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 內容来历于： 浏览量：

信息收入于：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。这也将是中华数字化创新的抗PD-1单抗第一回在非小细胞肺癌领域行业以书面内容评估报告内容在ASCO大会实行总结会，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。


也，我们人民群众解放出军东部地区战区总三甲医阮秦淮医疗保健区秦叔逵教受和西安尤品三甲医阮李进教受同时领导小组抓好的H药对於微卫星信号位置不安全（MSI-H）片体瘤的关键所在性注册会员II期临床可靠性试验探索（ASTRUM-010）又一次参评ASCO企业年会，数据库更新系统将以海报背景的形式分享。立于该可靠性试验没想到，H药已正规新批主要用于医治MSI-H片体瘤。



ASCO公司年终晚会是淋巴癌肿改善研发方向最沉要、最具后果力的国家会议安排之五，有何意义风采风采展示特定国家最先进的临床检验药理淋巴癌肿学科研开发课题和淋巴癌肿改善技术设备。这届公司年终晚会将于欧美西南部时长6月3日-7日召开会议。圆满结束将风采风采展示的有关的临床检验药理研发属于：

• ASTRUM-005

医学论文主题 ：改革创环保型抗PD-1抗体阳性斯鲁利单抗联席放放疗化疗与幼稚放放疗化疗在专业的中药治疗范围广期小細胞肺肿瘤中的有点：一方面亚太、自由Ⅲ期临床探析探析（提要序号：8505）

一般探究者：程颖，辽源市省肉瘤医疗机构

展示板形式：嘴上报表

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

报告格式事件：2022年6月5日，9:57 AM - 10:09 AM 美国中部夏令时

• ASTRUM-010

文献考题：革轻型抗PD-1表面抗原斯鲁利单抗在经控制、不去除或变动性微遥感卫星的高度不维持或错配处理疵点（MSI-H/dMMR）片体瘤用户中深入开展的Ⅱ期临床药理检测的作用及安全管理性结局更行（结语顺序号：2592）

协同注意科研者：秦叔逵，中国内地人民群众改变军常州八一醫院；李进，同济综合大学附属医院专家修真醫院

表现组织形式：海报设计

的时间：2023年6月3日，欧美中间夏令时

• 实体瘤I期研究

小作文提题：不断创创新人源化抗PD-1单克隆抗体阳性斯鲁利单抗在干癌实体店瘤病号中的某项Ⅰ期临床治疗实验（文献综述编号规则：e14560）

体现的方式：小结


H药小细胞肺癌数据亮眼

国产创新药风采绽放

小肿瘤组织膜癌症（SCLC）占癌症个数的15%-20%，是癌症中侵蚀性性最高的亚型，分局限于期小肿瘤组织膜癌症（LS-SCLC）和广泛应用期小肿瘤组织膜癌症，此二者一同点是恶劣水平高、适当转移早、皮肤疾病近展快速发展，总体经济愈后异常。免疫性体检点控剂型的出显为ES-SCLC业务领域的方法造成新也希望。


ASTRUM-005为这项在继往未认同过治疗方法的ES-SCLC患病者中较为H药注谢液共同放疗（卡铂-充沛发挥泊苷）及安慰女朋友剂共同放疗（卡铂-充沛发挥泊苷）的医学钻研钻研合理性和可靠性的重复、双盲、香港知名多心中、III期医学钻研钻研钻研。该实验室检测在国内 、墨西哥、欧洲共同体成员国瑞典、格鲁吉亚等好几个国家的共设有12七个实验室检测心中，但这里面114个实验室检测心中有受试者参与性了选择，共入组585例受试者，但这里面约31.5%为高加索人。202一年16月，集团公司组阁ASTRUM-005现已前期定性分析达到了其主要钻研始发站总经营期（OS）。钻研信息源信息显示信息，H药共同放疗在总体设计消费群体和东方人消费群体均可调长OS，信息显示信息出非常好的治疗作用和可靠性。充沛的香港知名医学钻研钻研实验室检测信息源也存在望扶持H药在欧洲共同体成员国、英国等时代趋势法律规定领域的申请上报，为国际医学钻研钻研适用决定核心。


目前为止，公司的的H药争对ES-SCLC的成功出现注册网站成功报名（NDA）已获政府食药监局业务办理，还有机会变成了长度首家闽东南诊治SCLC的抗PD-1单抗。H药合作手术最近也被《2022 CSCO小人体细胞肺癌患者医用指导意见》比较适合身为ES-SCLC闽东南方法，是对H药临床研究诊治作用及卫生性的长度同意。还有，H中药于SCLC诊治也于最近赢得法国FDA授勋的流浪儿童药资格证评定（Orphan-drug Designation），公司的的亦预计于2023年在欧洲共同体提出个人申请H药争对ES-SCLC满足症的成功出现注册网站成功报名。


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年会上将发布在该研究的更新数据文件。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，国际品牌也将立刻以病人供给为目标，依靠高效率的及研发的人工控制目标技能延续推广其他汉霖“质”造，为华人以至于亚洲病人构造极高产品品质的治疗药物和服務，构造生物体医药各个领域汉族国际品牌。


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药正式工应用在根治微遥感卫星长度不稳固（MSI-H）实体的瘤。紧扣H药，复宏汉霖积极行动深入推进其与集团厂家某些品牌的推进还有与特色化针灸的共同，接二连三提升中、欧美、欧共体等國家及地段的操作护理探究应力测试经营许可资料，在世界各国同时展开9项淋巴肿瘤免疫系统共同针灸操作护理探究应力测试，非常非常广泛重叠率1.非小血神经元癌症、食管癌、头颈鳞癌和食道癌等应用症，局面重叠率1.非小血神经元癌症超闽东南根治。截止日期现有，H药已经在中、土尔其、芬兰、格鲁吉亚等國家和地段累算入组超2800人，这之中2项国外金多重心操作护理探究应力测试入组高加索人种的比例图已超30%，是获取国外金操作护理探究统计数据较多的抗PD-1单抗之五。H药共同肿瘤化疗药根治轮廓骨转换或转换性鳞状非小血神经元1.非小血神经元癌症（sqNSCLC）和超闽东南根治非常非常广泛期小血神经元1.非小血神经元癌症（ES-SCLC）的NDA已提升NMPA立案划为选《2022 CSCO小血神经元1.非小血神经元癌症操作须知》成了ES-SCLC根治推建。因此，其根治小血神经元1.非小血神经元癌症（SCLC）也已提升欧美FDA遗孤药任职资格申报。集团厂家亦规划于22年在欧共体撤签ES-SCLC的退市注冊申请注册，已成定局成了世界各国首条超闽东南根治SCLC的抗PD-1单抗。在超闽东南根治食管鳞癌行业领域，H药共同肿瘤化疗药III期探究也已满足双重要探究终端。

关于复宏汉霖

复宏汉霖（2696.HK）有的是家国家化的自动全新发展微菌物制药业业品牌，秉持着于为世界各国客户能提供可承担的高茶叶品质微菌物药，类厂品网络覆盖肉瘤、本身抗体的传染性疾病、骨科的传染性疾病等业务领域，已在我国挂牌发售5款类厂品，在欧洲地区挂牌发售1款类厂品，13项适用症应用，3个挂牌发售注册的使用兑换我国otc保健药品监督菅理局受案。自206年设立的话，复宏汉霖已完工一身化微菌物制药业业的游戏平台，高及自动全新发展的自动内在功能穿过产品研发、研发及商家运作全制造业链。品牌已树立改进高的世界各国自动全新发展主，是以国家otc保健药品研发产品品质菅理规程（GMP）细则做研发和产品品质管理，不息压实一身化整体研发的游戏平台，进来，武汉徐汇基地面积面积已兑换我国和欧洲经济共同体otc保健药品GMP注册，松江基地面积面积（一）也已兑换我国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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