Telitacicept Meets Primary Endpoint in Phase III Trial for Primary Sj枚gren's Syndrome in China
RemeGen (REGMY) announced that its novel drug Telitacicept successfully met the primary endpoint in its Phase III clinical trial for primary Sj枚gren's syndrome (pSS) treatment in China. The drug, a first-in-class BLyS/APRIL dual-target fusion protein, demonstrated sustainable efficacy in improving clinical symptoms while maintaining a favorable safety profile.
The multicenter, randomized, double-blind, placebo-controlled study measured changes in ESSDAI scores at Week 24. Telitacicept targets a significant market, with 4-10 million potential patients in China alone, where the prevalence rate is 0.3% to 0.7%. The company plans to submit a Biologics License Application to China's NMPA and has already received Fast Track designation from the US FDA for global trials.
RemeGen (REGMY) ha annunciato che il suo nuovo farmaco Telitacicept ha raggiunto l'endpoint primario nello studio clinico di Fase III per il trattamento della sindrome di Sj枚gren primaria (pSS) in Cina. Il farmaco, una proteina di fusione di prima classe che mira contemporaneamente a BLyS e APRIL, ha mostrato un'efficacia duratura nel migliorare i sintomi clinici mantenendo un profilo di sicurezza favorevole.
Lo studio multicentrico, randomizzato, in doppio cieco e controllato con placebo ha valutato le variazioni dei punteggi ESSDAI alla settimana 24. Telitacicept si rivolge a un mercato significativo, con 4-10 milioni di pazienti potenziali solo in Cina, dove la prevalenza 猫 compresa tra lo 0,3% e lo 0,7%. L'azienda prevede di presentare una Biologics License Application all'NMPA cinese e ha gi脿 ottenuto la designazione Fast Track dalla US FDA per studi a livello globale.
RemeGen (REGMY) anunci贸 que su nuevo f谩rmaco Telitacicept cumpli贸 con el punto final primario en el ensayo cl铆nico de Fase III para el tratamiento del s铆ndrome de Sj枚gren primario (pSS) en China. El f谩rmaco, una prote铆na de fusi贸n de primera clase que apunta de forma dual a BLyS y APRIL, demostr贸 una eficacia sostenida en la mejora de los s铆ntomas cl铆nicos, manteniendo un perfil de seguridad favorable.
El estudio multic茅ntrico, aleatorizado, doble ciego y controlado con placebo midi贸 los cambios en las puntuaciones ESSDAI en la semana 24. Telitacicept se dirige a un mercado importante, con 4-10 millones de pacientes potenciales solo en China, donde la prevalencia es del 0,3% al 0,7%. La compa帽铆a planea presentar una Biologics License Application ante la NMPA china y ya ha recibido la designaci贸n Fast Track de la FDA estadounidense para ensayos globales.
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雼り赴甏� 氍挫瀾鞙� 氚办爼, 鞚挫雸堦皜毽�, 鞙勳暯雽�臁� 鞁滍棙鞚� 24欤检皑 ESSDAI 鞝愳垬 氤�頇旊ゼ 韽夑皜頄堨姷雼堧嫟. Telitacicept電� 欷戧淡鞐愳劀毵� 400毵寏1000毵� 氇呾潣 鞛犾灛 頇橃瀽鞚措澕電� 韥� 鞁滌灔鞚� 雽�靸侅溂搿� 頃橂┌, 鞙犽硲毳犾潃 0.3%~0.7%鞛呺媹雼�. 須岇偓電� 欷戧淡 NMPA鞐� 氚旍澊鞓れ潣鞎巾拡 項堦皜 鞁犾箔(Biologics License Application)鞚� 鞝滌稖頃� 瓿勴殟鞚措┌, 旮�搿滊矊 鞛勳儊鞚� 鞙勴暣 鞚措 氙戈淡 FDA搿滊秬韯� 韺姢韸疙姼霝� 歆�鞝曥潉 氚涭晿鞀惦媹雼�.
RemeGen (REGMY) a annonc茅 que son nouveau m茅dicament Telitacicept a atteint le crit猫re d'茅valuation principal lors de l'essai clinique de phase III pour le traitement du syndrome de Sj枚gren primaire (pSS) en Chine. Le m茅dicament, une prot茅ine de fusion de premi猫re classe ciblant 脿 la fois BLyS et APRIL, a d茅montr茅 une efficacit茅 durable pour am茅liorer les sympt么mes cliniques tout en conservant un profil de s茅curit茅 favorable.
L'茅tude multicentrique, randomis茅e, en double aveugle et contr么l茅e par placebo a mesur茅 les variations des scores ESSDAI 脿 la semaine 24. Telitacicept vise un march茅 significatif, avec 4-10 millions de patients potentiels rien qu'en Chine, o霉 la pr茅valence est de 0,3% 脿 0,7%. La soci茅t茅 pr茅voit de soumettre une Biologics License Application 脿 la NMPA chinoise et a d茅j脿 re莽u la d茅signation Fast Track de la FDA am茅ricaine pour des essais mondiaux.
RemeGen (REGMY) gab bekannt, dass sein neuartiges Arzneimittel Telitacicept den prim盲ren Endpunkt in der Phase-III-Studie zur Behandlung des prim盲ren Sj枚gren-Syndroms (pSS) in China erfolgreich erreicht hat. Das Medikament, ein First-in-Class Fusionsprotein mit dualer Zielrichtung auf BLyS und APRIL, zeigte anhaltende Wirksamkeit bei der Verbesserung klinischer Symptome und wies ein g眉nstiges Sicherheitsprofil auf.
Die multizentrische, randomisierte, doppelt verblindete, placebokontrollierte Studie erfasste die Ver盲nderungen der ESSDAI-Werte in Woche 24. Telitacicept adressiert einen bedeutenden Markt mit 4鈥�10 Millionen potenziellen Patienten allein in China, wo die Pr盲valenz bei 0,3% bis 0,7% liegt. Das Unternehmen plant, eine Biologics License Application bei der chinesischen NMPA einzureichen und hat bereits die Fast-Track-Zulassung der US FDA f眉r globale Studien erhalten.
- Successfully met primary endpoint in Phase III trial for Sj枚gren's syndrome
- First BLyS/APRIL dual-target fusion protein to complete Phase III study in this field
- Addresses large market potential of 4-10 million patients in China
- Received FDA Fast Track designation for global development
- Already recommended in multiple Chinese clinical practice guidelines
- Will require additional global trials for markets outside China
- Faces complex regulatory pathway with multiple jurisdictions
This multicenter, randomized, double-blind, placebo-controlled Phase III clinical study aimed to evaluate the efficacy and safety of Telitacicept in patients with primary Sj枚gren's syndrome. The primary endpoint was the change from baseline in the ESSDAI score (the gold standard for measuring Sj枚gren's syndrome disease activity) at Week 24. The clinical results demonstrated that Telitacicept sustainably and effectively improved the clinical symptoms of Sj枚gren's syndrome patients, while showing favorable safety profile.
Sj枚gren's syndrome is a chronic inflammatory autoimmune disease characterized primarily by lymphocyte infiltration and damage to exocrine glands. Beyond persistent dry mouth and dry eyes caused by salivary and lacrimal gland dysfunction, it can also affect multiple organ systems. The prevalence rate of Sj枚gren's syndrome in
Research indicates that the overactivation of autoreactive B cells is a crucial pathological basis for Sj枚gren's syndrome. Telitacicept, a novel dual-target fusion protein independently developed by Remegen, simultaneously inhibits the overexpression of B Lymphocyte Stimulator (BLyS) and A Proliferation-Inducing Ligand (APRIL). It effectively blocks the abnormal differentiation and maturation of B cells and has demonstrated favorable efficacy and safety in both clinical and real-world studies.
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