复宏汉霖H药小细胞肺癌数据亮眼 国产创新药大放异彩

发布时间:2022-05-30 信息内容来原于： 浏览量：

的内容来原于：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。这也将是中国国家专业化研发团队的抗PD-1单抗初次在1.肺癌领域行业以书面手段行业报告手段在ASCO企业年会对其进行小结，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。


 同时，在我国人民群众一汽中国中国人民解放军东南部战区总医疗机构机构秦淮医疗机构区秦叔逵客座客座教授和沈阳九洲医疗机构机构李进客座客座教授相互加强组织领导搞好的H药涉及微定位极度不可靠（MSI-H）小平面瘤的要素性注测II期临床检验深入分析（ASTRUM-010）第三步评选ASCO年终晚会，数据文件不断更新将以宣传海报表现形式体现。依托于该冲击试验没想到，H药已正式开启新批主要用于控制MSI-H小平面瘤。



ASCO公司年会活动是良性良性肿癌调理行业最终要、最具后果力的新知名电视电话会议中的一个，有赖于提供当下新知名最实验的临床药理实验良性良性肿癌学教学科研重大成果和良性良性肿癌调理系统。这届公司年会活动将于美利坚中西部地区日期6月3日-7日会议议程。契机将提供的涉及到临床药理实验实验具有：

• ASTRUM-005

职称论文小题目：改革创业创新产品抗PD-1表面抗原斯鲁利单抗联动手术与简单手术在品牌制疗多期小内部肺癌患者中的相对较：某些國際、随机性Ⅲ期诊疗探析（结语标码：8505）

常见深入分析者：程颖，吉林市省恶性肿瘤专科医院

展示出形式：口头方式意见书

郭德纲开箱：口头摘要专场/肺癌—非小细胞局部/小细胞/其他胸部肿瘤

评估时光：2022年6月5日，9:57 AM - 10:09 AM 美国中部夏令时

• ASTRUM-010

论文提纲题：创新发展型抗PD-1表面抗原斯鲁利单抗在经进行治疗、切不可切去或转到性微通讯卫星非常不可靠或错配清理的缺陷（MSI-H/dMMR）直营瘤我们中深入推进的Ⅱ期临床医学现场实验药效及应急性成果发布（引言号：2592）

联和主要是研究方案者：秦叔逵，国内我们彻底解决军合肥八一医院专家口腔科；李进，同济高校附屬南国医院专家口腔科

显示状态：宣传单页

耗时：明年6月3日，新加坡东北部夏令时

• 实体瘤I期研究

开题报告之类：科技创一种新型人源化抗PD-1单克隆抗原斯鲁利单抗在脑转移实际瘤用户中的几项Ⅰ期临床实践实验（绪论识别码：e14560）

展示出的形式：前言


H药小细胞肺癌数据亮眼

国产创新药风采绽放

小癌组织细胞系1.肝癌（SCLC）占1.肝癌总额的15%-20%，是1.肝癌中侵蚀性最好的亚型，划分为的局限期小癌组织细胞系1.肝癌（LS-SCLC）和很广期小癌组织细胞系1.肝癌，这两种方法各自点是恶变阶段高、更换早、常见疾病重大突破十分迅速，总体目标生存率不良的。免疫抗体定期监测点治理和改善剂的诞生为ES-SCLC邻域的医治带给新梦想。


ASTRUM-005为一系列在自始未接受了过诊疗的ES-SCLC用户中是比较H药注入液联席肿瘤放疗（卡铂-衬托泊苷）及安慰的话语剂联席肿瘤放疗（卡铂-衬托泊苷）的诊疗实验检验有效地性和可靠性的js随机数、双盲、新国外多心中、III期诊疗实验检验探索。该检验国内国、西班牙、欧洲联盟芬兰、格鲁吉亚等2个中国共新开设12九个检验心中，各举的114个检验心中有受试者参与进来了挑选，共入组585例受试者，各举的约31.5%为高加索人。202半年13月，集团正式ASTRUM-005己经中晚期讲解达成最主要的探索结束总荒岛生存期（OS）。探索数剧显现，H药联席肿瘤放疗在总体经济年龄层和亚洲区年龄层均可延长时间OS，显现出优秀的见效和可靠性。充分地的新国外诊疗实验检验检验数剧都有望的支持H药在欧洲联盟、芬兰等大众化相关法律法规市面 的申报纳税，为全国诊疗实验检验广泛应用确立条件。


现下，单位H药采取ES-SCLC的加拿大推出备案账号申請（NDA）已获发达国家药品监督管理局核发，有机会将成为全国首届标杆诊治SCLC的抗PD-1单抗。H药合力化疗药进期也被《2022 CSCO小細胞肝癌医用规范》推薦是ES-SCLC标杆自然疗法，是对H药临床实验效用及安全的性的程度承认。还有就是，H药用价值于SCLC诊治也于进期兑换加拿大FDA授勋的遗孤药资本介定（Orphan-drug Designation），单位亦计划书于2020年在欧盟成员国呈交H药采取ES-SCLC适用于症的加拿大推出备案账号申請。


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年会上将发布公告该研究的更新数据分析。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。

 

末来，子公司也将继读以朋友供给为主要，借助高质量及技术创新的综合性主要性能维持加快推进越来越多汉霖“质”造，为中国国家甚至是世界各国朋友提高至高品質的药物治疗和工作，建设生物技术医药集团这个领域少数民族企业品牌。


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。


2030年1月，H药确认新批适用于治愈微小行星特别不平衡（MSI-H）小平面瘤。贯穿H药，复宏汉霖关键助推其与工厂其它服务的分工协作与与特色化的医治方法的联席，会相继换取华人、英国、欧共体等的国家中北部及中南部的临床药学护理护理冲击耐压冲击耐压经营，在世界各国此次开发9项癌症免役联席的医治方法临床药学护理护理冲击耐压冲击耐压，比较广泛性合并肺腺癌、食管癌、头颈鳞癌和胃溃疡等融入症，着力合并肺腺癌一丝治愈。累计如今，H药于华人、西班牙、瑞典、格鲁吉亚等的国家中北部和中南部累记在组超2800人，在当中2项时代国际联盟多重点临床药学护理护理冲击耐压冲击耐压入组高加索人种的比率超30%，是拥有的时代国际联盟临床药学护理护理冲击耐压统计数据较多的抗PD-1单抗中之一。H药联席手术药治愈边缘骨更改或更改性鳞状非小生殖上皮受损人体细胞肺腺癌（sqNSCLC）和一丝治愈比较广泛性期小生殖上皮受损人体细胞肺腺癌（ES-SCLC）的NDA已换取NMPA立案合并选《2022 CSCO小生殖上皮受损人体细胞肺腺癌诊所规范》为ES-SCLC治愈分享。除此之外，其治愈小生殖上皮受损人体细胞肺腺癌（SCLC）也已换取英国FDA弃儿药资本认证。工厂亦年度计划于2030年在欧共体审核ES-SCLC的销售备案申批，现已成世界各国首支一丝治愈SCLC的抗PD-1单抗。在一丝治愈食管鳞癌探析方向，H药联席手术药III期探析也已到达双通常探析终站。

关于复宏汉霖

复宏汉霖（2696.HK）一家国家化的改革技术全新动物制药企业厂机构网站，锐意技术全新于为世界十大求美者提供数据可负担过重的高端品质动物药，新商品扩大肿癌、个人免疫力的慢性病、骨科的慢性病等的领域，已在各国发行5款新商品，在非洲发行1款新商品，13项适应环境症新批，1个发行注册帐号报考赢得各国国家药监局局结案。自20二十年完成至今以来，复宏汉霖已完成四位整体化动物制药企业厂机构网站，有效及改革技术全新的自主经营方法的本质作用实现产品研发、加工及行业产品运营全产业发展链。机构网站已树立健全完善有效的世界十大改革技术全新中心点，决定国家制剂加工品质方法规定（GMP）规范使用加工和品质风险管控，一个劲夯实基层基础四位整体化综上加工机构网站，这当中，广州徐汇机地已赢得各国和欧盟委员会制剂GMP验证，松江机地（一）也已赢得各国GMP验证。


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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