简体

简体

日本語

Française

Deutsch

Português

复宏汉霖汉斯状®成为首个且唯一在欧盟获批上市用于广泛期小细胞肺癌治疗的抗PD-1单抗

发布时间:2025-02-05 项目主要来出自： 浏览量：
主要内容来原：复宏汉霖


●

H药 汉斯状®是全球首个获批一线治疗ES-SCLC的抗PD-1单抗

●

H药 汉斯状®是首个且唯一在欧盟获批上市用于ES-SCLC治疗的抗PD-1单抗

●

H药 汉斯状®目前已在中国、欧洲和东南亚多个国家获批上市，惠及超过90,000位患者


2025年2月5日，复宏汉霖（2696.HK）宣布，抗PD-1单抗 H药 汉斯状®（斯鲁利单抗，欧洲商品名：Hetronifly®）正式获得欧盟委员会（European Commission, EC）批准，联合卡铂和依托泊苷用于广泛期小细胞肺癌（ES-SCLC）成人患者的一线治疗，标志着H药成为首个且唯一在欧盟获批上市用于广泛期小细胞肺癌治疗的抗PD-1单抗。



H药 汉斯状®是全球首个获批一线治疗小细胞肺癌的PD-1抑制剂。以临床需求为导向，复宏汉霖就H药进行了差异化、多维度布局，聚焦肺癌、消化道肿瘤等高发大癌种，在全球范围内累计入组逾4800名受试者。2023年，复宏汉霖与Intas达成合作，授权其H药在欧洲和印度共50多个国家的独家开发和商业化权益。本次获批覆盖欧盟全部27个成员国以及欧洲经济区国家挪威、冰岛和列支敦士登，该区域的商业化将由Intas子公司Accord负责。

复宏汉霖强制审理审理董事、顶尖强制审理官朱俊医学博士
H药在海外经济之间体新批什么时候上市，因素着复宏汉霖在劳有所得世界十大患有的速度中再进一部。相应提出申请不但进一部见证了我门在什么是创新药品开发与知名化设计上的技术领先效率，也为海外甚至世界十大丰富期小上皮细胞非小细胞肺癌患有面临了新的医疗但愿。以后，我门将依然以世界十大临床上使用需求为目标，与进行合作朋友与不断提高比较好的的治疗方法的可及性，之间为变患有生命值而努力的。

突破创新，聚焦未尽临床需求

肺癌是全球发病率和死亡率最高的癌症，据GLOBOCAN最新数据显示，2022年全球约有超过248万新发肺癌病例，占癌症新发病例的12.4%[1]。小细胞肺癌（SCLC）占肺癌总数的15%-20%，具有恶性程度高、转移早、疾病进展迅速等特点，预后极差。SCLC分为局限期和广泛期，其中约30%-40%的患者确诊时处于局限期，其余处于广泛期。欧盟SCLC的患者比例约为人口总数万分之一至五[2]。2022年12月，H药治疗SCLC获得EC授予的孤儿药资格认定，有助于H药用于治疗SCLC在欧盟研发、注册及商业化等方面享受一定的政策支持。2024年9月，欧洲药品管理局（EMA）人用药品委员会（CHMP）发布推荐Hetronifly®在欧盟获批上市积极意见。


本次H药获EC批准主要基于ASTRUM-005研究，ASTRUM-005研究是一项随机、双盲、安慰剂对照的国际多中心III期研究，旨在评估斯鲁利单抗联合化疗对比安慰剂联合化疗用于ES-SCLC一线治疗的疗效和安全性。该试验在中国、欧盟波兰、土耳其、格鲁吉亚等多个国家共开设128个试验中心，入组585例受试者，其中约31.5%为白人。ASTRUM-005临床试验结果于2022年美国临床肿瘤学会（ASCO）年会以口头报告方式首次发布，并于全球四大顶级医学期刊之一的《美国医学会杂志》（JAMA）发表，成为全球首个登上JAMA主刊的SCLC免疫治疗临床研究。基于ASTRUM-005研究，H药已陆续在中国、东南亚多国和欧盟获批用于一线治疗ES-SCLC，成为全球首个获批一线治疗小细胞肺癌的抗PD-1单抗。此外，公司正在美国开展一项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，以进一步支持H药在美国的上市申报。


全球布局，助力更多患者获益

复宏汉霖常期对车辆質量的按照严格耍求亦为之次H药获EC获批逐步形成最重要基础条件。202三年，H药一些产出现场和设施工作标准化菅理工作成功能够 欧共体GMP（Certificate of GMP Compliance of a Manufacturer）排查并兑换欧共体GMP资质证书，为H药平衡、优质化出售荷兰国家地区市场的出售有保障。厂家建设徐汇机地、松江机地（一）及松江机地（二）3个产出机地，总数商务化总产值已达48,000升，体现世界各国车辆常规化化出售，逐步涉及全国、荷兰国家地区、拉丁南美洲、西南亚北非、北美洲及西南亚。复宏汉霖之前保持一个适用國際質量规定的質量工作标准化菅理工作组织体制，涉及从好项目研发培训到原物料工作标准化菅理工作、车辆产出、質量操纵、车辆出售链工作标准化菅理工作或者车辆成功上市后监测的全人生生长期。之前，厂家商务化产出机地及整套搭配的質量工作标准化菅理工作组织体制已能够 全国国家地区食食品药品局、荷兰国家地区医疗耗材工作标准化菅理工作局（EMA）、澳大利亚食食食品药品局（FDA）、欧共体質量受权人（QP）或者厂家國際商务合伙同伴来进行的各项现地调查核实及审核，兑换全国、欧共体和澳大利亚GMP审核。


努力实现H药，复宏汉霖共谱环球金融业联合夥伴Accord、KGbio和银河集团官网 国药，全面性页面布局英国、欧洲各国及大部分大新國家餐饮市场，对外部品牌授权网络覆盖70多种國家和区域。回顾与展望十年后的中国，复宏汉霖将与联合夥伴密实警税，延续推广H药在多國家和区域的应用香港上市过程，为环球多爱美者保证更诸多的进行治疗选定。

【关联性文献资料】

[1] Bray F, Laversanne M, Sung H, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024;74(3):229-263. doi:10.3322/caac.21834

[2] Dingemans AC, Früh M, Ardizzoni A, et al. Small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up☆. Ann Oncol. 2021;32(7):839-853. doi:10.1016/j.annonc.2021.03.207

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，已在中国、欧盟以及多个东南亚国家获批上市。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，截至目前，H药已在中国获批用于治疗鳞状非小细胞肺癌（sqNSCLC）、广泛期小细胞肺癌（ES-SCLC）、食管鳞状细胞癌（ESCC）和非鳞状非小细胞肺癌（nsNSCLC）。H药治疗SCLC也已获得美国FDA和欧盟EC的孤儿药资格认定，并在美国积极推进一项H药对比一线标准治疗阿替利珠单抗的头对头桥接试验。


H药的4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）、Cancer Cell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。


关于复宏汉霖

复宏汉霖（2696.HK）是一个家國際化的全新动物药业有限集团有限工司集团有限工司，着力推进于为国内客户具备可负担过重的低品质效果动物药，食品包含癌症、自己的免役传染性常见疾病、皮肤科传染性常见疾病等业务领域，以有6款食品在国内 大陆地区内地获准开卖，4款食品在國際获准开卖，4个开卖申請各是获国内 内地食药监局、芬兰FDA和欧洲共同体国家EMA审批。自2015年注册的话，复宏汉霖已成立成集成一起化动物药业有限集团有限工司游戏工司，有效及全新的自主化重要效果贯彻创新技术、生產及商务在运营全领域链。集团有限工司已创立成熟有效的国内全新中间，可以依照國際医疗耗材生產效果处理实验室管理要求（GMP）要求对其进行生產和效果严格监督，快速夯实基层基础成集成一起化终合生產游戏工司，在这当中，集团有限工司商务化生產示范园区已接连兑换国内 内地、欧洲共同体国家和芬兰GMP资质认证。


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50多个分子，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。截至目前，公司已获批上市产品包括国内首个生物类似药汉利康®（利妥昔单抗）、自主研发的中美欧三地获批单抗生物类似药汉曲优®（曲妥珠单抗，美国商品名：HERCESSI™，欧洲商品名：Zercepac®）、汉达远®（阿达木单抗）、汉贝泰®（贝伐珠单抗）、全球首个获批一线治疗小细胞肺癌的抗PD-1单抗汉斯状®（斯鲁利单抗）以及汉奈佳®（奈拉替尼）。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。


Serplulimab Approved in the EU for First-Line Treatment of Extensive-Stage Small Cell Lung Cancer (ES-SCLC)

  • Serplulimab is the world’s first anti-PD-1 monoclonal antibody (mAb) approved for first-line treatment of ES-SCLC
  • Serplulimab is the first and only anti-PD-1 mAb approved in the European Union (EU) for the treatment of ES-SCLC
  • Serplulimab has now been approved in China, Europe, and several Southeast Asian countries, benefiting over 90,000 patients


Shanghai, China, Feb 5, 2025 — Shanghai Henlius Biotech, Inc. (2696.HK) announced that its anti-PD-1 mAb, HANSIZHUANG (serplulimab, marketed as Hetronifly® in Europe), has been officially approved by the European Commission (EC) for use in combination with carboplatin and etoposide as a first-line treatment of adult patients with ES-SCLC. This approval establishes serplulimab as the first and only anti-PD-1 mAb approved in the EU for the treatment of ES-SCLC.


Serplulimab is the world’s first anti-PD-1 mAb approved for first-line treatment of ES-SCLC. Underpinned by clinical needs, Henlius has carried out a differentiated and multi-dimensional layout of serplulimab in the fields of lung cancer and gastrointestinal cancer. To date, more than 4,800 subjects have been enrolled worldwide for clinical trials of serplulimab. In 2023, Henlius entered into a collaboration with Intas Pharmaceuticals, granting Intas exclusive rights to develop and commercialise serplulimab in over 50 countries across Europe and India. This latest approval covers all 27 EU member states as well as the European Economic Area countries, including Norway, Iceland, and Liechtenstein. Commercialisation in Europe will be led by Intas’ subsidiary, Accord Healthcare Ltd (“Accord”).


Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius, stated: “The approval of serplulimab in the EU represents another significant step forward in our mission to benefit patients worldwide. This milestone not only underscores our leadership in innovative drug development and global strategy, but also brings new hope to ES-SCLC patients in Europe and beyond. Moving forward, we will continue to collaborate with our partners to enhance the accessibility of advanced therapies and work together to make a meaningful difference in patients’ lives.”


Breakthrough Innovation to Address Unmet Clinical Needs

Lung cancer is the most common cancer worldwide in terms of incidence and mortality. According to GLOBOCAN 2022, there were over 2.48 million new cases of lung cancer globally in 2022, accounting for 12.4% of all new cancer cases.1 Small cell lung cancer (SCLC), which accounts for 15% to 20% of all lung cancers, is characterised by high malignancy, early metastasis, rapid progression, and poor prognosis. Among SCLC patients, approximately 30% to 40% are diagnosed at a limited stage, while the remaining cases are in extensive stage. In the EU, the prevalence of SCLC ranges from 1 to 5 per 10,000 people.2 In December 2022, serplulimab received orphan drug designation from the EC for the treatment of SCLC. The orphan-drug designation granted by the EC is beneficial for serplulimab to enjoy certain policy supports in the R&D, registration and commercialisation in the treatment of SCLC in the EU. In September 2024, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending Hetronifly® for approval in the EU.


The approval of serplulimab by the EC is primarily based on data from the ASTRUM-005 study, a randomized, double-blind, placebo-controlled international multi-centre Phase 3 study evaluating the efficacy and safety event profile of serplulimab in combination with chemotherapy versus placebo with chemotherapy as a first-line treatment for ES-SCLC. The study has set up a total of 128 sites across countries including China, Poland, Turkey, and Georgia, enrolling 585 subjects, of whom around 31.5% were Caucasians. Results from ASTRUM-005 were first presented orally at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting and later published in the Journal of the American Medical Association (JAMA), making it the first SCLC immunotherapy study to publish on JAMA. Based on ASTRUM-005, serplulimab has been approved in China, Southeast Asian countries, and the EU for the first-line treatment of ES-SCLC, establishing it as the world’s first anti-PD-1 mAb approved for the indication. Additionally, Henlius is conducting a head-to-head bridging trial in the U.S. comparing serplulimab with atezolizumab, the current standard of care, to further support its U.S. regulatory submission.


Global Expansion to Benefit More Patients

Henlius’ commitment to stringent quality standards has been instrumental in achieving EC approval for serplulimab. In 2023, Henlius’ manufacturing facilities and production lines of serplulimab successfully passed EU GMP inspections, ensuring a stable and high-quality supply of serplulimab for the European market. Henlius operates three facilities in Shanghai—Xuhui Facility, Songjiang First Plant, and Songjiang Second Plant—with a total commercial capacity of 48,000 litres, ensuring consistent global supply to regions including China, Europe, Latin America, the Middle East, North America, and Southeast Asia. The company has implemented a comprehensive quality management system in line with international standards, covering the entire product continuum ranging from R&D to material management, product manufacturing, quality control, product supply management and post-marketing surveillance. The company’s facilities and quality systems have been audited and certified by regulatory authorities including the National Medical Products Agency (NMPA), European Medicines Agency (EMA), United States Food and Drug Administration (FDA), and international business partners.


Henlius has established a robust global presence through partnerships with Accord, KGbio, and Fosun Pharma, extending its reach to over 70 countries and regions, including the U.S., Europe, Southeast Asia, and emerging markets. Looking ahead, Henlius will continue to work closely with its partners to expand the availability of serplulimab to more countries and regions, providing broader treatment options to patients worldwide.

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 and has been approved in China, the EU and several SEA countries. Focusing on lung and gastrointestinal cancer, the synergy of HANSIZHUANG with in-house products of the company and innovative therapies are being actively promoted. Up to date, HANSIZHUANG has been approved by the National Medicinal Products Administration (NMPA) for the treatment of squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma (ESCC) and non-squamous non-small cell lung cancer (nsNSCLC). Serplulimab was granted orphan drug designations by the 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.


The results of 4 pivotal trials of HANSIZHUANG were published in the Journal of the American Medical Association (JAMA), Nature Medicine, Cancer Cell and British Journal of Cancer, respectively. Furthermore, HANSIZHUANG was respectively 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 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.

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, 6 products have been launched in China, 4 have been approved for marketing in overseas markets, and 4 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 centre and Shanghai-based commercial manufacturing facilities certificated by China, the EU and U.S. GMP.


Henlius has pro-actively built a diversified and high-quality product pipeline covering over 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as the backbone. To date, the company's launched products include HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac® in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANDAYUAN (adalimumab), HANBEITAI (bevacizumab), HANSIZHUANG, the world’s first anti-PD-1 mAb for the first-line treatment of SCLC, and HANNAIJIA (neratinib). What’s more, Henlius has conducted over 30 clinical studies for 16 products, expanding its presence in major markets as well as emerging markets.



qq分享
上一条：太仓阿尔卑斯春节假期五日迎客近8万！ 下一条：节气·赏星｜二十四节气里的幸福“星”生活
关闭
x

抖音二维码

扫扫后