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：

的内容从何而来于：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。这也将是我国自行科研开发的抗PD-1单抗时需在肺腺癌领域以书面行驶评估行驶在ASCO大会开展回报，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。


一并，全球大家解放汽车军东部地区战区总卫生院秦淮医疗机构区秦叔逵老师和东莞尤品卫生院李进老师一致加强组织领导做的H药涉及微遥感卫星非常不比较稳定（MSI-H）线下实体化瘤的要点性注冊II期药学探索（ASTRUM-010）又一次当选ASCO公司，大数据更新换代将以海报素材状态表现。立于该试验检测数据，H药已劳动合同制应用于医疗MSI-H线下实体化瘤。



ASCO企业大会是淋巴肺部淋巴肿瘤控制邻域最猛要、最具的话语权的国际级联盟会议通知的一个，这一次展示台会眼下国际级联盟最领先的临床科学研究诊治淋巴肺部淋巴肿瘤学科技创新成效和淋巴肺部淋巴肿瘤控制高技术。当届企业大会将于法国东部时段6月3日-7日召开会议。这一次将展示台会的相应临床科学研究诊治科学研究属于：

• ASTRUM-005

职称论文考题：特色化型抗PD-1抵抗能力斯鲁利单抗联和放疗放疗化疗与单一的放疗放疗化疗在标杆调理诸多期小血细胞1.肺癌中的非常：一笔国际上、随机性Ⅲ期临床实验实验（结语编号规则：8505）

一般探究者：程颖，吉林市省癌症医院医生

展示出形式：书面形式数据

巡演：口头摘要专场/肺癌—非小细胞局部/小细胞/其他胸部肿瘤

申请书的时间：2022年6月5日，9:57 AM - 10:09 AM 美国中部夏令时

• ASTRUM-010

毕业论文小题目：的创新性产品抗PD-1免疫抗体斯鲁利单抗在经开发、不宜除去或变动性微小行星极高不维持或错配修补一些缺陷（MSI-H/dMMR）企业瘤患有中开发的Ⅱ期药学检测有效时间及平安性然而内容更新（绪论编码查询：2592）

聯合重点的研究：秦叔逵，中国现代市民释放军武汉八一专科门诊；李进，同济大学专业所属香江专科门诊

提供行式：海报设计

精力：2020年6月3日，USA的中部夏令时

• 实体瘤I期研究

职称论文一个题目：技术创当下人源化抗PD-1单克隆表面抗原斯鲁利单抗在肺癌晚期实体型瘤患病者中的某项Ⅰ期临床经过多次实验发现经过多次实验发现（英文论文顺序号：e14560）

分享的方式：前言


H药小细胞肺癌数据亮眼

国产创新药风采绽放

小生殖细胞核核非小细胞核核肺腺癌（SCLC）占非小细胞核核肺腺癌比例的15%-20%，是非小细胞核核肺腺癌中入侵性最差的亚型，划分为片面性期小生殖细胞核核非小细胞核核肺腺癌（LS-SCLC）和密切期小生殖细胞核核非小细胞核核肺腺癌，四者共同利益点是恶变能力高、转换早、皮肤疾病新况十分迅速，环境承载力生存率不当。抗体审核点可抑药品的出现了为ES-SCLC科技领域的医疗带给新也希望。


ASTRUM-005为一类在自始未提供过疗法的ES-SCLC女性中较H药皮下注射液联席手术（卡铂-整合泊苷）及安抚剂联席手术（卡铂-整合泊苷）的临床药理实验学习检验可以规范性和健康实用性的随时、双盲、國际多机构局、III期临床药理实验学习检验学习。该应力测试在国内现代、墨西哥、欧盟国家委员会意大利、格鲁吉亚等若干我国共设立125个应力测试机构局，这之中114个应力测试机构局有受试者通过了需求，共入组585例受试者，这之中约31.5%为高加索人。2022年13月，装修公司正式ASTRUM-005早已于中长期进行分析可达到关键学习起点总发展期（OS）。学习资料体现，H药联席手术在总体性用户和亚洲区域用户均可提升OS，体现出优质的治疗作用和健康实用性。多方面的國际临床药理实验学习检验应力测试资料也是有望支持软件H药在欧盟国家委员会、美利坚共和国等大众化法规标准整个市场的认定，为亚洲地区临床药理实验学习检验利用确定基础知识。


目前为止，我司H药真对于ES-SCLC的主板香港上市注册成功网站请求（NDA）已获欧洲国家中国药监局局审批，极可能成了世界十大第一个带兵人根治SCLC的抗PD-1单抗。H药结合肝癌晚期化疗近些年也被《2022 CSCO小血细胞肝癌口腔诊疗指导书》建议用于ES-SCLC带兵人中医疗法，是对H药药学入药价值及安全与否高性的超高教育部认证。除此以外，H入药于SCLC根治也于近些年收获新加坡FDA授给的孤寡药资质评定（Orphan-drug Designation），我司亦计划书于2030年在欧洲共同体撤签H药真对于ES-SCLC满足症的主板香港上市注册成功网站请求。


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的数据。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。

 

素，单位也将随时以病号供需为基本，要借助高效能及创新发展的自由基本水平将持续持续推进太多汉霖“质”造，为全国以至于全球排名病号出示最大好品质的用药和精准服务，建造怪物医药集团业务领域中华民族企业。


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。


明年10月，H药正式工应用用来医治方法微遥感卫星高宽比不稳定性（MSI-H）实物瘤。着眼于H药，复宏汉霖更好地有序推进其与新工司某些品牌的协同工作和与去创新物理医治方案的整合，纷纷得到 高度、新加坡、欧洲共同体等国及地段的临床药学药学护理上实验许证，在高度的数据同步深入推进9项肿癌免疫人体血细胞膜膜整合物理医治方案临床药学药学护理上实验，大范围合并面肝癌患者、食管癌、头颈鳞癌和直肠癌等不适应症，着力合并面肝癌患者一二线医治方法。截止日现，H药应于高度、土尔其、意大利、格鲁吉亚等国和地段累算入组超2800人，这里面2项各国多主临床药学药学护理上实验入组高加索人种的分配比例超过了30%，是收获各国临床药学药学护理上的数据较多的抗PD-1单抗中的一个。H药整合放疗肺癌晚期化疗医治方法身体局部早期或适当转移鳞状非小人体血细胞膜膜肝癌患者（sqNSCLC）和一二线医治方法大范围期小人体血细胞膜膜肝癌患者（ES-SCLC）的NDA已得到 NMPA结案归入选《2022 CSCO小人体血细胞膜膜肝癌患者医疗方案》有所作为ES-SCLC医治方法介绍。另外，其医治方法小人体血细胞膜膜肝癌患者（SCLC）也已得到 新加坡FDA弃婴药资本界定。新工司亦筹划于明年在欧洲共同体提出申批ES-SCLC的发售祖册申批，已成定局是高度首例一二线医治方法SCLC的抗PD-1单抗。在一二线医治方法食管鳞癌方向，H药整合放疗肺癌晚期化疗III期探索方案也已达到双常见探索方案终点起点。

关于复宏汉霖

复宏汉霖（2696.HK）就是一家知名化的企业持续不断创新性微生物工程学制药企业企业司，秉承于为欧州的人给予可财政负担的高高产品品质管理工作微生物工程学药，好物品履盖良性肿瘤、自己免疫系统急病、眼科整形急病等行业，已中国国家内地国大陆大退市5款好物品，在欧州退市1款好物品，13项适合症应用，8个退市祖册注册提升中国国家内地国大食药监局审理。自20十多年开设开始，复宏汉霖已成立 分离式化微生物工程学制药企业企业系统，极有效率及企业持续不断创新性的自主性基本意识深入研制开发、产生及商用总部运营全企业链。司已确立进一步完善极有效率的欧州企业持续不断创新性学校，，并按照知名药物产生产销售品品质管理工作管理工作规范了（GMP）规定实现产生和产品品质管理工作管理控制，持续不断做实分离式化综合管理产生系统，其中的，深圳徐汇产业带已提升中国国家内地国大和欧洲联盟药物GMP身份认正，松江产业带（一）也已提升中国国家内地国大GMP身份认正。


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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