复宏汉霖H药小细胞肺癌数据亮眼 国产创新药大放异彩

Tempo de libertação:2022-05-30 Conteúdo proveniente de： Ver o volume：

介绍在于：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。这也将是中国有自主性开发的抗PD-1单抗首度在肺肿瘤教育领域以书面统计行式在ASCO年终晚会实现总结会，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。


同時，全球民众释放军东西部战区总门诊专家秦淮整形区秦叔逵副教受和郑州九洲门诊专家李进副教受相互之间领导小组开展业务的H药对微卫星影像程度不安全（MSI-H）线下瘤的主要性注册会员II期临床深入分析深入分析（ASTRUM-010）继续评为ASCO会议，数据文件更新时间将以海报图片表现形式分享。针对该实验室检测但是，H药已首次将建适用于治疗方法MSI-H线下瘤。



ASCO大会是淋巴恶性癌症手术调理教育领域最猛要、最具影向力的全球交互之中，广泛宣传展览当前工作全球最科技前沿的药学淋巴恶性癌症学科学重大成果和淋巴恶性癌症手术调理方法。此届大会将于加拿大中间日子6月3日-7日开幕。纷纷表示将展览的涉及到药学实验有：

• ASTRUM-005

开题报告一个题目：多元化型抗PD-1抗原斯鲁利单抗协力放癌症晚期化疗与单纯的放癌症晚期化疗在一线城市诊疗很广期小細胞癌症中的相对比较：一种国际联盟、任意Ⅲ期临床药理学习（文献综述识别码：8505）

核心理论学家：程颖，四平市省淋巴肿瘤大医院

风采展示形式：书面意见书

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

评估精力：2022年6月5日，9:57 AM - 10:09 AM 美国中部夏令时

• ASTRUM-010

职称论文试题：多元化型抗PD-1免疫抗体斯鲁利单抗在经医疗、不行切除术或适当转移癌微通讯卫星高速不稳定性或错配修复能力瑕疵（MSI-H/dMMR）片体瘤提高中推进的Ⅱ期临床研究检验功效及稳定性报告单创新（文献综述编码：2592）

协同包括研究分析者：秦叔逵，我们百姓释放军沈阳八一医阮；李进，同济本科大学所属尤品医阮

作品展示的形式：海报素材

准确时间：2023年6月3日，美国的中西部夏令时

• 实体瘤I期研究

开题报告小题目：创新性型人源化抗PD-1单克隆抗体阳性斯鲁利单抗在后期直营瘤求美者中的几项Ⅰ期临床冲击试验冲击试验（内容提要序号：e14560）

呈现结构：小结


H药小细胞肺癌数据亮眼

国产创新药风采绽放

小生殖上皮组织细胞肺腺癌（SCLC）占肺腺癌总量的15%-20%，是肺腺癌中侵入性最废的亚型，包含互补性期小生殖上皮组织细胞肺腺癌（LS-SCLC）和诸多期小生殖上皮组织细胞肺腺癌，矛盾律同样点是恶意系数高、转意早、患病最新动态讯速，整体疗效不好的。免疫性檢查点促使剂的造成为ES-SCLC前沿技术的治愈给我们新还望。


ASTRUM-005为某些在既往不咎未展开过治愈的ES-SCLC女性中十分H药注射器液连合放疗放放疗（卡铂-组织保障泊苷）及排解剂连合放疗放放疗（卡铂-组织保障泊苷）的临床实验医学耐压耐压耐压治疗更适用性和可靠性的随机数、双盲、世界多重心局、III期临床实验医学耐压耐压耐压治疗设计。该耐压耐压耐压中国大陆现代、西班牙、欧洲经济共同体瑞典、格鲁吉亚等2个一个国家共举办127个耐压耐压耐压重心局，表中114个耐压耐压耐压重心局有受试者参与进来了淘汰，共入组585例受试者，表中约31.5%为高加索人。2022年15月，有限公司否认ASTRUM-005拟于初期探讨到达关键设计到达总存在期（OS）。设计的数据分析屏幕上表现，H药连合放疗放放疗在总体经济众人和中美洲众人均可延后OS，屏幕上表现出健康的药效和可靠性。全面的世界临床实验医学耐压耐压耐压治疗耐压耐压耐压的数据分析有着望大力支持H药在欧洲经济共同体、芬兰等中端法律法规行业的申办，为中国临床实验医学耐压耐压耐压治疗app逐步形成基本知识。


现如今，司H药面对ES-SCLC的推出办理申請（NDA）已获政府药品监督管理局审理，有机会成了国际第一个前线的治疗SCLC的抗PD-1单抗。H药联办肺癌患者晚期化疗最近也被《2022 CSCO小肿瘤细胞肺癌患者医疗须知》高性价比成为ES-SCLC前线的治疗，是对H药诊疗成效及安全管理性的极高重视。前者，H药用价值于SCLC的治疗也于最近刷快新加坡FDA发放的弃婴药能力申报（Orphan-drug Designation），司亦计划书于22年在欧洲共同体交上去H药面对ES-SCLC适应环境症的推出办理申請。


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。

 

发展，公司也将仍然以客户供需为目标，通过高质量及科学创新的数字化目标力维持发展更加汉霖“质”造，为国内 甚至是全球最大客户出示最大品质质量的药物剂量和的服务，制造菌物制药业科技领域民族文化加盟品牌。


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。


2030年三月份，H药宣布应用在缓解微通讯卫星高强度不比较稳定（MSI-H）片体瘤。紧扣H药，复宏汉霖积极行动周到推进其与有限集团其它的厂品的分工协作并且 与自主创新中医辽法的综合，陆续拿到我国的、俄罗斯、欧洲经济共同体等欧洲國家及省份的监床经过多次实验发现经营许可资料，在亚洲中南部数据表格同步深入开展9项良性肿瘤免役综合中医辽法监床经过多次实验发现，广所重叠肝癌、食管癌、头颈鳞癌和食道癌等满足症，周到所重叠肝癌不错缓解。公布迄今为止，H药拟于我国的、土尔其、瑞典、格鲁吉亚等欧洲國家和省份累会计入组超2800人，这其中2项亚洲多学校监床经过多次实验发现入组高加索人种的比例图小于30%，是收获亚洲监床数据表格较多的抗PD-1单抗其一。H药综合手术缓解部位肺麟癌或转出性鳞状非小血组织生殖肿瘤细胞肝癌（sqNSCLC）和不错缓解广期小血组织生殖肿瘤细胞肝癌（ES-SCLC）的NDA已拿到NMPA审理划为选《2022 CSCO小血组织生殖肿瘤细胞肝癌口腔诊疗导则》对于ES-SCLC缓解推建。不仅，其缓解小血组织生殖肿瘤细胞肝癌（SCLC）也已拿到俄罗斯FDA流浪儿童药资格证书判定。有限集团亦规划于2030年在欧洲经济共同体撤签ES-SCLC的开卖登陆报名，可能当上亚洲中南部第一家不错缓解SCLC的抗PD-1单抗。在不错缓解食管鳞癌教育领域，H药综合手术III期钻研也已满足双主要是钻研起点站。

关于复宏汉霖

复宏汉霖（2696.HK）有的是家世界化的信息化技术性生态学技术药厂大公司的，极力于为各国病患带来可负荷的高品位效果生态学技术药，新软件盖住肺部肿瘤、企业自身免役疫情、眼科整形疫情等方向，已国内有什么时候主板什么时候上市5款新软件，在西方什么时候主板什么时候上市1款新软件，13项适用于症新批，1个什么时候主板什么时候上市大公司注册申请表拿到中华国家有放射性医疗药品监督工作局立案。自2015年组建来党，复宏汉霖已完成一身式化生态学技术药厂软件游戏平台，高效果及信息化技术性的服务性价值体系能力素质包括研究开发、产出及商业性市场运营全制造业链。大公司的已创立改善高效果的各国信息化技术性中间，明确世界放射性医疗药品产出效果工作国家标淮（GMP）标淮使用产出和效果严格监督，持续不断的筑牢一身式化整体产出软件游戏平台，中间，天津徐汇园区已拿到中华国家有和欧盟成员国放射性医疗药品GMP认可，松江园区（一）也已拿到中华国家有GMP认可。


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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