重磅 | 复宏汉霖阿达木单抗HLX03完成3期临床试验

近日，复宏汉霖自主开发的HLX03——阿达木单抗注射液完成了中重度斑块状银屑病（plaque psoriasis，PS）适应症3期临床试验。

HLX03-Ps03是在中重度斑块状银屑病患者中开展的一项随机、多中心、双盲、阳性药平行对照的对比试验，共入组216例患者,主要目的是比较HLX03与原研阿达木单抗注射液之间的有效性、安全性、免疫原性和药代动力学，是证明HLX03和原研药生物相似性最重要的试验之一。

阿达木单抗注射液HLX03是复宏汉霖第二个提交新药上市申请的产品，主要用于斑块状银屑病（PS）、类风湿关节炎（rheumatoid arthritis, RA）和强直性脊柱炎（ankylosing spondylitis, AS）等疾病的治疗。2019年1月，复宏汉霖就阿达木单抗注射液HLX03向国家药监局递交新药上市申请（NDA）并获受理，HLX03随后被纳入优先审评程序药品注册申请名单。目前，复宏汉霖已完成HLX03斑块状银屑病3期临床试验，试验结果显示，HLX03治疗中重度斑块状银屑病的疗效等效于原研阿达木单抗注射液，在安全性、免疫原性和药代动力学方面与原研产品皆相似。

复宏汉霖联合创始人、总裁兼首席执行官刘世高博士表示：

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HLX03是复宏汉霖首个专注于自身免疫疾病领域的产品，我们很高兴看到最新临床结果进一步验证了其疗效。未来，我们将尽快推动HLX03进入市场，为自身免疫疾病患者带来更有效的治疗。作为一家扎根中国、国际领先的生物类似药和创新型生物药产品研发企业，复宏汉霖致力于为全球成百上千万的肿瘤及自身免疫疾病患者提供高质量和可负担的治疗方案。

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关于

复宏汉霖

复宏汉霖是一家中国领先的生物制药公司，致力于为全球患者提供质高价优的创新生物药。自2010年成立以来，公司在中国上海、台北和美国加州均设有研发中心，已经建立并持续拓展全面的生物类似药及生物创新药产品管线，产品覆盖肿瘤、自身免疫性疾病等领域。

截至目前，复宏汉霖已有1个产品成功上市，2个产品获得新药上市申请受理，13个产品、3个联合治疗方案在全球范围内开展20多项临床试验。其中，公司首款重磅产品汉利康®（利妥昔单抗注射液）于2019年1月获国家药监局新药上市注册批准，成为中国首个获批上市的生物类似药。HLX03（阿达木单抗注射液）与HLX02（注射用曲妥珠单抗）已获国家药监局新药上市申请受理，现已纳入优先审评程序。HLX02相继在中国大陆、乌克兰、欧盟波兰和菲律宾全面启动国际多中心3期临床试验，成为国内首个开展国际多中心3期临床研究的生物类似药，并于2019年6月获欧洲药品管理局上市申请受理。

Henlius has completed the Phase 3 study of its adalimumab injection HLX03

Henlius announced the completion of a Phase 3 clinical trial of adalimumab injection HLX03 in patients with moderate-to-severe plaque psoriasis (PS).

This confirmatory study was a randomized, double-blind, multicenter, active-controlled parallel phase 3 clinical study to investigate the efficacy, safety, immunogenicity and pharmacokinetics of recombinant fully humanized anti-TNFα monoclonal antibody injection (HLX03) compared with reference adalimumab injection in patients with moderate-to-severe plaque psoriasis. The study is one of the clinical studies to demonstrate the biosimilarity of HLX03 and reference drug.

HLX03 is the second monoclonal antibody (mAb) biosimilar developed by Henlius to submit New Drug Application (NDA). Henlius submitted NDA for HXL03 to NMPA for the indications of PS, Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS), which soon assigned HLX03 into its priority evaluation list. The results from the Phase 3 study of HLX03 showed the similarity in efficacy of HLX03 compare to reference drug for the treatment of moderate-to-severe plaque psoriasis. The pharmacokinetics, safety and immunogenicity profiles of HLX03 were similar to the reference drug.

"HLX03 is Henlius’ first product focused on autoimmune diseases,” said Dr. Scott Liu, the co-Founder, President and CEO at Henlius, “We expect the new drug to be launched as soon as possible to benefit more patients. As a leading biopharmaceutical company in China with robust pipeline, we are committed to provide high-quality, affordable treatments for patients with cancer and autoimmune diseases globally."

About Henlius

Henlius is a leading biopharmaceutical company in China that offers high-quality, affordable and innovative drugs to patients worldwide. Founded in 2010 and headquartered in Shanghai with two R&D centers in Taipei and California, Henlius has established and continues to expand its comprehensive product pipeline of biosimilars and bio-innovative drugs to treat tumors and autoimmune diseases.

Until now, in addition to one product launched commercially and two products under NDA/MAA review, Henlius has conducted over 20 clinical studies for 13 products and 3 combination therapies worldwide. HLX01 (rituximab injection), the first product of Henlius, has been granted approval by the NMPA as the first approved biosimilar in China. Moreover, HLX03 (adalimumab injection) and HLX02 (trastuzumab for injection) have their New Drug Applications under primary review by the NMPA. HLX02 is the first biosimilar developed in China to enter a global multi-center phase 3 clinical trial in China, Poland, Ukraine and the Philippines. In June 2019, the Marketing Authorization Application for HLX02 was accepted to review by EMA.

媒体联系人

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药时代寄语：

复宏汉霖联合创始人、总裁兼首席执行官刘世高博士将应邀出席2019年7月12、13日药时代主办的“新靶点 新技术 新机遇 助力新跨越！——2019中国抗癌药高峰论坛”，并做嘉宾演讲，介绍“中国生物类似药发展的机遇和趋势”。

热烈欢迎朋友们参加高峰论坛，与刘博士当面切磋探讨！共同规划中国企业更加美好的明天！