斯鲁利单抗肌内针剂液为复宏汉霖自主化开放的技术创新抗PD-1单抗，当下已换取中国内地、欧美、欧洲联盟等一个国家和省份的医学疲劳疲劳试验核准，总计下来做10项癌症免疫神经元医学疲劳疲劳试验，多方位遍布肺腺癌、食管癌、肝神经元癌、直肠癌、头颈癌等发病率大瘤种。202半年三月，斯鲁利单抗肌内针剂液采用经基准的治疗失利的、不容切除术或转入性宽度微定位时快时慢成型或错配清理偏差型（MSI-H/dMMR）物理瘤的关健性II期医学深入分析以达到关键深入分析终站，凸显出厂品在该适应性症上优良的效用及危险系数性。近年，斯鲁利单抗造成MSI-H物理瘤自我调节症的什么时候上市注册网站学生申请（NDA）已确认收获部委处方药参与操作局（NMPA）审理，并拟编入原则审评子程序。

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.

● 联动基本的领域专家

秦叔逵，中国国家人艮改变军广州八一医疗机构；李进，天津经典医疗机构

● 提供行驶

英文论文及壁报

● 摘要编号

2566

● 试验设计

本探索就是一项在基准医疗挫败的、没法做手术或移动性极度微北斗卫星发飘塑形或错配牙齿修复一些缺陷型片体瘤病人中实现的广泛宣传鉴定HLX10辽效、平安性及受性的单臂、休馆、多中央、II期临床治疗做实验的时候。归入的病人每两个星期血管打3 mg/kg HLX10，总共连续两年时间，到最近传染性疾病进行，经常出现没法收到的致癌性或病人踢出。该做实验的时候的常见终点起点为独有视频鉴定常务分委会（IRRC）意义RECIST v1.1基准鉴定的客观事实减轻率（ORR）。

● 测试报告

1）有效性

a）主要终点

本探索共入组108名病人，这当中68名经咨询中间探索室或探索咨询中间根本MSI-H的病人被编入重点效用浅析群体当。重点效用浅析群体当中，经自己视频鉴定常务研究会鉴定的ORR为38.2%（95% CI: 26.7%, 50.8%; 2例截然减缓）。

b）次责终端

主要明确疗效始点包涵分析者分析的主观性控制率，持续事件控制事件（DoR），无重大进展存在期（PFS），总存在期（OS）。中位DoR，PFS及OS并没有可达。

2）安会性

没想到揭示，HLX10体现了保持良好的健康危险性和耐热性。

● 实验结论

HLX10在标准单位调理出错的MSI-H/dMMR直营瘤提高中呈现了强势的抗癌肿催化活性和较高的安会性。做一类能够的阻止不来确定类胃癌中药，HLX10即将调节提高的临床护理药效。

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.

● 重点钻研者

吴令英，我国医美地理师范学院肿癌医疗

● 呈现手段

小结

● 摘要编号

e17510

● 试验设计

本钻研不是项在前线规则放化疗无法的骨转移宫腔癌病号中考核HLX10聯合白血清质紫杉醇治疗作用、安全管理性及耐受力性的单臂、盛开、多中央、分两关键期的II期临床护理实验室检测。列为的病号每二周静脉注射输注HLX10（4.5 mg/kg）和白血清质紫杉醇（260 mg/m²）。该经过多次实验发现的主耍起点为单独的影像系统评估报告方法理事会会（IRRC）前提RECIST v1.1准则评估报告方法的主观性减轻症状率（ORR）。 

● 检验结论

做实验的时候检测第一个价段为很安全的导出来及阶段性药用价值科学探索期，共入组21名朋友，其平均的合理阳性反应积分（CPS）为39.33。经IRRC及探析者考评的ORR分辨为52.4%（95% CI: 29.8%, 74.3%）和42.9%（95% CI: 21.8%, 66.0%）。做实验的时候检测认为，HLX10具备着良好的的很安全的性和耐热性。

● 依据

首位环节的试验报告但是信息显示HLX10携手白核蛋白紫杉醇在一线城市细则放化疗失效的骨转移宫颈口癌病患者中突显了很不错的治疗效果和安全保障性。

复宏汉霖（2696.HK）有的是家国.际化的特色化怪物制品医药化工集团，坚持不断创新驱动于为世界十大患病者打造可额外的负担的高品質怪物制品药，食品重叠淋巴肿瘤、政治意识免疫性皮肤传染性疾病、骨科皮肤传染性疾病等领域行业，已在国外大发售3款食品，在欧洲联盟发售1款食品，3款食品收获全国国家大发售注册的总部申请核发。自20多年创办至今，复宏汉霖已起建三合一化怪物制品医药化工电商平台，效率及特色化的个性化本质力量结合创新、研发部及业务运营的全房产链。集团已建立起完美效率的世界十大创新中央，决定国.际GMP细则通过研发部和的质量防范，处于西安徐汇的研发部营地已收获全国国家大和欧洲联盟GMP注册。

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.