RemeGen Announces the Acceptance of the Marketing Application of Telitaccept for the Treatment of Myasthenia Gravis in China
RemeGen announced that its drug Taicercept® for treating generalized myasthenia gravis (gMG) has been accepted for marketing application by China's Center for Drug Evaluation (CDE) and included in priority review. The drug targets a rare chronic autoimmune disease affecting an estimated 217,000 patients in China, with global cases expected to reach 1.5 million by 2025. Telitacept, a dual target antibody fusion protein, completed Phase III clinical trials in China in August 2024, showing continuous and effective improvement in gMG patients. The drug has received orphan drug and fast track status from the FDA and breakthrough therapy status from China's NMPA.
RemeGen ha annunciato che il suo farmaco Taicercept® per il trattamento della miastenia grave generalizzata (gMG) è stato accettato per la domanda di immissione in commercio dal Centro per la Valutazione dei Farmaci della Cina (CDE) ed è stato incluso nella revisione prioritaria. Il farmaco è destinato a una rara malattia autoimmune cronica che colpisce circa 217.000 pazienti in Cina, con casi globali che si prevede raggiungeranno 1,5 milioni entro il 2025. Telitacept, una proteina di fusione di anticorpi a doppio bersaglio, ha completato la fase III degli studi clinici in Cina nell'agosto 2024, dimostrando un miglioramento continuo ed efficace nei pazienti con gMG. Il farmaco ha ricevuto lo status di farmaco orfano e di percorsi rapidi dalla FDA e lo status di terapia innovativa dalla NMPA cinese.
RemeGen anunció que su medicamento Taicercept® para tratar la miastenia gravis generalizada (gMG) ha sido aceptado para la solicitud de comercialización por el Centro para la Evaluación de Medicamentos de China (CDE) y se ha incluido en la revisión prioritaria. El medicamento se dirige a una rara enfermedad autoinmune crónica que afecta a aproximadamente 217,000 pacientes en China, con casos globales que se espera alcancen los 1.5 millones para 2025. Telitacept, una proteína de fusión de anticuerpos de doble objetivo, completó los ensayos clínicos de fase III en China en agosto de 2024, mostrando una mejora continua y efectiva en pacientes con gMG. El medicamento ha recibido el estatus de medicamento huérfano y de vía rápida de la FDA, así como el estatus de terapia innovadora de la NMPA de China.
RemeGen은 자사 약물 Taicercept®가 일반화 근무력증(gMG) 치료를 위한 마케팅 신청이 중국 약물 평가 센터(CDE)에 의해 승인되었고, 우선 심사 대상에 포함되었다고 발표했습니다. 이 약물은 중국에서 약 217,000명의 환자에게 영향을 미치는 희귀 만성 자가 면역 질환을 치료합니다. 전 세계적으로 이 질환의 환자는 2025년까지 약 150만 명에 이를 것으로 예상됩니다. Telitacept, 이중 표적 항체 융합 단백질은 2024년 8월에 중국에서 3상 임상 시험을 완료했으며, gMG 환자에서 지속적이고 효과적인 개선을 보였습니다. 이 약물은 FDA로부터 희귀 의약품 및 신속 심사 지정을 받았고, 중국 NMPA로부터 혁신적 치료제 지정을 받았습니다.
RemeGen a annoncé que son médicament Taicercept® pour le traitement de la myasthénie grave généralisée (gMG) a été accepté pour une demande de mise sur le marché par le Centre chinois d'évaluation des médicaments (CDE) et inclus dans un examen prioritaire. Ce médicament cible une maladie auto-immune chronique rare affectant environ 217 000 patients en Chine, avec des cas mondiaux qui devraient atteindre 1,5 million d'ici 2025. Telitacept, une protéine de fusion d'anticorps à double cible, a achevé les essais cliniques de phase III en Chine en août 2024, montrant une amélioration continue et efficace chez les patients atteints de gMG. Ce médicament a reçu le statut de médicament orphelin et de voie rapide par la FDA, ainsi que le statut de thérapie innovante par la NMPA de Chine.
RemeGen gab bekannt, dass sein Medikament Taicercept® zur Behandlung der generalisierten Myasthenia gravis (gMG) von der chinesischen Arzneimittelbewertungsbehörde (CDE) für die Marktzulassung akzeptiert wurde und eine priorisierte Prüfung erhalten hat. Das Medikament zielt auf eine seltene chronische Autoimmunerkrankung, die schätzungsweise 217.000 Patienten in China betrifft, wobei die globalen Fälle bis 2025 voraussichtlich 1,5 Millionen erreichen werden. Telitacept, ein dual zielgerichtetes Antikörper-Fusionsprotein, hat im August 2024 die klinischen Phase-III-Studien in China abgeschlossen und dabei eine kontinuierliche und effektive Verbesserung bei gMG-Patienten gezeigt. Das Medikament hat den Status eines Waisenmedikaments und einen beschleunigten Zugang von der FDA sowie den Status einer bahnbrechenden Therapie von der chinesischen NMPA erhalten.
- Marketing application accepted with priority review status in China
- Large market potential with 217,000 patients in China and 1.5 million globally by 2025
- Successful completion of Phase III clinical trials showing effective improvement
- Received multiple regulatory designations (orphan drug, fast track, breakthrough therapy)
- Global expansion with US Phase III trial initiation
- None.
Myasthenia gravis (MG) is a rare chronic autoimmune disease that has been included in the First List of Rare Diseases in
Currently, there is no satisfactory treatment for myasthenia gravis, and effective, safe and precise targeted biological agents have become a hot spot in the research and development of myasthenia gravis drugs. In recent years, B-cell targeted therapies have shown a good therapeutic prospect in myasthenia gravis treatment. Studies have found that compared with traditional immunotherapy, B-cell targeted therapies can significantly reduce the recurrence rate of myasthenia gravis, and the withdrawal rate is low. Teritacept is a dual target antibody fusion protein, which can target 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 resulting in therapeutic effect.
In August 2024, the company announced the completion of the domestic phase Ⅲ clinical trial of telitacept in the treatment of generalized myasthenia gravis. The results of the clinical study showed that telitacept can continuously and effectively improve the clinical status of patients with generalized myasthenia gravis. Internationally, the global multicenter phase Ⅲ clinical trial of gMG has achieved the first patient enrollment in
About Telitacicept (RC18)
Telitacicept (RC18) is RemeGen's proprietary novel fusion protein for the treatment 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. It was granted complete marketing approval by China's National Medical Products Administration (NMPA) to treat systemic lupus erythematosus (SLE) in November 2023 and rheumatoid arthritis (RA) in July 2024.
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 in 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
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SOURCE RemeGen Co., Ltd
FAQ
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