2021-05-21

复宏汉霖利妥昔单抗类风湿枢纽炎 III 期临床研究数据在中华医学会第二十五次全国风湿 病学学术集会上宣布

2021年5月20日,复宏汉霖(2696.HK)宣布公司自主开发的HLX01(利妥昔单抗注射液)在类风湿枢纽炎(Rheumatoid Arthritis,RA)患者中的III期临床试验(HLX01-RA03,NCT03522415)数据以摘要及壁报的形式于中华医学会第二十五次全国风湿病学学术集会宣布。这是复宏汉霖首次宣布HLX01用于RA治疗的III期临床试验数据,该研究的主要研究者为北京协和医院风湿免疫科曾小峰教授。据悉,该项临床试验数据亦将于近日召开的2021年欧洲风湿病学大会(EULAR 2021)线上平台宣布。

HLX01(利妥昔单抗注射液)为复宏汉霖自主开发的首个单抗生物药,同时也是中国首个凭据2015年宣布的《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。HLX01已获得中国国家药监局批准用于非霍奇金淋巴瘤和白血病的治疗,商品名为汉利康®,全面笼罩原研利妥昔单抗在中国获批的所有适应症。鉴于原研利妥昔单抗的类风湿枢纽炎适应症仅于美国和欧盟获批,在中国尚未获批。复宏汉霖在开发血液肿瘤的基础上,针对HLX01(利妥昔单抗注射液)接纳了差别化的开发战略,积极探索其在类风湿枢纽炎患者中的疗效,以期惠及更多患者群体。2020年12月,HLX01(利妥昔单抗注射液)用于RA治疗的上市注册申请(NDA)获得国家药品监督治理局(NMPA)正式受理。

HLX01-RA03数据宣布详情:

● ?论文题目
Efficacy and Safety of HLX01 in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Had Inadequate Responses to Methotrexate: Results of a Randomised, Double-blind, Placebo-controlled Phase 3 Study
● 主要研究者
曾小峰,北京协和医院
● 展示形式
摘要及壁报
● 摘要编号
2099
● 试验设计
HLX01-RA03是一项在甲氨蝶呤治疗应答不完全(MTX-IR)的中重度运动性类风湿枢纽炎患者中评估HLX01(利妥昔单抗注射液)联合甲氨蝶呤(MTX)治疗的有效性和宁静性的随机、双盲、慰藉剂比照的III期临床研究。纳入的患者按2:1随机分为两组,划分在第1天和第15天静脉输注1000 mg HLX01或慰藉剂。在第169天(第24周第1天)和第183天,HLX01组和慰藉剂组受试者均静脉输注1000 mg HLX01。同时,所有受试者均接收稳定剂量的甲氨蝶呤(MTX)。第16周和20周时如患者对已接受治疗无应答,则进行挽救治疗。该研究的主要终点为第24周抵达美国风湿病学会20%缓解标准(ACR20)的患者比例。
● 试验结果
1)有效性
a)主要终点
本试验共入组275名患者(HLX01组,n = 183; 慰藉剂组,n = 92)。24周时,意向剖析集(ITT)人群中HLX01组抵达ACR20的患者比例相较于慰藉剂组有显著的提升(60.7% vs 35.9%; odds ratio [OR], 2.756 [95% CI 1.640, 4.632]; P < 0.001)。
b)次要终点
次要疗效终点包括抵达ACR20/50/70反应标准的患者比例、基于C反应卵白(CRP)及基于血沉(ESR)的28枢纽疾病运动度评分(DAS28)、基于健康评估问卷残疾指数(HAQ-DI)评估躯体功效的改善等。试验结果显示,HLX01各次要疗效终点较慰藉剂也有显著的提升。
2)宁静性
实验组和慰藉剂比照组治疗后不良事件(TEAE)、药物不良反应(ADR)及导致研究药物停用的TEAE的爆发率均相似。
● 结论
HLX01联合甲氨蝶呤相较于慰藉剂,在甲氨蝶呤治疗应答不完全的中国中重度运动性类风湿枢纽炎受试者中具有显著的临床疗效和良好的宁静性,证明HLX01联合MTX是一种可耐受、宁静、有效的治疗选择。

关于复宏汉霖
复宏汉霖(2696.HK)是一家国际化的立异生物制药公司,致力于为全球患者提供可担负的高品质生物药,产品笼罩肿瘤、自身免疫疾病、眼科疾病等领域,已在中国上市3款产品,在欧盟上市1款产品,3款产品获得中国上市注册申请受理。自2010年建立以来,复宏汉霖已建成一体化生物制药平台,高效及立异的自主焦点能力贯串研发、生产及商业运营全工业链。公司已建立完善高效的全球研发中心,凭据国际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。

复宏汉霖前瞻性结构了一个多元化、高质量的产品管线,涵盖20多种立异单克隆抗体,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。继海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®)、公司首个自身免疫疾病治疗产品汉达远®(阿达木单抗)相继获批上市,立异产品斯鲁利单抗MSI-H实体瘤的上市注册申请已纳入优先审评审批程序,HLX04贝伐珠单抗及HLX01利妥昔单抗类风湿枢纽炎新适应症的上市注册申请也正在审评中。公司亦同步就10个产品、8个联合治疗计划在全球规模内开展20多项临床试验,对外授权全面笼罩欧美主流生物药市场和众多新兴国家市场开展20多项临床试验,产品对外授权笼罩全球近100个国家和地区。


Phase 3 Clinical Results of Rituximab Injection HLX01 in RA Patients Was First Released by Henlius at the 25th
National Congress of Chinese Rheumatology Association

Shanghai, China, 20th May, 2021 - Shanghai Henlius Biotech, Inc. (2696.HK) announced that the abstract and poster of phase 3 clinical trial (HLX01-RA03,NCT03522415) results of HLX01, a rituximab injection which was independently developed by Henlius for the treatment of rheumatoid arthritis was reported at the 25th National Congress of Chinese Rheumatology Association ?by the Company. This is the first time for Henlius to release the results of HLX01-RA03. Professor Xiaofeng Zeng from Department of Rheumatology and Immunology, Peking Union Medical College Hospital is the leading principal investigator of this study. This clinical trial data will also be released on the online platform of European Congress of Rheumatology 2021(EULAR 2021) ?in the coming days.

HLX01 ( rituximab injection) is the first monoclonal antibody (mAb) biosimilar independently developed by Henlius and the first-ever China-manufactured biosimilar approved by the NMPA in accordance with the Technical Guidelines for the Development and Evaluation of Biosimilars (Tentative). It has been approved for the treatment of Non-hodgkin's lymphoma and leukemia, covering all the indications approved for the rituximab originator in Chinese Mainland. Since the rituximab originator has not been approved for RA in China, Henlius has adopted a differentiated strategy to fully develop the potential of HLX01 (rituximab injection) in RA and to benefit a broader patient population. In December 2020, the National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for a new indication of HLX01 to treat RA.?

Details of the publications of HLX01-RA03:

● Title
Efficacy and Safety of HLX01 in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Had Inadequate Responses to Methotrexate: Results of a Randomised, Double-blind, Placebo-controlled Phase 3 Study
● Leading PI
Xiaofeng Zeng, MD, PhD, Peking Union Medical College Hospital
● Form
Abstract and Poster?
● Abstract No.
2099
● Study Design
HLX01-RA03 is a randomised, double-blind, placebo-controlled, phase 3 study aimed to evaluate the efficacy and safety of HLX01 (rituximab injection) in combination with methotrexate (MTX) in patients with moderate to severe active rheumatoid arthritis (RA) who have had MTX-inadequate response (MTX-IR). Eligible patients were randomised 2:1 to receive 1000 mg HLX01 or placebo on day 1 and day 15 by intravenous infusion. Patients were retreated with or switched to receive (if initially assigned to placebo) 1000 mg HLX01 on day 169 (the first day of week 24) and day 183. A stable dose of MTX was administered to all patients during the study. Patients with inadequate responses at week 16 and week 20 could receive rescue treatments. The primary endpoint of the study is the proportion of patients who met American College of Rheumatology 20 (ACR20) criteria at week 24.
● Results
1) Efficacy
a) Primary endpoint
275 patients were enrolled (HLX01 group, n = 183; Placebo group, n = 92) in this study. A significantly greater proportion of patients achieved ACR20 response in the HLX01 group compared with the placebo group in the ITT population at week 24 (60.7% vs 35.9%; odds ratio [OR], 2.756 [95% CI 1.640, 4.632]; P < 0.001).
b) Secondary endpoints
The secondary efficacy endpoints include proportions of patients achieving ACR20/50/70, disease activity score measured by 28 joints (DAS28) based on C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR), improvement in physical function assessed by Health Assessment Questionnaire-Disability Index (HAQ-DI), and so on. The results demonstrated that the secondary efficacy endpoints were also significantly improved in HLX01 group compared with placebo group.
2) Safety
The overall incidence of treatment emergent adverse events (TEAEs), adverse drug reactions (ADRs), and TEAEs leading to drug discontinuation were similar among treatment groups.
● Conclusion
HLX01 plus MTX showed significantly improved clinical outcomes and comparable safety profiles compared with placebo in Chinese patients with moderate to severe active RA who had inadequate responses to MTX, demonstrating HLX01 in combination with MTX as a well-tolerated, safe, and efficient treatment option.

About Henlius
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, 3 products have been launched in China, 1 in the European Union (EU), the New Drug Applications (NDAs) of 3 products 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 commercialisation. 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 and 汉达远® (adalimumab), the Company's first product indicated for autoimmune diseases, the NDA of innovative product serplulimab indicated for MSI-H solid tumors has been granted priority review, and the NDAs of HLX04 (bevacizumab) and HLX01 (rituximab) for the treatment of rheumatoid arthritis are also under review. What's more, Henlius has conducted over 20 clinical studies for 10 products and 8 combination therapies worldwide, expanding its presence in major market as well as emerging market.
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