H药汉斯状®新适应症的上市注册申请获国家药品监督管理局受理

发布时间:2023-12-12 相关内容从何而来于： 浏览量：

东西来源于：复宏汉霖


2023年12月12日，复宏汉霖（2696.HK）宣布，公司自主研制的创新型抗PD-1单抗H药汉斯状®（通用名：斯鲁利单抗注射液）联合化疗一线治疗局部晚期或转移性非鳞状非小细胞肺癌（nsNSCLC）的上市注册申请（NDA）获得国家药品监督管理局（NMPA）受理。这是H药在中国获受理的第五项适应症，此前，H药已获批用于治疗微卫星高度不稳定（MSI-H）实体瘤、鳞状非小细胞肺癌（sqNSCLC）、广泛期小细胞肺癌（ES-SCLC）和食管鳞状细胞癌（ESCC）。


肺癌是全球死亡率最高的癌症，据世界卫生组织国际癌症研究机构（IARC）发布的最新数据显示，2020年全球癌症死亡人数达996万，其中肺癌死亡人数约180万，占比约18%。在中国，肺癌的发病率和死亡率均列首位，且发病率呈逐年上升趋势-1 。非小细胞肺癌（NSCLC）是肺癌最常见的组织学分型，约占肺癌患者的85%，其中又以非鳞状NSCLC的发病率最高[3]。在NSCLC的治疗中，以PD-1/PD-L1为代表的免疫检查点抑制剂（ICI）发展迅速，抗PD-1单抗联合化疗已被美国国立综合癌症网络（NCCN）和中国临床肿瘤学会（CSCO）等指南推荐为非鳞状NSCLC的一线标准治疗方案-1，H药针对该领域的治疗策略有望为患者提供更多治疗选择。


我局获审批主耍依据每一项较为H药合力手术（卡铂-培美曲塞）与手术（卡铂-培美曲塞）专业的诊治脑转移非鳞状非小组织肺肿瘤病人中的重复、双盲、多咨询中心III期临床药学探究。探究的结果彰显，H药合力手术比对手术有明显廷长了无新况存活期（PFS），提高设置的优效原则，且很安全系数系数好的，未观看到新的很安全系数系数电磁波。
算作复宏汉霖率先随时升级研制开发的创新性型单抗，H药聚交非小肿瘤细胞核1.肺肿瘤和消化酶道肺部肿瘤等易发癌种，并在全世界开展业务10多项以H药为监管处的天然免疫连合辽法临床实践根治学习学习，特别在非小肿瘤细胞核1.肺肿瘤诊治各个领域，厂家临床实践根治学习布局图已全方位涵盖非小肿瘤细胞核1.肺肿瘤二线诊治。在其中，对应ES-SCLC，复宏汉霖于2030年在意大利开启打了个项H药对照二线规范诊治阿替利珠单抗适用于ES-SCLC的头对头桥接试验检测，以进一点适用H药在意大利的退市鉴定，且，H药连合放疗药二线诊治ES-SCLC的退市申批也已得到欧式经济共同体国家区域EMA立案，一般于2028年上一年后得到审批权。当即，H药诊治小肿瘤细胞核非小肿瘤细胞核1.肺肿瘤（SCLC）已陆续的得到意大利食品类保健药品监控功能监管局（FDA）和欧式经济共同体国家区域理事会会（EC）的流浪儿童药基础鉴定。在优越性期小肿瘤细胞核非小肿瘤细胞核1.肺肿瘤（LS-SCLC）工作方面， H药连合放疗药导入放疗二线诊治LS-SCLC的全球多基地III期临床实践根治学习学习也在提高认识推行中，当今已搞定国内、意大利、欧式、英国等国家区域和区域的首个人给药。


以后，复宏汉霖将再继续以客户为主导，快速提拔创研技能，促使引起更具的临床诊治商业价值，为中国有做为环球客户带来了大多高质、可及、可额外负担的物品和诊治解决方案。

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），是全球首个获批一线治疗小细胞肺癌的抗PD-1单抗，目前已有4项适应症获批上市，2项适应症上市申请分别在中国和欧盟获受理，10余项临床试验同步在全球开展。 


2022年3月，H药正式获批上市，目前可用于治疗微卫星高度不稳定（MSI-H）实体瘤、鳞状非小细胞肺癌（sqNSCLC）、广泛期小细胞肺癌（ES-SCLC）及食管鳞状细胞癌（ESCC）。H药联合化疗一线治疗广泛期小细胞肺癌（ES-SCLC）的上市申请也已获得欧盟EMA受理。聚焦肺癌和消化道肿瘤，复宏汉霖积极推进H药与公司其他产品的协同以及与创新疗法的联合，相继获得中国、美国、欧盟等国家及地区的临床试验许可，在全球同步开展10余项肿瘤免疫联合疗法临床试验。截至目前，H药已于中国、美国、土耳其、波兰、格鲁吉亚等国家和地区累计入组超3600人，其中2项国际多中心临床试验入组白人的比例超过30%，是拥有国际临床数据较多的抗PD-1单抗之一。H药的3项关键性临床研究结果分别发表于知名期刊《美国医学会杂志》（JAMA）、《自然-医学》（Nature Medicine）和British Journal of Cancer。此外，H药还荣获《CSCO 小细胞肺癌诊疗指南》、《CSCO 非小细胞肺癌诊疗指南》、《CSCO 食管癌诊疗指南》、《CSCO 结直肠癌诊疗指南》、《CSCO 免疫检查点抑制剂临床应用指南》和《中国食管癌放射治疗指南》等多部权威指南推荐，为肿瘤临床诊疗提供重要参考。海外方面，H药治疗SCLC已获得美国FDA和欧盟EC的孤儿药资格认定，并在美国启动了一项H药对比一线标准治疗阿替利珠单抗用于ES-SCLC的头对头桥接试验。

关于复宏汉霖

复宏汉霖（2696.HK）也是家国际上联盟级化的什么是开发菌物医药化工大工司，专业专注于为世界上患儿能提供可额外负担的高的质理菌物药，商品合并肉瘤、自身业务天然免疫疫情、护眼疫情等区域，已在国新加坡市场销售5款商品，在国际上联盟级新加坡市场销售1款商品，19项认知症将建，3个新加坡市场销售使用分离获国NMPA、新加坡FDA和欧共体EMA业务办理。自20十五年注册成立之初，复宏汉霖已成立成集成分离式化菌物医药化工网上网上平台，便捷化及什么是开发的独立自主核心思想功能贯串开发、生孩子及工业推广全行业链。大工司已确立成熟的便捷化的世界上什么是开发主，假设按照国际上联盟级医疗药品生孩子质理工作服务质量管理制度标准（GMP）标准去生孩子和质理电脑监控，持续不断做实成集成分离式化网络综合生孩子网上网上平台，里面，上海市徐汇幼儿园已兑换国和欧共体GMPv审核，松江幼儿园（一）也已兑换国GMPv审核。


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®，澳大利亚商品名：Tuzucip®和Trastucip®）、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、鳞状非小细胞肺癌、广泛期小细胞肺癌和食管鳞状细胞癌，并成为全球首个获批一线治疗小细胞肺癌的抗PD-1单抗。公司亦同步就16个产品在全球范围内开展30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。


The NDA for New Indication of Henlius Anti-PD-1 mAb Serplulimab in Combination with Chemotherapy for the First-line Treatment of non-squamous NSCLC Accepted by the NMPA

Shanghai, China, Dec. 12th, 2023 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that the NDA for new indication of HANSIZHUANG, serplulimab, an innovative anti-PD-1 mAb independently developed by the company, in combination with chemotherapy as a first-line treatment for patients with locally advanced or metastatic non-squamous non-small cell lung cancer (nsNSCLC) has been accepted by the National Medical Products Administration (NMPA), which is the fifth indication for HANSIZHUANG accepted by the NMPA. To date, HANSIZHUANG has been approved for the treatment of microsatellite instability-high (MSI-H) solid tumors, squamous non-small cell lung cancer (sqNSCLC) , extensive-stage small cell lung cancer (ES-SCLC) and esophageal squamous cell carcinoma (ESCC).


Lung cancer is the cancer with the highest global mortality rate. According to the latest data released by the International Agency for Research on Cancer (IARC) of the World Health Organization, the number of cancer deaths worldwide in 2020 reached 9.96 million, of which approximately 1.8 million died from lung cancer, accounting for 18%. In China, the incidence rate and mortality of lung cancer rank first, and the incidence rate is increasing year by year -1. The non-small cell lung cancer (NSCLC) is the most common histological type of lung cancer, accounting for about 85% of lung cancer patients, among which nsNSCLC has the highest incidence rate [3]. In the treatment of NSCLC, immune checkpoint inhibitors (ICI), such as PD-1/PD-L1, have developed rapidly, notably, the anti-PD-1 mAb plus chemotherapy has been recommended by the latest NCCN guidelines and CSCO guidelines as the first-line treatment for nsNSCLC-1 , and serplulimab therefore is expected to bring a new option for patients.


The NDA for new indication of HANSIZHUANG is mainly based on a randomized, double-blind, multi-center phase 3 clinical study of HANSIZHUANG in combination with chemotherapy, or chemotherapy as a first-line treatment for patients with advanced non-squamous non-small cell lung cancer. The study results demonstrated that HANSIZHUANG in combination with chemotherapy significantly prolonged progression-free survival (PFS) compared with chemotherapy, which has met the pre-specified superiority criteria, with good safety and no detection of new safety signal.


HANSIZHUANG, Henlius’ first self-developed innovative monoclonal antibody, focuses on lung and gastrointestinal cancer and has initiated more than 10 clinical studies on immuno-oncology combination therapies worldwide. It covers the full range of first-line treatment of lung cancer, in which a head-to-head bridging trial of HANSIZHUANG versus first-line standard-of-care atezolizumab for ES-SCLC was launched in the U.S. in 2022, which is beneficial for its registration and commercialization in the U.S. In addition, the Marketing Authorization Application (MAA) for HANSIZHUANG on ES-SCLC has been validated by the European Medicines Agency (EMA), with approval expected in the first half of 2024. Previously, HANSIZHUANG was also granted orphan drug designations by the U.S. Food and Drug Administration (FDA) and European Commission (EC) for the treatment of SCLC. Furthermore, Henlius is steadily advancing a global phase 3 multi-center clinical research of HANSIZHUANG for the limited stage small cell lung cancer (LS-SCLC) and its first patients in China, the U.S., Europe, and Australia have been dosed, respectively. 


In the future, Henlius will continue to improve its innovation capabilities to meet patients’ needs and create greater clinical value, aiming to provide more accessible, affordable, and high-quality products and solutions to patients around the world.

【参考价值文献资料】


[1] Sung H,Ferlay J,Siegel RL,Laversanne M,SoerjomataramI,Jemal A,Bray F.Global cancer statistics 2020:GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries.CA Cancer J Clin.2021 Feb 4.

 [2] Cao W, Chen HD, Yu YW, Li N, Chen WQ.Changing profiles of cancer burden worldwide and in China: a secondary analysis of the global cancer statistics 2020. Chin Med J (Engl). 2021;134(7):783-791.

[3] Schabath MB, Cote ML. Cancer Progress and Priorities: Lung Cancer. CancerEpidemiol Biomarkers Prev. 2019 Oct;28(10):1563-1579. doi:10.1158/1055-9965.EPI-19-0221.

[4] 《中国国家临床治疗恶性肿瘤学习（CSCO）非小神经元肺肿瘤医疗服务须知2023》

[5] NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines® ) for Non-Small Cell Lung Cancer V.3.2023

About HANSIZHUANG

HANSIZHUANG (recombinant humanized anti-PD-1 monoclonal antibody injection, generic name: serplulimab injection) is the first anti-PD-1 mAb for the first-line treatment of SCLC. Up to date, 4 indications are approved for marketing in China, 2 marketing applications are under review in China and the EU, and more than 10 clinical trials are ongoing across the world.


HANSIZHUANG was launched in March 2022 and has been approved by the NMPA for the treatment of MSI-H solid tumours, squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC), and esophageal squamous cell carcinoma (ESCC). Its marketing application of the first-line treatment for ES-SCLC is under review by the EMA. Focusing on lung and gastrointestinal cancer, the synergy of HANSIZHUANG with in-house products of the company and innovative therapies are being actively promoted. It has successively obtained clinical trial approvals in China, the U.S., the EU and other countries and regions to initiate more than 10 clinical trials on immuno-oncology combination therapies in a wide variety of indications. As of now, the company has enrolled more than 3,600 subjects in China, the U.S., Turkey, Poland, Georgia and other countries and regions, and the proportion of White is over 30% in two MRCTs, making HANSIZHUANG an anti-PD-1 mAb with one of the largest global clinical data pools. The results of 3 pivotal trials of HANSIZHUANG were published in the Journal of the American Medical Association (JAMA), Nature Medicine and the British Journal of Cancer, respectively. Furthermore, HANSIZHUANG was recommended by the CSCO Guidelines for Small Cell Lung Cancer, the CSCO Guidelines for Non-Small Cell Lung Cancer, the CSCO Guidelines for Esophageal Cancer, the CSCO Guidelines for Colorectal Cancer, the CSCO Clinical Practice Guidelines on Immune Checkpoint Inhibitor, the China Guidelines for Radiotherapy of Esophageal Cancer, and other definitive guides, providing valuable references for clinical diagnosis and treatment of tumours. On the other hand, serplulimab was granted orphan drug designations by the U.S. FDA and the EC for the treatment of SCLC, and its bridging head-to-head trial in the United States to compare HANSIZHUANG to standard of care atezolizumab (anti-PD-L1 mAb) for the first-line treatment of ES-SCLC is well under way.

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 has been approved for marketing in overseas markets, 19 indications are approved worldwide, and 3 marketing applications have been accepted for review in China, the U.S., and the EU, respectively. 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 for injection, trade name in Europe: Zercepac®; trade names in Australia: Tuzucip® and Trastucip®), 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, squamous non-small cell lung cancer (sqNSCLC) and extensive-stage small cell lung cancer (ES-SCLC), and esophageal squamous cell carcinoma (ESCC), making it the world's first anti-PD-1 mAb for the first-line treatment of SCLC. What's more, Henlius has conducted over 30 clinical studies for 16 products, expanding its presence in major markets as well as emerging markets. 







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