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 东西主要来缘于： 浏览量：

主要内容起取决于：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。这也将是国内 选择研发培训的抗PD-1单抗第一次 在肺肿瘤教育领域以书面形态报告单形态在ASCO年终晚会确定汇报会，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。


 另外，中华人艮彻底解决军东部地区战区总医疗医生秦淮诊疗区秦叔逵先生和沈阳東方医疗医生李进先生之间领头抓好的H药对应微北斗卫星高强度不不稳（MSI-H）线下瘤的根本性备案II期临床冲击试验实验（ASTRUM-010）再者参评ASCO公司，资料创新将以活动海报形势展览。应用场景该冲击试验成果，H药已仪式将建用来治愈MSI-H线下瘤。



ASCO大会是癌肿医疗教育领域最沉要、最具损害力的全国多媒体之1，从而展览眼下全国最前端的医学癌肿学科技研究方案研究方案成果和癌肿医疗方法。当届大会将于荷兰中东部耗时6月3日-7日会议通知。这回将展览的涉及到医学研究方案涵盖：

• ASTRUM-005

本文大题目：科学创多功能抗PD-1表面抗原斯鲁利单抗聯合肿瘤化疗药与单一肿瘤化疗药在带兵人医疗相当广泛期小肿瘤细胞肺癌患者中的相当：一类展览、随机的Ⅲ期临床上科学研究（结语标码：8505）

重要研究探讨者：程颖，辽源市省良性肿瘤卫生院

展出形式：口碑申请书

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

报表用时：2022年6月5日，9:57 AM - 10:09 AM 美国中部夏令时

• ASTRUM-010

文题型：多元化型抗PD-1抗原斯鲁利单抗在经中药治疗、不能不切除术或移动性微通讯卫星特别不安稳或错配休复弊病（MSI-H/dMMR）实体线瘤病号中开发的Ⅱ期临床研究检验成效及防护性結果的更新（前言编码：2592）

联和关键研发者：秦叔逵，我国人民群众解放汽车军合肥八一醫院；李进，同济上大学加盟北京东方醫院

表现状态：广告图

时期：2030年6月3日，美国的太平洋沿岸夏令时

• 实体瘤I期研究

参考文献题目大全：革一种新型人源化抗PD-1单克隆表面抗原斯鲁利单抗在骨转移实体型瘤女性中的这项Ⅰ期临床药学可靠性试验（前言编号规则：e14560）

展出组织形式：内容提要


H药小细胞肺癌数据亮眼

国产创新药风采绽放

小组织肺腺癌（SCLC）占肺腺癌占比的15%-20%，是肺腺癌中侵入性厉害的亚型，为仅限期小组织肺腺癌（LS-SCLC）和大面积期小组织肺腺癌，任何事物联合点是恶意情况高、转出早、常见疾病最新进展十分迅速，综合性生存率不好。免疫系统检测点压剂型的出显为ES-SCLC方面的方法引来新祝愿。


ASTRUM-005为某项在已往未接受了过医疗的ES-SCLC自身中是比较H药肌注液整合手术（卡铂-借助泊苷）及安慰自己的话剂整合手术（卡铂-借助泊苷）的监床治疗检验合理合理性和应急性的随机函数、双盲、全国金多管理中心局局、III期监床治疗检验科学深入分析。该实验在我国、西班牙、欧洲经济共同体匈牙利、格鲁吉亚等好几个国家地区共设有124个实验管理中心局局，中仅114个实验管理中心局局有受试者操作了淘汰，共入组585例受试者，中仅约31.5%为高加索人。202在一年15月，集团否认ASTRUM-005应于后期浅析达到包括科学深入分析终端总求生期（OS）。科学深入分析数据源资料出现，H药整合手术在总体设计年龄段和北美年龄段均可变长OS，出现出正常的较果和应急性。足够的全国金监床治疗检验实验数据源资料亦有望支撑H药在欧洲经济共同体、欧美等比较主流法律规定市场的的办理，为欧洲监床治疗检验使用贡献力量框架基础框架。


近年，集团H药真对ES-SCLC的什么时候面市注册成功工厂审请（NDA）已获国内食药监局审理，现已加入环球第一例前线进行根治SCLC的抗PD-1单抗。H药合作放疗近年来也被《2022 CSCO小神经元非小细胞肺癌诊治手册》推存身为ES-SCLC前线针灸，是对H药临床医学有效时间及安全卫生性的相对高度喜爱。还有，H中药于SCLC进行根治也于近年来赚取美FDA授与的弃婴药审请资格认证（Orphan-drug Designation），集团亦筹划于22年在欧盟成员国审核H药真对ES-SCLC适宜症的什么时候面市注册成功工厂审请。


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年会上将揭晓该研究的更新数据信息。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。

 

发展，公司也将坚持以糖尿病用户诉求为基本点，驱使高效、性价比更高及转型升级的综合性基本点意识坚持促进许多汉霖“质”造，为国内 做为全球各地糖尿病用户提拱更高品質的食用的药物和提供服务，打照生物工程制作药品行业领域少数名族产品。


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。


22年9月，H药正式工应用用来进行开展微遥感卫星间距不可靠（MSI-H）三维线瘤。把握H药，复宏汉霖正极进行其与集团总部另一產品的联动与与转型升级治开展法的联手，再度换取世界上各地、美利坚共和国、欧盟国家成员国等祖国及国家的医疗药理做实验的时候做实验的时候经营许可证，在世界上各地导入积极开展9项肺部肿瘤免疫性联手治开展法医疗药理做实验的时候做实验的时候，宽泛包括肺腺癌、食管癌、头颈鳞癌和食道癌等适应能力症，多方面包括肺腺癌前线进行开展。载止近些年，H药己经世界上各地、土尔其、匈牙利、格鲁吉亚等祖国和国家累会计入组超2800人，这当中2项知名多中心点医疗药理做实验的时候做实验的时候入组高加索人种的基数以上30%，是存在知名医疗药理做实验的时候大数据较多的抗PD-1单抗的一种。H药联手手术进行开展布局脑转换或转换性鳞状非小组织内部肺腺癌（sqNSCLC）和前线进行开展宽泛期小组织内部肺腺癌（ES-SCLC）的NDA已换取NMPA业务办理合并选《2022 CSCO小组织内部肺腺癌医疗指引》对于ES-SCLC进行开展推送。与此同时，其进行开展小组织内部肺腺癌（SCLC）也已换取美利坚共和国FDA孤寡药基础查证。集团总部亦规划于22年在欧盟国家成员国呈交ES-SCLC的发售注册账号申请表，还有机会作为世界上各地首位前线进行开展SCLC的抗PD-1单抗。在前线进行开展食管鳞癌方面，H药联手手术III期研究探讨分析也已高达双常见研究探讨分析终点站。

关于复宏汉霖

复宏汉霖（2696.HK）都是家全球英文化的科技企业创新技术动物制作医药单位，着力推进于为世界病员给予可负担重的高品控动物药，的物品扩大恶性肿瘤、自己本身免疫力传染性疾病症状、眼科整形传染性疾病症状等行业领域，已在全国市场销售5款的物品，在澳大利亚市场销售1款的物品，13项顺应症应用，5个市场销售注册的使用刷快全国医药监督治理局业务办理。自20十年成立厂家十八大以来，复宏汉霖已投入使用分立式化动物制作医药网上系统，便捷及科技企业创新技术的自主经营价值体系特性贯串新产品开发、制作及商业服务运营推广全财产链。单位已构建逐步完善便捷的世界科技企业创新技术重点，以全球英文医药制作效果治理规范性（GMP）基准对其进行制作和效果监管，不断的抓实分立式化综上制作网上系统，之中，广州徐汇集地已刷快全国和欧盟委员会医药GMP审核，松江集地（一）也已刷快全国GMP审核。


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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