HANGZHOU, China, SHANGHAI and BOSTON

中国杭州、上海和波士顿

,

，

Oct. 27, 2026

2026年10月27日

/PRNewswire/ -- Lynk Pharmaceuticals Co., Ltd. ('Lynk Pharmaceuticals'), a clinical-stage innovative drug development company focused on immune and inflammatory diseases, today announced positive long-term results from its pivotal Phase III clinical trial evaluating zemprocitinib, an investigational, selective, second-generation oral Janus kinase 1 (JAK1) inhibitor, in adult patients with moderate-to-severe active rheumatoid arthritis (RA) who had experienced inadequate response or intolerance to biologic disease-modifying antirheumatic drugs (bDMARDs)..

/美通社/ -- 专注于免疫和炎症疾病的临床阶段创新药物开发公司 Lynk Pharmaceuticals Co., Ltd.（“Lynk Pharmaceuticals”）今日宣布，其评估 zemprocitinib（一种在研的选择性第二代口服 Janus 激酶 1 [JAK1] 抑制剂）的关键性 III 期临床试验在对生物制剂类改善病情抗风湿药 (bDMARDs) 反应不足或不耐受的中重度活动性类风湿关节炎 (RA) 成年患者中取得了积极的长期结果。

The study met its primary endpoint of ACR20 response and key secondary endpoints at Week 24, demonstrating a statistically significant improvement with zemprocitinib versus placebo (p<0.0001). The Week 52 and Week 76 results further demonstrate continued improvements in all disease activity measurements and physical function during long-term treatment by Week 52 and sustained clinical responses through Week 76..

该研究在第24周达到了ACR20应答的主要终点和关键次要终点，显示出泽莫昔替尼相较于安慰剂具有统计学意义的显著改善（p<0.0001）。第52周和第76周的结果进一步表明，在长期治疗至第52周时，所有疾病活动度指标和身体功能均持续改善，并且临床缓解效果维持至第76周。

The double-blind, placebo-controlled Phase III study randomized 430 patients with moderate-to-severe active RA who had experienced an inadequate response or intolerance to prior bDMARDs, of whom 429 received at least one dose of study treatment. During the initial 24-week double-blind treatment period, patients received zemprocitinib 12 mg twice daily or placebo.

这项双盲、安慰剂对照的III期研究将430名中度至重度活动性类风湿关节炎（RA）患者随机分组，这些患者此前对生物制剂疾病修饰抗风湿药（bDMARDs）的反应不足或不耐受，其中429名患者接受了至少一剂研究治疗。在初始24周的双盲治疗期内，患者接受zemprocitinib 12 mg每日两次或安慰剂治疗。

Following this period, patients continued or transitioned to active treatment, with efficacy and safety assessed through Week 76..

在此阶段之后，患者继续或转为接受积极治疗，并对疗效和安全性进行评估直至第76周。

Long-Term Sustained Efficacy Through Week 76

截至第76周的长期持续疗效

Among patients receiving continuous zemprocitinib treatment, ACR20, ACR50, and ACR70 response rates were 93.0%, 79.9%, and 52.5%, respectively, at Week 52. Responses remained at Week 76, with ACR20 and ACR50 rates of 91.8% and 80.5%, respectively, while ACR70 increased to 62.4%, demonstrating sustained ACR responses during long-term treatment..

在接受连续zemprocitinib治疗的患者中，第52周时ACR20、ACR50和ACR70的缓解率分别为93.0%、79.9%和52.5%。到第76周时，缓解情况依然保持，其中ACR20和ACR50的缓解率分别为91.8%和80.5%，而ACR70则上升至62.4%，表明在长期治疗过程中ACR缓解效果持续存在。

Beyond ACR responses, zemprocitinib demonstrated sustained improvements across measures of disease activity, clinical remission and physical function through Week 76 (selected data are presented in the table below). At Week 52 and Week 76, among patients receiving continuous zemprocitinib treatment, 85.5% and 81.4% achieved low disease activity, respectively, defined as disease activity score (DAS28(CRP) ≤3.2).

除ACR应答外，zemprocitinib在截至第76周的疾病活动度、临床缓解和身体功能各项指标中均显示出持续改善（部分数据见下表）。在第52周和第76周，接受连续zemprocitinib治疗的患者中，分别有85.5%和81.4%达到了低疾病活动度，定义为疾病活动度评分（DAS28(CRP) ≤3.2）。

Based on the clinical disease activity index (CDAI), 81.5% and 81.0% of patients achieved low disease activity (CDAI ≤10), respectively. Improvements in physical function were also observed with 84.5% and 86.7% of patients achieving an improvement of at least 0.22 points in the health assessment questionnaire–disability index (HAQ-DI) from baseline at Week 52 and Week 76, respectively..

根据临床疾病活动指数（CDAI），分别有81.5%和81.0%的患者达到了低疾病活动度（CDAI ≤10）。在身体功能方面也观察到改善，在第52周和第76周时，分别有84.5%和86.7%的患者健康评估问卷–残疾指数（HAQ-DI）较基线改善了至少0.22分。

Selected efficacy results in patients receiving zemprocitinib 12 mg twice daily*:

接受泽普罗西替尼 12 mg 每日两次治疗的患者的选定疗效结果*：

Selected Results

精选结果

Week 52

第52周

Week 76

第76周

Efficacy endpoint

疗效终点

ACR20

ACR20

93.0 %

93.0%

91.8 %

91.8%

ACR50

ACR50

79.9 %

79.9%

80.5 %

80.5%

ACR70

ACR70

52.5 %

52.5%

62.4 %

62.4%

Low Disease Activity

低疾病活动度

DAS28(CRP) ≤3.2

DAS28(CRP) ≤3.2

85.5 %

85.5%

81.4 %

81.4%

CDAI ≤10

CDAI ≤10

81.5 %

81.5%

81.0 %

81.0%

Physical Function

物理功能

HAQ-DI improvement ≥0.22

HAQ-DI 改善 ≥0.22

84.5 %

84.5%

86.7 %

86.7%

Abbreviations: ACR, American College of Rheumatology; DAS28(CRP), Disease Activity Score 28 joints using C-reactive protein; CDAI, Clinical Disease Activity Index; HAQ-DI, Health Assessment Questionnaire–Disability Index.

缩略语：ACR，美国风湿病学会；DAS28(CRP)，基于C反应蛋白的28关节疾病活动度评分；CDAI，临床疾病活动指数；HAQ-DI，健康评估问卷–残疾指数。

*The 24-week results of efficacy and safety of zemprocitinib, in patients with rheumatoid arthritis from the Phase III COURAGE-RA study, were presented at the EULAR 2026 Congress (Abstract #OP0208). The EULAR 2026 abstract archive can be found

在2026年欧洲抗风湿病联盟（EULAR）大会上公布了III期COURAGE-RA研究中泽姆普罗西替尼（zemprocitinib）治疗类风湿关节炎患者的24周疗效和安全性结果（摘要编号#OP0208）。EULAR 2026摘要档案可查阅

here

这里

.

。

Patients who initially received placebo and switched to zemprocitinib at Week 24 also demonstrated increased clinical responses by Week 76, with ACR20, ACR50, and ACR70 response rates of 92.0%, 77.6%, and 55.1%, respectively, and achieved comparable responses in all other efficacy measurements comparing the patients with continuous dosing of zemprocitinib through Week 76.

最初接受安慰剂并在第24周切换至zemprocitinib的患者，在第76周时也显示出增加的临床反应，ACR20、ACR50和ACR70的反应率分别为92.0%、77.6%和55.1%，并且在所有其他疗效指标中，与持续服用zemprocitinib直至第76周的患者相比，达到了相似的响应效果。

These findings complement the sustained ACR responses and provide a broader picture of long-term clinical outcomes in patients who had an inadequate response or intolerance to bDMARDs..

这些发现补充了持续的ACR反应，并为对bDMARDs反应不足或不耐受的患者提供了更全面的长期临床结局图景。

Long-Term Safety and Tolerability Through Week 76

截至第76周的长期安全性和耐受性

During the initial 24-week double-blind, placebo-controlled period, the safety profile of zemprocitinib was generally comparable to that of placebo as reported at EULAR 2026*. The safety profile remained consistent through Week 76 with no new safety signals identified during long-term treatment. An additional observation was the cleaner lab parameters suggesting a cleaner profile of zemprocitinib, particularly with the increase in mean hemoglobin levels, rare incidence of grade 3 or 4 in ALT elevations and grade 3 in AST elevations, and the lack of reports on grade 4 AST elevations.

在为期24周的初始双盲、安慰剂对照期间，zemprocitinib的安全性特征与安慰剂大致相当，正如在2026年EULAR会议上所报告的那样*。直至第76周，其安全性特征保持一致，在长期治疗期间未发现新的安全信号。另外还观察到实验室指标更为良好，提示zemprocitinib具有更优的安全性特征，具体表现为平均血红蛋白水平升高、ALT升高至3级或4级的发生率罕见、AST升高至3级的发生率罕见，且未报告AST升高至4级的病例。

These findings provide additional information on the safety and tolerability of zemprocitinib during long-term treatment in patients with RA..

这些发现为泽普罗西替尼在类风湿关节炎患者长期治疗中的安全性和耐受性提供了更多信息。

Professor Xiaofeng Zeng, Principal Investigator of the study from Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, said: 'Treatment options remain limited for patients with difficult-to-treat rheumatoid arthritis, leaving significant unmet medical needs. The long-term results from the Phase III clinical study of zemprocitinib are very encouraging.

中国医学科学院北京协和医院的研究主要研究者曾小峰教授表示：“对于难治性类风湿关节炎患者，治疗选择仍然有限，存在巨大的未满足医疗需求。泽普替尼III期临床试验的长期结果令人非常鼓舞。”

We observed favorable efficacy not only in patients who had an inadequate response or intolerance to bDMARDs, but also in patients who had an inadequate response to prior JAK inhibitor therapy. Zemprocitinib also demonstrated a favorable long-term safety profile. These findings suggest that zemprocitinib may offer an important additional treatment option for patients whose disease remains inadequately controlled with existing therapies.'.

我们不仅在对生物制剂改善病情抗风湿药（bDMARDs）反应不足或不耐受的患者中观察到了良好的疗效，也在对既往JAK抑制剂治疗反应不足的患者中观察到了良好的疗效。Zemprocitinib还显示出良好的长期安全性特征。这些发现表明，zemprocitinib可能为现有治疗方案下疾病控制仍不充分的患者提供一个重要的额外治疗选择。

'These long-term results represent an important milestone in the clinical development of zemprocitinib,' said Dr. Zhao-Kui (ZK) Wan, Founder and CEO of Lynk Pharmaceuticals. 'We are encouraged by the sustained clinical responses and safety profiles observed through Week 76 in patients who had an inadequate response or intolerance to prior biologic therapies.

“这些长期结果代表了泽姆普罗西替尼临床开发中的一个重要里程碑，” Lynk Pharmaceuticals 创始人兼首席执行官赵奎（ZK）万博士表示。“我们对在先前生物制剂治疗反应不足或不耐受的患者中，截至第76周观察到的持续临床应答和安全性特征感到鼓舞。”

These findings add to the clinical evidence supporting the continued development of zemprocitinib for patients with rheumatoid arthritis.'.

这些发现为支持继续开发zemprocitinib用于类风湿关节炎患者提供了更多的临床证据。

'We are encouraged by the long-term efficacy and safety results from the Phase III study of zemprocitinib, which provide further clinical evidence of its best-in-class potential as a treatment option for patients with moderate-to-severe rheumatoid arthritis,' said Dr. Aik Goh, Chief Medical Officer of Simcere Pharmaceutical Group.

先声药业集团首席医学官Aik Goh博士表示：“zemprocitinib III期研究的长期疗效和安全性结果令人鼓舞，这为其作为中重度类风湿关节炎患者治疗选择的同类最佳潜力提供了进一步的临床证据。”

'As the commercialization partner for zemprocitinib in Greater China, we look forward to helping address the unmet treatment needs of patients with rheumatoid arthritis in China soon.'.

“作为泽姆普罗西替尼在大中华区的商业化合作伙伴，我们期待不久后能够帮助满足中国类风湿关节炎患者尚未被满足的治疗需求。”

About Zemprocitinib

关于泽姆普罗西替尼

Zemprocitinib is an investigational, orally administered, selective second-generation JAK1 inhibitor discovered and developed by Lynk Pharmaceuticals. It is being developed for inflammatory and autoimmune diseases, including rheumatoid arthritis, atopic dermatitis, and ankylosing spondylitis. In addition to its RA development program, zemprocitinib has completed a pivotal Phase III study in atopic dermatitis, and a New Drug Application has been submitted to and accepted for review by China's National Medical Products Administration.

Zemprocitinib 是一种在研的口服选择性第二代 JAK1 抑制剂，由 Lynk Pharmaceuticals 发现并开发。该药正在开发用于治疗炎症性和自身免疫性疾病，包括类风湿关节炎、特应性皮炎和强直性脊柱炎。除类风湿关节炎研发项目外，zemprocitinib 已完成一项针对特应性皮炎的关键性 III 期临床研究，且其新药上市申请已提交至中国国家药品监督管理局并被受理审评。

A Phase III clinical program in ankylosing spondylitis is also underway. In March 2022, Lynk Pharmaceuticals entered into a commercialization collaboration with Simcere to jointly advance the commercialization of zemprocitinib for rheumatoid arthritis and ankylosing spondylitis in Greater China..

强直性脊柱炎的III期临床试验计划也在进行中。2022年3月，Lynk Pharmaceuticals与先声药业达成商业化合作，共同推进zemprocitinib在大中华区用于类风湿关节炎和强直性脊柱炎的商业化进程。

About the Phase III Rheumatoid Arthritis Study

关于类风湿性关节炎的III期研究

The Phase III study was a randomized, double-blinded, placebo-controlled clinical trial evaluating the efficacy and safety of zemprocitinib in adults with moderate-to-severe active rheumatoid arthritis (RA) who had experienced an inadequate response or intolerance to prior biologic disease-modifying antirheumatic drugs (bDMARDs)..

这项III期研究是一项随机、双盲、安慰剂对照的临床试验，旨在评估zemprocitinib在既往对生物制剂类改善病情抗风湿药（bDMARDs）反应不足或不耐受的中等至重度活动性类风湿关节炎（RA）成人患者中的疗效和安全性。

A total of 430 patients were randomized, of whom 429 received at least one dose of study treatment. The primary efficacy endpoint was the proportion of patients achieving an ACR20 response at Week 24. Key secondary endpoints included ACR50 response and DAS28(CRP) ≤3.2 at Week 24.

共有430名患者被随机分组，其中429名患者接受了至少一剂研究治疗。主要疗效终点为第24周时达到ACR20应答的患者比例。关键次要终点包括第24周时的ACR50应答以及DAS28(CRP) ≤ 3.2。

Following the initial 24-week double-blind treatment period, patients continued or transitioned to active treatment, with long-term efficacy and safety assessed through Week 76, followed by a 4-week safety follow-up period.

在初始的24周双盲治疗期结束后，患者继续或过渡到活性治疗，长期疗效和安全性评估持续至第76周，随后进行为期4周的安全性随访。

About Simcere:

关于先声药业：

Simcere Pharmaceutical Group Limited

先声药业有限公司

(

（

02096

02096

)

）

is a pharmaceutical company driven by innovation and focusing on four therapeutic areas including Neuroscience, Oncology, Autoimmune Diseases and Anti-infection. We proactively explore areas with significant unmet needs, and our mission is for patients, for life. Driven by our in-house R&D efforts and synergistic innovation, Simcere has established strategic cooperation partnerships with many innovative companies and research institutes..

先声药业是一家以创新为驱动、聚焦神经科学、肿瘤、自身免疫性疾病和抗感染四大治疗领域的制药公司。我们积极探索存在重大未满足需求的领域，秉持“为患者，为生命”的使命。依托自主研发与协同创新，先声药业已与众多创新型企业和研究机构建立了战略合作伙伴关系。

About Lynk Pharmaceuticals

关于 Lynk 制药公司

Lynk Pharmaceuticals is a clinical-stage innovative drug company focused on autoimmune and inflammatory diseases, committed to addressing unmet clinical needs through first-in-class innovation, developing differentiated small-molecule therapies, and providing superior oral alternatives to biologics.

Lynk Pharmaceuticals 是一家处于临床阶段的创新药物公司，专注于自身免疫性和炎症性疾病，致力于通过首创性创新满足未竟的临床需求，开发具有差异化的小分子疗法，并提供优于生物制剂的口服替代方案。

The company was founded by senior R&D leaders from Pfizer, MSD, and Johnson & Johnson, focusing on the JAK-STAT and expanding to TYK2 signaling pathways, and mastering targeted protein degradation..

公司由来自辉瑞、默沙东和强生的资深研发领导创立，专注于JAK-STAT通路并拓展至TYK2信号通路，同时掌握靶向蛋白降解技术。

The company combines AI-assisted drug design, comprehensive biological evaluation, and protein degradation technologies into an integrated innovative R&D platform spanning target discovery, molecular design, translational research, and clinical development to advance differentiated therapies for patients worldwide.

该公司将人工智能辅助药物设计、全面生物评估和蛋白质降解技术整合为一个一体化的创新研发平台，涵盖靶点发现、分子设计、转化研究和临床开发，旨在为全球患者推进差异化疗法。

To date, Lynk Pharmaceuticals has successfully developed and progressed multiple Class 1 new drug candidates and advanced multiple pipeline programs through internal research and development as well as global partnerships..

迄今为止，Lynk Pharmaceuticals 已通过内部研发及全球合作，成功开发并推进了多个1类新药候选药物，并推动了多个管线项目的进展。

Forward-Looking Statements

前瞻性陈述

This press release contains certain forward-looking statements. These statements relate to future events and may include, but are not limited to, expectations, plans, or objectives regarding the Company's future research and development programs, business development, collaboration arrangements, and other future matters..

本新闻稿包含某些前瞻性陈述。这些陈述涉及未来事件，可能包括但不限于对公司未来研发计划、业务发展、合作安排及其他未来事项的期望、计划或目标。

Because future events are subject to numerous uncertainties, these forward-looking statements are based on the Company's management's current information, views, assumptions, estimates, and judgments at the time such statements are made. They do not constitute guarantees of future performance, development, or results.

由于未来事件存在诸多不确定性，这些前瞻性陈述基于公司管理层在作出该等陈述时所掌握的信息、观点、假设、估计和判断。它们不构成对未来业绩、发展或结果的保证。

Actual events, outcomes, or developments may differ materially from those expressed or implied by such forward-looking statements..

实际事件、结果或发展可能与这些前瞻性陈述中明示或暗示的内容存在重大差异。

Except as required by applicable laws and regulations, the Company undertakes no obligation to update, revise, or supplement any forward-looking statements contained in this press release as a result of future developments or changes in circumstances, nor does the Company assume any responsibility for the failure of any forward-looking statements to materialize or for any differences between such statements and actual results..

除适用法律和法规要求外，公司不承担因未来发展或情况变化而更新、修订或补充本新闻稿中任何前瞻性陈述的义务，也不对任何前瞻性陈述未能实现或此类陈述与实际结果之间的任何差异承担任何责任。

SOURCE Lynk Pharmaceuticals Co., Ltd.

来源：领康制药有限公司