24-hour urine protein-to-creatinine ratio at 39 weeks compared with placebo. RemeGen recently partnered with Vor Bio on the drug outside of China.Other News of Note:6. Nippon Kayaku, Formiica, CBC form Singapore JV to license drugs in Asia (release)7. Nasdaq-listed LakeShore receives buyout offer from investment consortium (release)8. Chinese CRO ChemPartner gets ready to debut new Boston research facility

Phase 3Executive ChangeAcquisitionClinical ResultBiosimilar

27 Aug 2025

·www.fiercepharma.com

RemeGen and Vor score again with telitacicept, this time in IgA nephropathy

RemeGen and Vor Bio have reported a phase 3 trial win for telitacicept in IgA nephropathy. It is the second phase 3 success for the therapy in the last two weeks, with the other coming in Sjögren’s disease. China biotech RemeGen and its new U.S. partner Vor Bio are on a roll with their first-in-class autoimmune treatment telitacicept.Two weeks after RemeGen revealed the success of a China phase 3 trial of telitacicept in Sjögren’s disease, the companies have reported another late-stage win for the injected treatment, this time in IgA nephropathy (IgAN).In Stage A of a phase 3 study of 318 adult patients in China who had received standard therapy, telitacicept achieved its primary endpoint, showing a 55% reduction in 24-hour urine protein-to-creatinine ratio (UPCR) at 39 weeks compared to placebo, Vor reported.UPCR, which is a measure of kidney damage obtained through a urine sample, is a globally recognized regulatory marker in IgAN. High levels of protein (proteinuria) indicate kidney disease progression in patients with the condition.The FDA has approved other IgAN drugs—like Novartis’ Vanrafia—using the same UPCR metric.RemeGen said it plans to reveal full results of the trial at an upcoming medical conference and will submit a Biologics License Application (BLA) to regulators in China. Two weeks ago, the company said it would submit a BLA for telitacicept in Sjögren’s disease.RemeGen gained its first approval for telitacicept in China for systemic lupus erythematosus (SLE) in 2021. That was followed by nods in China for rheumatoid arthritis (RA) and generalized myasthenia gravis (gMG).In June of this year, Vor Bio paid $45 million upfront to acquire ex-China rights to telitacicept. The deal also includes an initial payment of $80 million in warrants that grant a RemeGen subsidiary roughly a 23% stake in Vor. Long-term, potential clinical and commercial milestones could earn RemeGen up to $4.1 billion from the deal. The licensing deal marked a major reversal for Vor, which had said in May that it was winding down its existing clinical and manufacturing operations and eliminating 95% of its workforce. Vor had been developing two lead cell therapy assets in acute myeloid leukemia and cited a “challenging fundraising environment” as the rationale behind its pivot.The companies tout the dual action of telitacicept, targeting two cell-signaling molecules for B-lymphocyte development—B lymphocyte stimulator (BlyS) and A proliferation-inducing ligand (APRIL). “By directly targeting the upstream drivers of IgAN and stopping the downstream signaling that fuels disease progression, telitacicept has the potential to modify the disease at its core, potentially leading to deeper, more durable responses and long-term kidney preservation for patients,” said Jean-Paul Kress, M.D., Vor’s CEO and chairman, in an Aug. 27 release. “Taken together, these data reinforce our conviction that telitacicept is a pipeline-in-a-product with the potential to deliver a best-in-class profile across multiple autoimmune diseases.”

Phase 3Cell TherapyLicense out/inDrug ApprovalClinical Result

100 Deals associated with Telitacicept

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Myasthenia Gravis	China	RemeGen Co., Ltd.	20 May 2025
Rheumatoid Arthritis	China	RemeGen Co., Ltd.	16 Jul 2024
Systemic Lupus Erythematosus	China	RemeGen Co., Ltd.	09 Mar 2021

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Sjogren's Syndrome	NDA/BLA	China	RemeGen Co., Ltd.	09 Sep 2025
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.	-
Interstitial lung disease due to connective tissue disease	IND Approval	China	RemeGen Co., Ltd.	19 May 2025
Nephrosis	IND Approval	China	RemeGen Co., Ltd.	22 Jul 2024

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05799287 (Corporate Publications) Manual	Phase 3	Glomerulonephritis, IGA	318	泰它西普	hakykctadl(ylvrhqzjnl): Difference (%) = 55, P-Value = <0.0001 Met	Positive	27 Aug 2025
				Placebo
PRNewswire Manual	Phase 3	Primary Sjögren's syndrome	-	Telitacicept	fyxahifgxh(mqqaofulvm) = The clinical results demonstrated that Telitacicept sustainably and effectively improved the clinical symptoms of Sjögren's syndrome patients, while showing favorable safety profile. gceivwmwxh (uclufmirdd ) Met	Positive	13 Aug 2025
				Placebo
GlobeNewswire Manual	Phase 3	Primary Sjögren's syndrome	-	Telitacicept	fvrjwlhtrn(wcpxbnimlb) = reduction baowaszdlr (jmjhurlnya ) Met	Positive	13 Aug 2025
EULAR2025	Not Applicable	Purpura, Thrombocytopenic, Idiopathic \| Systemic Lupus Erythematosus	22	Telitacicept 160mg/week	okmqvvzzok(cksbeogkzs) = The main adverse reactions observed in this study were infections, with 1 patient experiencing pulmonary infection and 1 patient developing herpes zoster secsabhfjn (fcclywthnj )	Positive	11 Jun 2025
NCT05737160 (PipelineReview) Manual	Phase 3	Myasthenia Gravis	114	Telitacicept 240 mg	cjmcvocgsc(nssmovvhxq) = qggjlnkwlf rmrhfgeyhw (arctgtdmzx ) View more	Positive	08 Apr 2025
				Placebo	cjmcvocgsc(nssmovvhxq) = njdlugdxtn rmrhfgeyhw (arctgtdmzx ) View more
NCT06456580 (RemeMG, AAN2025) Manual	Phase 3	Myasthenia Gravis	114	Telitacicept 240 mg	aezxkvbypl(aktoxrsfts) = iluldpkvmk bpmzkranot (csibnumjrw ) View more	Positive	05 Apr 2025
				Placebo	aezxkvbypl(aktoxrsfts) = avbofdgmbh bpmzkranot (csibnumjrw ) View more
NEWS Manual	Not Applicable	Glomerulonephritis, IGA	-	Telitacicept	cpzojkdhhy(bphanlnvwm) = fvqbmxkbnp ksabmseaem (qzkruqdxtg ) View more	Positive	15 Nov 2024
				Supportive treatment	cpzojkdhhy(bphanlnvwm) = glebtvmkjt ksabmseaem (qzkruqdxtg ) View more
ACR2024	Not Applicable	Systemic Lupus Erythematosus	195	Belimumab	jdfwuauasu(mvhyifijbj) = junsmtvtvt ypzwcgefsz (sgkscwjnli ) View more	Similar	10 Nov 2024
				Telitacicept	jdfwuauasu(mvhyifijbj) = frfgcosbyk ypzwcgefsz (sgkscwjnli ) View more
NCT05737160 (NEWS)	-	Myasthenia Gravis	-	泰它西普	tutoygrirv(pgwzfyovhx) = Clinical results have reached the endpoint mesuilismy (teukruprad )	Positive	13 Aug 2024
				安慰剂
NCT02885610 (Pubmed \| Ann Rheum Dis) Manual	Phase 2	Systemic Lupus Erythematosus	249	Telitacicept 80 mg	xpsdjfpyjs(yurfrogeeg) = fitpjcyufr mfncrmwspb (uxhtipgicm )	Positive	01 Apr 2024
				Telitacicept 160 mg	xpsdjfpyjs(yurfrogeeg) = beteooyvjt mfncrmwspb (uxhtipgicm )

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