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:2023-05-30 Inhalte aus： Lautstärke anzeigen：

资源來缘于：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。这也将是国自由创新的抗PD-1单抗首届在肝癌区域以口头上通知单类型在ASCO公司采取小结，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。


互相，我们大家一汽解放军部队东部地区战区总诊所秦淮医疗保健区秦叔逵教学和武汉龙腾诊所李进教学各自主办行实施的H药对於微小行星位置不增强（MSI-H）线下瘤的至关重要性注册申请II期药学论述（ASTRUM-010）第三步评为ASCO企业年会，数据资料版本更新将以海报背景表现形式分享。源于该疲劳试验毕竟，H药已正式的获准应用于根治MSI-H线下瘤。



ASCO年终晚会是良性癌肿调理领域最终要、最具印象力的香港新国际例会之四，广泛宣传展现出台所选香港新国际最探讨的临床药学实验良性癌肿学研发探讨成果和良性癌肿调理工艺。此届年终晚会将于美国的东南部時间6月3日-7日闭幕。与会人员将展现出台的各种相关临床药学实验探讨分为：

• ASTRUM-005

研究综述主题：全新型的抗PD-1抗体阳性斯鲁利单抗联和手术与纯粹手术在标杆治疗方法宽泛期小体细胞癌症中的相对比较：一种国际性、随即Ⅲ期临床试验论述（内容提要编号规则：8505）

主要是研究方案者：程颖，吉林市省良性肿瘤三甲医院

作品展示形式：口头协议通知单

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

计划书時间：2022年6月5日，9:57 AM - 10:09 AM 美国中部夏令时

• ASTRUM-010

职称论文便秘尴尬检查经历：特色化型抗PD-1抗原斯鲁利单抗在经开始、不摘除或转变性微遥感卫星间距不稳定性或错配恢复缺点（MSI-H/dMMR）实体的瘤糖尿病患者中开始的Ⅱ期临床实验试验报告效果及防护性但是更新时间（文献综述编码查询：2592）

携手最主要的探究者：秦叔逵，国内 百姓释放军上海八一卫生院医生；李进，同济二本大学其他修真卫生院医生

展现出方法：海报设计

日期：2020年6月3日，美式的中部夏令时

• 实体瘤I期研究

开题报告考题：去创新颖人源化抗PD-1单克隆抵抗能力斯鲁利单抗在骨转移实体店瘤爱美者中的项Ⅰ期临床上现场实验（内容提要编码：e14560）

展示英文方法：绪论


H药小细胞肺癌数据亮眼

国产创新药风采绽放

小細胞肺肿瘤（SCLC）占肺肿瘤总人数的15%-20%，是肺肿瘤中入侵性最差的亚型，可分为片面期小細胞肺肿瘤（LS-SCLC）和很广期小細胞肺肿瘤，这两种方法共同利益点是梭形细胞肿瘤限度高、移转早、发病发展快速，总体布局疗效较差。抗体检查报告点抑止剂的出显为ES-SCLC层面的改善有新小编希望。


ASTRUM-005为一个在自始未确认过手术治疗的ES-SCLC的人中较为H药滴注液综合技术放疗手术（卡铂-引领泊苷）及劝解剂综合技术放疗手术（卡铂-引领泊苷）的监床医学很好性和稳定性防护性的自由、双盲、世界多管理中央、III期监床医学理论分析分析。该耐压在我们、俄罗斯、欧洲联盟委员会芬兰、格鲁吉亚等多条国共建立12七个耐压管理中央，在这这里面114个耐压管理中央有受试者参入了筛分，共入组585例受试者，在这这里面约31.5%为高加索人。202一年111月，总部发出ASTRUM-005在后期分析分析分析可达到具体理论分析分析终点站总求生存期（OS）。理论分析分析数据报告库凸显，H药综合技术放疗手术在综合客户群和亞洲客户群均可延长至OS，凸显出很好的有效时间和稳定性防护性。有效的世界监床医学耐压数据报告库亦有望的支持H药在欧洲联盟委员会、韩国等流行的法律行业的办理，为中国监床医学运用确定基本知识。


现有，集团集团H药面对ES-SCLC的退市办理集团申报办理（NDA）已获政府食药监局核发，极可能成亚洲首只基层控制SCLC的抗PD-1单抗。H药联和放疗化疗近两天也被《2022 CSCO小组织癌症诊疗规范须知》推荐英文身为ES-SCLC基层療法，是对H药临床药理成效及的安全稳定的极高喜爱。凡此种种，H入药于SCLC控制也于近两天收获英国FDA授勋的弃婴药资证认证（Orphan-drug Designation），集团集团亦项目于明年在欧盟成员国送审H药面对ES-SCLC适于症的退市办理集团申报办理。


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年会上将披露该研究的更新统计资料。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。

 

前景，工厂也将继读以病号诉求为中心，根据高效率的及研发的自动中心力不间断推动越来越多汉霖“质”造，为中国有以至于全球各地病号具备最大口感的口服药物和精准服务，打造的生物制品医药化工行业明族加盟品牌。


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。


22年7月，H药已经应用大部分用于制疗微通讯卫星长度不安全（MSI-H）实体模型瘤。强调H药，复宏汉霖正面积极推进其与大集团许多成品的推进还有与什么是创新辽法的携手技术，前不久才能得到我们、法国、欧洲共同体等國家及的地方的临床实验药理进行医疗检测检测同意，在世界十大排名一起推进9项肿癌天然免疫携手技术辽法临床实验药理进行医疗检测检测，比较范围广遮盖肝癌、食管癌、头颈鳞癌和直肠癌等应用症，周全遮盖肝癌品牌制疗。到当前，H药于我们、俄罗斯、芬兰、格鲁吉亚等國家和的地方累计到组超2800人，这之中2项世界十大多机构临床实验药理进行医疗检测检测入组高加索人种的标准超出30%，是占有世界十大临床实验药理进行医疗检测信息较多的抗PD-1单抗一种。H药携手技术化疗药药制疗部分区域早期或更换性鳞状非小内部系肝癌（sqNSCLC）和品牌制疗比较范围广期小内部系肝癌（ES-SCLC）的NDA已才能得到NMPA核发划入选《2022 CSCO小内部系肝癌医疗规程》充当ES-SCLC制疗推存。另外，其制疗小内部系肝癌（SCLC）也已才能得到法国FDA遗孤药执证判定。大集团亦打算于22年在欧洲共同体提交ES-SCLC的市场销售注册成功申批，力争已成为世界十大排名第一个品牌制疗SCLC的抗PD-1单抗。在品牌制疗食管鳞癌方面，H药携手技术化疗药药III期深入分析方案也已实现双大部分深入分析方案终端。

关于复宏汉霖

复宏汉霖（2696.HK）也是家国家化的科学全新技术微海洋生物体药业有限司司，着力推进于为世界糖尿病患者保证可财政负担的高品控微海洋生物体药，好物料的遍及肿癌、内在天然免疫疫情、皮肤科疫情等行业领域，已在我国的发行5款好物料的，在欧州发行1款好物料的，13项应用症应用，2发行注册的申批换取我国的医药监督经营局审批。自206年解散后，复宏汉霖已建设成二合一化微海洋生物体药业有限司电商品台，便捷及科学全新技术的选择目标业务能力推动研制、产量及房地产业运营经营产业链。司已搭建改善便捷的世界科学全新技术公司，依据国家医药产量性能经营经营正确（GMP）条件来进行产量和性能经营监管，不停做实二合一化标准化产量电商品台，之中，广州徐汇产业带已换取我国的和欧共体医药GMP注册，松江产业带（一）也已换取我国的GMP注册。


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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