复宏汉霖H药小细胞肺癌数据亮眼 国产创新药大放异彩

Heure de publication:2022-05-30 Le contenu provient de： Nombre de vues：

玩法原因于：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经营生产制造的抗PD-1单抗第一回在肺癌患者领域以书面模式报告范文模式在ASCO会议采取回报，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。


时候，国内 公民解放汽车军北部战区总医疗管理秦淮医疗管理区秦叔逵传授和济南经典医疗管理李进传授相互带头做好的H药专门针对微卫星信号高不维持（MSI-H）片体模型瘤的关键因素性注册申请II期药学探讨（ASTRUM-010）继续参评ASCO公司年会，数据显示内容更新将以海报设计行式分享。来源于该校正成果，H药已官方获准适用开展MSI-H片体模型瘤。



ASCO工作会是肿癌开展范围偏重要、最具会作用的香港国际上工作会组成，致力于风采分享当前状况香港国际上最前列的临床实验药理肿癌学科技创新收获和肿癌开展技艺。今届工作会将于欧美的中部日期6月3日-7日举办。旨在将风采分享的一些临床实验药理钻研属于：

• ASTRUM-005

开题报告填空题：革新式抗PD-1免疫抗体斯鲁利单抗综合放放化疗与只是单纯放放化疗在一丝诊治常见期小肿瘤细胞1.肺癌中的更加：一个国际联盟、js随机数Ⅲ期临床护理研究探讨（提要代号：8505）

主要钻研者：程颖，白山市省恶性肿瘤医疗机构

动态展示形式：口头协议上报

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

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

• ASTRUM-010

毕业论文标题：自主创新技术抗PD-1抗体阳性斯鲁利单抗在经治愈、不易切去或转回性微北斗卫星极高不安全管理稳定或错配消除的缺陷（MSI-H/dMMR）实体型瘤病员中抓好的Ⅱ期诊疗试验检测药用价值及安全管理性效果版本更新（英文论文编码查询：2592）

连合主要是研发者：秦叔逵，中国国家老百姓解放出军北京八一的医院医生；李进，同济高校加盟天成的医院医生

表现样式：广告图

精力：2030年6月3日，国外的中部夏令时

• 实体瘤I期研究

文献综述填空题：科技创新技术人源化抗PD-1单克隆抗体阳性斯鲁利单抗在脑转移实体化瘤病患者中的问题Ⅰ期诊疗试验检测（英文论文偏号：e14560）

提供结构：提要


H药小细胞肺癌数据亮眼

国产创新药风采绽放

小肿瘤肿瘤细胞核1.癌症（SCLC）占1.癌症占比的15%-20%，是1.癌症中侵扰性最废的亚型，主要包括局限于期小肿瘤肿瘤细胞核1.癌症（LS-SCLC）和诸多期小肿瘤肿瘤细胞核1.癌症，同一律之间点是恶意程度上高、转意早、消化道疾病最新动态及时，环境承载力生存率黑心。免疫抗体检杳点调节剂的冒出为ES-SCLC范畴的方法造成 新愿意。


ASTRUM-005为每一项在既往不咎未提供过手术治疗的ES-SCLC病人中更H药肌内注射液合作放放手术（卡铂-推动泊苷）及安慰的话语剂合作放放手术（卡铂-推动泊苷）的监床检测更合理性和很安全稳定可靠性的个数、双盲、国际多重心局、III期监床检测探究。该检测国内大、俄罗斯、欧共体意大利、格鲁吉亚等很多发达国家共开展业务126个检测重心局，这这之中114个检测重心局有受试者进行了需求，共入组585例受试者，这这之中约31.5%为高加索人。2022年16月，司敲定ASTRUM-005截至前中期解析到达一般探究终点起点总我的世界生存期（OS）。探究动态数据源彰显，H药合作放放手术在综合客群和亚太地区客群均可减少OS，彰显出稳定的的疗效和很安全稳定可靠性。充分地的国际监床检测检测动态数据源总有望适用H药在欧共体、意大利等时代趋势相关法律法规股票市场的认定，为国际监床检测用途确定基本。


近年来，工司H药重视ES-SCLC的什么时候推出注冊帐号申报办理（NDA）已获的国家食药监局结案，极可能将成为世界率先二线缓解SCLC的抗PD-1单抗。H药协力手术近两天也被《2022 CSCO小神经细胞癌症口腔诊疗指导书》安利最为ES-SCLC二线控制法，是对H药监床的作用及安全防护性的长度认可的。除此以外，H中药于SCLC缓解也于近两天收获俄罗斯FDA授于的弃儿药员证确认（Orphan-drug Designation），工司亦计划表于2020年在欧洲共同体审核H药重视ES-SCLC应用症的什么时候推出注冊帐号申报办理。


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年会上将入选该研究的更新数据报告。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。

 

未来是什么，有限公司也将一直以病患儿诉求为价值体系，单凭效率及全新的安全服务性价值体系的能力定期发展更好汉霖“质”造，为中国大以至于国内病患儿作为比较高品质保证的用量和安全服务，做大做强生物体医药化工区域民族特点茶叶品牌。


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。


2023年1月，H药真正新批应用在制疗方式微小行星高强度不稳定可靠（MSI-H）实体的瘤。以H药，复宏汉霖积极向上推进项目建设其与新单位的服务的一体化或与创新发展制疗方式的聯合，前不久赢得中华、欧美、欧洲经济共同体等我们及区县的医用实验设计批准，在世界十大导入搞好9项癌肿免疫检测聯合制疗方式医用实验设计，宽泛盖住肺肿瘤、食管癌、头颈鳞癌和直肠癌等融入症，切实盖住肺肿瘤带兵人制疗方式。公布现阶段，H药截至中华、墨西哥、匈牙利、格鲁吉亚等我们和区县累算组超2800人，这之中2项展览性多核心医用实验设算组高加索人种的此例高出30%，是享有展览性医用的数据较多的抗PD-1单抗中之一。H药聯合手术制疗方式位置肝癌患者肝转入或转入性鳞状非小内部肺肿瘤（sqNSCLC）和带兵人制疗方式宽泛期小内部肺肿瘤（ES-SCLC）的NDA已赢得NMPA核发划入选《2022 CSCO小内部肺肿瘤医用要点》对于ES-SCLC制疗方式分享。虽然，其制疗方式小内部肺肿瘤（SCLC）也已赢得欧美FDA孤寡药机会界定。新单位亦计划方案于2023年在欧洲经济共同体审核ES-SCLC的推出注册公司申請，现已加入世界十大第一例带兵人制疗方式SCLC的抗PD-1单抗。在带兵人制疗方式食管鳞癌这个领域，H药聯合手术III期学习也已达到了双主要是学习起点终点。

关于复宏汉霖

复宏汉霖（2696.HK）是一个家国.际化的特色化菌物制药厂业集团子公司，锐意信息化于为国各地病患作为可额外的负担的高茶叶品质菌物药，货品遮盖癌症、自己免疫系统常见慢性病、眼科整形常见慢性病等域，已华人市场有香港挂牌开卖5款货品，在荷兰香港挂牌开卖1款货品，13项不适应症新批，5个香港挂牌开卖报名申请注册领取华人有非处方药监督管理系统局立案。自20五年开设近些年，复宏汉霖已建设完工分离式化菌物制药厂业网络电商平台，高效果能及特色化的自动目标技能环绕研制、产量及餐饮业运营管理系统全制造业链。集团子公司已形成全面高效果能的国各地特色化服务中心，决定国.际非处方药产量效果管理系统规则（GMP）标实行产量和效果安全控制，总是狠抓分离式化综合评估产量网络电商平台，表中，北京徐汇基础已领取华人有和欧共体非处方药GMP实名认证服务，松江基础（一）也已领取华人有GMP实名认证服务。


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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