汉利康^®是国内唯一申报获批类风湿关节炎适应症的利妥昔单抗，此前已经获批用于非霍奇金淋巴瘤，包括先前未经治疗的CD20 阳性III-IV 期滤泡性非霍奇金淋巴瘤、初治滤泡性淋巴瘤患者经利妥昔单抗联合化疗后达完全或部分缓解后的单药维持治疗、复发或化疗耐药的滤泡性淋巴瘤、CD20 阳性弥漫大B细胞性非霍奇金淋巴瘤 (DLBCL)，以及慢性淋巴细胞白血病：与氟达拉滨和环磷酰胺（FC）联合治疗先前未经治疗或复发性/难治性慢性淋巴细胞白血病（CLL）患者。目前，汉利康^®是国内获批适应症最多的利妥昔单抗。

复宏汉霖董事长、执行董事兼首席执行官张文杰表示：

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汉利康^®作为中国首个生物类似药，其适应症的布局和相应的临床研发一直走在同类药物的前列。本次针对类风湿关节炎的获批是公司继先前阿达木单抗汉达远^®上市后在风湿免疫领域又一里程碑，将覆盖更多患者群体，并为他们提供更多治疗选择。

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类风湿关节炎是一种以侵蚀性关节炎为主要临床表现的慢性进行性自身免疫病，以关节滑膜炎为主要特征，多为对称性的关节炎，随着病程的延长，患者残疾及功能受限发生率升高。该病可发生于任何年龄，全球发病率为0.5%-1% ^[1]，中国大陆地区发病率为0.42% ^[2]。目前类风湿关节炎无法完全治愈，仅能通过治疗进行缓解，并需长期治疗，其中常见的治疗手段为使用改善病情的抗风湿药物（DMARDs）。传统合成DMARDs (csDMARDs) 是治疗类风湿关节炎的基础，但对部分患者疗效不佳，这部分患者可使用甲氨蝶呤（MTX）联合利妥昔单抗等生物类DMARDs (bDMARDs)，以取得良好的治疗效果。汉利康^® 针对该适应症，每年仅需使用两个疗程，每疗程给药两次，其给药频次远低于市场同类bDMARDs，并且药效持续时间长，积极提升患者用药的便利性，改善患者生活质量。

汉利康^®类风湿关节炎适应症III期临床试验牵头人，北京协和医院风湿免疫科曾小峰教授表示：

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汉利康^®在既往多轮临床研究中即展现出良好的疗效和可靠的安全性。作为国内首个上市治疗类风湿关节炎的利妥昔单抗，汉利康^®将以低频次给药及持久的药效有效提振患者持续用药信心，为类风湿关节病患者的疾病缓解做出积极贡献。

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汉利康^®是复宏汉霖自主开发的首个单抗生物药，同时也是中国首个根据2015年发布的《生物类似药研发与评价技术指导原则（试行）》开发并批准上市的生物类似药，全面覆盖原研利妥昔单抗在中国获批的所有适应症。原研利妥昔单抗针对于类风湿关节炎适应症的治疗仅在美国和欧盟获批，未在中国上市。汉利康^®在开发现有适应症的基础上，针对类风湿关节炎展开创新性临床试验，以差异化的开发策略，为国内风湿免疫治疗开辟了新路径。依托江苏复星领先的商业化平台及在风湿疾病领域成熟的商业化能力，汉利康^®将高效触达市场，造福更多患者。

复星医药执行总裁兼首席发展官李胜利表示：

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在汉利康^®上市三周年之际，其新适应症类风湿关节炎正式获批，可喜可贺。复星医药将充分借助在既往风湿治疗领域的成功经验，为患者提供更便捷、更可及的治疗新方案。

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复星医药董事长兼首席执行官吴以芳表示：

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围绕未被满足的临床需求，复星医药始终以创新研发为核心驱动力，持续探索，为患者提供高品质、可负担的创新药物和治疗方案。相信本次汉利康^®类风湿关节炎适应症获批上市将惠及更多中国类风关患者。

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复宏汉霖（2696.HK）是一家国际化的创新生物制药公司，致力于为全球患者提供可负担的高品质生物药，产品覆盖肿瘤、自身免疫疾病、眼科疾病等领域，已在中国上市4款产品，在欧盟上市1款产品，12项适应症获批，2个上市注册申请获得中国药监局受理。自2010年成立以来，复宏汉霖已建成一体化生物制药平台，高效及创新的自主核心能力贯穿研发、生产及商业运营全产业链。公司已建立完善高效的全球研发中心，按照国际药品生产质量管理规范（GMP）标准进行生产和质量管控，位于上海徐汇的生产基地已获得中国和欧盟GMP认证。

复宏汉霖前瞻性布局了一个多元化、高质量的产品管线，涵盖20多种创新单克隆抗体，并全面推进基于自有抗PD-1单抗斯鲁利单抗的肿瘤免疫联合疗法。继国内首个生物类似药汉利康^®（利妥昔单抗）、中国首个自主研发的中欧双批单抗药物汉曲优^®（曲妥珠单抗，欧盟商品名：Zercepac^®）、汉达远^®（阿达木单抗）和汉贝泰^®（贝伐珠单抗）相继获批上市，创新产品斯鲁利单抗MSI-H实体瘤的上市注册申请已纳入优先审评审批程序，斯鲁利单抗鳞状非小细胞肺癌适应症的上市注册申请也正在审评中。公司亦同步就12个产品、9个免疫联合治疗方案在全球范围内开展20多项临床试验，对外授权全面覆盖欧美主流生物药市场和众多新兴市场。

Shanghai, China, March 1^st, 2022 – Shanghai Henlius Biotech, Inc. (2696. HK) today announced that 汉利康^® (rituximab injection), its first independently developed monoclonal antibody, has been granted approval by the National Medical Products Administration (NMPA) in combination with methotrexate for the treatment of adult patients with moderately-to severely-active Rheumatoid Arthritis (RA) who have inadequate response to one or more TNF-alpha antagonist therapies, providing an alternative treatment option for patients with autoimmune diseases.

汉利康^® is the only rituximab that gets the approval in China to treat rheumatoid arthritis and it was approved by NMPA for the treatment of adult patients in below indications: Non-Hodgkin’s lymphoma includes previously untreated follicular, CD20-positive, stage III-IV non-Hodgkin’s lymphoma, single-agent maintenance therapy after complete or partial response under rituximab in combination with chemotherapy in patients with previously untreated follicular lymphoma, relapsed or refractory follicular lymphoma, CD20-positive, diffuse large B-cell non-Hodgkin’s lymphoma (DLBCL); Chronic Lymphocytic Leukemia includes in combination with fludarabine and cyclophosphamide (FC) in patients with previously untreated or relapsed/refractory Chronic Lymphocytic Leukemia (CLL). As of now, 汉利康^® is the rituximab with the largest number of approved indications in China.

“汉利康^® is the first biosimilar approved in China and its indication plan and corresponding clinical research have always been at the forefront of biosimilars. In addition to adalimumab 汉达远^®, the approval for 汉利康^®on rheumatoid arthritis is another milestone of Henlius in rheumatic immunity and will reach more patient population and provide them with alternative treatment options,” said Wenjie Zhang, Chairman, Executive Director and CEO of Henlius.

Unique Superiority Improves Patients' Quality of Life

Rheumatoid arthritis is a chronic progressive autoimmune disease with aggressive arthritis as the main clinical manifestation and its common clinical symptoms include synovitis, most are symmetrical arthritis. With the prolongation of the course of disease, the incidence of disability and functional limitation increases. The incidence rate is 0.5%-1% ^[1] at any age globally and is about 0.42% in Chinese mainland ^[2]. At present, rheumatoid arthritis is incurable and can only be alleviated through treatment, long-term treatment is required. The common treatment for RA patients is to take disease-modifying anti-rheumatic drugs (DMARDs) in which the conventional synthetic DMARDs (csDMARDs) are the basis for the treatment of rheumatoid arthritis. Patients who have inadequate response to csDMARDs are encouraged to try biological DMARDs (bDMARDs), such as methotrexate (MTX) in combination with rituximab to achieve good therapeutic results. For rheumatoid arthritis, the dose regimen of 汉利康^® is twice per course and approximately two courses every year, which is significantly less than that of similar bDMARDs on the market. Furthermore, this rituximab demonstrates sustained efficacy. With these key advantages, 汉利康^® is able to actively improve the convenience of medication and patients’ quality of life.

Professor Xiaofeng Zeng, the leading principal investigator of the Phase III clinical study of 汉利康^® on rheumatoid arthritis, from the Department of Rheumatology and Immunology, Peking Union Medical College Hospital, said, “汉利康^® has shown good efficacy and reliable safety in clinical studies. As the first rituximab approved in China for the treatment of rheumatoid arthritis, 汉利康^® will effectively boost patients' confidence in continuous medication with low-frequency administration and sustained efficacy and make a positive contribution to symptom relief of rheumatoid arthritis.”

Differentiated Strategy Benefits a Wider Patient Population

汉利康^® is the first monoclonal antibody independently developed by Henlius as well as the first biosimilar developed and approved based on the Technical Guideline for the Development and Evaluation of Biosimilars (Tentative) issued in 2015, covering all indications of the originator rituximab approved in China. The originator rituximab for rheumatoid arthritis was approved in the United States and European Union but not listed in China previously. 汉利康^® launched innovative clinical trials on rheumatoid arthritis based on its existing treatment research, opening up a new path for domestic rheumatic immunotherapy with differentiated strategies. On the other hand, upon the superior commercial platform and mature ability of commercialization in rheumatic diseases, Jiangsu Fosun will promote 汉利康^® to the market more efficiently to benefit a wider patient population.

Shengli Li, Executive President and Chief Growth Officer of Fosun Pharma, said, “On the occasion of the 3^rd anniversary of 汉利康^® launched, we are happy to see that its new indication rheumatoid arthritis is approved by the NMPA. Fosun Pharma will fully leverage its successful practices in rheumatism treatment to provide patients with a new more convenient and accessible treatment.”

Yifang Wu, Chairman and Chief Executive Officer of Fosun Pharma, said, “Focusing on the unmet clinical needs, Fosun Pharma will always take innovative R&D as the core driving force and continue exploring quality and affordable innovative drugs and treatment for patients. We believe that the approval of 汉利康^® would benefit more patients with rheumatoid arthritis in China.”

【参考文献】

[1] Smolen, Josef S et al. “Rheumatoid arthritis.” Lancet vol. 388,10055 (2016): 2023-2038.

[2] 医学会风湿病学分会. 2018中国类风湿关节炎诊疗指南[J]. 中华内科杂志, 2018(4).

Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases and ophthalmic diseases. Up to date, 4 products have been launched in China, 1 in the European Union (EU), 12 indications approved worldwide, and 2 New Drug Applications (NDAs) accepted for review in China. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global R&D centers and a Shanghai-based manufacturing facility certificated by China and the EU Good Manufacturing Practice (GMP).

Henlius has pro-actively built a diversified and high-quality product pipeline covering over 20 innovative monoclonal antibodies (mAbs) and has continued to explore immuno-oncology combination therapies with proprietary serplulimab (anti-PD-1 mAb) as backbone. Apart from the launched products 汉利康^® (rituximab), the first China-developed biosimilar, 汉曲优^® (trastuzumab, Zercepac^® in the EU), the first China-developed mAb biosimilar approved both in China and in the EU, 汉达远^® (adalimumab) and 汉贝泰^® (bevacizumab), the NDA of innovative product serplulimab indicated for MSI-H solid tumors has been granted priority review, and the NDA of serplulimab for the treatment of squamous non-small cell lung cancer is also under review. What's more, Henlius has conducted over 20 clinical studies for 12 products and 9 combination therapies worldwide, expanding its presence in major market as well as emerging market.