Vor Bio Announces Late-Breaking Poster Presentation of Phase 3 Primary Sjögren’s Disease Clinical Study at ACR Convergence 2025
Vor Bio (NASDAQ:VOR) announced that clinical data from their Phase 3 study of telitacicept in primary Sjögren's disease will be presented at ACR Convergence 2025 (October 24-29, 2025) in Chicago. The study, conducted in collaboration with RemeGen Co., Ltd, will be featured as a late-breaking poster presentation.
Notably, RemeGen has already submitted a Biologics License Application (BLA) to China's National Medical Products Administration for telitacicept in primary Sjögren's disease. If approved, this will mark telitacicept's fourth approved indication in China.
Vor Bio (NASDAQ:VOR) ha annunciato che i dati clinici del loro studio di fase 3 su telitacicept per la malattia di Sjögren primaria saranno presentati all'ACR Convergence 2025 (24-29 ottobre 2025) a Chicago. Lo studio, condotto in collaborazione con RemeGen Co., Ltd, sarà presentato come poster di aggiornamento tardivo.
In particolare, RemeGen ha già presentato una Biologics License Application (BLA) all'Amministrazione Nazionale dei Prodotti Medici della Cina per telitacicept nella Sjögren primaria. Se approvata, questa segnerà la quarta indicazione approvata di telitacicept in Cina.
Vor Bio (NASDAQ:VOR) anunció que los datos clínicos de su estudio de fase 3 sobre telitacicept en la enfermedad de Sjögren primaria se presentarán en la ACR Convergence 2025 (del 24 al 29 de octubre de 2025) en Chicago. El estudio, realizado en colaboración con RemeGen Co., Ltd, se destacará como una presentación de póster de última hora.
Cabe señalar que RemeGen ya ha presentado una Biologics License Application (BLA) ante la Administración Nacional de Productos Médicos de China para telitacicept en Sjögren primaria. Si se aprueba, esto marcará la cuarta indicación aprobada de telitacicept en China.
Vor Bio (NASDAQ:VOR)가 원발성 쇼그렌병(primary Sjögren's disease)에서 텔리타시세프(telitacicept)의 3상 임상 데이터가 ACR Convergence 2025에서 발표될 것이라고 발표했습니다(2025년 10월 24-29일, 시카고). 이 연구는 RemeGen Co., Ltd와의 협력으로 수행되었으며, 최신 발표 포스터로 소개될 예정입니다.
또한 RemeGen은 이미 중국 국가약품감독관리국(NMPA)에 텔리타시세프를 위한 원발성 쇼그렌병에 대해 생물의약품허가신청(BLA)을 제출했습니다. 승인될 경우, 이는 중국에서 텔리타시세프의 네 번째 승인 적응증이 됩니다.
Vor Bio (NASDAQ:VOR) a annoncé que les données cliniques de leur étude de phase 3 sur le telitacicept dans la maladie de Sjögren primaire seront présentées lors de l'ACR Convergence 2025 (du 24 au 29 octobre 2025) à Chicago. L’étude, réalisée en collaboration avec RemeGen Co., Ltd, sera présentée comme une affiche à la une.
Notamment, RemeGen a déjà soumis une Biologics License Application (BLA) à la National Medical Products Administration de Chine pour le telitacicept dans la Sjögren primaire. Si cette demande est approuvée, cela marquera la quatrième indication approuvée du telitacicept en Chine.
Vor Bio (NASDAQ:VOR) gab bekannt, dass klinische Daten aus ihrer Phase-III-Studie von Telitacicept bei der primären Sjögren-Autoimmunerkrankung auf der ACR Convergence 2025 (24.–29. Oktober 2025) in Chicago präsentiert werden. Die Studie, die in Zusammenarbeit mit RemeGen Co., Ltd durchgeführt wurde, wird als late-breaking Posterpräsentation vorgestellt.
Bemerkenswert ist, dass RemeGen bereits einen Biologics License Application (BLA) bei der chinesischen National Medical Products Administration für Telitacicept bei der primären Sjögren-Erkrankung eingereicht hat. Falls genehmigt, wäre dies die vierte Zulassung für Telitacicept in China.
Vor Bio (NASDAQ:VOR) أعلنت أن البيانات السريرية من دراستهم من المرحلة الثالثة عن Telitacicept في مرض جفن Sjögren الأولي ستُعرض في ACR Convergence 2025 (من 24 إلى 29 أكتوبر 2025) في شيكاغو. ستُقام الدراسة، التي أُجريت بالتعاون مع RemeGen Co., Ltd، كعرض ملصق متأخر الأحدث.
ومن الجدير بالذكر أن RemeGen قد قدّمت بالفعل طلب ترخيص بيولوجي (BLA) إلى إدارة المنتجات الطبية الوطنية الصينية لـ Telitacicept في Sjögren الأولي. إذا نُوقش ووافقت السلطات، فسيكون هذا رابع استخدام معتمد لـ Telitacicept في الصين.
Vor Bio (NASDAQ:VOR)宣布，其在原发性干燥综合征的telitacicept III 期研究的临床数据将于ACR Convergence 2025（2025年10月24-29日）在芝加哥举行的会议上提交。该研究与RemeGen Co., Ltd的合作完成，将以作为<最新进展海报的形式展示。
值得注意的是，RemeGen已向中国国家药品监督管理局（NMPA）提交了telitacicept用于原发性干燥综合征的生物药许可申请（BLA）。若获批，这将是telitacicept在中国的第四个获批适应症。
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BOSTON, Sept. 29, 2025 (GLOBE NEWSWIRE) -- Vor Bio (Nasdaq: VOR), a clinical-stage biotechnology company transforming the treatment of autoimmune diseases, today announced that clinical data from the Phase 3 study in China evaluating telitacicept in adults with primary Sjögren’s disease, a study sponsored by Vor’s collaborator RemeGen Co., Ltd (HKEX: 9995, SHA: 688331), will be presented as a late-breaking poster presentation at ACR Convergence 2025, being held October 24-29, 2025, at McCormick Place in Chicago, Illinois.
Late-Breaking Presentation Details
Abstract Title: Efficacy and Safety of Telitacicept in Patients with Sjögren's Disease: Results from a Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Clinical Study
Session: Late-Breaking Posters
Date & Time: Tuesday, October 28th, 10:30 AM – 12:30 PM CT
In early September, RemeGen announced the acceptance by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China of its Biologics License Application (BLA) for primary Sjögren’s disease, which will become telitacicept’s fourth approved indication in China.
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 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 placebo adjusted 4.83-point improvement in MG-ADL (Myasthenia Gravis Activities of Daily Living scale) 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, South America, and Asia-Pacific to support potential approval in the United States, Europe, and Japan.
About Sjögren’s Disease (formerly known as Sjögren’s Syndrome)
Sjögren’s disease is a chronic autoimmune condition in which overactive B cells drive inflammation, damaging moisture-producing glands and, in many cases, other organs. Hallmark symptoms include dry eyes and dry mouth, alongside fatigue, pain, and systemic complications affecting the skin, lungs, kidneys, and nervous system. About one-third of patients develop significant extraglandular involvement, and the disease carries an elevated lymphoma risk, often leading to substantial impairment in daily life.
One of the most common rheumatic autoimmune diseases, Sjögren’s remains underdiagnosed, with roughly half of cases unrecognized and women comprising the vast majority of patients. Despite its prevalence and burden, no systemic disease-modifying therapies exist; current care focuses on symptom management with incomplete relief.
Media & Investor Contacts:
Carl Mauch
cmauch@vorbio.com
Sarah Spencer
investors@vorbio.com
FAQ
When will Vor Bio present their Phase 3 telitacicept data at ACR Convergence 2025?
What is the status of telitacicept's regulatory approval for Sjögren's disease in China?
What type of clinical trial was conducted for VOR's telitacicept in Sjögren's disease?
Who is Vor Bio's collaboration partner for telitacicept in China?
