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:2023-05-30 网站内容起源于： 浏览量：

主要内容起出自于：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。这也将是中国国家自主化研究开发的抗PD-1单抗第一回在1.肺癌层面以嘴上评估报告手段在ASCO企业年会对其进行汇报会，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。


时候，在我国人民群众改变军东北部战区总宠物三甲医院秦淮医疗保障区秦叔逵专家和天津中国宠物三甲医院李进专家统一领头做的H药涉及微卫星信号角度不固定（MSI-H）直营瘤的主要性注册会员II期临床护理理论研究（ASTRUM-010）其次选入ASCO公司年会，动态数据不断更新将以海报设计的方式展示板。因为该检验可是，H药已真正将建在方法MSI-H直营瘤。



ASCO公司是肉瘤缓解范围最重要要、最具后果力的新国际上电视电话会议之六，意在展现特定新国际上最学术前沿的监床医学肉瘤学科技创新优秀成果和肉瘤缓解技艺。当届公司将于法国中间时光6月3日-7日闭幕。这次将展现的相关联监床医学设计以及：

• ASTRUM-005

论文填空题填空题：特色化型抗PD-1抗原斯鲁利单抗综合手术与天真手术在闽东南改善密切期小肿瘤细胞1.肺癌中的会比较：一方面国际级、随意Ⅲ期临床治疗的研究（绪论识别码：8505）

最主要的的调查人员：程颖，辽源市省癌肿青岛博士整形医院医院

展现形式：口头上汇报

盛典：口头摘要专场/肺癌—非小细胞局部/小细胞/其他胸部肿瘤

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

• ASTRUM-010

文献题目的：革当下抗PD-1抵抗能力斯鲁利单抗在经制疗、必不可肿瘤切除或改变性微遥感卫星高不动态平衡或错配处理疵点（MSI-H/dMMR）线下瘤患病者中发展的Ⅱ期监床测试效果及平安性后果发布（结语代码：2592）

综合核心探析者：秦叔逵，我国的群众解放汽车军深圳八一医疗；李进，同济综合大学附加香江医疗

展示出的方式：宣传图

日子：明年6月3日，新西兰中间夏令时

• 实体瘤I期研究

开题报告题型：改革创最新科技人源化抗PD-1单克隆免疫抗体斯鲁利单抗在胆襄癌实体模型瘤女性中的下列Ⅰ期临床研究试验报告（文献综述识别码：e14560）

提供结构类型：内容提要


H药小细胞肺癌数据亮眼

国产创新药风采绽放

小細胞癌症（SCLC）占癌症统计数的15%-20%，是癌症中侵蚀性性最大的亚型，以分成片面期小細胞癌症（LS-SCLC）和宽泛期小細胞癌症，前者双方点是恶劣水平高、转回早、皮肤疾病近展尽快，总体布局继发性无良。免疫力捡查点治理和改善剂的造成为ES-SCLC领域的治疗方法创造新机会。


ASTRUM-005为一个在自始未使用过控制的ES-SCLC病员中更H药打瘦脸针液联动放疗放疗放疗（卡铂-依据泊苷）及开导剂联动放疗放疗放疗（卡铂-依据泊苷）的监床上护理医学高效性和安全级别高管理性的自由、双盲、香港国际级多大公司、III期监床上护理医学探讨。该冲击检验台在内地、土尔其、欧盟委员会发达国家意大利、格鲁吉亚等多家发达国家共增设124个冲击检验台大公司，里面的114个冲击检验台大公司有受试者操作了选择，共入组585例受试者，里面的约31.5%为高加索人。202在一年16月，大公司宣告ASTRUM-005已经和阶段理论探索达到主要探讨终站总我的世界生存期（OS）。探讨数据显示统计屏幕上展示，H药联动放疗放疗放疗在总体性患者和北美洲患者均可廷长OS，屏幕上展示出健康的药效和安全级别高管理性。加以的香港国际级监床上护理医学冲击检验台数据显示统计有着望搭载H药在欧盟委员会发达国家、芬兰等大众化相关法律法规行业的申请上报，为环球监床上护理医学应该用打下了基本。


现，集团工厂H药对于ES-SCLC的退市登记提交申请书（NDA）已获各国中国药监局局立案，有希望为全球各地第一个优质治療方法SCLC的抗PD-1单抗。H药联办放疗这段时间也被《2022 CSCO小神经细胞肺癌患者医疗机构规程》介绍作ES-SCLC优质治療法，是对H药临床实践成效及安全防护性的角度青睐。除此以外，H中药于SCLC治療方法也于这段时间领取芬兰FDA给予的流浪儿童药员证评估（Orphan-drug Designation），集团工厂亦年度计划于2020年在欧盟国家交上去H药对于ES-SCLC自我调节症的退市登记提交申请书。


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年会上将公布该研究的更新数剧。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，司也将马上以病人需要量为中心，借助更高效及的创新的自主性中心业务能力持继持续推进更加汉霖“质”造，为在我国以至于中国病人供应最高的人品性的制剂和服务性，构建怪物化工各个领域中国的民族品牌标志。


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5月，H药正式宣布应用代替诊治方法微通信卫星位置不稳定的（MSI-H）实体化瘤。需紧紧围绕H药，复宏汉霖充分进行其与公司的其他的產品的信息化各类与创新发展保健法的联办，依次刷出华人国、瑞典、欧洲共同体等我国及东北部的诊治实验诊治做实验的时候允许，在世界同时落实9项癌肿抗体联办保健法诊治实验诊治做实验的时候，多方面网络包含癌症、食管癌、头颈鳞癌和胃溃疡等适用于症，周全网络包含癌症第优质诊治方法。截止现在现在，H药在华人国、西班牙、意大利、格鲁吉亚等我国和东北部累算作组超2800人，在这当中2项各国多重心诊治实验诊治做实验的时候入组高加索人种的比列少于30%，是存在各国诊治实验诊治的数据较多的抗PD-1单抗组成。H药联办肿瘤放疗化疗诊治方法小面积的中晚期或转意性鳞状非小神经细胞核膜系癌症（sqNSCLC）和第优质诊治方法多方面期小神经细胞核膜系癌症（ES-SCLC）的NDA已刷出NMPA立案并到选《2022 CSCO小神经细胞核膜系癌症诊治须知》是ES-SCLC诊治方法强烈推荐。凡此种种，其诊治方法小神经细胞核膜系癌症（SCLC）也已刷出瑞典FDA弃儿药資格确定。公司的亦筹划于2023年在欧洲共同体送审ES-SCLC的退市注册的申请办理，即将被选为世界第一家第优质诊治方法SCLC的抗PD-1单抗。在第优质诊治方法食管鳞癌各个领域，H药联办肿瘤放疗化疗III期科学研发也已高达双通常科学研发始发站。

关于复宏汉霖

复宏汉霖（2696.HK）是家时代多元化的革新生态学化工我司，锐意科学去创新于为亚洲地区女性带来了可压力的高口感生态学药，商品复盖淋巴肿瘤、自己的免疫性病症状、皮肤科病症状等行业，已在国内 退市5款商品，在西方退市1款商品，13项自我调节症将建，多个退市注册网站办理可以提升了国内 货品监督处理局核发。自2012年开办至今，复宏汉霖已建设一起化生态学化工网上app平台，便捷及革新的有意识的主动核心区学习能力影响新产品研发、研发及商业运作处理全财产链。我司已建立联系落实便捷的亚洲地区革新重点，依照规定时代世界货品研发安全性能水平处理实验室管理规范（GMP）规范确定研发和安全性能水平安全控制，总是狠抓一起化综和研发网上app平台，当中，伤害徐汇机地已可以提升了国内 和欧洲经济共同体货品GMP身份资格认证，松江机地（一）也已可以提升了国内 GMP身份资格认证。


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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