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+ [10]

Inactive Indication-

Originator Organization

RemeGen Co., Ltd.

Active Organization

RemeGen Co., Ltd.

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), Breakthrough Therapy (China), Conditional marketing approval (China), Priority Review (China)

Structure/Sequence

Sequence Code 616721115

Source: *****

Clinical Trials associated with Telitacicept

NCT07052981

/ Not yet recruitingPhase 3IIT

Clinical Study on the Efficacy and Safety of Telitacicept in the Treatment of Pediatric IgA Nephropathy or IgA Vasculitis Nephritis

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.

NCT07008196

/ Not yet recruitingPhase 4IIT

An Exploratory Clinical Study on Telitacicept for the Treatment of Refractory Rheumatoid Arthritis

This is a single-center, single-arm, open-label, prospective study on the efficacy and safety of Telitacicept in patients with refractory rheumatoid arthritis.

Start Date10 Jun 2025

Sponsor / Collaborator

Chinese SLE Treatment And Research Group

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]

100 Clinical Results associated with Telitacicept

100 Translational Medicine associated with Telitacicept

100 Patents (Medical) associated with Telitacicept

119

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 Aug 2025·PEDIATRIC NEPHROLOGY

Telitacicept as a BAFF/APRIL dual inhibitor: efficacy and safety in reducing proteinuria for refractory childhood IgA vasculitis nephritis

Article

Author: He, Xue ; Mao, Jianhua ; Sheng, Aiqin ; Zhu, Jianhong ; Zhao, Manli ; Jin, Yanyan ; Lin, Qian ; Fu, Haidong

BACKGROUND:

Persistent proteinuria is an independent risk factor for poor prognosis in immunoglobulin A vasculitis nephritis (IgAVN). Recent studies have shown that telitacicept effectively reduces proteinuria levels in patients with IgA nephropathy (IgAN). The treatment has been associated with a significant decrease in galactose-deficient IgA1 (Gd-IgA1) levels. This study aims to elucidate the effectiveness and safety of telitacicept in treating refractory childhood IgAVN.

METHODS:

This is a single-center, retrospective observational study of seven children with IgAVN who had previously received glucocorticoids and at least one immunosuppressive therapy but still exhibited proteinuria. Telitacicept was administered subcutaneously once a week. Dosage was 80 mg for individuals weighing < 40 kg and 160 mg for those weighing > 40 kg.

RESULTS:

The study encompassed seven children, comprising two boys and five girls, with a median age of 15 years. Among the participants, six children (85.7%) exhibited a reduction in proteinuria, ranging from - 23.6 to - 97.5% compared to baseline levels. Conversely, one child (14.3%) did not show any decrease in proteinuria. Throughout the follow-up period, two children (28.6%) achieved complete remission, characterized by proteinuria level below 0.2 g/day/1.73 m² and negative dipstick test for blood. Additionally, all participants demonstrated a significant decline in urinary red blood cell counts. In terms of medication administration, all patients discontinued the use of steroids and immunosuppressants. Furthermore, there was a reduction in the incidence of hospitalizations. Importantly, no serious adverse reactions were reported.

CONCLUSIONS:

Telitacicept has demonstrated both efficacy and safety in treating children with refractory IgAVN.

01 Jul 2025·JOURNAL OF NEUROLOGY

Response to telitacicept in optic neuritis associated with Sjogren's syndrome: a case report and literature review

Review

Author: Chen, Xue ; Yang, YanLong ; Wang, Ling ; Sun, MingFang ; Dai, HuanZi

BACKGROUND:

Optic neuritis (ON) frequently presents as the initial symptom of multiple sclerosis and neuromyelitis optica. Additionally, ON is one of the manifestations of central nervous system damage in Sjögren's syndrome (SS). However, there is little research on SS-associated ON. Currently, there are no standard treatment methods for SS-associated ON, and the recurrence rate remains high.

METHODS:

A 54-year-old female patient primarily exhibited symptoms of dry mouth and dry eyes, along with rapidly deteriorating vision and pain in the left eye. Laboratory tests revealed strong positivity for anti-Sjögren's-syndrome-related antigen A and anti-Sjögren's-syndrome-related antigen B antibodies, and a labial salivary gland biopsy showed focal lymphocytic sialadenitis with a focus score of 13 per 4 mm². Visual evoked potentials indicated a significant absence of waveform in the left eye. The patient was diagnosed with SS-associated ON; however, treatment with glucocorticoid (GC) and cyclophosphamide was unsatisfactory. The patient declined plasma exchange and Rituximab therapy; consequently, she was treated with GC and telitacicept.

RESULTS:

During a 9-month follow-up period, at the minimum GC dosage, the patient's symptoms of dryness and visual acuity in the left eye improved significantly, with no reported recurrence or adverse drug reactions. This indicates both good clinical efficacy and safety.

CONCLUSION:

SS-associated ON is uncommon and easily misdiagnosed. Conventional therapies for ON cannot control recurrence. Telitacicept might represent a promising choice to treat SS-associated ON.

News (Medical) associated with Telitacicept

28 Jun 2025

·endpoints.news

Sources say FDA commissioner sought rejection of KalVista’s rare disease drug; FDA looks into Sarepta’s Duchenne therapy after deaths; and more

Welcome back to Endpoints Weekly! Thanks for spending your Saturday with us. We start this week’s recap with reporting from Endpoints News’ senior biopharma correspondent Andrew Dunn on the FDA’s review of KalVista Pharmaceuticals’ rare disease drug. We also have coverage from the American Diabetes Association conference, a roundup of this week’s notable deals, and details on Novo Nordisk’s decision to call off its partnership with Hims & Hers. As a reminder, nominations close next week for our seventh annual Women in Biopharma R&D report. Click here to learn more about the project, or here to submit a nomination. Nominations close on July 3. — Nicole DeFeudis Multiple sources said Marty Makary was behind a short-lived request to reject a rare disease drug application from KalVista Pharmaceuticals, Endpoints’ Andrew Dunn reported this week . Senior FDA scientists pushed back internally and raised legal concerns, he reported. Academic and legal experts weighed in here . Andrew Nixon, HHS director of communications, said in a statement that the claim that FDA leadership requested a CRL for KalVista’s drug is “totally false and untrue.” He said the drug’s review “is still ongoing, and the FDA will ensure the gold standard of science is used for all decisions.” KalVista announced on June 13 that it had been informed that the agency would not meet its review target for the company’s hereditary angioedema treatment, sebetralstat, “due to heavy workload and limited resources.” KalVista has since said in a statement that the company was unaware of “any internal deliberations at the FDA and we do not comment on rumors.” “We continue to have productive engagement with the FDA and remain focused on the goal of bringing this important new therapy to people living with HAE,” the company said. You can read more here. The agency said it will investigate the deaths after Sarepta reported earlier this month that a second patient died due to liver failure. The patient, a 15-year-old boy, died after being administered the gene therapy Elevidys. The patient was non-ambulatory, meaning he couldn’t walk independently, which is typically seen in older Duchenne patients with more advanced disease. He was participating in Sarepta’s confirmatory clinical trial for the treatment, which was first approved in 2023 for children aged 4 and 5 before getting an expanded approval for older individuals last year. Sarepta has said it would take steps to mitigate future deaths and safety events. The company said this month that it would pause the shipping of Elevidys to non-ambulatory Duchenne patients and stop administering it to such individuals in its confirmatory study. In order for dosing to resume, “regulatory alignment” is needed, Sarepta said. Currently, Elevidys’ prescribing information includes the risk of serious liver injury. But it notably does not include a warning for liver failure or death. It’s not yet clear whether Sarepta will need an updated label. The other patient who died earlier this year, a 16-year-old who got the therapy commercially, was also non-ambulatory. Our reporters covered a handful of deals this week, including Gilead’s agreement with Kymera Therapeutics for a partnership that focuses on degrading CDK2 . CDK2 is implicated primarily in breast cancer but also other solid tumors. Kymera will conduct research, and Gilead will have the option to exclusively license the program. The partners didn’t disclose the upfront payment, but said the upfront and option exercise payments are worth up to $85 million. Kymera can receive up to $750 million in total. Meanwhile, Novartis struck a deal with the proteomics specialist ProFound Therapeutics focused on the cardiovascular space. Under the four-year partnership, Novartis will pay $25 million in upfront and near-term milestones. Illumina has agreed to pay $350 million upfront to acquire proteomics player SomaLogic, in a deal that builds on a yearslong partnership between the companies. Vor Bio said it inked a deal featuring $45 million in cash to license a BAFF/APRIL inhibitor called telitacicept from China’s RemeGen, and announced it’s raising $175 million in a private placement. And biotech correspondent Kyle LaHucik detailed how a dinner in Paris set the stage for Sanofi’s $9.5B deal for Blueprint Medicines earlier this month. Novo Nordisk, which sells the diabetes and weight loss drug semaglutide, abruptly canceled its deal with Hims & Hers after less than two months. The deal had allowed Hims to offer compounded versions of semaglutide — the main component of Ozempic (diabetes brand) and Wegovy (weight loss) — at a discounted price. Hims has been a provider of compounded semaglutide, making it a competitor to Novo. But the relationship soured quickly. Novo accused Hims of “fail[ing] to adhere to the law” and offering “illegitimate” and “knockoff” versions of Wegovy. Hims accused Novo of anticompetitive practices and said it was pressured to sell brand-name Wegovy regardless of whether it was best for patients. A Novo spokesperson declined to say what legal action, if any, the company might take against Hims. Read more from our Health Tech team here . The annual meeting for the American Diabetes Association took place in Chicago this week, and our senior biopharma journalist Elizabeth Cairns broke down some of the biggest readouts and updates presented at the conference. The biggest news? A major update from Vertex, saying its cell therapy for type 1 diabetes allowed 10 of 12 patients (83%) to stop taking insulin a year after they were infused. Other news from the confab included data from the Phase 1/2 obesity trial of Novo’s amycretin, which saw a puzzling lack of dose response. There were also updates from Eli Lilly’s orforglipron, Sciwind Biosciences’ ecnoglutide and Novo Nordisk’s CagriSema. And Amgen said it’s planning lower and slower doses of its long-acting shot MariTide.

AcquisitionDrug Approval

27 Jun 2025

·www.fiercepharma.com

Fierce Pharma Asia—Vor-RemeGen, Otsuka-Harbour autoimmune deals; Datroway's lung cancer nod

Vor Bio and RemeGen's market-dividing licensing deal, Otsuka and Harbour BioMed's BCMA T-cell engager pact, and Datroway's second FDA nod made our news this week. A potential $4 billion licensing deal with Vor Bio triggered a slide in RemeGen's stock price. Otsuka obtained a BCMAXCD3 bispecific from Harbour BioMed to develop against autoimmune diseases. AstraZeneca and Daiichi Sankyo's Datroway secured a lung cancer approval from the FDA. And more.1. Vor Bio's surprise $4B revival deal for RemeGen's autoimmune drug triggers divergent stock reactionsOn the brink of shutting down, Vor Bio has been revived by a licensing deal with China’s RemeGen. For $45 million upfront and up to $4.1 billion in milestones, the Massachusetts biotech is gaining ex-China rights to RemeGen’s BLyS/APRIL dual-target fusion protein telitacicept, which is approved in China to treat several autoimmune diseases. However, RemeGen’s stock price dropped sharply after the news.2. Otsuka pens $670M pact to point Harbour's preclinical T-cell engager toward autoimmune diseaseIn another autoimmune-focused deal involving a Chinese biotech, Otsuka agreed to pay Harbour BioMed $47 million upfront for ex-China rights to a preclinical BCMAxCD3 bispecific candidate. While Harbour got the Chinese green light to test the asset in cancer patients, Otsuka plans to test the drug, HBM7020, against autoimmune conditions.3. AZ, Daiichi's Datroway scores its 2nd FDA approval—this time in lung cancer subsetAstraZeneca and Daiichi Sankyo’s TROP2-targeted antibody-drug conjugate Datroway has picked up its second FDA nod after a refile. Datroway secured the EGFR-mutated non-small cell lung cancer indication after the companies had withdrawn an earlier application in nonsquamous NSCLC following a phase 3 overall survival miss.4. Corxel, Sciwind post GLP-1 data as China's obesity push gathers paceGLP-1 assets from China are showing their power at the American Diabetes Association Scientific Sessions. Sciwind’s phase 3 data linked its injectable GLP-1 receptor agonist ecnoglutide to a mean weight loss of 15.4% after 48 weeks. Phase 2 data on Corxel and Vincentage’s small-molecule GLP-1 candidate showed a 9.7% weight reduction in 16 weeks when given at a fast titration to the highest dose.5. BrightGene tops Novo drug in diabetes ahead of Zepbound showdownAlso at ADA, China’s BrightGene reported that its GLP-1/GIP receptor agonist BGM0504 topped Novo Nordisk’s Ozempic in Chinese patients with Type 2 diabetes in a midstage trial. The drug saw dose-dependent reductions in HbA1c of up to 2.48% after 12 weeks, versus 1.43% for Ozempic and 0.28% for placebo. The biotech also shared phase 2 obesity data comparing BGM0504 against placebo, and the company is pitting the drug against Eli Lilly’s Zepbound in another phase 2 study.6. FDA moves to block Olympus endoscope imports over manufacturing issuesThe FDA warned healthcare providers that it’s shutting down imports of 58 models of aparoscopes, bronchoscopes, nasopharyngoscopes and ureteroscopes, as well as automated cleaners and reprocessing accessories, made by Olympus. The agency cited concerns around quality requirements at a production site in Japan.Other News of Note:7. GSK, Bharat Biotech to slash the price of first malaria vaccine to less than $5 per dose by 20288. Hummingbird uses VISTA buzz to secure $290M pact for phase 2-ready tumor drug9. Arbutus regains China rights to potential functional hep B cure as part of strategic rethink10. Korea’s Abion Bio inks $1.3B deal over CLDN3, other cancer targets (Korea Biomedical Review)

Clinical ResultPhase 3Drug ApprovalPhase 2License out/in

26 Jun 2025

·pipelinereview.com

Vor Bio Enters into Exclusive Global License Agreement with RemeGen for Late-Stage Autoimmune Asset

– Vor Bio receives ex-Greater China rights to develop and commercialize telitacicept, a novel, dual-target recombinant fusion protein in global Phase 3 development for generalized myasthenia gravis -RemeGen receives initial payment of $125 million consisting of an upfront payment of $45 million plus $80 million of warrants, potential regulatory and commercial milestones exceeding $4 billion, as well as tiered royalties -Seasoned biopharma leader, Jean-Paul Kress, MD, appointed as Chief Executive Officer and Chairman of the Board, bringing proven track record in clinical development, commercialization, and strategic growth CAMBRIDGE, MA, USA I June 25, 2025 I Vor Bio, Inc. (Nasdaq: VOR) and RemeGen Co., Ltd. (HKEX: 9995, SHA: 688331) today announced entry into an exclusive license agreement granting Vor Bio global rights (excluding China, Hong Kong, Macau and Taiwan) to develop and commercialize telitacicept, a novel dual-target fusion protein approved in China for generalized myasthenia gravis (gMG), systemic lupus erythematosus (SLE), and rheumatoid arthritis (RA). Under the terms of the agreement, Vor Bio will pay RemeGen an initial payment of $125 million consisting of an upfront payment of $45 million as well as $80 million of warrants to purchase common stock with an exercise price of $0.0001 per share. The agreement also provides for potential regulatory and commercial milestones exceeding $4 billion, in addition to tiered royalties. Telitacicept is a novel, investigational fusion protein that targets key immune pathways involved in autoimmune disease. By selectively inhibiting BlyS (also known as BAFF) and APRIL – cytokines critical to B cell survival – telitacicept reduces autoreactive B cells and autoantibody production. RemeGen is conducting a global Phase 3 clinical trial which is now enrolling in the United States, Europe, and South America, with initial results expected in the first half of 2027. Vor Bio also announced that its Board of Directors (the “Board”) has appointed Jean-Paul Kress, M.D., as Chief Executive Officer and Chairman of the Board, effective today. This follows Dr. Robert Ang’s resignation from the positions of Chief Executive Officer and director earlier today. Dr. Ang will continue with Vor Bio as a strategic advisor to assist in the transition through October 2025. Dr. Kress’s strategic vision and track record of transformative leadership position him to guide the company into its next phase of growth. “I am absolutely thrilled to be leading Vor Bio as we transform the company to become a major player in autoimmune disease treatment,” said Dr. Kress, Chairman and Chief Executive Officer, Vor Bio. “Targeting BAFF/APRIL signaling with telitacicept represents a significant advancement in addressing autoantibody driven diseases, which is highly differentiated from other modalities in this space. With a clinically advanced asset, we are uniquely positioned to develop this innovative therapy, with the goal of making a meaningful impact for patients living with autoimmune diseases around the world.” Dr. Kress brings decades of executive leadership experience in the pharmaceutical and biotech industries. He most recently served as Chief Executive Officer of MorphoSys, where he led the development, approval and commercialization of Monjuvi®️ (tafasitamab), and advanced the company’s pipeline through the landmark acquisition of Constellation Pharmaceuticals in 2021, strengthening MorphoSys’ position in oncology innovation and ultimately leading to its subsequent acquisition by Novartis in 2024. Prior to that, he was CEO of Syntimmune, guiding its lead immunology program through to acquisition by Alexion Pharmaceuticals. He currently serves on the Board of Sanofi S.A. and has held senior roles across leading biopharma companies. “Today marks a transformative milestone for RemeGen and the global development of telitacicept,” said Dr. Jianmin Fang, CEO of RemeGen. “The strategic out-licensing of telitacicept’s ex-China rights accelerates our mission to deliver this innovative therapy to patients worldwide and will help maximize telitacicept’s clinical and commercial potential on the global scale.” About Telitacicept Telitacicept is a novel, investigational recombinant fusion protein designed to treat autoimmune diseases by selectively inhibiting BLyS (BAFF) and APRIL – two cytokines essential to B cell and plasma cell survival. This dual-target mechanism reduces autoreactive B cells and autoantibody production, key drivers of autoimmune pathology. In a Phase 3 clinical trial in generalized myasthenia gravis in China, telitacicept demonstrated a 4.8-point improvement in MG-ADL (Myasthenia Gravis Activities of Daily Living scale) vs. placebo at 24 weeks, the primary endpoint of the trial. Telitacicept is approved in China for systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and generalized myasthenia gravis (gMG). A global Phase 3 clinical trial in gMG is currently underway across the United States, Europe, and South America to support potential approval in the United States and Europe. About Vor Bio Vor Bio is a clinical-stage biotechnology company transforming the treatment of autoimmune diseases. The company is focused on rapidly advancing telitacicept, a novel dual-target fusion protein, through Phase 3 clinical development and commercialization to address serious autoantibody-driven conditions worldwide. For more information visit www.vorbio.com. About RemeGen Co. Ltd. Founded in 2008, RemeGen 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. SOURCE: Vor Bio

Phase 3Executive ChangeLicense out/inDrug ApprovalAcquisition

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
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.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
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
Immunoglobulin G4-Related Disease	IND Approval	China	RemeGen Co., Ltd.	17 Jun 2024

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05737160 (PipelineReview) Manual	Phase 3	Myasthenia Gravis	114	Telitacicept 240 mg	kamehrhgto(xrbbruwmni) = sjchubxzcs xwwyoqufcp (oatfstbhak ) View more	Positive	08 Apr 2025
				Placebo	kamehrhgto(xrbbruwmni) = yoseugygas xwwyoqufcp (oatfstbhak ) View more
NCT06456580 (RemeMG, AAN2025) Manual	Phase 3	Myasthenia Gravis	114	Telitacicept 240 mg	gbuuveyqle(cizuwutiyl) = mqxxgeomvt xwptasfviy (ljocgzvhfe ) View more	Positive	05 Apr 2025
				Placebo	gbuuveyqle(cizuwutiyl) = puekjvhasl xwptasfviy (ljocgzvhfe ) View more
NEWS Manual	Not Applicable	Glomerulonephritis, IGA	-	Telitacicept	qrbmgvahzp(jnkparbvqu) = kmqyccijzr ktzegyrobc (lnervcfror ) View more	Positive	15 Nov 2024
				Supportive treatment	qrbmgvahzp(jnkparbvqu) = reewlyudpv ktzegyrobc (lnervcfror ) View more
NCT02885610 (Pubmed \| Ann Rheum Dis) Manual	Phase 2	Systemic Lupus Erythematosus	249	Telitacicept 80 mg	etwxgigpjv(dmvvuudbzx) = gggzcynxbz vlarvoqpmy (thxkpetrcw )	Positive	01 Apr 2024
				Telitacicept 160 mg	etwxgigpjv(dmvvuudbzx) = gfekpgdycy vlarvoqpmy (thxkpetrcw )
NCT04078386 (Literature) Manual	Phase 2	Primary Sjögren's syndrome	42	telitacicept 160 mg	fgeizfrboq(rgmhyfkuwh) = None yjwqdbhbjr (fecexhjuut ) View more	Positive	01 Mar 2024
				telitacicept 240 mg
NCT03016013 (ACR2023) Manual	Phase 3	Rheumatoid Arthritis	479	Telitacicept 160 mg	knwovqxzsp(fkjdqfruea) = cqkbtzglsb rglkqvlrqi (hmahisjfgk ) View more	Positive	24 Oct 2023
				Placebo	knwovqxzsp(fkjdqfruea) = jdxsdrxtuk rglkqvlrqi (hmahisjfgk ) View more
NCT04078386 (Corporate Publications) Manual	Phase 2	Primary Sjögren's syndrome	42	placebo	zjzpsjbars(izpzutcppi) = wzrcfgqtwt iwhhjlktir (wrytcbvqnh, 4.55)	Positive	17 Jul 2023
				Telitacicept 160 mg	zjzpsjbars(izpzutcppi) = wttxhzstob iwhhjlktir (wrytcbvqnh, 2.73)
EULAR2023	Phase 3	Systemic Lupus Erythematosus ANA/anti-dsDNA \| C3 \| C4 ... View more	335	Telitacicept 160 mg	xdczfdvscm(yaxjdkoyhe) = vhxcdaisho kvuqqtpvau (xnzaccusdg )	Positive	31 May 2023
				Placebo	xdczfdvscm(yaxjdkoyhe) = isrncskbdg kvuqqtpvau (xnzaccusdg )
Pubmed Manual	Not Applicable	Systemic Lupus Erythematosus	20	Telitacicept	bguomswjkj(psavzrufce) = pljdqusoaj aptgjjsaog (gylqehvtyo ) View more	Positive	23 Nov 2022
NCT04302103 (Corporate Publications) Manual	Phase 2	Myasthenia Gravis	29	泰它西普 (160mg)	udmzfgzqwx(osmqyuoabn) = sdolbqyjvh bjynlcvzbh (mweikiwgvz )	Positive	31 Oct 2022
				泰它西普 (240mg)	udmzfgzqwx(osmqyuoabn) = ouviapabbu bjynlcvzbh (mweikiwgvz )

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