斯鲁利单抗皮下接种液为复宏汉霖自动开发设计的革最新科技抗PD-1单抗，近年来已有我们、新西兰、欧盟成员国等国家和中北部的药学实验室检测准许，共要开始10项肺部肿瘤免疫细胞膜药学实验室检测，新一轮包括肺腺癌、食管癌、肝细胞膜癌、直肠癌、头颈癌等频发大瘤种。2015时间内7月，斯鲁利单抗皮下接种液适用经标淮治疗方法失利的、不能不摘除或传递性超高微北斗卫星动摇定型剂或错配修补缺点型（MSI-H/dMMR）实体的瘤的要素性II期药学探索达到了核心探索终端，提示盛产品在该自我调节症上优质的的疗效及稳定性。现在，斯鲁利单抗对MSI-H物理瘤适合症的推出注册账号申请注册（NDA）已宣布换取中国货品督察经营局（NMPA）授理，并拟纳为先审评过程。 

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.

● 联和包括科研者

秦叔逵，国大家彻底解决军深圳八一门诊；李进，西安东方经典门诊

● 体现样式

前言及壁报

● 摘要编号

2566

● 试验设计

本深入分析是一个项在准则手术治疗诞生未知错误的、无法除去或转入性程度微遥感卫星不稳定塑型或错配修整偏差型实体线瘤患有中开始的宗旨在评测HLX10见效、安全卫生性及容忍性的单臂、盛开、多重心、II期诊疗实验。划入的患有每半个月动脉滴注3 mg/kg HLX10，许多持续不断一年，陪你到皮肤疾病重大进展，诞生无法容忍的毒素或患有撤销。该实验的核心终点起点为独立的数字影像开展常务管委会（IRRC）数据RECIST v1.1准则开展的直接避免率（ORR）。

● 实验室检测报告

1）有效性

a）主要终点

本经过多次实验室建设中的安防系统发现共入组108名人，其中的68名经中实验室建设中的安防系统室或研究探讨中认定MSI-H的人被定为其最主要的作用概述人们。其最主要的作用概述人们中，经独有摄像测评常务医学会测评的ORR为38.2%（95% CI: 26.7%, 50.8%; 2例完成改善）。

b）主要始点

其次是的作用起点终点例如学习者评价指标的主观减轻症状率，保持减轻症状时刻（DoR），无重大突破生活期（PFS），总生活期（OS）。中位DoR，PFS及OS还提升。

2）完整性性

毕竟得出结论，HLX10具备顺畅的安会性和耐受力性。

● 结语

HLX10在标准规范医疗失败的的MSI-H/dMMR实体模型瘤患病者中塑造了特殊的抗癌肿亲水性和较佳的危险系数高性。作为一个一款有郊的机构不断定类癌症晚期中成药，HLX10一般调节患病者的临床上较果。

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.

● 核心研究方案者

吴令英，国分子生物学科学性院良性肿瘤专科医院

● 展示板模式

前言

● 摘要编号

e17510

● 试验设计

本调查是一种项在二线规定手术故障的后期子宫癌糖尿病女性中评估报告格式HLX10共同白核核蛋白紫杉醇药用价值、稳定性及耐受力性的单臂、开放式、多平台、分两时段.的II期监床现场实验。融入 的糖尿病女性每五周静脉注射输注HLX10（4.5 mg/kg）和白核核蛋白紫杉醇（260 mg/m²）。该测试的注意始发站为独立空间影像技术评价指标联合会会（IRRC）原则RECIST v1.1细则评价指标的理性得到缓解率（ORR）。

● 耐压结果显示

应力测试弟一周期为可靠接入及系统化治疗作用找寻期，共入组21名病员，其评均宗合抗体阳性考分（CPS）为39.33。经IRRC及探析者评估报告的ORR区别为52.4%（95% CI: 29.8%, 74.3%）和42.9%（95% CI: 21.8%, 66.0%）。应力测试反映出，HLX10更具不错的可靠性和受性。

● 预期结果

 首要的阶段的耐压结果表明表明HLX10合力白血清紫杉醇在标杆标准的肺癌脑转移化疗失利的脑转移宫劲癌的人中能够了比较好的效果和安全卫生性。

复宏汉霖（2696.HK）是一种家香港集团化的全新发展动物药业有限企业企业，努力于为全国用户带来了可的负担的高高重量动物药，货品涵盖癌肿、自己天然免疫症状、骨科症状等范畴，已在有发行3款货品，在欧洲共同体发行1款货品，3款货品可以取得中国现代有有发行注册网站报名立案。自20二十年设立来党，复宏汉霖已建设一体机化动物药业有限企业工作平台，快速及全新发展的自动重点作用穿梭研究开发培训、生育及商业服务推广全企业链。企业已创建全面快速的全国研究开发培训工厂，都按照香港展览GMP标准规范做生育和重量质量管控，应用于郑州徐汇的生育工厂已可以取得中国现代有有和欧洲共同体GMP审核。

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.