斯鲁利单抗填充液体液为复宏汉霖个性化发掘的研发型抗PD-1单抗，现在已取得国内 、欧美、欧洲联盟等国家的和省市的药学实验审批，共有做好10项癌症免役药学实验，局面盖住肺癌患者、食管癌、肝组织细胞癌、胃溃疡、头颈癌等易发大瘤种。202半年9月，斯鲁利单抗填充液体液使用在经标准单位治療无效的、切不可切去或转让性相对高度微北斗卫星动摇塑型或错配复原问题型（MSI-H/dMMR）小平面瘤的关健性II期药学科研可达到关键科研最后一步，提示生产加工品在该适应环境症上正常的药用价值及卫生性。当今，斯鲁利单抗对于MSI-H片体瘤认知症的挂牌上市注册公司使用（NDA）已宣布赢得发达国家医药监督检查方法局（NMPA）受案，并拟例入先审评系统软件。

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.

● 携手主要探索者

秦叔逵，中国大各族人民解放汽车军上海市八一机构；李进，上海市星河机构

● 表现结构

小结及壁报

● 摘要编号

2566

● 试验设计

本调查是一个项在原则改善不成功的、难以肿瘤切除或转回性极高微卫星信号忽高忽低定型剂或错配修复能力瑕疵型企业瘤女性中采取的契机考核HLX10药用价值、安全保障性及受性的单臂、开放式、多中心站、II期临床治疗实验室检测。列入的女性每一周门静脉肌内注射3 mg/kg HLX10，最高将持续这两年，直至症状近况，展现难以承受的致癌性或女性取消。该实验室检测的主要的终端为孤立成像测评研究会会（IRRC）合理性RECIST v1.1原则测评的主客观缓减率（ORR）。

● 试验检测报告

1）有效性

a）主要终点

本测试共入组108名女性，里面68名经服务主科学试验室或实验服务主证明MSI-H的女性被列为关键成效分享年龄层。关键成效分享年龄层中，经人格独立影像技术测评报告常务研究会测评报告的ORR为38.2%（95% CI: 26.7%, 50.8%; 2例完整可以缓解）。

b）主要起点

其次是明确疗效终端包含的学者评定的从客观可以舒缓率，不间断可以舒缓精力（DoR），无重大进展存活期（PFS），总存活期（OS）。中位DoR，PFS及OS还未做到。 

2）应急性

报告单表达，HLX10具备有正常的很设计安全性和耐受性。

● 报告的格式

 HLX10在标准的调节错误的MSI-H/dMMR三维线瘤客户中展现出了相关性的抗恶性肿瘤活性酶类和适合的的可靠性。看作另一种合理的组织结构不认定类肿瘤治疗药物，HLX10力争调节客户的临床试验功效。

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.

● 首要理论研究员

吴令英，国家临床完美院肿癌医院专家

● 展览风格

引言

● 摘要编号

e17510

● 试验设计

本论述一项在前线规范放疗出错的肺癌晚期宫腔癌的人中开展HLX10合力白核核蛋白紫杉醇功效、安全可靠性及免疫原性性的单臂、打开、多重心、分两的时候的II期临床医学校正。收录的的人每一个半月动脉输注HLX10（4.5 mg/kg）和白核核蛋白紫杉醇（260 mg/m²）。该可靠性试验的最主要的终点起点为独有印象评价管委会会（IRRC）要求RECIST v1.1要求评价的事实缓解放松率（ORR）。

● 检测导致

疲劳试验报告第二价段为安会拷贝到及进行有效时间生命的进化期，共入组21名病号，其平均的终合弱阳评分（CPS）为39.33。经IRRC及研发者测评的ORR分离为52.4%（95% CI: 29.8%, 74.3%）和42.9%（95% CI: 21.8%, 66.0%）。疲劳试验报告表示，HLX10具保持良好的安会性和接受性。

● 报告的格式

独一阶段中的试验台最后现示HLX10综合白核蛋白紫杉醇在一专多能标准单位化疗药失敗的肺癌晚期宫颈口癌病人中塑造了好的见效和的安全性能。

复宏汉霖（2696.HK）就是家国际级上化的科技革新生态学药厂有限单位，全力于为全.球我们供应可经济负担的高品性生态学药，品牌包含癌症、主观能动性免疫抗体妇科常见疾病、眼科整形妇科常见疾病等教育领域，已在国家什么时候销售3款品牌，在欧洲共同体什么时候销售1款品牌，3款品牌换取国家什么时候销售注册帐号申请办理审理。自20二十年揭牌近些年，复宏汉霖已成立一体板化生态学药厂平台网站，效率高能及科技革新的有意识的主动基本点作用包括产品开发、种植及商业服务经营全第三产业化。有限单位已设立改善效率高能的全.球产品开发核心，确定国际级上GMP规定对其进行种植和的品质管理控制，座落成都徐汇的种植基地网已换取国家和欧洲共同体GMP申请认证。

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.