YANTAI, China, April 2, 2024 /PRNewswire/ -- RemeGen Co. Ltd. ('RemeGen' or 'the Company') (9995.HK, 688331.SH), a commercial-stage biotechnology company, obtained Fast Track Designation (FTD) by the United States Food and Drug Administration (FDA) recently for its innovative BLyS/APRIL dual-target fusion protein drug, Telitacicept (RC18), independently developed by RemeGen for the treatment of patients with primary Sjögren's syndrome (pSS).

中国烟台，2024年4月2日/PRNewswire/-RemeGen Co.Ltd.（“RemeGen”或“公司”）（9995.HK，688331.SH），一家商业阶段的生物技术公司，最近因其创新的BLyS/April双靶融合蛋白药物Telitacicept（RC18）获得美国食品和药物管理局（FDA）的快速通道指定（FTD），该药物由RemeGen独立开发，用于治疗原发性干燥综合征（pSS）患者。

The FDA grants FTD to accelerate the development and review of new drugs that have the potential to treat life-threatening conditions and address unmet medical needs..

FDA授予FTD加速新药的开发和审查，这些新药有可能治疗危及生命的疾病并解决未满足的医疗需求。。

Primary Sjögren's syndrome (pSS) is a common rheumatic disease characterized by autoimmune exocrinopathy that clinically manifests as dry eyes and mouth caused by glandular dysfunction as a result of autoimmune damage with multiple organ systems also at risk of being affected. Studies have shown that B-cells are key immune cells involved in the pathogenesis of pSS, and excessive activation of B-cells is a pathogenic indicator of pSS that has long been regarded as a key target for intervention..

原发性干燥综合征（pSS）是一种常见的风湿性疾病，其特征是自身免疫性外分泌病，临床表现为由于自身免疫损伤导致的腺体功能障碍引起的眼睛和口腔干燥，多器官系统也有受到影响的风险。研究表明，B细胞是参与pSS发病机制的关键免疫细胞，B细胞的过度激活是pSS的致病指标，长期以来一直被认为是干预的关键目标。。

Independently developed by RemeGen, Telitacicept is an innovative BLyS/APRIL dual-target fusion protein drug that simultaneously inhibits the overexpression of two cytokines, B-cell lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL). Telitacicept prevents abnormal differentiation and maturation of B-cells through a two-pronged approach, thereby treating various autoimmune diseases mediated by B-cells.

Telitacicept由RemeGen独立开发，是一种创新的BLyS/APRIL双靶融合蛋白药物，可同时抑制两种细胞因子B细胞淋巴细胞刺激因子（BLyS）和增殖诱导配体（APRIL）的过表达。Telitacicept通过双管齐下的方法防止B细胞异常分化和成熟，从而治疗由B细胞介导的各种自身免疫性疾病。

In December 2023, Telitacicept was granted Investigational New Drug (IND) by the FDA for the treatment of active pSS in adults. A phase III clinical trial for this indication is currently underway in China..

2023年12月，Telitacicept被FDA批准用于治疗成人活动性PS的研究性新药（IND）。目前，中国正在进行该适应症的III期临床试验。。

Dr. Jianmin Fang, CEO of RemeGen, commented, 'As the first fusion protein drug of its kind independently developed by RemeGen, we are delighted the FDA has recognized Telitacicept for fast track designation. It has performed well in clinical studies for multiple indications that have been marketed in China, including primary Sjögren's syndrome (pSS) and systemic lupus erythematosus (SLE) with rheumatoid arthritis, igA nephritis, and myasthenia gravis (MG) in the pipeline.

RemeGen首席执行官方建民博士评论道：“作为RemeGen独立开发的第一种融合蛋白药物，我们很高兴FDA认可Telitacicept为快速通道药物。它在中国上市的多种适应症的临床研究中表现良好，包括原发性干燥综合征（pSS）和系统性红斑狼疮（SLE），伴有类风湿性关节炎，igA肾炎和重症肌无力（MG）。

Multiple Phase III clinical trials are progressing smoothly both domestically and abroad and we are accelerating global development of multiple indications of Telitacicept, and we are confident of cementing a leadership position in B-cell-mediated autoimmunity drugs.'.

国内外多个III期临床试验进展顺利，我们正在加速全球开发替利西普的多种适应症，我们有信心巩固B细胞介导的自身免疫药物的领导地位。”。

About Telitacicept (RC18)

关于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（RC18）是RemeGen专有的新型融合蛋白，用于治疗自身免疫性疾病。它由人跨膜激活剂和钙调节剂的胞外结构域和亲环蛋白配体相互作用（TACI）受体以及人免疫球蛋白G（IgG）的片段可结晶（Fc）结构域构建。

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 completed marketing approval by China's National Medical Products Administration (NMPA) to treat systemic lupus erythematosus (SLE) in November 2023..

Telitacicept靶向对B淋巴细胞发育至关重要的两种细胞信号分子：B淋巴细胞刺激因子（BLyS）和增殖诱导配体（APRIL），这使其能够有效减少与几种自身免疫疾病有关的B细胞介导的自身免疫反应。2023年11月，它被中国国家医药产品管理局（NMPA）批准用于治疗系统性红斑狼疮（SLE）。。

About RemeGen Co. Ltd.

关于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..

RemeGen（9995.HK，上海：688331）成立于2008年，是中国领先的生物制药公司，致力于为患有危及生命的疾病的患者提供未满足的临床需求的解决方案。RemeGen在中国和美国设有研究实验室和办事处。该公司致力于在自身免疫、肿瘤和眼科疾病的关键治疗领域发现、开发和商业化具有重要临床价值的创新和分化生物药物。。

For more details, please visit: www.remegen.com

有关更多详细信息，请访问：www.remegen.com

SOURCE RemeGen Co., Ltd

SOURCE RemeGen有限公司