斯鲁利单抗滴注液为复宏汉霖自主化开发技术的全新式抗PD-1单抗，现阶段已获得了全国、美利坚共和国、欧洲共同体等欧洲国家和地域的临床实验药理检验检验装置准许，共出发展10项肉瘤免役临床实验药理检验检验装置，率先复盖癌症、食管癌、肝生殖细胞癌、胃溃疡、头颈癌等易发大瘤种。2022年2月，斯鲁利单抗滴注液使用于经规范的治疗无法的、不得除去或更换性间距微卫星影像时快时慢定形或错配修护障碍型（MSI-H/dMMR）线下实体瘤的核心性II期临床实验药理检验深入分析超过主耍深入分析始点，体现 生产加工品在该不适应症上优异的治疗效果及防护性。目前为止，斯鲁利单抗对应MSI-H实体化瘤适用症的主板上市注册的报考（NDA）已正式宣布获得了国医疗药品质量监督管控局（NMPA）结案，并拟列入最优审评程序代码。

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.

● 联动重要探索者

秦叔逵，国内 国民彻底解决军武汉八一机构；李进，伤害玄幻机构

● 展示出风格

内容提要及壁报

● 摘要编号

2566

● 试验设计

本调查是一种项在标诊治错误的、不容切掉或转回性高宽比微北斗卫星忽高忽低塑形或错配处理障碍型线下实体瘤我们中去的有赖于考核HLX10药用价值、稳定性及免疫原性性的单臂、开发、多中、II期临床研究经过多次实验发现。列为的我们每半个月门静脉接种3 mg/kg HLX10，一般维持三年，是直到病症进步，冒出不容认同的致癌性或我们进入。该经过多次实验发现的常见结束为独立空间影像系统评价理事会会（IRRC）证据RECIST v1.1标评价的主观性减轻症状率（ORR）。

● 实验室检测可是

1）有效性

a）主要终点

本校正共入组108名爱美者，里面68名经中心点的实践室或学习中心点的证明MSI-H的爱美者被被列入主要是的治疗作用研究剖析年龄层。主要是的治疗作用研究剖析年龄层中，经人格独立摄像评价委会会评价的ORR为38.2%（95% CI: 26.7%, 50.8%; 2例彻底得到缓解）。

b）主要始点

次责较果始点涉及到研发者评价的合理性缓和率，将持续缓和耗时（DoR），无最新动态求生期（PFS），总求生期（OS）。中位DoR，PFS及OS尚末提高。

2）安全可靠性

没想到阐明，HLX10还具有好的防护性和耐受力性。

● 结果

HLX10在细则缓解错误的MSI-H/dMMR实体店瘤我们中体现出了相关系数的抗肿癌可溶性和较高的健康性。是 1种可以有效的结构不肯定类肠癌药材，HLX10一般改善效果我们的临床医学的疗效。

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.

● 常见实验者

吴令英，中药学合理院良性肿瘤醫院

● 动态展示形态

小结

● 摘要编号

e17510

● 试验设计

本调查就是项在品牌标肿瘤化疗超时的胆襄癌子乳腺癌糖尿病病患中鉴定HLX10合作白球蛋白质紫杉醇成效、健康性及承受性的单臂、开放式、多中心点、分两价段的II期临床药学疲劳试验。列为的糖尿病病患每几周动脉输注HLX10（4.5 mg/kg）和白球蛋白质紫杉醇（260 mg/m²）。该检验的最主要的始发站为自立成像风险分析评估理事会会（IRRC）重要依据RECIST v1.1标准的风险分析评估的相对主义缓解放松率（ORR）。

● 实验结论

应力测试最步骤为很安全稳定高带到及分步的疗效探险期，共入组21名朋友，其年均合理阳型分数线（CPS）为39.33。经IRRC及调查者分析的ORR对应为52.4%（95% CI: 29.8%, 74.3%）和42.9%（95% CI: 21.8%, 66.0%）。应力测试表述，HLX10具备优秀的很安全稳定高性和接受性。

● 得出结论

一是环节的试验装置没想到表现HLX10联手白蛋白酶紫杉醇在一线城市规定放疗化疗无法的到晚期子宫癌糖尿病患者中体现了适合的药效和稳定性。

复宏汉霖（2696.HK）就是家国际联盟联盟化的革新微生物制品学制作药品业单位，着眼于于为欧洲患病者提供了可不良影响的高厂品服务质量微生物制品学药，厂品遮盖肿癌、自身业务免疫性消化道病症、眼科医生消化道病症等域，已在我国的人大陆地区大发行3款厂品，在欧洲经济共同体委员会发行1款厂品，3款厂品提升我国的人大发行登陆报考审理。自205年解散至今以来，复宏汉霖已起建合二为一化微生物制品学制作药品业网上平台，效率及革新的个性化基本点意识惯穿科研开发、分娩加工及商业性市场运营全产业群链。单位已实现进一步优化效率的欧洲科研开发中，都按照国际联盟联盟GMP规范开始分娩加工和服务质量控制，坐落于东莞徐汇的分娩加工集散地已提升我国的人大和欧洲经济共同体委员会GMP资格认证。

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.