Drugs / Telitacicept
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed generalized myasthenia gravis 1 milestone | |||||
| Filed | China (NMPA) | Tai'ai® | generalized myasthenia gravis | 2024-10-27 | “the BLA of Telitacicept for the treatment of gMG has been accepted by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration” remegen.com ↗ |
| Filed IgA glomerulonephritis 1 milestone | |||||
| Filed | China (NMPA) | — | IgA glomerulonephritis | 2025-11-08 | “has been submitted to the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China for IgAN” vorbio.com ↗ |
| Filed rheumatoid arthritis 1 milestone | |||||
| Filed | China (NMPA) | — | rheumatoid arthritis | 2023-11-22 | “the biologics license application of Telitacicept for treatment of rheumatoid arthritis (RA) has been received by Center of Drug Evaluation (CDE), NMPA in China.” remegen.com ↗ |
Trials 48
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT06549959 | Aug → Nov 2024 overdue | — | RemeGen Co., Ltd. | Recruiting | No outcome recorded |
| Phase 1 | NCT05687526 | May 2023 → Nov 2025 | pediatric systemic lupus erythematosus | RemeGen Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT05247203 | May 2022 → Oct 2023 | systemic lupus erythematosus | RemeGen Co., Ltd. | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT06656962 | Oct 2024 → Dec 2025 overdue | pauci-immune glomerulonephritis with ANCA | Renmin Hospital of Wuhan University | Active not recruiting | No outcome recorded |
| Phase 215 trials | ||||||
| Phase 2 | NCT07836660 | Oct 2026 → Nov 2027 expected | Sjogren syndrome | Innovent Biologics (Suzhou) Co. Ltd. | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07796516 | Sep 2026 → Dec 2027 expected | rheumatoid arthritis | Peking University People's Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT07687134 | Jul 2026 overdue | thrombocytopenia due to immune destruction | Institute of Hematology & Blood Diseases Hospital, China | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07522099 | May 2026 → Jul 2028 expected | IgA glomerulonephritis, complement 3 glomerulopathy, membranoproliferative glomerulonephritis | ADARx Pharmaceuticals, Inc. | Recruiting | No outcome recorded |
| Phase 2 | NCT07340463 | Dec 2025 → Jun 2027 expected | lupus nephritis, systemic lupus erythematosus | Nanjing University School of Medicine | Recruiting | No outcome recorded |
| Phase 2 | NCT07111338 | Jul 2025 → May 2027 expected | proliferative glomerulonephritis | Peking University First Hospital | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06375005 | Jan 2025 → Jan 2027 expected | diffuse cutaneous systemic sclerosis | Second Affiliated Hospital, School of Medicine, Zhejiang University | Recruiting | No outcome recorded |
| Phase 2 | NCT06614985 | Oct 2024 → Oct 2026 expected | idiopathic membranous glomerulonephritis | Renmin Hospital of Wuhan University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05998759 | Dec 2023 → Dec 2025 overdue | connective tissue disorder, thrombocytopenia | Beijing Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06315530 | Dec 2023 → Apr 2025 | primary antiphospholipid syndrome | Ruijin Hospital | Completed | No outcome recorded |
| Phase 2 | NCT05929248 | Jul 2023 → Jun 2024 | systemic lupus erythematosus | Guanmin Gao | Unknown | No outcome recorded |
| Phase 2 | NCT05680480 | Apr 2023 → Dec 2025 overdue | lupus nephritis | RemeGen Co., Ltd. | Recruiting | No outcome recorded |
| Phase 2 | NCT04905212 | Nov 2021 → Nov 2023 | IgA glomerulonephritis | RemeGen Co., Ltd. | Terminated | No outcome recorded |
| Phase 2 | NCT05078710 | Jul 2021 → Jul 2022 | antiphospholipid syndrome | Peking Union Medical College Hospital | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT04302103 | Jul 2020 → Jan 2022 | generalized myasthenia gravis | RemeGen Co., Ltd. | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT07355257 | Feb → Dec 2026 expected | myositis disease | Zhongming Qiu | Not yet recruiting | No outcome recorded |
| Phase 2/3 | NCT05596708 | Mar 2023 → Jun 2025 overdue | IgA glomerulonephritis | Second Affiliated Hospital, School of Medicine, Zhejiang University | Not yet recruiting | No outcome recorded |
| Phase 314 trials · 3 met primary | ||||||
| Phase 3 | NCT07495033 | Apr 2026 → May 2029 expected | interstitial lung disease | RemeGen Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07404865 | Feb 2026 → Dec 2028 expected | Sjogren syndrome | Vor Biopharma | Recruiting | No outcome recorded |
| Phase 3 | NCT07249632 | Jan → Dec 2026 expected | ocular myasthenia gravis | RemeGen Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT07052981 | Aug 2025 → Jun 2027 expected | IgA glomerulonephritis, immune complex mediated vasculitis | Guixia Ding | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06456567 | Sep 2024 → Jan 2025 | systemic lupus erythematosus | Vor Biopharma | Withdrawn | No outcome recorded Stop: Business |
| Phase 3 | NCT07098897 | Aug 2024 → May 2025 overdue | IgA glomerulonephritis | The Affiliated Hospital of Xuzhou Medical University | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06456580 | Jul 2024 → May 2027 expected | generalized myasthenia gravis | Vor Biopharma | Recruiting | No outcome recorded |
| Phase 3 | NCT06125405 | Nov 2023 → Oct 2026 expected | nephrotic syndrome | The Children's Hospital of Zhejiang University School of Medicine | Recruiting | No outcome recorded |
| Phase 3 | NCT05799287 | Apr 2023 → Jun 2026 overdue | IgA glomerulonephritis | RemeGen Co., Ltd. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05673993 | Apr 2023 → Oct 2024 | Sjogren syndrome | RemeGen Co., Ltd. | Completed | Met primary |
| Phase 3 | NCT05737160 | Mar 2023 → Nov 2024 | generalized myasthenia gravis | RemeGen Co., Ltd. | Completed | Met primary |
| Phase 3 | NCT05339217 | Feb 2023 → Jul 2025 | systemic lupus erythematosus | Liu Tian | Unknown | No outcome recorded |
| Phase 3 | NCT05306574 | Jun 2022 → Jan 2025 | systemic lupus erythematosus | Vor Biopharma | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT04082416 | Oct 2019 → Apr 2022 | systemic lupus erythematosus | RemeGen Co., Ltd. | Completed | Met primary |
| Phase 48 trials | ||||||
| Phase 4 | NCT07077486 | Aug 2025 → Oct 2026 expected | interstitial lung disease, systemic lupus erythematosus | Tongji Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT07008196 | Jun → Dec 2025 overdue | rheumatoid arthritis | Chinese SLE Treatment And Research Group | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06723548 | Dec 2024 → Dec 2025 overdue | myasthenia gravis | First Affiliated Hospital of Wenzhou Medical University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06546540 | Jun 2024 → Dec 2025 overdue | systemic sclerosis | Peking University Third Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT05962840 | Jun 2023 → Dec 2026 expected | anti-neutrophil cytoplasmic antibody-associated vasculitis | Chinese SLE Treatment And Research Group | Recruiting | No outcome recorded |
| Phase 4 | NCT05965284 | Mar 2023 → Dec 2025 overdue | anti-neutrophil cytoplasmic antibody-associated vasculitis | Chinese SLE Treatment And Research Group | Recruiting | No outcome recorded |
| Phase 4 | NCT05666336 | Dec 2022 → Jun 2024 | systemic lupus erythematosus | Fen Li | Unknown | No outcome recorded |
| Phase 4 | NCT05899907 | Sep 2022 → Mar 2025 | systemic lupus erythematosus | Peking Union Medical College Hospital | Unknown | No outcome recorded |
| Phase not applicable5 trials | ||||||
| — | NCT07298928 | Mar 2026 → Dec 2028 expected | — | The Children's Hospital of Zhejiang University School of Medicine | Not yet recruiting | No outcome recorded |
| — | NCT07597733 | Sep 2025 → Aug 2027 expected | chronic inflammatory demyelinating polyradiculoneuropathy | Sichuan Academy of Medical Sciences | Active not recruiting | No outcome recorded |
| — | NCT06827587 | Feb 2025 → Feb 2026 overdue | generalized myasthenia gravis, neuromuscular disease | First Affiliated Hospital of Wenzhou Medical University | Not yet recruiting | No outcome recorded |
| — | NCT06654596 | Dec 2024 → Dec 2026 expected | IgA glomerulonephritis | Ruijin Hospital | Recruiting | No outcome recorded |
| — | NCT06394063 | Jun 2024 → Jun 2027 expected | systemic lupus erythematosus | RenJi Hospital | Recruiting | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 4 | NCT06677801 Comparator | Oct 2024 → Oct 2026 expected | systemic lupus erythematosus | Second Affiliated Hospital, School of Medicine, Zhejiang University | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 23
| Date | Issuer | Release |
|---|---|---|
| 2026-09-29 | Vor Biopharma | Results Telitacicept Demonstrates Deep and Durable Minimal Symptom Expression Through 48 Weeks in Generalized Myasthenia Gravis vorbio.com ↗
More than 94% of participants achieved a ≥5-point MG-ADL improvement at Week 48 |
| 2026-06-08 | RemeGen Co., Ltd. | Regulatory Remegen's Telitacicept Two Indications Approved on the Same Day, Patients with Sjögren's Syndrome (Dry Disease) and IgA Nephropathy Welcome the World's First Dual-Target Biologic Drug remegen.com ↗
Telitacicept (RC18) has received approval from the China National Medical Products Administration (NMPA) for two new indications: the treatment of Sjögren's syndrome (dry disease) and IgA nephropathy. |
| 2026-06-08 | Vor Biopharma | Regulatory Telitacicept Receives NMPA Conditional Approval for the Treatment of IgA Nephropathy in China vorbio.com ↗
Vor Bio (Nasdaq: VOR), a clinical-stage biotechnology company transforming the treatment of autoimmune diseases, and RemeGen Co., Ltd., (HKEX: 9995, SHA: 688331) today announced that China’s National Medicinal Products Administration (NMPA) has conditionally approved telitacicept for the treatment of adult patients with IgAN. |
| 2026-06-08 | Vor Biopharma | Regulatory Telitacicept Receives NMPA Approval for the Treatment of Sjögren’s Disease in China vorbio.com ↗
China’s National Medicinal Products Administration (NMPA) has approved telitacicept for the treatment of adult patients with SjD. |
| 2026-05-14 | Vor Biopharma | Results Vor Bio Announces Publication of Interim Analysis of TELIGAN, a China Phase 3 Trial of Telitacicept in IgA Nephropathy, in The New England Journal of Medicine vorbio.com ↗
Interim analysis demonstrated a 55.0% relative reduction in proteinuria versus placebo at 39 weeks with eGFR remaining stable through treatment |
| 2025-11-08 | Vor Biopharma | Results Telitacicept Achieved Primary Endpoint of Reducing Proteinuria in Stage A of a Phase 3 Clinical Study for IgA Nephropathy in China vorbio.com ↗
Treatment with telitacicept for 39 weeks resulted in a rapid, clinically meaningful, and statistically significant reduction in proteinuria, with a favorable safety profile |
| 2025-10-29 | Vor Biopharma | Results Telitacicept Demonstrates Sustained Efficacy and Favorable Safety Profile in 48-Week China Phase 3 Open-Label Extension Generalized Myasthenia Gravis Data vorbio.com ↗
100% of patients on telitacicept for 48 weeks achieved ≥2-point Myasthenia Gravis Activities of Daily Living (MG-ADL) improvement, with a mean reduction of -7.5 points |
| 2025-10-16 | Vor Biopharma | Results Vor Bio Announces Publication of China Phase 3 Study of Telitacicept in Systemic Lupus Erythematosus in The New England Journal of Medicine vorbio.com ↗
For the first time, a therapy in a Phase 3 trial is delivering more than double the clinical response seen with the current standard of care in lupus. |
| 2025-10-14 | Vor Biopharma | Results Telitacicept Demonstrates Clinically Meaningful and Statistically Significant Impact on ESSDAI Compared to Placebo in Late-Breaking China Phase 3 Results in Primary Sjögren’s Disease at ACR 2025 vorbio.com ↗
Telitacicept met primary and all secondary endpoints, demonstrating clinically meaningful improvements in disease activity versus placebo |
| 2025-08-27 | Vor Biopharma | Results Telitacicept Achieved Primary Endpoint in Phase 3 Clinical Study for IgA Nephropathy vorbio.com ↗ |
| 2025-08-13 | RemeGen Co., Ltd. | Results Telitacicept Meets Primary Endpoint in Phase III Trial for Primary Sjögren's Syndrome in China remegen.com ↗
The clinical results demonstrated that Telitacicept sustainably and effectively improved the clinical symptoms of Sjögren's syndrome patients, while showing favorable safety profile. |
| 2025-08-13 | Vor Biopharma | Results Telitacicept Achieved Primary Endpoint in Phase 3 Clinical Study for Primary Sjögren's Disease vorbio.com ↗
today announced that its collaborator, RemeGen Co., Ltd (HKEX: 9995, SHA: 688331), achieved the primary endpoint in a Phase 3 clinical study in China evaluating telitacicept in adults with primary Sjögren's disease. |
| 2025-05-27 | RemeGen Co., Ltd. | Regulatory RemeGen’s Telitacicept Approved for Treatment of Myasthenia Gravis in China remegen.com ↗
telitacicept (synonym: RC18, brand name: 泰爱®), was approved for marketing by China’s National Medical Products Administration (NMPA) |
| 2025-04-09 | RemeGen Co., Ltd. | Results Remegen Announces Exciting Results of Telitacicept Phase 3 Clinical Trial for Patients with Generalized Myasthenia Gravis remegen.com ↗
With the highest MG-ADL response rate among all drugs for gMG with phase 3 studies reported to date, Telitacicept will provide an important new treatment option gMG. |
| 2024-10-27 | RemeGen Co., Ltd. | Regulatory Priority Review Granted to BLA of RemeGen’s Telitacicept for Its Third Indication of Myasthenia Gravis remegen.com ↗
the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) had officially accepted its Biologics License Application (BLA) of its innovative drug Telitacicept (RC18, trade name: Tai'ai®) for the treatment of generalized myasthenia gravis (gMG) and granted priority review. |
| 2024-08-13 | RemeGen Co., Ltd. | Results BLA on Agenda: A Phase III Trial on Telitacicept for Myasthenia Gravis Achieves Primary Endpoint in China remegen.com ↗
The results demonstrated that Telitacicept had favorable efficacy and safety profiles, evidenced by the continuous reduction of clinical symptoms among gMG patients in the treatment group. |
| 2024-07-23 | RemeGen Co., Ltd. | Regulatory IND of Telitacicept for Membranous Nephropathy Cleared by CDE remegen.com ↗
IND of Telitacicept Injection for the treatment of adult patients with primary membranous nephropathy (PMN) had been cleared by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA). |
| 2024-04-02 | RemeGen Co., Ltd. | Regulatory RemeGen's Telitacicept Granted Fast Track Designation by US FDA for Treatment of Primary Sjögren's Syndrome Following Permission of the Phase 3 Multicenter Global Clinical Trial remegen.com ↗ |
| 2023-12-25 | RemeGen Co., Ltd. | Results Annals of the Rheumatic Diseases, the Top International Rheumatology Journal, Published the Study Results of Telitacicept in the Treatment of Active Systemic Lupus Erythematosus remegen.com ↗ |
| 2023-11-22 | RemeGen Co., Ltd. | Regulatory RemeGen’s Telitacicept Granted Full Approval by NMPA remegen.com ↗
RemeGen Co., Ltd. (688331.SH/ 9995.HK) (“RemeGen”) announced on November 22nd that Telitacicept for Injection, a novel fusion protein targeting both B lymphocyte stimulator (BlyS) and a proliferation-inducing ligand (APRIL), has been granted full approval by China’s National Medial Product Administration (NMPA). |
| 2022-10-17 | RemeGen Co., Ltd. | Regulatory RemeGen receives approval to conduct a global multicenter phase 3 clinical trial of Telitacicept for SLE in the European Union and China remegen.com ↗
The clinical trial was approved by the European Union and NMPA, marking the acceleration of the globalization of Telitacicept. |
| 2022-10-12 | RemeGen Co., Ltd. | Regulatory RemeGen gains FDA’s Orphan Drug designation for Telitacicept in myasthenia gravis remegen.com ↗
On October 12, RemeGen announced that Telitacicept was granted Orphan Drug designation by the US Food and Drug Administration (FDA) for the treatment of myasthenia gravis (MG). |
| 2022-05-09 | RemeGen Co., Ltd. | Results New clinical data of Telitacicept was published in Lupus, for the indication of children's systemic lupus erythematosus (cSLE) remegen.com ↗
On May 9th, RemeGen Co., Ltd. announced that the clinical data of a self-control trial on the safety and efficacy of Telitacicept in treating refractory children's systemic lupus erythematosus was published in the journal Lupus. |
All press releases naming this drug 33 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 50 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Telitacicept | “BACKGROUND: Telitacicept, a new dual inhibitor of the cytokines B-lymphocyte stimulator (BLyS) and APRIL (a proliferation-inducing ligand), showed efficacy in adults with...” PMID 41092329 ↗ Oct 202548“Telitacicept, a TACI-Fc fusion protein, dual-targets BAFF and APRIL, inhibiting B cell and plasma cell function and reducing autoantibody production, potentially providing...” NCT07687134 ↗ “A multicenter, randomized, open-label, phase 2 clinical study of telitacicept in adult patients with generalized myasthenia gravis.” PMID 38726639 ↗ May 2024 |
| Known as | RC18 | “This is a Phase 2, multi-center, randomized, double-blind, placebo-controlled clinical study with an optional open label extension to evaluate the safety and efficacy of...” NCT04905212 ↗1“Telitacicept (RC18) is a recombinant TACI-Fc fusion protein that simultaneously neutralizes B-lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL), thereby...” NCT07111338 ↗ |
| Action | Inhibit | “Telitacicept, a new dual inhibitor of the cytokines B-lymphocyte stimulator (BLyS) and APRIL (a proliferation-inducing ligand)” PMID 41092329 ↗ Oct 2025 |
| Modality | Protein / enzyme biologic | “a Recombinant Human B Lymphocyte Stimulating Factor Receptor-Antibody Fusion Protein” NCT04082416 ↗ |
| Route | Subcutaneous | “participants with active SLE were randomly assigned (in a 1:1 ratio) to receive telitacicept (160 mg) or placebo subcutaneously once weekly for 52 weeks” PMID 41092329 ↗ Oct 2025 |