Remegen Announces Exciting Results of Telitacicept Phase 3 Clinical Trial for Patients with Generalized Myasthenia Gravis
RemeGen (REGMY) has announced breakthrough Phase 3 clinical trial results for Telitacicept in treating generalized myasthenia gravis (gMG). The trial, presented at the American Academy of Neurology Annual Meeting 2025, showed remarkable efficacy with 98.1% of patients in the Telitacicept 240 mg group achieving ≥3-point reduction in MG-ADL score and 87% showing ≥5-point reduction in QMG score at Week 24.
The multicenter, randomized, double-blind study involved 114 gMG patients, demonstrating significant improvements in clinical outcomes with a favorable safety profile. At Week 24, the Telitacicept group showed MG-ADL score changes of -5.74 versus -0.91 in the placebo group. The drug's Biologics License Application has been accepted by China's regulatory authorities, with approval expected in Q2 2025.
RemeGen (REGMY) ha annunciato risultati straordinari della fase 3 dello studio clinico per Telitacicept nel trattamento della miastenia grave generalizzata (gMG). Lo studio, presentato all'American Academy of Neurology Annual Meeting 2025, ha mostrato un'efficacia notevole con il 98.1% dei pazienti nel gruppo Telitacicept 240 mg che ha raggiunto una riduzione di ≥3 punti nel punteggio MG-ADL e 87% che ha mostrato una riduzione di ≥5 punti nel punteggio QMG alla settimana 24.
Lo studio multicentrico, randomizzato e in doppio cieco ha coinvolto 114 pazienti gMG, dimostrando miglioramenti significativi nei risultati clinici con un profilo di sicurezza favorevole. Alla settimana 24, il gruppo Telitacicept ha mostrato cambiamenti nel punteggio MG-ADL di -5.74 contro -0.91 nel gruppo placebo. La domanda di licenza biologica del farmaco è stata accettata dalle autorità regolatorie cinesi, con approvazione prevista per il secondo trimestre del 2025.
RemeGen (REGMY) ha anunciado resultados innovadores de ensayos clínicos de fase 3 para Telitacicept en el tratamiento de la miastenia gravis generalizada (gMG). El ensayo, presentado en la Reunión Anual de la Academia Americana de Neurología 2025, mostró una eficacia notable con el 98.1% de los pacientes en el grupo de Telitacicept 240 mg logrando una reducción de ≥3 puntos en la puntuación MG-ADL y 87% mostrando una reducción de ≥5 puntos en la puntuación QMG a la semana 24.
El estudio multicéntrico, aleatorizado y doble ciego involucró a 114 pacientes con gMG, demostrando mejoras significativas en los resultados clínicos con un perfil de seguridad favorable. A la semana 24, el grupo Telitacicept mostró cambios en la puntuación MG-ADL de -5.74 frente a -0.91 en el grupo placebo. La solicitud de licencia biológica del medicamento ha sido aceptada por las autoridades regulatorias de China, con aprobación esperada para el segundo trimestre de 2025.
RemeGen (REGMY)는 일반화된 중증 근무력증(gMG) 치료를 위한 Telitacicept의 3상 임상 시험에서 혁신적인 결과를 발표했습니다. 2025년 미국 신경학회 연례 회의에서 발표된 이 시험은 Telitacicept 240 mg 그룹의 98.1%의 환자가 MG-ADL 점수에서 ≥3점 감소를 달성하고 87%가 QMG 점수에서 5점 이상 감소를 보였음을 보여주었습니다.
이 다기관, 무작위, 이중 맹검 연구에는 114명의 gMG 환자가 참여했으며, 유의미한 임상 결과 개선과 우수한 안전성 프로필을 입증했습니다. 24주 차에 Telitacicept 그룹은 MG-ADL 점수에서 -5.74의 변화가 있었고, 위약 그룹은 -0.91의 변화를 보였습니다. 이 약물의 생물학적 라이센스 신청이 중국 규제 당국에 의해 수락되었으며, 2025년 2분기에 승인이 예상됩니다.
RemeGen (REGMY) a annoncé des résultats révolutionnaires d'un essai clinique de phase 3 pour Telitacicept dans le traitement de la myasthénie grave généralisée (gMG). L'essai, présenté lors de la Réunion Annuelle de l'Académie Américaine de Neurologie 2025, a montré une efficacité remarquable avec 98.1% des patients du groupe Telitacicept 240 mg atteignant une réduction ≥3 points dans le score MG-ADL et 87% montrant une réduction ≥5 points dans le score QMG à la semaine 24.
L'étude multicentrique, randomisée et en double aveugle a impliqué 114 patients gMG, démontrant des améliorations significatives des résultats cliniques avec un profil de sécurité favorable. À la semaine 24, le groupe Telitacicept a montré des changements du score MG-ADL de -5.74 contre -0.91 dans le groupe placebo. La demande de licence biologique du médicament a été acceptée par les autorités réglementaires chinoises, avec une approbation attendue pour le deuxième trimestre 2025.
RemeGen (REGMY) hat bahnbrechende Ergebnisse der Phase 3 klinischen Studie zu Telitacicept bei der Behandlung der generalisierten Myasthenia gravis (gMG) bekannt gegeben. Die Studie, die auf dem Jahrestreffen der American Academy of Neurology 2025 präsentiert wurde, zeigte eine bemerkenswerte Wirksamkeit, da 98.1% der Patienten in der Telitacicept 240 mg-Gruppe eine Reduktion von ≥3 Punkten im MG-ADL-Score und 87% eine Reduktion von ≥5 Punkten im QMG-Score nach 24 Wochen erreichten.
Die multizentrische, randomisierte, doppelblinde Studie umfasste 114 gMG-Patienten und zeigte signifikante Verbesserungen der klinischen Ergebnisse bei einem günstigen Sicherheitsprofil. Nach 24 Wochen wies die Telitacicept-Gruppe Veränderungen im MG-ADL-Score von -5.74 gegenüber -0.91 in der Placebo-Gruppe auf. Der Antrag auf eine Biologics-Lizenz für das Medikament wurde von den chinesischen Regulierungsbehörden akzeptiert, und eine Genehmigung wird für das 2. Quartal 2025 erwartet.
- Exceptional efficacy with 98.1% response rate in MG-ADL score reduction
- Strong safety profile with lower infection-related adverse events than placebo
- BLA acceptance by Chinese regulators with expected approval in Q2 2025
- Large market opportunity with 1.2 million global MG patients
- Sustained improvement in clinical outcomes through Week 24
- Global Phase 3 trial still ongoing, limiting immediate international market access
- Currently pending regulatory approval, no immediate revenue generation
According to the presented data, among the participants in the Telitacicept 240 mg group,
Telitacicept is a novel fusion protein targeting both BlyS and APRIL independently designed and developed by RemeGen Co.,Ltd. ("RemeGen"). The multicenter, randomized, double-blind, placebo-controlled phase 3 clinical trial was conducted in
The data showed that Telitacicept achieved sustained and significant improvement in clinical outcomes for patients with gMG, with a favorable safety profile：
- Telitacicept demonstrated significant improvements in MG-ADL and QMG scores after 4 weeks' treatment compared to placebo.
- At Week 24, change in MG-ADL was -5.74 and -0.91 with Telitacicept and placebo group, respectively.
98.1% and12.0% of Telitacicept and placebo group patients had ≥3-point reduction in MG-ADL, respectively. The MG-ADL scale quantifies the impact of MG symptoms on daily life quality, focusing on patients' subjective experience and daily function. These data showed that patients treated with Telitacicept achieved clinically meaningful improvement. - At Week 24, change in QMG was -8.66 and -2.27 with Telitacicept and placebo group, respectively.
87.0% and16.0% of Telitacicept and placebo group patients had ≥ 5-point reduction in QMG, respectively. The QMG score assesses the strength and endurance of the whole body muscle group, focusing on objective measurement. These data demonstrated that patients treated with Telitacicept achieved clinically meaningful reductions in disease severity. There is a strong correlation between MG-ADL and QMG in evaluating treatment response, and the combination of MG-ADL and QMG can comprehensively reflect the disease severity. - Sustained improvement: MG-ADL and QMG scores continued to decline over time in the Telitacicept group, with peak improvement at the last reported observation, Week 24.
- Telitacicept was well tolerated during the treatment, with an overall adverse event (AE) incidence similar to that in the placebo group and an incidence of infection-related AEs lower than that in the placebo group (
45.6% vs.59.6% ).
The principal investigator Prof. Yin Jian of Beijing Hospital said "Telitacicept demonstrated rapid and significant clinical improvement in the phase 3 trial, and was well tolerated. Its dual-targeting mechanism not only inhibits abnormal B cells and plasma cells thoroughly and reduces the level of pathogenic antibodies, but also effectively slows down disease progression in the long term, and reduces steroid dosage as symptoms improve, providing a more precise, efficient, persistent, and safer option for gMG treatment."
Dr. Jianmin Fang, CEO of RemeGen, said "The phase 3 data of Telitacicept for MG is clinically meaningful. There is a large unmet medical need in MG because the disease presents significant threat to patients' health and life-span. This breakthrough means that we have an new, effective treatment for MG as Telitacicept can significantly improve patients' symptoms and bring long term benefits to MG patients. We look forward to working with global experts and scholars to overcome more complex autoimmune diseases and benefit more patients."
MG is an autoimmune disease caused by neuromuscular junction transmission disorders. It is characterized by fatigue and fluctuations in symptoms, long treatment cycles and high recurrence rate. More than
The newly disclosed "best-in-class" data mark a breakthrough achievement of Chinese innovative drugs in the field of neuroimmunology. Currently, the BLA of Telitacicept for the treatment of gMG has been accepted by the Center for Drug Evaluation (CDE) of
Meanwhile, RemeGen is advancing a global multicenter Phase 3 trial of Telitacicept for the treatment of gMG, aiming to validate the efficacy and safety of Telitacicept in a wider patient population, and to provide a superior treatment option for gMG patients worldwide.
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SOURCE RemeGen Co., Ltd
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