Tai'ai (telitacicept) / Rongchang Pharma, Vor Biopharma - LARVOL DELTA

A Randomized Controlled Study of Fumarate Tegileridine versus Sufentanil for Postoperative Analgesia in Abdominal Surgery: A Comparison of Efficacy and Safety (ChiCTR) - P1 | N=60 | Not yet recruiting | Sponsor: The Second Affiliated Hospital of Xinjiang Medical University; The Second Affiliated Hospital of Xinjiang Medical University

New P1 trial

Emerging Therapies in IgA Nephropathy: From A Proliferation-Inducing Ligand (APRIL) and B-cell Activating Factor (BAFF) Inhibitors to Precision Medicine. (PubMed, Cureus) - "This review synthesizes current evidence on evolving treatments, with a focus on A Proliferation-Inducing Ligand (APRIL) and B-cell Activating Factor (BAFF) (e.g., sibeprenlimab, atacicept, povetacicept, telitacicept), complement pathway modulators (e.g., iptacopan, cemdisiran, ravulizumab), and novel agents such as felzartamab and sparsentan. It also explores precision medicine strategies, including biomarker-guided therapy, individualized risk stratification, and combination regimens. Supported by high-quality recent clinical trial data and the latest kidney disease outcome guidelines, these innovations represent a paradigm shift toward personalized, disease-modifying treatment in IgAN, offering a new horizon for improved renal outcomes and long-term disease control."

Journal • Review • Chronic Kidney Disease • Glomerulonephritis • IgA Nephropathy • Nephrology • Renal Disease

Case Report: Complete remission of Guillain-Barré syndrome in neuropsychiatric lupus with telitacicept. (PubMed, Front Immunol) - "Following inadequate response to intravenous immunoglobulin monotherapy, combination treatment was initiated with methylprednisolone (40mg daily), cyclophosphamide (0.6g biweekly), hydroxychloroquine, and telitacicept (160mg weekly), a novel dual inhibitor of B lymphocyte stimulator and a proliferation-inducing ligand that simultaneously targets B cells and plasma cells. Corticosteroids were successfully tapered to 4mg daily without disease flare. This first report of telitacicept use in NPSLE-GBS demonstrates that dual BLyS/APRIL inhibition can achieve complete remission in refractory cases, offering a promising therapeutic approach that warrants further investigation in controlled trials."

Journal • CNS Disorders • Immunology • Inflammatory Arthritis • Lupus • Pain • Psychiatry • Systemic Lupus Erythematosus

Case Report: Telitacicept exposure in early pregnancy in a patient with SLE delivering an infant without any physical defect. (PubMed, Front Med (Lausanne)) - "The use of biologics is not recommended during pregnancy in SLE patients; belimumab or rituximab may be considered selectively only during lactation...During gestation, she was maintained on oral glucocorticoids, hydroxychloroquine, and tacrolimus. On 23 June 2025, at 32 weeks of gestation, she underwent a cesarean section due to "intrauterine growth restriction and preeclampsia" and delivered a male infant without any physical defects. This case suggests that exposure to telitacicept in the early stage of pregnancy did not result in structural defects in this case."

Journal • Gynecology • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Immunology : what's new in 2025 (PubMed, Rev Med Suisse) - "Among therapeutic advances in systemic autoimmune diseases, obinutuzumab, when added to the standard of care, has proved effective in treating active lupus nephritis, anifrolumab has confirmed its long-term benefits in treating systemic lupus erythematosus (SLE), new drugs such as telitacicept and ianalumab have passed phase III trials, and T-cell engagers show promise in controlling refractory autoimmune diseases. Finally, cardiovascular risk scores (Systematic COronary Risk Evaluation - SCORE2, QRESEARCH risk estimator version 3 - QRISK3, Predicting Risk of Cardiovascular Disease Events - PREVENT), which were developed for the general population, were specifically evaluated in SLE, given its particularly high burden of cardiovascular events."

Journal • Cardiovascular • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Rheumatology • Systemic Lupus Erythematosus

Use of Telitacicept in Rescue Therapy for Rituximab (RTX)-Refractory/Relapsed Membranous Nephropathy (MN) (ChiCTR) - P=N/A | N=50 | Not yet recruiting | Sponsor: The First Affiliated Hospital of Zhengzhou University; The First Affiliated Hospital of Zhengzhou University

New trial • Glomerulonephritis • Renal Disease

Telitacicept versus belimumab in proliferative lupus nephritis. (PubMed, Front Immunol) - "In this preliminary study, telitacicept appears to induce earlier renal and immunologic remission than belimumab, along with a potential reduction in the need for glucocorticoids and immunosuppressants. Further validation in larger studies is needed."

Clinical • Journal • Retrospective data • Chronic Kidney Disease • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Renal Disease • Systemic Lupus Erythematosus

A Prospective Comparative Study Involving Multiple Units to Evaluate the Efficacy and Safety of Telitacicept and Belimumab in the Treatment of Systemic Lupus Erythematosus. (clinicaltrials.gov) - P=N/A | N=180 | Not yet recruiting | Sponsor: Yipeng Liu | Trial completion date: Jun 2028 ➔ Sep 2029 | Initiation date: Aug 2025 ➔ Feb 2026 | Trial primary completion date: Jun 2027 ➔ Sep 2029

Trial completion date • Trial initiation date • Trial primary completion date • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

A Comparative Study of the Efficacy and Safety of Telitacicept and Belimumab in the Treatment of Systemic Lupus Erythematosus Involving Multiple Units, Based on Previous Data. (clinicaltrials.gov) - P=N/A | N=180 | Active, not recruiting | Sponsor: Yipeng Liu | Trial completion date: Aug 2025 ➔ Mar 2026 | Initiation date: May 2025 ➔ Nov 2025 | Trial primary completion date: Jun 2025 ➔ Mar 2026

Trial completion date • Trial initiation date • Trial primary completion date • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Comparing Efficacy and Safety of Telitacicept and Belimumab in Lupus Nephritis: A Retrospective Multicenter Cohort Study. (clinicaltrials.gov) - P=N/A | N=56 | Completed | Sponsor: Yipeng Liu | Active, not recruiting ➔ Completed | Trial completion date: Aug 2025 ➔ Dec 2025 | Initiation date: May 2025 ➔ Oct 2025 | Trial primary completion date: Jun 2025 ➔ Dec 2025

Trial completion • Trial completion date • Trial initiation date • Trial primary completion date • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology

Cost-utility analysis of telitacicept versus belimumab in the treatment of systemic lupus erythematosus in China. (PubMed, Front Public Health) - "Telitacicept is more cost-saving than belimumab (Dominant). Under current pricing, treatment settings and efficacy data in China, telitacicept demonstrates superior cost-effectiveness compared with belimumab for long-term SLE management by reducing medication costs while delivering additional health benefits."

HEOR • Journal • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

A multicenter prospective cohort study comparing the efficacy and safety of telitacicept and belimumab in the treatment of systemic lupus erythematosus. (ChiCTR) - P=N/A | N=180 | Not yet recruiting | Sponsor: Shandong Provincial Qianfoshan Hospital; Shandong Provincial Qianfoshan Hospital

New trial • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

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 (ChiCTR) - P=N/A | N=78 | Recruiting | Sponsor: The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital); The First Affiliated Hospital of Universit | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Efficacy and Safety of Tacrolimus and Telitacicept in PLA2R-Associated Membranous Nephropathy (ChiCTR) - P4 | N=120 | Not yet recruiting | Sponsor: The First Affiliated Hospital of the Air Force Medical University; The First Affiliated Hospital of the Air Force Medical University

New P4 trial • Glomerulonephritis • Renal Disease

An observational study based on B cell function and homeostasis to identify early predictors of therapeutic response to Taitacept in systemic lupus erythematosus (ChiCTR) - P=N/A | N=161 | Recruiting | Sponsor: The First Affiliated Hospital of Xi'an Jiaotong University; The First Affiliated Hospital of Xi'an Jiaotong University

New trial • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

The Efficacy of Telitacicept in the Treatment of Persistent Hypocomplementemia in Patients with Lupus Nephritis (ChiCTR) - P=N/A | N=190 | Not yet recruiting | Sponsor: Affiliated Hospital of Guangdong Medical University; Affiliated Hospital of Guangdong Medical University

New trial • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology

The efficacy and safety of telitacicept in children with IgA vasculitis nephritis：A multicenter retrospective study (ChiCTR) - P=N/A | N=300 | Recruiting | Sponsor: Children's Hospital,Zhejiang University School of Medicine; Children's Hospital,Zhejiang University School of Medicine

New trial • Nephrology • Vasculitis

Study on the Efficacy and Safety of Short-Course Telitacicept in Sjögren's Syndrome (ChiCTR) - P=N/A | N=60 | Recruiting | Sponsor: The First Affiliated Hospital of Nanchang University; The First Affiliated Hospital of Nanchang University

New trial • Sjogren's Syndrome

Telitacicept in combination with systemic steroid therapy in a patient with refractory pemphigus vulgaris and tuberculosis: a case report. (PubMed, Eur J Dermatol) - No abstract available

Journal • Dermatology • Immunology • Infectious Disease • Pemphigus Vulgaris • Pulmonary Disease • Respiratory Diseases • Tuberculosis

A Study of Telitacicept for the Treatment of Generalized Myasthenia Gravis (RemeMG) (clinicaltrials.gov) - P3 | N=180 | Recruiting | Sponsor: Vor Biopharma | Trial completion date: Oct 2027 ➔ Jan 2028 | Trial primary completion date: Jul 2026 ➔ Dec 2026

Trial completion date • Trial primary completion date • CNS Disorders • Myasthenia Gravis

Effects of Telitacicept vs Cyclophosphamide on Lupus Related Interstitial Lung Disease (clinicaltrials.gov) - P4 | N=100 | Recruiting | Sponsor: Tongji Hospital | Enrolling by invitation ➔ Recruiting | Trial completion date: Dec 2025 ➔ Mar 2027 | Trial primary completion date: Dec 2025 ➔ Oct 2026

Enrollment status • Trial completion date • Trial primary completion date • Immunology • Inflammatory Arthritis • Interstitial Lung Disease • Lupus • Pulmonary Disease • Respiratory Diseases • Systemic Lupus Erythematosus

Telitacicept for systemic lupus erythematosus-associated peripheral neuropathy: a case report. (PubMed, Front Immunol) - "Current standard therapies, including glucocorticoids (GCs) and cyclophosphamide (CYC), are often effective but carry significant risks, such as gonadal toxicity with CYC, which is a major concern for young women...The patient had a 17-year history of SLE and lupus nephritis, previously treated with high cumulative doses of CYC (13.2g), GCs, and mycophenolate mofetil (MMF)...Due to her age and fertility concerns, subcutaneous telitacicept (160 mg/week) was added to her ongoing regimen of prednisone (10 mg/day) and MMF...It demonstrates that telitacicept can be a highly effective and steroid-sparing therapy, offering a safer alternative for patients where conventional immunosuppressants like CYC are contraindicated, particularly those of reproductive age. Future studies should explore parallels with immune checkpoint inhibitor (ICI)-related neuropathies."

IO biomarker • Journal • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Oncology • Pain • Renal Disease • Systemic Lupus Erythematosus

Telitacicept for childhood HSPN: A prospective self-controlled study. (PubMed, Clin Rheumatol) - "RC18 effectively reduces urine protein and RBC in HSPN children, with good clinical effects and safety. Key Points • Efficacy and safety study of Telitacicept in the treatment of children with HSPN. • Preliminary exploration on the mechanism of Telitacicept in the treatment of children with HSPN."

Journal • Nephrology • CD4 • CD8

TELITACICEPT IN INFLAMMATORY MYOPATHIES(TELITACICEPT-IM) (clinicaltrials.gov) - P2/3 | N=30 | Not yet recruiting | Sponsor: Zhongming Qiu

New P2/3 trial • Myositis

Telitacicept in the Treatment of Pediatric IgA Vasculitis-Associated Nephritis (clinicaltrials.gov) - P=N/A | N=300 | Not yet recruiting | Sponsor: The Children's Hospital of Zhejiang University School of Medicine

New trial • Nephrology • Pediatrics • Vasculitis