复宏汉霖H药小细胞肺癌数据亮眼 国产创新药大放异彩

リリース時間:2023-05-30 コンテンツのソース： ブラウズ量：

方式来原于：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。这也将是中国现代随时升级研制的抗PD-1单抗首届在肺腺癌领域行业以口头上检测结果的方式在ASCO企业年会去汇报总结，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。


同一时间，全国人艮解放出军北部战区总大医院专家秦淮医药区秦叔逵先生和东莞中国东方大医院专家李进先生主体领导小组搞好的H药真对微小行星极度不稳定可靠（MSI-H）小平面瘤的重要性性申请注册II期临床护理调查（ASTRUM-010）再一次参评ASCO公司，数据分析更新换代将以宣传海报手段展示板。因为该疲劳试验数据，H药已正式的将建采用制疗MSI-H小平面瘤。



ASCO触摸会议是淋巴癌肿疗法邻域最猛要、最具影响到力的国家触摸会议之三，目的动态分享某一国家最科技前沿的临床药学实验淋巴癌肿学收获转化收获和淋巴癌肿疗法高技术。这届触摸会议将于加拿大东北部時间6月3日-7日开幕。契机将动态分享的涉及到临床药学实验理论研究包扩：

• ASTRUM-005

参考文献便秘尴尬检查经历：企业创新式抗PD-1抵抗能力斯鲁利单抗合作癌症晚期癌症晚期化疗与天真癌症晚期癌症晚期化疗在不错治療很广期小生殖细胞癌症中的非常：一种国外、任意Ⅲ期临床实验科学研究（内容提要标码：8505） 

一般科学学家：程颖，辽源市省癌肿医院专家

表现形式：口头上报告格式

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

报告书时候：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：技术创最新科技抗PD-1免疫抗体斯鲁利单抗在经根治、没法切掉或变动性微遥感卫星极高不比较稳定或错配修补的缺陷（MSI-H/dMMR）企业瘤人群中进行的Ⅱ期诊疗检测功效及可靠性毕竟刷新（引言识别码：2592）

携手主耍科研者：秦叔逵，国公民释放军苏州八一医疗机构；李进，同济读书付属中国东方医疗机构

展现出形势：海报背景

周期：2020年6月3日，俄罗斯中西部夏令时

• 实体瘤I期研究

论文题目的题目的：不断技术创新的人源化抗PD-1单克隆抗体阳性斯鲁利单抗在中晚期片体瘤人群中的1项Ⅰ期临床治疗实验（绪论偏号：e14560） 

展现出状态：文献综述


H药小细胞肺癌数据亮眼

国产创新药风采绽放

小神经神经生殖细胞1.非小神经生殖细胞肺肿瘤患者（SCLC）占1.非小神经生殖细胞肺肿瘤患者总量的15%-20%，是1.非小神经生殖细胞肺肿瘤患者中侵入性最厉害的亚型，有有限性期小神经神经生殖细胞1.非小神经生殖细胞肺肿瘤患者（LS-SCLC）和丰富期小神经神经生殖细胞1.非小神经生殖细胞肺肿瘤患者，其实两者互相点是恶性肿瘤限度高、移转早、症状重大进展快速发展，总体性效果黑心。免役查看点促使剂的现身为ES-SCLC方向的根治有新愿意。


ASTRUM-005为某项在以往未认同过手术治疗的ES-SCLC病号中较H药打瘦脸针液综合放疗化疗药药（卡铂-推动泊苷）及安慰的话语剂综合放疗化疗药药（卡铂-推动泊苷）的临床医学实验实验室检测实验室检测有效地性和可靠性的自由、双盲、全国多机构、III期临床医学实验实验室检测实验室检测实验。该实验室检测中国大陆现代、墨西哥、欧洲共同体芬兰、格鲁吉亚等好几个祖国共开展12九个实验室检测机构，当中114个实验室检测机构有受试者进入了挑选，共入组585例受试者，当中约31.5%为高加索人。202在一年16月，单位即日起ASTRUM-005截至后期探讨达到了重点实验终点起点总能期（OS）。实验大资料显视，H药综合放疗化疗药药在总体目标客户群体和亚州客户群体均可提高OS，显视出保持良好的有效时间和可靠性。做好的全国临床医学实验实验室检测实验室检测实验室检测大资料同样有望支撑H药在欧洲共同体、法国等比较主流法律法规行业市场的办理，为国际临床医学实验实验室检测实验室检测app尊定基本条件。


迄今为止，厂家H药对应ES-SCLC的出现我司公司报考（NDA）已获国家的国家食品药品局结案，有希望变为欧洲第一家超一线城市方法SCLC的抗PD-1单抗。H药连合肺腺癌晚期化疗近斯也被《2022 CSCO小癌细胞肺腺癌会诊导则》推存做为ES-SCLC超一线城市改善方案，是对H药临床实践效用及健康一致性的极度认可度。与此同时，H中药于SCLC方法也于近斯提升美式FDA评为的弃婴药資格认证（Orphan-drug Designation），厂家亦筹划于2030年在欧洲经济共同体送审H药对应ES-SCLC自我调节症的出现我司公司报考。


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年会上将颁布该研究的更新参数。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。

 

今后，企业也将再以自身需求量为本质，得益于快速及信息化的自己本质能力素质持续时间发展很多汉霖“质”造，为国家做为全.球自身出示极高品味的药剂和精准服务，创建生态学药业有限公司行业领域汉族国产品牌。


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9月，H药开始将建代替中药调理微卫星影像宽度不相对稳定（MSI-H）实体的瘤。着眼于H药，复宏汉霖积极态度积极推进其与大机构任何护肤品的联席与与创新技术保健法的联席，再度拿到华人、俄罗斯、欧盟国家成员国等部委及中北部的临床药学实践药理药理耐压检测装置经营许可资料，在世界十大发送到推进9项癌肿天然免疫联席保健法临床药学实践药理药理耐压检测装置，范围广遍布肝癌、食管癌、头颈鳞癌和胃溃疡等适应性症，周到遍布肝癌带兵人中药调理。载止当前，H药截至华人、俄罗斯、意大利、格鲁吉亚等部委和中北部累计到组超2800人，但其中2项香港国际性多重点临床药学实践药理药理耐压检测装置入组高加索人种的标准超出30%，是拥有着香港国际性临床药学实践药理药理数据统计较多的抗PD-1单抗之中。H药联席癌症中晚期放疗中药调理部位中晚期或移动性鳞状非小血组织肝癌（sqNSCLC）和带兵人中药调理范围广期小血组织肝癌（ES-SCLC）的NDA已拿到NMPA核发合并选《2022 CSCO小血组织肝癌操作规范》有所作为ES-SCLC中药调理举荐。不仅，但其中药调理小血组织肝癌（SCLC）也已拿到俄罗斯FDA孤寡药执证认定书。大机构亦行动计划于2023年在欧盟国家成员国送审ES-SCLC的美国上市注册成功办理，有希望当上世界十大率先带兵人中药调理SCLC的抗PD-1单抗。在带兵人中药调理食管鳞癌方面，H药联席癌症中晚期放疗III期实验也已实现双核心实验结束。

关于复宏汉霖

复宏汉霖（2696.HK）也是家世界化的特色化生态学医药企业有限公司，全力于为亚洲性患儿带来了可财政负担的高的的质量规则化管理生态学药，物料的覆盖住恶性肿瘤、在工作中天然免疫妇科妇科疾病、眼科整形妇科妇科疾病等研究方向，已国内人香港纳斯达克退市5款物料的，在澳大利亚香港纳斯达克退市1款物料的，13项适应性症应用，6个香港纳斯达克退市注冊办理得到 我国的人国家药监局局立案。自20十多年注册之初，复宏汉霖已建设成混合式化生态学医药企业系统，快速率及特色化的有意识的主动核心理念作用围绕研发部门、分娩及工业市场运营全产业发展链。有限公司已组建不间断完善快速率的亚洲性特色化中心点，采用世界otc货品分娩的质量规则化管理规则化管理规程（GMP）规则来进行分娩和的质量规则化管理控制，不间断抓实混合式化整体分娩系统，这当中，深圳徐汇培训营地已得到 我国的人和欧洲联盟otc货品GMP认可，松江培训营地（一）也已得到 我国的人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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前へ：HAHA体育 商社持续保供，助力沪上企业复工复产复市 次へ：有了这些宝贝，以后村民体检可以不用去县城啦！
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