YANTAI, China, May 21, 2024 /PRNewswire/ -- RemeGen Co. Ltd. ('RemeGen' or 'the Company') (9995.HK, 688331.SH), a commercial-stage biotechnology company, recently announced significant progress of Telitacicept (RC18), that two Phase III clinical trials in China for the treatment of IgA nephropathy and primary Sjögren's syndrome (pSS) have completed patient enrollments..

中国烟台，2024年5月21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，最近宣布Telitacicept（RC18）取得重大进展，中国治疗IgA肾病和原发性干燥综合征（pSS）的两项III期临床试验已完成患者登记。。

Dr. Jianmin Fang, CEO of RemeGen, commented, 'This marks further continued progress in RemeGen's research achievements for the treatment of these two diseases and we remain steadfastly committed to providing patients with more efficient and convenient treatment options. The smooth progress of these two clinical trials is an important milestone on the road to achieving this goal.'.

RemeGen首席执行官方建民博士评论道：“这标志着RemeGen在治疗这两种疾病方面的研究成果取得了进一步的进展，我们仍然坚定地致力于为患者提供更有效和方便的治疗选择。这两项临床试验的顺利进行是实现这一目标道路上的一个重要里程碑。”。

IgA nephropathy is a kidney disease, for which there is currently no cure, caused by the build-up of a germ-fighting protein called immunoglobulin A (IgA) in the kidneys, causing inflammation that can make it harder for the kidneys to filter waste from the blood. A total of 318 patients were enrolled between June 2023 and May 2024 in the clinical study led by Professor Zhang Hong from Peking University First Hospital.

IgA肾病是一种肾脏疾病，目前尚无治愈方法，它是由肾脏中一种称为免疫球蛋白a（IgA）的抗菌蛋白的积累引起的，引起炎症，使肾脏更难过滤血液中的废物。2023年6月至2024年5月期间，北京大学第一医院张红教授领导的临床研究共招募了318名患者。

It has been designed to evaluate the efficacy and safety of RemeGen's telitacicept in the treatment of patients with primary IgA nephropathy who are at risk of progression to end-stage kidney disease (ESKD). The study uses pre-filled injections which can provide patients with a more convenient administration method and simplified medication use compared with the approved lyophilized powder injection form of telitacicept for the treatment of systemic lupus erythematosus (SLE)..

它旨在评估雷米根的telitacicept治疗有进展为终末期肾病（ESKD）风险的原发性IgA肾病患者的疗效和安全性。该研究使用预先填充的注射剂，与批准的用于治疗系统性红斑狼疮（SLE）的泰利他西普冻干粉针剂相比，可以为患者提供更方便的给药方法和简化的药物使用。。

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。

A total of 381 patients were enrolled between the end of 2022 and May 2024 in the clinical study led by Professor Zeng Xiaofeng from Peking Union Medical College Hospital. This study aims to evaluate the efficacy and safety of telitacicept in the treatment of patients with primary Sjögren's syndrome (pSS) with a primary endpoint of a change in the EULAR Sjögren's syndrome (SS) disease activity index (ESSDAI) score from baseline at week 24 of treatment.

2022年底至2024年5月，北京协和医院曾晓峰教授领导的临床研究共招募了381名患者。本研究旨在评估telitacicept治疗原发性干燥综合征（pSS）患者的疗效和安全性，其主要终点是治疗第24周时EULAR干燥综合征（SS）疾病活动指数（ESSDAI）评分从基线变化。

Telitacicept has previously displayed a significant clinical benefit in a randomized, double-blind, placebo-controlled Phase II clinical trial in the treatment of adult patients with pSS that can significantly improve ESSDAI scores and Multidimensional Fatigue Inventory (MFI-20), thereby reducing immunoglobulin levels in patients..

Telitacicept之前在一项随机，双盲，安慰剂对照的II期临床试验中显示出显着的临床益处，该试验用于治疗成年pSS患者，可显着改善ESSDAI评分和多维疲劳量表（MFI-20），从而降低患者的免疫球蛋白水平。。

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。。