美通社

2024-08-06 17:00

First patient enrollment in the U.S. - A milestone for the global multi-center phase Ⅲ clinical trial of telitacicept for myasthenia gravis

YANTAI, China, Aug. 6, 2024 /PRNewswire/ -- RemeGen Co. Ltd. ("RemeGen" or "the Company") (9995.HK, SHA:688331), a commercial-stage biotechnology company, announced that the company's self-developed BLyS/APRIL dual targeting fusion protein innovative drug telitacicept has achieved the first patient enrollment in the United States for its global multi-center phase III clinical trial for the treatment of generalized myasthenia gravis (gMG). 

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 China.

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 the United States and 22,000 in China.

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 China in March 2021, telitacicept has benefited more than 40,000 patients with excellent efficacy and safety. In China, in addition to the two approved indications of systemic lupus erythematosus and rheumatoid arthritis, telitacicept has the potential to be approved for myasthenia gravis, Sjogren's syndrome, IgA nephritis, and neuromyelitis optica in the coming years.

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.

source: RemeGen Co., Ltd

《說說心理話》身體唔舒服查唔到原因?周身痠痛疲累?可能係患有心身症!點解原生家庭會長時間影響一個人?點樣脫離循環?► 即睇

人氣文章
財經新聞
評論
專題
專業版
HV2
精裝版
SV2
串流版
IQ 登入
強化版
TQ
強化版
MQ

【etnet 30周年】多重慶祝活動一浪接一浪,好禮連環賞!

【etnet30周年連環賞】睇住賞Maxcare美天復康寶(升級版) (價值HK$1,680)

etnet榮獲HKEX Awards 2023 「最佳證券數據供應商」大獎

回顧24 展望25

大國博弈

貨幣攻略

說說心理話

聖誕新年特輯

Watche Trends 2024

北上食買玩

Artcation

秋冬養生食療

消委會報告

山今養生智慧

輕鬆護老