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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 网站内容体现了于： 浏览量：

的内容來来自：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。这也将是我们人工控制新产品开发的抗PD-1单抗时需在肺肿瘤层面以嘴上计划书形势在ASCO企业年会实行汇报会，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。


一同，中国有人艮解放出军西北部战区总大诊所秦淮诊所区秦叔逵教学和成都中国东方大诊所李进教学互相统筹协调积极开展的H药面对微北斗卫星层面不比较稳定（MSI-H）线下瘤的至关重要性办理II期临床药理科研（ASTRUM-010）其次选入ASCO企业年会，数据表格创新将以海报背景的形式展示出。应用来该应力测试可是，H药已真正应用用来诊疗MSI-H线下瘤。



ASCO公司活动是肿癌方法方向最猛要、最具干扰力的时代國際会仪中的一种，宗旨在展现出目前时代國際最科技前沿的临床实践医治肿癌学教学科研重大成果和肿癌方法高技术。我院公司活动将于韩国中部地区日子6月3日-7日隆重召开。我院将展现出的有关系临床实践医治研究分析是指：

• ASTRUM-005

开题报告主题：特色化型抗PD-1免疫抗体斯鲁利单抗联动放放疗化疗与不谙世事放放疗化疗在不错制疗大范围期小癌细胞1.肺癌中的很：某些世界、随机函数Ⅲ期新药临床试验方案研究方案（提要偏号：8505）

主要研究探讨者：程颖，辽源市省恶性肿瘤诊所

商品展示形式：口碑报告模板

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

统计时刻：2022年6月5日，9:57 AM - 10:09 AM 美国中部夏令时

• ASTRUM-010

研究综述试题：科学创当下抗PD-1抵抗能力斯鲁利单抗在经调理、不得切除术或更换性微定位间距不稳定性高或错配清理问题（MSI-H/dMMR）线下瘤患有中大力开展的Ⅱ期医学实验室检测效用及人身安全等级但是更新软件（提要编码查询：2592）

合作主要是的生物学家：秦叔逵，我国人民群众解放汽车军长沙八一卫生院；李进，同济综合大学附加北京东方卫生院

动态展示方式：宣传单页

准确时间：22年6月3日，瑞典东部夏令时

• 实体瘤I期研究

医学论文小题目：革环保型人源化抗PD-1单克隆表面抗原斯鲁利单抗在后期实体化瘤人群中的一种Ⅰ期临床实验做实验的时候（文献综述识别码：e14560）

展示会方法：提要


H药小细胞肺癌数据亮眼

国产创新药风采绽放

小神经组织细胞核肝癌（SCLC）占肝癌数量统计的15%-20%，是肝癌中肉瘤样癌性最強的亚型，以分成片面期小神经组织细胞核肝癌（LS-SCLC）和多期小神经组织细胞核肝癌，矛盾律一起点是恶性瘤地步高、转意早、疾病症状发展发展，总体经济继发性较差。抗体捡查点限药制剂的显示为ES-SCLC行业领域的治疗方法介绍新小编希望。


ASTRUM-005为哪项在已往未学习过手术治疗的ES-SCLC病患中是比较H药滴注液合力放疗肿瘤化疗药（卡铂-凭借于泊苷）及开导剂合力放疗肿瘤化疗药（卡铂-凭借于泊苷）的药学实验合理时效性和可靠性的个数、双盲、國際多主点、III期药学实验科研。该现场实验在我国的、墨西哥、欧洲共同体意大利、格鲁吉亚等2个中国共创建12七个现场实验主点，之中114个现场实验主点有受试者参与到了筛分，共入组585例受试者，之中约31.5%为高加索人。2023年111月，公司的宣明ASTRUM-005应于中后期了解到达最主要的科研终点起点总存活期（OS）。科研动态数剧提示 ，H药合力放疗肿瘤化疗药在总体目标客户群体和亚洲区域客户群体均可延长了OS，提示 出比较好的效果和可靠性。做好的國際药学实验现场实验动态数剧也有着望的支持H药在欧洲共同体、美等发展趋势标准行业市场的申报纳税，为中国药学实验用途打下基础上。


现阶段，总部H药采取ES-SCLC的开卖登陆请求（NDA）已获国家药品监督管理局审理，有机会形成环球正式启动一二线方法SCLC的抗PD-1单抗。H药共同1.肺癌晚期化疗近些年也被《2022 CSCO小细胞核1.肺癌操作规程》选择看作ES-SCLC一二线制疗方案，是对H药临床医学较果及安全防护性的高认可度。再者，H入药于SCLC方法也于近些年收获美利坚FDA发放的弃儿药资格考试确认（Orphan-drug Designation），总部亦规划于2020年在欧共体送审H药采取ES-SCLC适应能力症的开卖登陆请求。


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年会上将入选该研究的更新数据统计。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，单位也将仍然以女性的需求为管理处，仰仗高效、性价比比较高及自主经营创新的自主经营管理处意识持继加快推进其他汉霖“质”造，为在我国甚至全球排名女性出示比较高高质量的药品和服务项目，做大做强海洋生物药厂行业人民高端品牌。


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。


明年6月，H药首次将建主要是用于治療微小行星程度不稳定性（MSI-H）实体化瘤。着眼于H药，复宏汉霖多方面力促其与工司的的产品的信息化同时与去创新开展的协力，随后取得在我国、国外、欧洲经济共同体等各国及的中北部的药学药理检验台可证，在全国同步操作积极开展9项肿癌免役协力开展药学药理检验台，普遍遍及1.癌症、食管癌、头颈鳞癌和食道癌等满足症，进一步遍及1.癌症闽东南治療。到近年，H药拟于在我国、俄罗斯、匈牙利、格鲁吉亚等各国和的中北部累算作组超2800人，在这其中2项全国多中心局药学药理检验台入组高加索人种的比率高于30%，是得到全国药学药理信息较多的抗PD-1单抗之首。H药协力放疗放化疗治療局部位中晚期或转出性鳞状非小生殖受损内部1.癌症（sqNSCLC）和闽东南治療普遍期小生殖受损内部1.癌症（ES-SCLC）的NDA已取得NMPA结案归入选《2022 CSCO小生殖受损内部1.癌症医疗指引》看做ES-SCLC治療推送。最后，其治療小生殖受损内部1.癌症（SCLC）也已取得国外FDA弃儿药条件确认。工司亦年度计划于明年在欧洲经济共同体送审ES-SCLC的销售登记公司申请，有机会变成了全国首届闽东南治療SCLC的抗PD-1单抗。在闽东南治療食管鳞癌领域，H药协力放疗放化疗III期论述也已做到双主要是论述起点终点。

关于复宏汉霖

复宏汉霖（2696.HK）都是家國际化的科技企业革新菌物药厂集团，专注于于为世界自个出具可损失的高的类物品性能水平菌物药，的类物品涉及肉瘤、自个免疫抗体病毒、眼科医生病毒等方面，已在国内 大陆地区国家发售5款的类物品，在欧式发售1款的类物品，13项适用于症应用，两个发售提交申请提交申请兑换国内 国家食药监局授理。自2020年申请加入十八大以来，复宏汉霖已完成立体式化菌物药厂网络软件平台，优质及科技企业革新的随时升级关键力实现研制、种植及商业楼方法全工业链。集团已创建加强制度建设优质的世界科技企业革新中间，遵循國际产品种植性能水平方法规范要求（GMP）要求进行种植和性能水平控制，持续不断增强立体式化综和种植网络软件平台，这里面，苏州徐汇基底已兑换国内 国家和欧盟国家产品GMP认证证书证书，松江基底（一）也已兑换国内 国家GMP认证证书证书。


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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