First patient enrollment in the U.S. - A milestone for the global multi-center phase Ⅲ clinical trial of telitacicept for myasthenia gravis
RemeGen Co. (9995.HK, SHA:688331) has announced the first patient enrollment in the U.S. for its global phase III clinical trial of telitacicept, a BLyS/APRIL dual targeting fusion protein, for treating generalized myasthenia gravis (gMG). This milestone marks a significant step in telitacicept's worldwide clinical development. The trial aims to recruit 180 patients globally to evaluate the drug's efficacy and safety.
Telitacicept has received orphan drug and fast track status from the FDA and breakthrough therapy designation from China's NMPA. Since its approval in China in March 2021, telitacicept has treated over 40,000 patients with excellent efficacy and safety. The global myasthenia gravis patient population is expected to reach 1.15 million by 2025, highlighting the significant market potential for this innovative treatment.
RemeGen Co. (9995.HK, SHA:688331) ha annunciato il primo arruolamento di pazienti negli Stati Uniti per la sua fase III di sperimentazione clinica globale di telitacicept, una proteina di fusione che mira contemporaneamente a BLyS/APRIL, per il trattamento della miastenia gravis generalizzata (gMG). Questo traguardo rappresenta un passo significativo nello sviluppo clinico mondiale di telitacicept. La sperimentazione intende arruolare 180 pazienti a livello globale per valutare l'efficacia e la sicurezza del farmaco.
Telitacicept ha ricevuto lo status di farmaco orfano e di accesso accelerato dalla FDA e la designazione di terapia innovativa dalla NMPA cinese. Dalla sua approvazione in Cina nel marzo 2021, telitacicept ha trattato oltre 40.000 pazienti con eccellenti risultati in termini di efficacia e sicurezza. Si prevede che la popolazione globale di pazienti affetti da miastenia gravis raggiunga 1,15 milioni entro il 2025, evidenziando il notevole potenziale di mercato per questo trattamento innovativo.
RemeGen Co. (9995.HK, SHA:688331) ha anunciado el primer reclutamiento de pacientes en EE. UU. para su estudio clínico de fase III global de telitacicept, una proteína de fusión que apunta simultáneamente a BLyS/APRIL, para tratar la miastenia gravis generalizada (gMG). Este hito marca un paso significativo en el desarrollo clínico mundial de telitacicept. El ensayo tiene como objetivo reclutar 180 pacientes a nivel global para evaluar la eficacia y seguridad del fármaco.
Telitacicept ha recibido estatus de medicamento huérfano y vía rápida de la FDA y designación de terapia innovadora de la NMPA de China. Desde su aprobación en China en marzo de 2021, telitacicept ha tratado a más de 40,000 pacientes con excelente eficacia y seguridad. Se espera que la población global de pacientes con miastenia gravis alcance 1.15 millones para 2025, lo que resalta el considerable potencial de mercado para este tratamiento innovador.
RemeGen Co. (9995.HK, SHA:688331)는 텔리타시셉트에 대한 글로벌 3상 임상 시험의 첫 번째 환자 등록을 미국에서 발표했습니다. 이는 BLyS/APRIL 이중 표적 융합 단백질로, 전신성 중증 근무력증(gMG) 치료를 위한 것입니다. 이 이정표는 텔리타시셉트의 세계적인 임상 개발에 중요한 단계를 의미합니다. 이 시험은 180명의 환자를 전 세계적으로 모집하여 약물의 효능과 안전성을 평가하는 것을 목표로 하고 있습니다.
텔리타시셉트는 FDA로부터 희귀 의약품 및 신속 심사 지위를, 중국 NMPA로부터 신약 혁신 치료제 지위를 받았습니다. 2021년 3월 중국에서 승인된 이후, 텔리타시셉트는 40,000명 이상의 환자를 치료하며 뛰어난 효능과 안전성을 보여주었습니다. 전 세계의 중증 근무력증 환자 수는 2025년까지 115만 명에 이를 것으로 예상되며, 이는 이 혁신적 치료법의 상당한 시장 잠재력을 강조합니다.
RemeGen Co. (9995.HK, SHA:688331) a annoncé le premier recrutement de patients aux États-Unis pour son essai clinique de phase III mondial de telitacicept, une protéine de fusion ciblant à la fois BLyS/APRIL, pour le traitement de la myasthénie grave généralisée (gMG). Ce jalon marque une étape significative dans le développement clinique mondial de telitacicept. L'essai vise à recruter 180 patients à l'échelle mondiale afin d'évaluer l'efficacité et la sécurité du médicament.
Telitacicept a reçu le statut de médicament orphelin et de voie rapide de la FDA ainsi que la désignation de thérapie révolutionnaire de la NMPA chinoise. Depuis son approbation en Chine en mars 2021, telitacicept a traité plus de 40 000 patients avec d'excellents résultats en termes d'efficacité et de sécurité. La population mondiale de patients atteints de myasthénie grave devrait atteindre 1,15 million d'ici 2025, soulignant ainsi le potentiel de marché significatif de ce traitement innovant.
RemeGen Co. (9995.HK, SHA:688331) hat die Rekrutierung des ersten Patienten in den USA für seine globale Phase-III-Studie zu Telitacicept, einem BLyS/APRIL dual zugelassenen Fusionsprotein zur Behandlung von generalisierter Myasthenia gravis (gMG), bekannt gegeben. Dieser Meilenstein stellt einen bedeutenden Schritt in der weltweiten klinischen Entwicklung von Telitacicept dar. Die Studie hat das Ziel, 180 Patienten weltweit zu rekrutieren, um die Wirksamkeit und Sicherheit des Medikaments zu bewerten.
Telitacicept hat von der FDA Orphan Drug-Status und Fast-Track-Status sowie von der chinesischen NMPA die Breakthrough-Therapy-Deklaration erhalten. Seit seiner Zulassung in China im März 2021 hat Telitacicept über 40.000 Patienten mit hervorragender Wirksamkeit und Sicherheit behandelt. Es wird erwartet, dass die globale Patientenzahl für Myasthenia gravis bis 2025 auf 1,15 Millionen ansteigt, was das erhebliche Marktpotential für diese innovative Therapie verdeutlicht.
- First patient enrolled in U.S. for global phase III clinical trial of telitacicept for gMG
- Telitacicept granted orphan drug and fast track status by FDA, and breakthrough therapy designation by China's NMPA
- Over 40,000 patients treated with telitacicept in China since March 2021 approval, showing excellent efficacy and safety
- Potential for telitacicept to be approved for multiple indications in China, expanding market opportunities
- None.
This milestone marks an important step in the worldwide clinical development of telitacicept, which will bring new hope to myasthenia gravis patients globally. Previously, telitacicept was granted orphan drug and fast track status for myasthenia gravis indication by the US Food and Drug Administration (FDA) and breakthrough therapy designation by the National Medical Products Administration (NMPA) of
This global, multicenter, randomized, double-blind, placebo-controlled, phase III study aims to evaluate the efficacy and safety of telitacicept in the treatment of gMG. The trial plans to recruit 180 patients from multiple countries and regions around the world.
Myasthenia gravis (MG) is a rare, chronic autoimmune disease that leads to impaired transmission at neuromuscular junctions, which can affect eye movement, swallowing, speech, general movement and respiratory function at varying degrees. According to the Frost & Sullivan report, the global number of myasthenia gravis patients is expected to reach 1.15 million in 2025, with about 70,000 in
At present, the main treatment methods for myasthenia gravis include cholinesterase inhibitors, glucocorticoids and immunosuppressants. However, a substantial unmet medical need remains as there are many patients can not be effectively treated due to lack of efficacy, tolerability or contraindications of existing therapies.
Telitacicept is a dual targeting antibody fusion protein that targets BLyS and APRIL at the same time, and directly attack the source of pathogenic antibodies -- B cells and plasma cells, thereby reducing the production of pathogenic antibodies and achieving its therapeutic purpose. Preliminary clinical studies have shown that telitacicept can continuously and effectively improve the clinical status of patients with generalized myasthenia gravis.
Since its approval in
About RemeGen Co. Ltd.
Founded in 2008, RemeGen (9995.HK, SHA: 688331) is a leading biopharmaceutical company in China committed to providing solutions to the unmet clinical needs of patients suffering from life-threatening illnesses. RemeGen has research laboratories and offices throughout China and the United States. The company is committed to discovering, developing, and commercializing innovative and differentiated biologic drugs of significant clinical value in the key therapeutic areas of autoimmune, oncology, and ophthalmic diseases. For more details, please visit: www.remegen.com
About Telitacicept (RC18)
Telitacicept (RC18) is RemeGen's proprietary novel fusion protein for the treatments of autoimmune diseases. It is constructed with the extracellular domain of the human transmembrane activator and calcium modulator and cyclophilin ligand interactor (TACI) receptor and the fragment crystallizable (Fc) domain of human immunoglobulin G(IgG). Telitacicept targets two cell-signaling molecules critical for B-lymphocyte development: B-lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL), which allows it to effectively reduce B-cell mediated autoimmune responses that are implicated in several autoimmune diseases.
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SOURCE RemeGen Co., Ltd
FAQ
What is the purpose of RemeGen's phase III clinical trial for telitacicept (REGMY)?
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What regulatory designations has telitacicept (REGMY) received for myasthenia gravis?
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