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

想要獨家投資理財Tips?即Like etnet 全新Facebook專頁► 立即讚好

人氣文章
最近7天
1
高息定存 | 工銀亞洲推3個月5厘息搶新客,招商永隆推快閃優惠
2
神州經脈 | PMI遜預期,滬指全年止跌回升,人幣年度貶幅擴
3
神州經脈 | 換手機可獲政府補貼,政策利率將降,滬指周挫逾5%
4
【FOCUS】零售寒冬襲京滬港,逆市奇葩值借鏡
5
回顧展望-A股自強 | 憧憬國策利好,機構對明年股市走勢樂觀
6
回顧展望-人幣走貶 | 關稅殺到,先貶為敬,人幣明年勢見7.5
7
港股 | 蕭猷華:恒指春節前目標21500點
8
高息定存 | 一周高息合集,恒生1個月定存4厘,工銀亞洲3個月最高5厘
9
奧特曼 | 內地玩具商布魯可招股入場費1.8萬元,四基投認購
10
易經看世界 | 從乙巳年立春八字看香港前景:哪行業當旺?哪行業運滯?(有片)
1
高息定存 | 一周高息合集,大新3個月最高4.1厘,華僑及信銀國際見4厘
2
高息定存 | 滙豐3個月港元存息高達3.8厘,6個月3.55厘
3
高息定存 | 銀行高息搶存,東亞上調3個月定存息至3.9厘,花旗加至3.7厘
4
高息定存 | 建行亞洲上調3個月存息至3.85厘,富邦3.8厘
5
港股 | 蕭猷華:關注中央經濟工作會議,美團股價落後
6
高息定存 | 華僑銀行208日定存年息高達3.8厘
7
基建債券 | 認購額178.5億首未足額,發言人:受減息步伐影響
8
神州經脈 | 政治局會議定調明年貨幣政策適度寬鬆,CPI遜預期
9
詹培忠父子涉隱瞞秘密「買殼」串謀欺詐罪成
10
神州經脈 | 11月進出口數據降溫,貨幣政策轉向股匯齊漲
11
專訪|林本利系列專訪逢周五登場,股市篇:勿驚美股調整,港股那些可以放心買那些勿沾手(有片)
12
專訪|林本利系列專訪一連三個周五登場,樓市篇:中原指數長線重返180,買樓勿買新樓(有片)
13
特首述職|習近平讚揚李家超務實進取,中央全力支持帶領各界改革
14
滙控 | 擬推改革削減成本,股價再創17年新高,聖誕鐘真係要買滙豐?
15
神州經脈 | 特別國債或發3萬億,滬指逼近三千四,日外相訪華
16
高息定存 | 一周高息合集,華僑1個月定存4厘208日3.8厘
17
資源有限窒礙中小企轉型? 營商生態圈助你開拓無限商機!
18
中經會 | 明年提高財政赤字率,適時降準降息,穩住樓市股市
19
高息定存 | 工銀亞洲推3個月5厘息搶新客,招商永隆推快閃優惠
20
利率波動難測 如何以債券策略爭取「財息兼收」?
21
居屋2024 | 新一期居屋攪珠結果出爐,預計最快明年第二季揀樓
22
2025年環球經濟與輪證投資前瞻
23
高息定存 | 信銀國際上調1個月定存年息至高達3.88厘
24
神州經脈 | 工業利潤降幅收窄,低空經濟發展司成立,滬指全周升
25
基建債券 | 基建債券認購100手或以下獲全額配發
26
【穩醣趨勢: 揀無糖飲品、原型食物,戒澱粉質係咪就得? 】
27
回顧展望-共渡時艱 | 表列機構對今明年本港經濟增長預測
28
【FOCUS】個人養老金制度升級,一石二鳥未改挑戰
29
高息定存 | 聖誕前夕銀行加存息吸資金,大眾3個月加至3.6厘
30
【FOCUS】「無厘頭」減息釀驚嚇,長債失控顯聯儲失信譽
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Moon-River RELOVE 蛋白酵素去漬抑菌手洗精 (價值HK$188)

etnet榮獲HKEX Awards 2023 「最佳證券數據供應商」大獎

大國博弈

貨幣攻略

說說心理話

聖誕新年特輯

Watch Trends 2024

北上食買玩

Art Month 2024

秋天養生食療

消委會報告

山今養生智慧

輕鬆護老