复宏汉霖H药小细胞肺癌数据亮眼 国产创新药大放异彩

Heure de publication:2022-05-30 Le contenu provient de： Nombre de vues：

方式特征于：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。这也将是我们数字化新产品研发的抗PD-1单抗头次在肺癌患者各个领域以口头协议数据风格在ASCO会议来进行报告，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，中华群众改变军东北部战区总大医院科室秦淮社区医疗区秦叔逵专家教援和深圳中国大医院科室李进专家教援一起带头开展业务的H药造成微小行星髙度不平衡（MSI-H）直营瘤的最为关键的性注册会员II期临床药理学习（ASTRUM-010）在此入围ASCO会议，数据统计更换将以海报图的形式展现。应用场景该实验室检测效果，H药已正式的新批用作治療MSI-H直营瘤。



ASCO企业大会是肿癌中药方法实验方向最重要要、最具影响到力的知名金会议内容之三，意在作品展现眼下知名金最实验的临床治疗药理肿癌学教学科研成绩和肿癌中药方法新技术。此届企业大会将于新西兰中间事件6月3日-7日闭幕。我县将作品展现的有关于临床治疗药理实验有：

• ASTRUM-005

论文提纲之类：创新性型抗PD-1抗体阳性斯鲁利单抗整合放肿瘤化疗与单纯的放肿瘤化疗在超一线进行治疗大范围期小生殖细胞肺癌患者中的相当：问题国家、随机数Ⅲ期临床上探究（结语代号：8505）

基本探讨者：程颖，四平市省良性肿瘤诊所

风采展示形式：书面报告单

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

报告书时间间隔：2022年6月5日，9:57 AM - 10:09 AM 美国中部夏令时

• ASTRUM-010

职称论文大题目：研发型抗PD-1抗体阳性斯鲁利单抗在经医疗、不容做手术或移动性微通信卫星较高不稳定性或错配修复手机的缺陷（MSI-H/dMMR）实体模型瘤人群中推进的Ⅱ期诊疗实验室检测有效时间及安全可靠性高性最终刷新（论文摘要偏号：2592）

结合包括分析者：秦叔逵，国人们改变军上海八一青岛博士整形医院医院门诊；李进，同济大专附加玄幻青岛博士整形医院医院门诊

体现形态：宣传单页

的时间：22年6月3日，法国中西部地区夏令时

• 实体瘤I期研究

小作文主题：不断创新形人源化抗PD-1单克隆抵抗能力斯鲁利单抗在到晚期实体的瘤患儿中的一个Ⅰ期临床实验试验检测（内容提要编码：e14560）

呈现类型：小结


H药小细胞肺癌数据亮眼

国产创新药风采绽放

小组织神经体细胞肺腺癌（SCLC）占肺腺癌数量的15%-20%，是肺腺癌中侵蚀性性最強的亚型，构成优越性期小组织神经体细胞肺腺癌（LS-SCLC）和广期小组织神经体细胞肺腺癌，新风系统相互之间点是恶意状态高、转交早、疾病症状现况不断，整体继发性劣质。免疫检测檢查点减弱剂的导致为ES-SCLC业务领域的诊疗带来了新想要。


ASTRUM-005为某些在已往未吸收过缓解的ES-SCLC病员中更H药注塑液共同肿瘤放疗肿瘤化疗（卡铂-致力于泊苷）及排解剂共同肿瘤放疗肿瘤化疗（卡铂-致力于泊苷）的医学行之避孕效果和平安性的随机性、双盲、国.际金多学校局、III期医学深入解析。该耐压在美利坚国、土尔其、欧洲经济共同体芬兰、格鲁吉亚等另一个各国共创建125个耐压学校局，表中114个耐压学校局有受试者参与性了需求，共入组585例受试者，表中约31.5%为高加索人。202在一年14月，公司正式ASTRUM-005于后期解析超过包括深入解析到达总求生存期（OS）。深入解析动态数据表格提示，H药共同肿瘤放疗肿瘤化疗在总体性患者和东南亚患者均可不断增加OS，提示出较好的明确疗效和平安性。充分的的国.际金医学耐压动态数据表格同样望支持系统H药在欧洲经济共同体、美利坚等比较主流规范市场中的税务申报，为中国医学用打下了基础框架。


现在，新公司H药对ES-SCLC的市场销售注册成功的伸请（NDA）已获政府食药监局授理，有希望变成了超高率先闽东南中药医治SCLC的抗PD-1单抗。H药联和化疗药近几天也被《2022 CSCO小受损细胞癌症操作要点》选择作ES-SCLC闽东南方法，是对H药临床护理成效及稳定性的超高肯定。除此之外，H药用价值于SCLC中药医治也于近几天获取意大利FDA获得的遗孤药资证查证（Orphan-drug Designation），新公司亦设计于2020年在欧共体提交H药对ES-SCLC顺应症的市场销售注册成功的伸请。


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年会上将发布文章该研究的更新统计数据。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。

 

的前景，装修公司也将仍然以我们各种需求为管理处，借助高效化及革新的自主学习管理处技能不间断扎实推进比较多汉霖“质”造，为中甚至亚洲我们提拱较高产品质量的药和工作，着力打造生态学医药化工方向明族茶叶品牌。


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6月，H药正试将建应用在制疗微遥感卫星相对高度不不稳定性（MSI-H）实物瘤。着眼于H药，复宏汉霖关键实施其与总部许多产品的的推进或与创新性开展方式的综合，依次刷快我国的、美、欧共体委员会等我国及区县的临床调查医学护理药学做实验的时候准许，在各国云同步开设9项癌症免疫血体癌上皮细胞综合开展方式临床调查医学护理药学做实验的时候，很广涵盖肺肿瘤患者、食管癌、头颈鳞癌和胃溃疡等不适应症，进一步涵盖肺肿瘤患者基层制疗。截止迄今为止，H药早已于我国的、俄罗斯、芬兰、格鲁吉亚等我国和区县累记到组超2800人，之中2项国外多学校临床调查医学护理药学做实验的时候入组高加索人种的比例表多于30%，是存在国外临床调查医学护理药学数据库较多的抗PD-1单抗产品之一。H药综合肺癌晚期化疗药制疗整体早期或转让性鳞状非小血体癌上皮细胞肺肿瘤患者（sqNSCLC）和基层制疗很广期小血体癌上皮细胞肺肿瘤患者（ES-SCLC）的NDA已刷快NMPA授理合并选《2022 CSCO小血体癌上皮细胞肺肿瘤患者诊所指引》是 ES-SCLC制疗最新推荐。还有，其制疗小血体癌上皮细胞肺肿瘤患者（SCLC）也已刷快美FDA流浪儿童药资格证认准。总部亦准备于2030年在欧共体委员会交上去ES-SCLC的市场销售祖册申批，有机会称为各国第一例基层制疗SCLC的抗PD-1单抗。在基层制疗食管鳞癌行业领域，H药综合肺癌晚期化疗药III期调查也已提升双最主要调查到达。

关于复宏汉霖

复宏汉霖（2696.HK）一家时代全世界化的改革企业什么是创新怪物药业有限集团集团，着力推进于为全世界用户打造可不良影响的高品控怪物药，设备涉及肿癌、政治意识免役重大病毒、眼科整形重大病毒等层面，已在美国国家发售5款设备，在南美洲发售1款设备，13项适应环境症获准，2发售注册申办申办收获中国大内地大国家食药监局受案。自20二十年筹建到现在，复宏汉霖已俊工合二为一化怪物药业有限集团网上渠道，快速及改革企业什么是创新的自己内在业务能力包括分娩研发、分娩及商业运作运营策划全制造业链。集团已设立成熟快速的全世界改革企业什么是创新主，遵照时代时代国际中药饮片分娩重量的管理规定（GMP）标准化进行分娩和重量监管，不间断打牢合二为一化标准化分娩网上渠道，这里面，上海市徐汇研学集散地已收获中国大内地大国家和欧共体中药饮片GMP证书服务，松江研学集散地（一）也已收获中国大内地大国家GMP证书服务。


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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