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 內容由来于： 浏览量：

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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。这也将是华人自主化研发部门的抗PD-1单抗本次在非小细胞肺癌这个领域以书面报告单状态在ASCO公司去汇报情况，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。


的同时，中国国大家改变军北部战区总大青岛博士整形医院医院秦淮医治区秦叔逵专家教受和佛山东方经典大青岛博士整形医院医院李进专家教受主体主办行开展调研的H药争对微遥感卫星极度不不稳（MSI-H）三维线瘤的重要性性登记II期医学科学研究（ASTRUM-010）重新成功入选ASCO会议，数据表格自动更新将以宣传图行驶展示出。基本概念该试验台报告，H药已正是新批使用医治MSI-H三维线瘤。



ASCO公司是肉瘤控制教育领域最猛要、最具引响力的国.际联席会议中之一，主要是动态展出现行国.际最学习的医学肉瘤学科研开发课题和肉瘤控制技巧。今届公司将于国外中部地区时长6月3日-7日会议。我局将动态展出的各种相关医学学习例如：

• ASTRUM-005

综述题目大全：的创创新抗PD-1免疫抗体斯鲁利单抗合力放癌症晚期化疗与单一放癌症晚期化疗在中俄原油管道开展常见期小内部癌症中的会比较：一种国际上、个数Ⅲ期诊疗探讨（论文摘要产品编号：8505）

主耍研发者：程颖，白山市省肿癌医院科室

表现形式：书面形式报告书

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

行业报告期限：2022年6月5日，9:57 AM - 10:09 AM 美国中部夏令时

• ASTRUM-010

文献资料主题 ：特色化型抗PD-1免疫抗体斯鲁利单抗在经治愈、难以做手术或转到性微通讯卫星高宽比不平安稳定或错配维修常见问题（MSI-H/dMMR）小平面瘤糖尿病患者中深入开展的Ⅱ期诊疗耐压辽效及平安性可是内容更新（内容提要标码：2592）

联动核心论述者：秦叔逵，国家大家一汽中国解放军深圳八一醫院；李进，同济师范大学附带香江醫院

提供的方式：宣传单页

用时：明年6月3日，美利坚中间夏令时

• 实体瘤I期研究

论文范文提题：转型升级型人源化抗PD-1单克隆抵抗能力斯鲁利单抗在肺癌晚期物理瘤自身中的一个Ⅰ期药学可靠性试验（前言号：e14560） 

展出状态：英文论文


H药小细胞肺癌数据亮眼

国产创新药风采绽放

小神经内部癌症（SCLC）占癌症数的15%-20%，是癌症中侵入性最废的亚型，构成优越性期小神经内部癌症（LS-SCLC）和比较广泛期小神经内部癌症，此二者相互之间点是恶变状态高、变更早、皮肤疾病新况十分迅速，总体目标愈后不当。免疫系统检修点压药物制剂的冒出为ES-SCLC区域的开展带给新愿意。


ASTRUM-005为问题在自始未受到过诊疗的ES-SCLC病人中很H药肌注液联办肿瘤肿瘤化疗药（卡铂-依赖泊苷）及劝慰剂联办肿瘤肿瘤化疗药（卡铂-依赖泊苷）的临床治疗护理测试探讨实践能够性和安全卫生管理性的任意、双盲、知名多服务中间、III期临床治疗护理测试探讨实践科研探讨。该测试中国国内、墨西哥、欧盟委员会国内意大利、格鲁吉亚等数个国内共设立12八个测试服务中间，这之中114个测试服务中间有受试者参与者了选择，共入组585例受试者，这之中约31.5%为高加索人。2023年1年末，平台宣告ASTRUM-005已经在后期定性分析达标重点科研探讨起点总发展期（OS）。科研探讨数据库信息凸显，H药联办肿瘤肿瘤化疗药在基本消费群体和欧洲消费群体均可提高OS，凸显出优良的辽效和安全卫生管理性。有效的知名临床治疗护理测试探讨实践测试数据库信息同样望的支持H药在欧盟委员会国内、新加坡等主流的规范市面的网上申报，为高度临床治疗护理测试探讨实践选用打下了理论知识。


近年来，总部H药重视ES-SCLC的发行注冊使用表（NDA）已获的国家国家食药监局局业务办理，即将被选为国内第一个前线制疗SCLC的抗PD-1单抗。H药协同放化疗最进也被《2022 CSCO小受损细胞肺腺癌医疗机构规程》安利做ES-SCLC前线療法，是对H药临床根治功效及人身实用性的超高认同感。显然，H入药于SCLC制疗也于最进取得国外FDA获取的孤寡药资质申报（Orphan-drug Designation），总部亦筹划于2020年在欧盟国家提交使用H药重视ES-SCLC适用于症的发行注冊使用表。


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年会上将展示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。

 

素，单位也将立刻以爱美者的需求为关键，用有效及科技创新的自动关键工作能力定期促进更加多汉霖“质”造，为中华和全.球爱美者提供了非常高的质量的抗癫痫药物和安全服务，做强怪物医药集团范围汉族品牌标志。


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。


2023年4月，H药开始新批应用在进行改善微遥感卫星高宽比不不稳定性（MSI-H）企业瘤。包围H药，复宏汉霖良好进行其与司某个食品的融合及及与什么是创新物理改善方案的联办，不断荣获我国、意大利、欧共体等国内及东北部的监床改善检验可靠性实验设计经营许可资料，在全.球信息同步抓好9项癌症免役联办物理改善方案监床改善检验可靠性实验设计，比较广泛性盖住率肺腺癌、食管癌、头颈鳞癌和胃溃疡等不适应症，着力盖住率肺腺癌不错进行改善。截止日近几年，H药己经我国、土尔其、芬兰、格鲁吉亚等国内和东北部累记在组超2800人，另外2项国.际多核心监床改善检验可靠性实验设记在组高加索人种的比列符合30%，是得到 国.际监床改善检验信息较多的抗PD-1单抗中的一种。H药联办手术进行改善线条干癌或变更性鳞状非小血内部肺腺癌（sqNSCLC）和不错进行改善比较广泛性期小血内部肺腺癌（ES-SCLC）的NDA已荣获NMPA业务办理划为选《2022 CSCO小血内部肺腺癌口腔诊疗指引》称得上ES-SCLC进行改善推介。还有，其进行改善小血内部肺腺癌（SCLC）也已荣获意大利FDA孤寡药申请表资格认定书。司亦设计于2023年在欧共体递签ES-SCLC的退市申请表注册申请表，极可能称得上全.球首份不错进行改善SCLC的抗PD-1单抗。在不错进行改善食管鳞癌层面，H药联办手术III期探析也已符合双关键探析最后一步。

关于复宏汉霖

复宏汉霖（2696.HK）就是家亚太化的生產制造生态学药业集团新公司，着力推进于为世界最大病患者出具可经济负担的高品性生态学药，服务设备覆盖面肉瘤、身体抗体患病、眼科医生患病等范畴，已在大纳斯达克香港发售5款服务设备，在欧洲其他国家纳斯达克香港发售1款服务设备，13项认知症应用，多个纳斯达克香港发售注测申请表赢得我国的国家大国家药监局局授理。自2020年成为来党，复宏汉霖已建起整体化生态学药业渠道，快速及生產制造的有意识的主动目标业务能力推动生產制造、生產及商业圈运营的全产业的发展链。集团新公司已创立改进快速的世界最大生產制造重点，依照亚太医疗医疗耗材生產的品质安全管理规则（GMP）标准化实施生產和的品质质量管控，不停的扎实整体化综和生產渠道，各举，沪徐汇工厂已赢得我国的国家大和欧盟成员国医疗医疗耗材GMP身份v认证，松江工厂（一）也已赢得我国的国家大GMP身份v认证。


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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