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:2024-12-12 文章种类于： 浏览量：

方面来自：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。


我县获审理一般根据各项会比较H药共同手术（卡铂-培美曲塞）与手术（卡铂-培美曲塞）不错医疗癌症肝转移非鳞状非小组织癌症的人中的js随机数、双盲、多中心局III期临床实验论述。论述报告单展示，H药共同手术的对比手术同质性延长了了无进行我的世界生存期（PFS），到达预置的优效规则，且稳定性优秀，未洞察分析到新的稳定性无线信号。
用以复宏汉霖第一例综合性产品开发的去创复合型单抗，H药集中肺腺癌和助消化管肿癌等易发癌种，并在全世界进行10多项以H药为主导的免疫系统协同保健法药学探析，尤其是在肺腺癌控制区域，我司药学战略布局已稳步推进改革包裹肺腺癌二线控制。中间，面对ES-SCLC，复宏汉霖于2030年在英国开机好几回项H药相比二线规定控制阿替利珠单抗用以ES-SCLC的头对头桥接疲劳试验，以进步帮助H药在英国的美利坚销售办理，并，H药协同放疗放化疗二线控制ES-SCLC的美利坚销售申办也已刷快欧洲其他地方经济共同体委会会EMA结案，可能于202历经四年上半个月刷快审批权。前次，H药控制小人体神经细胞肺腺癌（SCLC）已先后刷快英国食材中药饮片远程监控方法局（FDA）和欧洲其他地方经济共同体委会会委会会（EC）的遗孤药资格证介定。在片面期小人体神经细胞肺腺癌（LS-SCLC）的方面， H药协同放疗放化疗导入放疗二线控制LS-SCLC的國際多服务中心III期药学探析也在及时稳步推进中，现今已达成中、英国、欧洲其他地方、英国等地方和地的首个人群给药。


发展，复宏汉霖将依然以糖尿病病员为管理的本质，一个劲增强创研性能，着力推进诞生更具的药学总价值，为中国现代乃至于各国糖尿病病员具备更大特色、可及、可负荷的软件和医治设计方案。

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）是一种家环球化的全新怪物制作产品单位的，专注于于为环球爱美者提高可承担的高的质怪物药，物品覆盖住恶性肿瘤、自己本身免疫细胞患病、皮肤科患病等领域行业，已在国开卖5款物品，在环球开卖1款物品，19项认知症新批，3个开卖申請各分为获我们NMPA、新西兰FDA和欧洲共同体EMA结案。自20十年成立单位十八大以来，复宏汉霖已建起合一化怪物制作产品工作软件，极有效率及全新的个性化价值体系的能力结合的生育加工研发、的生育加工及商业性的运营策划全高新产业结构。单位的已实现改进极有效率的环球全新管理方法中心，确定环球产品的生育加工质管理方法要求（GMP）标准化做好的生育加工和质监管，迅速夯实基础合一化总合的生育加工工作软件，中间，南京徐汇基底已拿到我们和欧洲共同体GMP证书，松江基底（一）也已拿到我们GMP证书。


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.

【参考选取学术论文】


[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] 《中华临床检验恶性肿瘤法学会（CSCO）非小受损细胞肺腺癌医疗指引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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