斯鲁利单抗打针液为复宏汉霖人工控制开放的多元化型抗PD-1单抗，近几年已赢得我国的、美、欧盟委员会等地段和地段的药学实验设计检测获准，共要开发10项肉瘤抗体药学实验设计检测，全面的涉及癌症、食管癌、肝体细胞癌、食道癌、头颈癌等频发大瘤种。2022年1月，斯鲁利单抗打针液用来经基准诊疗超时的、不能够肿瘤切除或转让性宽度微卫星信号忽上忽下成形或错配复原问题型（MSI-H/dMMR）物理瘤的关键所在性II期药学论述超过主要的论述起点站，表明加工品在该适应环境症上正常的药效及健康性。到目前为止，斯鲁利单抗面向MSI-H实物瘤改变症的挂牌上市注册的申请注册（NDA）已正规刷出一个国家消毒产品远程监控管理工作局（NMPA）审理，并拟收入择优审评源程序。

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.

● 联席一般研究分析者

秦叔逵，全球各族人民解放汽车军武汉八一的的医院；李进，沪玄幻的的医院

● 体现样式

引言及壁报

● 摘要编号

2566

● 试验设计

本的研究是项在规则规范诊疗失效的、没法切除术或转换性较高微遥感卫星发飘成型或错配处理偏差型线下瘤病员中通过的指在好评HLX10辽效、可靠性及使用性的单臂、开馆、多心中、II期临床实验经过多次实验发现。推行的病员每三周静脉注谢注谢3 mg/kg HLX10，最常坚持两年左右，到最近皮肤疾病进况，产生没法使用的毒副作用或病员踢出。该经过多次实验发现的主耍起点站为人格独立影像技术估评常务促进会（IRRC）措施RECIST v1.1规则规范估评的从客观避免率（ORR）。

● 现场实验结论

1）有效性

a）主要终点

本测试共入组108名客户，在其中68名经平台测试室或探析平台核对MSI-H的客户被列为通常功效研究消费群体。通常功效研究消费群体中，经独力影象测试理事会会测试的ORR为38.2%（95% CI: 26.7%, 50.8%; 2例完成解决）。

b）主要站点

主次成效始点是指探讨者测评的理性解决率，连续解决时长（DoR），无重大突破荒岛生存游戏下载期（PFS），总荒岛生存游戏下载期（OS）。中位DoR，PFS及OS没有完成。

2）平安性

后果表示，HLX10具有着顺畅的安全管理性和接受性。

● 分析方法

HLX10在标准单位医治错误的MSI-H/dMMR小平面瘤用户中展示了强势的抗癌肿生物和较高的卫生性。身为一类有效地的团体不知道好类肝癌治疗药物，HLX10力争改进用户的临床护理效果。

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.

● 常见研究方案者

吴令英，我国医药学数高校良性肿瘤医疗机构

● 风采展示结构类型

论文摘要

● 摘要编号

e17510

● 试验设计

本论述有的是项在带兵人标准规定手术不成功的胆襄癌官颈癌用户中考核HLX10携手白淀粉酶酶紫杉醇见效、应急性及耐热性的单臂、开放政策、多中间、分两时段的II期医学实验设计。划入的用户每两周冠状动脉输注HLX10（4.5 mg/kg）和白淀粉酶酶紫杉醇（260 mg/m²）。该可靠性试验的其主要始发站为孤立数字影像分析测评常务专委会（IRRC）通过RECIST v1.1标准化分析测评的客观性可以缓解率（ORR）。

● 经过多次实验发现的结果

做实验的时候首个价段为稳定导进及阶段效果宇宙探索期，共入组21名人群，其最低值宗合呈阳性评分（CPS）为39.33。经IRRC及探索者评诂的ORR各用为52.4%（95% CI: 29.8%, 74.3%）和42.9%（95% CI: 21.8%, 66.0%）。做实验的时候阐明，HLX10都具有很好的稳定性和耐热性。

● 得出结论

 第1 阶段中的测试毕竟展示HLX10联手白蛋清紫杉醇在优质标肿瘤化疗失敗的肺癌腺癌宫颈的癌朋友中出现了好的成效和应急性。

复宏汉霖（2696.HK）也是家國際化的不断的创新生态学微生物技术制药厂司，专注于于为在我国现代大客户提供了可的压力的高好品质生态学药，厂品设备覆盖住肉瘤、自我抗体的慢性病、眼科医生的慢性病等方向，已在国内大出现3款厂品设备，在欧盟成员国国家出现1款厂品设备，3款厂品设备刷出在我国现代大出现登陆报名结案。自2020年建设之初，复宏汉霖已投入使用一体式化生态学微生物技术制药厂渠道，极有效率及不断的创新的服务性层面效果结合科研开发项目管理、出产及企业运行全家产链。司已建设建立健全极有效率的在我国现代大科研开发项目管理中心点，遵循國際GMP标准化参与出产和产品品质管理，处于郑州徐汇的出产机地已刷出在我国现代大和欧盟成员国国家GMP认正。

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.