复宏汉霖H药小细胞肺癌数据亮眼 国产创新药大放异彩

Freigabezeit:2022-05-30 Inhalte aus： Lautstärke anzeigen：

项目来原于：复宏汉霖


2022年5月30日，复宏汉霖（2696.HK）宣布，公司首个创新药产品H药 汉斯状®（斯鲁利单抗）的多项临床研究将在2022年美国临床肿瘤学会（ASCO）年会进行发布。一项H药针对一线广泛期小细胞肺癌（ES-SCLC）的国际多中心III期临床研究（ASTRUM-005）获选为口头报告，该研究由吉林省肿瘤医院程颖教授担任主要研究者。这也将是中华自主性研发管理的抗PD-1单抗第一次 在1.肺癌这个领域以书面报告单组织形式在ASCO公司年会完成回报，充分展现出中国医药企业的创新生物药领先的研发能力和国际临床运营实力。详细研究数据将在6月5日进行公布，敬请期待。


的同时，国内 人们释放军西北部战区总医药机构秦淮医药区秦叔逵教受和佛山上海东方医药机构李进教受同样带头搞好的H药专门针对微通讯卫星角度不稳定可靠（MSI-H）线下片体瘤的重要性性公司II期临床研发研发（ASTRUM-010）又一次选为ASCO企业年会，数据资料发布将以宣传页方法分享。由于该耐压最后，H药已正规应用于中药治疗MSI-H线下片体瘤。



ASCO会议活动是肺部癌肿疗法业务领域最重要要、最具影向力的世界会仪之1，有赖于展现出如今世界新趋势性的诊疗开展肺部癌肿学教育科研课题和肺部癌肿疗法技艺。当届会议活动将于瑞典中东部時间6月3日-7日闭幕。圆满结束将展现出的有关系诊疗开展钻研还有：

• ASTRUM-005

文献资料选择题：改革创一种新型抗PD-1抗原斯鲁利单抗协力手术与只是手术在二线诊治范围广期小癌细胞肺癌患者中的非常：几项国际上、随机的Ⅲ期临床试验研发（结语序号：8505）

其主要探究者：程颖，白山市省肺部肿瘤医院专家

展览形式：书面形式汇报

盛典：口头摘要专场/肺癌—非小细胞局部/小细胞/其他胸部肿瘤

意见书日子：2022年6月5日，9:57 AM - 10:09 AM 美国中部夏令时

• ASTRUM-010

整形论文问题：信息化型抗PD-1抵抗能力斯鲁利单抗在经治愈、不得切掉或移转性微遥感卫星高强度不安稳或错配修复能力障碍（MSI-H/dMMR）小平面瘤朋友中展开的Ⅱ期临床实践耐压试验药用价值及安全卫生性毕竟最新（引言号：2592）

合力首要研发者：秦叔逵，全国市民改变军扬州八一宠物卫生院；李进，同济综合大学加盟上海东方宠物卫生院

体现样式：宣传单页

时间段：明年6月3日，美中间夏令时

• 实体瘤I期研究

论文题型题型：革一种新型人源化抗PD-1单克隆抗体阳性斯鲁利单抗在肺癌腺癌企业瘤提高中的一方面Ⅰ期临床经过多次实验发现经过多次实验发现（前言编码查询：e14560）

展览组织形式：小结


H药小细胞肺癌数据亮眼

国产创新药风采绽放

小神经元癌症患者（SCLC）占癌症患者占比的15%-20%，是癌症患者中侵扰性最吊的亚型，涵盖片面性期小神经元癌症患者（LS-SCLC）和常见期小神经元癌症患者，矛盾律一致点是恶性瘤数量高、转交早、问题突破及时，综合性效果不良现象。免疫细胞检查报告点减弱剂的突然出现为ES-SCLC范畴的的治疗给我们新祝愿。


ASTRUM-005为一类在以往未承受过疗法的ES-SCLC女性中相对H药打瘦脸针液连合放疗放疗（卡铂-有力发挥泊苷）及劝慰剂连合放疗放疗（卡铂-有力发挥泊苷）的医学有效率性和安会性的js随机数、双盲、知名多服务中间、III期医学钻研。该检验在我国国内现代、土尔其、欧洲共同体瑞典、格鲁吉亚等多家部委共组建123个检验服务中间，里面114个检验服务中间有受试者操作了挑选，共入组585例受试者，里面约31.5%为高加索人。202半年15月，工厂宣明ASTRUM-005应于中长期解析完成主耍钻研最后一步总求生期（OS）。钻研参数提示 提示 ，H药连合放疗放疗在综合消费群体和大洋洲消费群体均可廷长OS，提示 出积极的有效时间和安会性。有力的知名医学检验参数提示 当然也有望兼容H药在欧洲共同体、国外等大众化规范股票市场的澳大利亚红酒进口报关，为欧洲医学采用打下了根本。


近些年，单位H药造成ES-SCLC的市场销售办理申报（NDA）已获的国家国家食品药品局核发，力争变成 全世界首份标杆改善SCLC的抗PD-1单抗。H药合作放疗化疗近日也被《2022 CSCO小癌细胞非小细胞肺癌口腔诊疗导则》介绍做为ES-SCLC标杆物理疗法，是对H药监床明确疗效及防护性的高强度大力支持。最后，H药用价值于SCLC改善也于近日拥有国外FDA评为的孤寡药资质认证（Orphan-drug Designation），单位亦行动计划于22年在欧洲联盟提出注册H药造成ES-SCLC满足症的市场销售办理申报。


差异化MSI-H实体瘤适应症

“不限癌种”免疫治疗新选择

据统计，中国每年新发MSI-H肿瘤患者逾30万，其中部分患者缺乏有效治疗，目前我国鲜有针对MSI-H晚期实体瘤获批的PD-1抑制剂，临床治疗需求远未被满足，H药的获批为众多实体瘤患者带去新的治疗选择。ASTRUM-010为一项针对MSI-H实体瘤的单臂、多中心、关键性II期临床研究，该试验的主要终点为独立影像评估委员会（IRRC）依据RECIST v1.1标准评估的客观缓解率（ORR）。该项临床试验结果曾分别于2021年ASCO年会、2021年CSCO年会上发布，此次ASCO年会上将展示该研究的更新的数据。研究结果表明，H药单药治疗既往标准治疗失败的、不可切除或转移性MSI-H实体瘤获益显著，达到预设的主要终点标准，且具有良好的安全性和耐受性。

 

未来是什么，有限公司也将依然以病员供给为中心，借助于极有效率及企业创新的自主性中心作用保持全面推进太多汉霖“质”造，为中国人甚至是世界十大病员给出更高的质量的用药和产品，构建怪物药厂方面民族特点高端品牌。


关于H药 汉斯状®

H药 汉斯状®为重组人源化抗PD-1单抗注射液（通用名：斯鲁利单抗注射液），是复宏汉霖首个自主研发的创新型单抗，目前1项适应症获批上市，2项适应症上市申请获受理，9项临床试验同步在全球开展。


2020年2月，H药正式的获准重点用于的控制微卫星信号高不固定（MSI-H）实际瘤。着力H药，复宏汉霖乐观实施其与新公司的另一厂品的协同管理同时与转型升级辽法的合力，随后兑换我国、美利坚、欧洲联盟等祖国及沿海的地方的监床药理实践做实验的时候检测许证，在各国导入深入开展9项肿癌免疫系统合力辽法监床药理实践做实验的时候检测，多方面涵盖非小内部1.1.肺癌患者患者患者、食管癌、头颈鳞癌和直肠癌等适应环境症，全方面涵盖非小内部1.1.肺癌患者患者患者基层的控制。截止日到目前为止，H药已经在我国、土尔其、瑞典、格鲁吉亚等祖国和沿海的地方累记入组超2800人，中仅2项國际多中心站监床药理实践做实验的时候检测入组高加索人种的的比例可超过30%，是享用國际监床药理实践大数据较多的抗PD-1单抗一个。H药合力放疗放疗的控制一部分干癌或适当肿瘤转移鳞状非小内部非小内部1.1.肺癌患者患者患者（sqNSCLC）和基层的控制多方面期小内部非小内部1.1.肺癌患者患者患者（ES-SCLC）的NDA已兑换NMPA审批划为选《2022 CSCO小内部非小内部1.1.肺癌患者患者患者医疗方案》用于ES-SCLC的控制选择。除此之外，其的控制小内部非小内部1.1.肺癌患者患者患者（SCLC）也已兑换美利坚FDA孤寡药资质认为。新公司的亦计划方案于2020年在欧洲联盟出具ES-SCLC的发行备案报名，极可能将成为各国第一家基层的控制SCLC的抗PD-1单抗。在基层的控制食管鳞癌层面，H药合力放疗放疗III期调查也已达到双重点调查到达。

关于复宏汉霖

复宏汉霖（2696.HK）不是家欧洲其他国家化的去的技术创新海洋生态学技术化工集团品牌，锐意的技术创新于为欧洲其他国家朋友供给可额外的负担的高品控海洋生态学技术药，物料遮盖淋巴肿瘤、自我抗体病症状、护眼病症状等范围，已在日本国美国发售5款物料，在欧洲其他国家美国发售1款物料，13项改变症新批，俩美国发售申请注册注册申请注册有华人国进口otc药品监督的管理局核发。自20十多年成立品牌起来，复宏汉霖已建好二合一化海洋生态学技术化工工作app平台，高质理及去的技术创新的服务性关键力量深入研制、出产及商业运作运作全品牌链。集团品牌已制定健全完善高质理的欧洲其他国家去的技术创新国防教育基础，安装欧洲其他国家进口otc药品出产质理的管理办法性（GMP）标准单位通过出产和质理风险管控，迅速压实二合一化合理出产工作app平台，表中，沈阳徐汇国防教育基础已有华人国和欧洲共同体进口otc药品GMP申请安全认证，松江国防教育基础（一）也已有华人国GMP申请安全认证。


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H药汉斯状®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，欧洲商品名：Zercepac®）、汉达远®（阿达木单抗）和汉贝泰®（贝伐珠单抗）相继获批上市，创新产品汉斯状®（斯鲁利单抗）已获批用于治疗微卫星高度不稳定（MSI-H）实体瘤，其鳞状非小细胞肺癌和广泛期小细胞肺癌两项适应症的上市注册申请也正在审评中。公司亦同步就12个产品、10个免疫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市场。



Three Clinical Studies of Novel Anti-PD-1 mAb Serplulimab will be Presented on 2022 ASCO Annual Meeting


Shanghai, China, May 30th, 2022 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that three clinical studies of HANSIZHUANG (serplulimab), an anti-PD-1 mAb independently developed by Henlius, will be presented at 2022 American Society of Clinical Oncology (ASCO) Annual Meeting. ASTRUM-005, an international randomized phase 3 study of serplulimab as first-line treatment for extensive-stage small-cell lung cancer (ES-SCLC) was selected as an oral presentation by ASCO committee. The leading principal investigator is Professor Ying Cheng from Jilin Cancer Hospital. Serplulimab is the first China-developed anti-PD-1 mAb which will be presented orally at ASCO Annual Meeing in lung cancer. More detailed results of ASTRUM-005 will be released on June 5th.


Meanwhile, the updated results from the phase 2 study (ASTRUM-010) of serplulimab in patients with microsatellite instability-high or mismatch repair-deficient (MSI-H/dMMR) solid tumors was selected as a poster for the second time. ASTRUM-010 was co-led by Professor Shukui Qin from Qinhuai Medical Area, Eastern Theater General Hospital of PLA China and Professor Jin Li from Shanghai East Hospital, Tongji University. Based on the study results of ASTRUM-010, serplulimab has been approved for the treatment of MSI-H solid tumors by NMPA.


ASCO Annual Meeting is one of the most influential and important oncology congresses all over the world, aimed to display the latest advances in clinical oncology researches and therapeutic technologies for tumor treatment. The 2022 ASCO Annual Meeting will be held from June 3rd to June 7th CDT. Details of three studies are as follows:

• ASTRUM-005

Title: Serplulimab, a novel anti-PD-1 antibody, plus chemotherapy versus chemotherapy alone as first-line treatment for extensive-stage small-cell lung cancer: An international randomized phase 3 study (Abstract No. 8505)

Leading PI:  Ying Cheng, Jilin Cancer Hospital

Form: Oral presentation

Session: Oral Abstract Session/ Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers

Presentation Time: June 5, 2022, 9:57 AM - 10:09 AM CDT

• ASTRUM-010

Title: Updated efficacy and safety results from the phase 2 study of serplulimab, a novel anti-PD-1 antibody, in patients with previously treated unresectable or metastatic microsatellite instability-high or mismatch repair-deficient solid tumors (Abstract No. 2592)

Co-Leading PI: Shukui Qin, Qinhuai Medical Area, Eastern Theater General Hospital of PLA China; Jin Li, Shanghai East Hospital, Tongji University

Form: Poster

Time: June 3, 2022, CDT

• Phase 1 study on solid tumors

Title: A phase 1 study of serplulimab, a novel humanized monoclonal anti-PD-1 antibody, in patients with advanced solid tumors (Abstract No. e14560)

Form: Abstract


Being a breakthrough in SCLC treatment, serplulimab shows the power of Chinese innovation

Small cell lung cancer (SCLC) accounts for 15%–20% of all cases and is the most aggressive type of lung cancer. It is classified into two stages: limited stage (LS-SCLC) and ES-SCLC, with both exhibiting high malignancy, strong invasiveness, early metastasis, fast disease progression, and a poor prognosis. The advent of immune checkpoint inhibitors has been proved to bring hope to patients with ES-SCLC.


ASTRUM-005 is a randomized, double-blind, international, multi-center, phase 3 clinical study that aims to compare the efficacy and safety of HANSIZHUANG with placebo when combined with chemotherapy (carboplatin-etoposide) in previously untreated patients with ES-SCLC. This study has set up a total of 128 sites in China, Turkey, Poland, Georgia, etc. and enrolled 585 subjects from 114 sites, among whom 31.5% were Caucasian. In December 2021, ASTRUM-005 had met its primary study endpoint of the overall survival (OS) in the interim analysis and demonstrated HANSIZHUANG with a manageable safety profile. The global clinical data lays a solid foundation for future applications across the world.


Previously, the NDA of HANSIZHUANG for the treatment of ES-SCLC has been accepted by NMPA. Recently, HANSIZHUANG was recommended by the 2022 CSCO Guidelines for Diagnosis and Treatment of SCLC for the treatment of ES-SCLC, stating the highly recognition for the efficacy and security of HANSIZHUANG. In addition, the FDA has granted orphan drug designation to HANSIZHUANG for treatment of SCLC, and Henlius also plans to file MAA on ES-SCLC in the EU in 2022.

The differentiated MSI-H indication, "Pan-cancer" treatment benefits a broader patient population


It is estimated that there are more than 300,000 new MSI-H tumor cases in China every year, and some patients lack effective treatment. Furthermore, there are few PD-1 inhibitors approved for MSI-H advanced solid tumors in China currently. The clinical treatment demand is far from being met. ASTRUM-010 is a single-arm, multi-center, pivotal phase 2 clinical study. The primary efficacy endpoint was objective response rate (ORR) assessed by independent radiological review committee (IRRC) per RECIST v1.1. This study results have been presented at the 2021 ASCO annual meeting and the 2021 CSCO annual meeting. At 2022 ASCO, we will present its updated data. The study has met its primary endpoint and brought significant benefits to unresectable or metastatic MSI-H solid tumors patients who have failed to respond to previous standard treatments with good safety and tolerability.


In the future, Henlius will keep focusing on patient needs and inspire more "made-by-Henlius" products with efficient and innovative in-house capabilities, aiming to provide highest quality solutions and services for patients in China and across the world and to build a national brand in biopharmaceutical industry.


About HANSIZHUANG

HANSIZHUANG (recombinant humanized anti-PD-1 monoclonal antibody injection, generic name: serplulimab injection) is the first innovative monoclonal antibody developed by Henlius. Up to date, 1 indication is approved for marketing in China, 2 NDAs have been accepted by the NMPA, and 9 clinical trials are ongoing across the world.


HANSIZHUANG was approved by the NMPA for the treatment of MSI-H solid tumors in March 2022 and actively promotes its synergy with in-house products of the company and innovative therapies. It has successively obtained clinical trial licenses in China, the United States, the European Union and other countries and regions to initiate 9 clinical trials on immuno-oncology combination therapies worldwide in a wide variety of indications, such as lung cancer, esophageal carcinoma, head and neck squamous cell carcinoma and gastric cancer, etc., and covering the full range of first-line treatments of lung cancers. As of now, the company has enrolled more than 2,800 subjects in China, Turkey, Poland, Georgia and other countries and regions, and the proportion of Caucasian is over 30% in two MRCTs, making HANSIZHUANG an anti-PD-1 mAb with one of the largest global clinical data pools. The NDAs of the treatment for squamous non-small cell lung cancer (sqNSCLC) and the first-line treatment of extensive small-cell lung cancer (ES-SCLC) have been accepted by the NMPA. Furthermore, HANSIZHUANG was recommended by the 2022 CSCO Guidelines for Diagnosis and Treatment of Small Cell Lung Cancer (SCLC) for the treatment of ES-SCLC and was also granted orphan drug designation by the FDA for treatment of SCLC. The MAA of ES-SCLC is expected to be filed in the EU in 2022, which makes HANSIZHUANG potentially the world’s first anti-PD-1 mAb for the first-line treatment of SCLC. In the field of esophageal squamous cell carcinoma, the phase 3 clinical trial of HANSIZHUANG in combination with chemotherapy has met the co-primary endpoints.

About Henlius

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, 5 products have been launched in China, 1 in Europe, 13 indications approved worldwide, and 2 New Drug Application (NDA) 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 commercialization. It has established global innovation centers and Shanghai-based manufacturing facilities in line with global Good Manufacturing Practice (GMP), including Xuhui Plant certificated by China and the EU GMP and Songjiang First Plant certificated by China 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 HANSIZHUANG (anti-PD-1 mAb) as backbone. Apart from the launched products HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab, trade name in Europe: Zercepac®), the first China-developed mAb biosimilar approved both in China and Europe, HANDAYUAN (adalimumab) and HANBEITAI (bevacizumab), the innovative product HANSIZHUANG has been approved by the NMPA for the treatment of MSI-H solid tumors and its NDA for the treatment of squamous non-small cell lung cancer and extensive small-cell lung cancer (ES-SCLC) are under review. What's more, Henlius has conducted over 20 clinical studies for 12 products and 10 combination therapies.

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