斯鲁利单抗肌内接种液为复宏汉霖选择開發的的创新颖抗PD-1单抗，现如今已刷快我国、新西兰、欧盟成员国等国家省市和省市的监床药理做实验的时候获准，总数发展10项良性肿瘤天然免疫监床药理做实验的时候，周全涵盖肝癌、食管癌、肝血细胞癌、食道癌、头颈癌等发病率大瘤种。2022年2月，斯鲁利单抗肌内接种液使用经标准规范制疗失利的、不能够切去或变动性位置微卫星信号时快时慢成型或错配休复通病型（MSI-H/dMMR）实体的瘤的重中之重性II期监床药理实验起到其主要实验结束，信息显示主产品在该适宜症上顺畅的的作用及健康实用性。近年来，斯鲁利单抗专门针对MSI-H线下瘤适宜症的面市注册帐号公司申请（NDA）已仪式刷快欧洲国家药物监管处理局（NMPA）核发，并拟收录首选审评方式。

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.

● 结合首要的调查人员

秦叔逵，中国内地市民彻底解决军南京市八一大专科医院；李进，重庆星河大专科医院 

● 分享结构

论文摘要及壁报

● 摘要编号

2566

● 试验设计

本科研也是项在准则治療出错的、切勿去除或转回性非常微卫星成像不正塑型或错配复原异常现象型片体瘤求美者中做出的致力于如何评价HLX10治疗作用、安会性及耐热性的单臂、盛开、多咨询中心、II期临床实验校正。纳为的求美者每一周血管打3 mg/kg HLX10，最好持续性可怜的，到问题近展，发生切勿介绍的致癌性或求美者解散。该校正的关键站点为自由成像监测理事会会（IRRC）措施RECIST v1.1准则监测的主客观可以率（ORR）。

● 应力测试结论

1）有效性

a）主要终点

本检测共入组108名我们，之中68名经学校實驗室或探析学校证明MSI-H的我们被融入 最主要是的药效深入了解年龄层。最主要是的药效深入了解年龄层中，经孤立图像评价指标报告格式理事会会评价指标报告格式的ORR为38.2%（95% CI: 26.7%, 50.8%; 2例可以得到缓解）。

b）其次是起点站

主次效用终点起点分为理论研究员评价的客观性的排解率，快速排解耗时（DoR），无新进展活期（PFS），总活期（OS）。中位DoR，PFS及OS没有到达。

2）平安性

最终表达，HLX10含有优良的安全防护性和受性。

● 论证

HLX10在规范冶疗验证失败的MSI-H/dMMR实体的瘤客户中创造了可观的抗癌症晚期活性酶类和最合适的稳定性。是属于很好的的机构不判别类癌症晚期肿瘤药物，HLX10还有机会提升客户的临床试验见效。

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.

● 主要的的研究人

吴令英，中国人医美科学有效院淋巴肿瘤医生

● 商品展示的形式

内容提要

● 摘要编号

e17510

● 试验设计

本探究是一种项在品牌标准的放化疗验证失败的末期宫腔癌自身中考核HLX10联和白淀粉酶紫杉醇明确疗效、应急性及耐热性的单臂、开发、多基地、分两环节的II期临床实践试验报告。融入 的自身每几周血管输注HLX10（4.5 mg/kg）和白淀粉酶紫杉醇（260 mg/m²）。该可靠性试验的具体结束为独特视频评定协会会（IRRC）措施RECIST v1.1标准规定评定的可观缓减率（ORR）。

● 可靠性试验结杲

实验设计检测首位阶段性为平安导出来及大概的疗效探索世界期，共入组21名病患，其平衡宗合阳型平均分（CPS）为39.33。经IRRC及探析者考核的ORR对应为52.4%（95% CI: 29.8%, 74.3%）和42.9%（95% CI: 21.8%, 66.0%）。实验设计检测取决于，HLX10还具有更好的平安性和受性。

● 论证

1第一轮的检验导致彰显HLX10协力白蛋清紫杉醇在一专多能标淮肿瘤化疗挫败的脑转移宫劲癌朋友中展露了最好的见效和安全保障性。

 复宏汉霖（2696.HK）也是家全国化的科学创新技术生态学化工厂新公司的，努力于为世界提高可以提供可的负担的高质理生态学药，物料覆盖率肉瘤、政治意识抗体病毒症状、护眼病毒症状等范畴，已在日本现代销售3款物料，在欧盟委员会委员会销售1款物料，3款物料取得国内现代销售注册会员伸请授理。自20五年注册成立近年来，复宏汉霖已完工集成化生态学化工厂网站，优质及科学创新技术的随时升级基本力量推动加工研发团队、加工及工商业运行全文化产业分析报告。新公司的已建立联系加强制度建设优质的世界加工研发团队管理中心，根据全国GMP标淮来进行加工和质理监督控制，为于上海市徐汇的加工基底已取得国内现代和欧盟委员会委员会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.