斯鲁利单抗注入液为复宏汉霖自由开发设计的创新性型抗PD-1单抗，现下已才能得到华人、新加坡、欧共体等国家东南部和东南部的药学上医学试验装置检测特批，总计有开发10项癌症免疫力药学上医学试验装置检测，多方面覆盖住1.肺癌、食管癌、肝受损细胞癌、胃溃疡、头颈癌等比较严重大瘤种。202半年6月，斯鲁利单抗注入液广泛用于经的标准调理错误的、必不可去除或迁移性高强度微通讯卫星不住定型剂或错配处理通病型（MSI-H/dMMR）实体店瘤的的决策性II期药学上医学论述以达到包括论述终点站，界面显示生产出来品在该自我调节症上更好的效用及防护性。当今，斯鲁利单抗专门针对MSI-H实际瘤适宜症的纳斯达克上市注册公司使用（NDA）已宣布赢得国家地区消毒产品监查管理制度局（NMPA）结案，并拟融入 先期审评程度。

以下为斯鲁利单抗（HLX10）的数据发表详情：

HLX10-010-MSI201

●  论文题目

Efficacy and safety of HLX10, a novel anti-PD-1 antibody, in patients with previously treated unresectable or metastatic microsatellite instability-high or mismatch repair-deficient solid tumors: a single-arm, multicenter, phase 2 study.

● 联席关键学习者

  秦叔逵，中国国家我们释放军无锡八一医疗机构；李进，上海市东方经典医疗机构

● 商品展示形势

论文摘要及壁报

● 摘要编号

2566

● 试验设计

本调查不是项在准则的治疗验证失败的、必没法割掉或传递性极高微遥感卫星不正定型剂或错配牙齿修复缺点型实体型瘤病号中对其进行的指在评议HLX10治疗作用、卫生性及耐受力性的单臂、开放政策、多管理中心、II期临床药理检验检测。并入的病号每三周静脉血管注塑3 mg/kg HLX10，至多不断五年，终会重大疾病最新动态，发现必没法接手的毒副作用或病号关闭程序。该检验检测的核心始点为自己影象风险评估报告理事会会（IRRC）意义RECIST v1.1准则风险评估报告的客观事实解决率（ORR）。

● 现场实验效果

1）有效性

a）主要终点

本试验检测共入组108名病患病者，在其中68名经公司检测室或理论研究公司认可MSI-H的病患病者被归入主要是治药效果分享消费人群当。主要是治药效果分享消费人群当中，经单独的影相开展专委会会开展的ORR为38.2%（95% CI: 26.7%, 50.8%; 2例压根调理）。 

b）主要到达

每项成效终点站还包括研发者鉴定的主观可以舒缓率，将持续可以舒缓用时（DoR），无近展我的世界生活工作期（PFS），总我的世界生活工作期（OS）。中位DoR，PFS及OS暂时无法可达到。

2）稳定性高性

导致反映，HLX10兼备顺畅的稳定高性和免疫原性性。

● 结语

HLX10在的标准调理出错的MSI-H/dMMR线下瘤患儿中展现出了偏态的抗恶性肿瘤吸附性和好一点的很保密性。看作其中一种更有效的团体不确认类肠癌口服药物，HLX10可能改善效果患儿的临床医学药用价值。

HLX10-011-CC201

●  论文题目

Efficacy and safety evaluation of HLX10 (a recombinant humanised anti-PD-1 monoclonal antibody) combined with albumin-bound paclitaxel in patients with advanced cervical cancer who have progressive disease or intolerable toxicity after first-line standard chemotherapy: a single-arm, open-label, phase 2 study.

● 通常钻研者

吴令英，国内医学研究合理院肉瘤三甲医院

● 表现样式

英文论文

● 摘要编号

e17510

● 试验设计

本钻研是一种项在一二线标准单位手术未能的中晚期宫腔癌用户中考核HLX10共同白淀粉酶酶紫杉醇效果、安全可靠性及受性的单臂、休馆、多核心、分两步骤的II期临床药学试验装置。纳为的用户每五周血管输注HLX10（4.5 mg/kg）和白淀粉酶酶紫杉醇（260 mg/m²）。该耐压试验的主耍起点站为孤立影响鉴定理事会会（IRRC）前提RECIST v1.1条件鉴定的主观性改善率（ORR）。

● 试验检测結果

可靠性实验室检测第二第一个环节为应急加入及大概的疗效探求期，共入组21名患病者，其均匀综上阳型总成绩（CPS）为39.33。经IRRC及研发者鉴定的ORR分开为52.4%（95% CI: 29.8%, 74.3%）和42.9%（95% CI: 21.8%, 66.0%）。可靠性实验室检测是因为，HLX10包括较好的应急性和耐热性。

● 假设

弟一时间段的试验台数据提示HLX10共同白核蛋白紫杉醇在优质基准肺癌中晚期化疗验证失败的中晚期子直肠癌患儿中呈现了很不错的见效和安全卫生性。

复宏汉霖（2696.HK）是一种家國际化的科研生物体技术制品化工新单位，锐意去创新于为亚洲提高展示 可额外负担的高好品质生物体技术制品药，软件设备包裹癌症、工作中天然免疫慢性病、眼科整形慢性病等这个领域，已在国内 什么时候推出3款软件设备，在欧洲联盟什么时候推出1款软件设备，3款软件设备领取国内 什么时候推出备案申請业务办理。自2012年注册成立之后，复宏汉霖已建设完工整体化生物体技术制品化工手机平台，有效及科研的独立自主体系化效果围绕科研、生產及金融业单位运营全产业群链。新单位已建造更加完善有效的亚洲科研管理中心，确定國际GMP规则进行生產和线质量控制，处在西安徐汇的生產园区已领取国内 和欧洲联盟GMP认证服务。

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^®）、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，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，HLX04贝伐珠单抗及HLX01利妥昔单抗类风湿关节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国家市场开展20多项临床试验，产品对外授权覆盖全球近100个国家和地区。

Henlius Has Released Two Clinical Studies of Anti-PD-1 mAb Serplulimab for the First Time at 2021 ASCO Annual Meeting

Shanghai, China, June 7th, 2021 –Shanghai Henlius Biotech, Inc. (2696.HK) announced that the company released the results of two phase 2 clinical studies (HLX10-010-MSI201& HLX10-011-CC201) of Serplulimab injection in patients with microsatellite instability-high or mismatch repair-deficient (MSI-H/dMMR) solid tumours and advanced cervical cancer (CC) at 2021 American Society of Clinical Oncology (ASCO) Annual Meeting for the first time. 

Serplulimab injection is an innovative anti-PD-1 mAb independently developed by Henlius. Up to now, Serplulimab have been approved for clinical trials in China, the United States, the European Union, as well as other countries and regions. A total of 10 immuo-oncology therapy clinical studies of Serplulimab have been conducted to evaluate its safety and efficacy in a variety of most common tumours that cover lung cancer, esophageal cancer, hepatocellular cancer, gastric cancer, head and neck cancer, etc. In March 2021, the pivotal phase 2 study of Serplulimab in patients with unresectable or metastatic microsatellite instability-high or mismatch repair-deficient (MSI-H/dMMR) solid tumours who have progressed on or been intolerant to standard therapies met the primary endpoint, demonstrating the good efficacy and safety of Serplulimab. As of now, the New Drug Application (NDA) of serplulimab injection for the treatment of MSI-H solid tumors has been accepted by the National Medical Products Administration (NMPA) and proposed to be granted priority review.

Details of the two studies are as follows:

HLX10-010-MSI201

● Title

Efficacy and safety of HLX10, a novel anti-PD-1 antibody, in patients with previously treated unresectable or metastatic microsatellite instability-high or mismatch repair-deficient solid tumors: a single-arm, multicentre, phase 2 study.

● Co-Leading PI

Shukui Qin, MD, PhD, Chinese People's Liberation Army Cancer Center of Nanjing Bayi Hospital; Jin Li, MD, PhD, Shanghai East Hospital

● Form

Abstract and Poster 

● Abstract No.

2566

● Study Design

This single-arm, open-label, multi-centre, phase 2 study aimed to evaluate the efficacy, safety, and tolerability of HLX10 in patients with unresectable or metastatic microsatellite instability-high or mismatch repair-deficient solid tumours who have progressed on or been intolerant to standard therapies. Eligible patients were recruited to receive 3 mg/kg HLX10 every two weeks intravenously for up to 2 years until disease progression, unacceptable toxicity, or patient withdrawal. The primary efficacy endpoint was objective response rate (ORR) assessed by independent radiological review committee (IRRC) per RECIST v1.1.

● Results

1) Efficacy

a) Primary endpoint

108 patients were enrolled and 68 with MSI-H confirmed by central laboratory or study sites were included in the main efficacy analysis population. IRRC assessed ORR was 38.2% (95% CI: 26.7%, 50.8%; 2 complete response) in the main efficacy analysis population.

b) Secondary endpoints

Secondary efficacy endpoints included ORR assessed by investigators, duration of response (DoR), progression-free survival (PFS), and overall survival (OS). Median DoR, PFS and OS have not been reached.

2) Safety

The results demonstrated that HLX10 was safe and well-tolerated.

● Conclusion

HLX10 provides encouraging antitumor activity with a manageable safety profile in patients with MSI-H/dMMR solid tumors who have progressed on or been intolerant to standard therapies. As an effective tissue-agnostic treatment, HLX10 possesses the potential to improve patients’ clinical outcomes.

HLX10-011-CC201

● Title

Efficacy and safety evaluation of HLX10 (a recombinant humanised anti-PD-1 monoclonal antibody) combined with albumin-bound paclitaxel in patients with advanced cervical cancer who have progressive disease or intolerable toxicity after first-line standard chemotherapy: a single-arm, open-label, phase 2 study.

● Leading PI

 Lingying Wu, MD, PhD, Cancer Hospital Chinese Academy of Medical Science

● Form

Abstract 

● Abstract No.

e17510

● Study Design

This is a single-arm, open-label, multi-centre, two-stage phase 2 study, aimed to evaluate the clinical efficacy of HLX10 in combination with albumin-bound paclitaxel for the treatment of advanced cervical cancer patients who have failed to respond to the first-line standard chemotherapy. Eligible patients were enrolled and given intravenous infusion of HLX10 (4.5 mg/kg) plus albumin-bound paclitaxel (260 mg/m²) every 3 weeks. The primary efficacy endpoint was objective response rate (ORR) assessed by independent radiological review committee (IRRC) per RECIST v1.1.

● Results

The stage one of this study was a safety run-in and preliminary efficacy exploration study. 21 patients were enrolled with an average Combined Positive Score (CPS) of 39.33. The ORR assessed by IRRC and investigators were 52.4% (95% CI: 29.8%, 74.3%) and 42.9% (95% CI: 21.8%, 66.0%), respectively. The results demonstrated that HLX10 was safe and well tolerated.

● Conclusion

Stage one results demonstrated a manageable safety profile and encouraging efficacy of HLX10 plus albumin-bound paclitaxel in advanced cervical cancer patients who have failed to respond to the first-line standard chemotherapy.

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.