广泛期小细胞肺癌是一种高度侵袭性的恶性肿瘤，每年在英格兰和威尔士约有4,500例新发病例，其发病人数与卵巢癌、胃癌和肝癌相当1-6。
小细胞肺癌约占英国每年新发肺癌病例的15%，是预后最差的肺癌亚型之一；在自然病程下，患者中位总生存期仅约2–4个月1,3。
基于ASTRUM-005研究，超过五分之一的患者在接受斯鲁利单抗治疗四年后仍然存活7。
Accord Healthcare英国(以下简称“Accord”)与复宏汉霖（HK2696）近日宣布，H药汉斯状(斯鲁利单抗，欧洲商品名：Hetronifly)已获英国国家卫生与临床优化研究所(NICE)推荐正式纳入英格兰和威尔士国家医疗服务（881175）体系(NHS)常规临床使用范围。
随着NICE推荐正式落地及NHS挂网的完成，H药成为首个获得NICE批准、可在英格兰和威尔士用于ES-SCLC治疗的抗PD-1单抗8。临床研究数据显示，与安慰剂组相比，斯鲁利单抗治疗组的中位总生存期(OS)达到15.8个月，而安慰剂组为11.1个月；约22%的患者在接受治疗的四年内仍然存活7,9。
英格兰和威尔士每年约有4,500人被诊断为ES-SCLC13。小细胞肺癌约占所有肺癌病例的15%，其中约三分之二的患者在确诊时已处于广泛期1。该疾病的五年死亡率超过90%，在接受化疗治疗的情况下，大多数患者确诊后的生存期仍不足一年。因此，即便是生存期的小幅延长，对于患者及其家属而言也具有重要意义10,11。
英国Roy Castle肺癌基金会首席执行官Paula Chadwick表示：“这一批准对于广泛期小细胞肺癌患者及其家属而言，是一项重要且期待已久的突破。数十年来，小细胞肺癌治疗领域的进展远远落后于非小细胞肺癌。如今，非小细胞肺癌患者已经能够从越来越多的靶向治疗和免疫治疗中获益；相比之下，小细胞肺癌患者长期面临治疗选择有限、预后极差的困境。小细胞肺癌具有高度侵袭性且疾病进展迅速。因此，新治疗方案为患者带来的每一个额外生存月份、每一个重要里程碑，以及每一段宝贵时光，都具有非凡意义。对于受这一疾病影响的患者家庭而言，这些时间是真正无价的。”
斯鲁利单抗是一种免疫治疗药物，通过帮助人体自身免疫系统识别并攻击癌细胞发挥作用12。该药物此前已获得英国药品和医疗保健产品监管局(MHRA)批准，成为英国首个获批用于ES-SCLC治疗的抗PD-1单抗13。
英国朴茨茅斯大学医院（884301）NHS基金会信托肺癌及泌尿系统肿瘤专家Giuseppe Banna医生表示：“即使在当前标准治疗方案下，英格兰和威尔士广泛期小细胞肺癌患者的中位生存期仍仅约12个月，且大多数患者会在短时间内复发。NICE推荐斯鲁利单抗进入NHS报销体系，标志着我们在拓展这一极具挑战性疾病患者治疗选择方面迈出了重要一步。我非常感谢NICE让符合条件的患者有机会获得这一治疗选择。尽管广泛期小细胞肺癌仍将是临床治疗领域面临的一项重大挑战，但这一决定创造了新的可能性，使我们能够通过NHS为患者提供新的免疫治疗方案。”
NICE的推荐主要基于全球III期临床研究ASTRUM-005的积极结果。斯鲁利单抗的安全性特征与既往研究结果一致，最常见的3级及以上不良事件包括中性粒细胞减少(65.3%)、白细胞减少(33.7%)、血小板减少(23.1%)、贫血(19.8%)、低钠血症(10.0%)和淋巴细胞减少(5.1%)14。
复宏汉霖国际市场首席商务官
Darius Panaligan表示
“
复宏汉霖（HK2696）致力于将创新免疫治疗带给全球患者，H药获NICE的推荐正式纳入英国NHS报销体系便是对这一坚定承诺的有力印证。我们很高兴能够携手Accord，推动H药纳入NHS体系。未来，我们将继续支持符合条件的患者及时获得这一创新疗法，使更多患者从中获益。
”
Accord Healthcare首席执行官
Paul Tredwell表示
“
在Accord Healthcare，我们始终致力于支持肺癌患者。H药已被证明能够改善小细胞肺癌患者的生存获益，其获NICE的推荐意味着，英格兰和威尔士的广泛期小细胞肺癌患者将有机会接受这一药物的治疗。我们将继续与NHS及肿瘤学界紧密合作，确保所有可能从该治疗中获益的患者能够尽快获得治疗机会。
”
关于斯鲁利单抗
斯鲁利单抗是一种抗PD-1单克隆抗体，通过阻断免疫细胞表面的PD-1受体，激活机体免疫系统识别并攻击肺癌细胞12。该药物已获得英国药品和医疗保健产品监管局(MHRA)批准，成为英国首个用于广泛期小细胞肺癌(ES-SCLC)治疗的抗PD-1单抗13。此外，在欧洲肿瘤内科学会(ESMO)临床获益量表(Magnitude（MAGH） of Clinical Benefit Scale,MCBS)评估中，斯鲁利单抗在ES-SCLC适应症上获得了4分(满分5分)的较高评分15。
关于ASTRUM-005研究
在ASTRUM-005研究中，斯鲁利单抗联合化疗相比单纯化疗显著延长了广泛期小细胞肺癌(ES-SCLC)患者的总生存期(OS)。研究结果显示，斯鲁利单抗联合化疗组的中位总生存期达到15.8个月，而安慰剂联合化疗组为11.1个月；超过20%的患者在接受治疗4年后仍然存活7,9。
斯鲁利单抗的安全性特征与既往研究结果一致。最常见的3级及以上不良事件包括中性粒细胞减少(65.3%)、白细胞减少(33.7%)、血小板减少(23.1%)、贫血(19.8%)、低钠血症(10.0%)和淋巴细胞减少(5.1%)14。
关于肺癌
肺癌是全球发病率和死亡率均位居前列的恶性肿瘤。根据GLOBOCAN2022数据，2022年全球新发肺癌病例超过248万例，占所有新发癌症病例的12.4%16。
小细胞肺癌(SCLC)约占全部肺癌病例的15%至20%，是一种高度侵袭性的肺癌亚型，具有恶性程度高、进展迅速、易发生早期转移及预后较差等特点。约30%至40%的患者在确诊时处于局限期，其余大多数患者在确诊时已进展至广泛期1,17。
在欧洲，小细胞肺癌的患病率约为每万人1至5例11。
复宏汉霖（HK2696）(2696.HK)是一家国际化创新生物制药企业，致力于为全球患者提供高品质、可负担的生物药，产品覆盖肿瘤、自身免疫疾病、眼科疾病等领域。自2010年成立以来，公司已构建涵盖全球研发、临床、注册、生产及商业化的全产业链平台，拥有全球员工近4,000人，并在中国、美国和日本等多地设有运营及分支机构。依托生物类似药形成的稳健现金流反哺创新研发，复宏汉霖（HK2696）正稳步迈入“全球化2.0”阶段，持续打造可复制、可持续的全球增长模式。截至目前，公司共有10款产品在全球60余个国家和地区获批上市，其中8款已在中国获批。在欧美主流生物药市场，复宏汉霖（HK2696）亦取得多项里程碑式突破，已有4款产品获得美国FDA批准、5款产品获得欧盟EC批准，充分体现了公司在研发体系、质量管理及生产能力方面已全面对标国际最高标准。
在创新驱动方面，复宏汉霖（HK2696）依托上海、美国等多地协同布局的研发体系，构建了多元化、平台化的创新技术矩阵，覆盖免疫检查点抑制剂、免疫细胞衔接器(包括多特异性TCE)、抗体偶联药物(ADC)以及AI驱动的早期研发平台等前沿方向。目前，公司拥有50余项处于早期阶段的创新资产，其中约70%具备同类最佳(Best-in-Class)潜力，并在全球同步推进30余项临床研究。核心产品H药汉斯状(斯鲁利单抗，欧洲商品名：Hetronifly)作为全球首个获批一线治疗小细胞肺癌和首个获批胃癌围术期适应症的抗PD-1单抗，正加速全球布局，已在全球50个市场获批上市；同时，多款潜力创新资产，包括PD-L1ADC HLX43及新表位HER2单抗HLX22(通用名：dulpatatug)正全面推进全球关键性临床研究。依托通过中、欧、美三地GMP认证的生产体系，复宏汉霖（HK2696）已建成总产能达84,000升的生物药生产平台，形成覆盖全球六大洲的稳定供应网络。未来，复宏汉霖（HK2696）将始终坚持以患者为中心，聚焦未满足的临床需求，持续推动创新成果向临床价值与患者可及转化，在全球生物医药创新生态中创造长期而稳健的价值。
关于Accord Healthcare Accord Healthcare总部位于英国，是欧洲发展最快的制药公司之一。Accord拥有欧洲仿制药和生物类似药公司中最大的市场份额之一，其仿制药销往全球80多个国家。凭借这一全球布局，Accord能够为各国医疗卫生系统提供至关重要且价格合理的药品，从而支持医疗专业人士改善全球患者的治疗结局。
Accord秉持灵活创新的策略以及突破常规的思维模式，始终致力于改进产品并提升患者的可及性，力求为全球患者带来更多福祉。
肿瘤领域是Accord长期深耕的重点治疗领域之一。目前，公司拥有54款肿瘤相关产品，并布局了丰富的在研管线，未来五年内预计将有多个产品进入监管审评阶段。作为欧洲最大的化疗药物供应商之一，欧洲市场每三支肿瘤注射制剂中，就有一支来自Accord。公司重点关注乳腺癌、前列腺癌等高发肿瘤，同时覆盖血液肿瘤及肿瘤支持治疗等领域。
与此同时，Accord正持续加大对未来肿瘤治疗创新的投入。目前，公司正在英国建设全新的研发中心，重点聚焦生物制品（881142）和疫苗研发，进一步提升创新能力，以更好地满足患者在癌症治疗全周期（883436）中的多元化需求。
HETRONIFLY (SERPLULIMAB)FORMALLY ENTERS ROUTINE USE IN THE NHS FOLLOWING NICE RECOMMENDATION,BECOMING THE First（FFBC） ANTI-PD-1IMMUNOTHERAPY FOR EXTENSIVE-STAGE SMALL CELL LUNG CANCER IN ENGLAND and WALES
. Extensive-stage small cell lung cancer(ES-SCLC)is a highly aggressive type of cancer with4,500new cases each year in England and Wales,almost equivalent to the incidence of ovarian,stomach and liver cancers.1-6
. Small cell lung cancer cases represent approximately15%of UK lung cancer diagnoses each year with one of the worst prognoses,an average median overall survival of only2-4months in the natural course.1,3
. Over one in five patients treated with serplulimab in the ASTRUM-005study were alive at four years.7
Accord Healthcare UK(Accord)and Shanghai Henlius Biotech,Inc.(2696.HK)recently announced that HETRONIFLY(serplulimab)has been recommended by the National Institute for Health and Care Excellence(NICE)for routine use within the national health（NHI） Service（SCI）(NHS)in England and Wales.According to publicly available UK pricing information,serplulimab has now been listed on the NHS.
With NICE’s recommendation now implemented and the product listed on the NHS,serplulimab has become the First（FFBC） anti-PD-1monoclonal antibody recommended by NICE and available through the NHS in England and Wales for the treatment of ES-SCLC,8supported by clinical trial data demonstrating a median overall survival of15.8months versus11.1months for placebo,with approximately22%of patients still alive four years after starting treatment.7,9
Every year,around4,500People（PPLI） in England and Wales are diagnosed with ES-SCLC.1,2,3Small-cell lung cancer accounts for approximately15%of all lung cancer cases,with two-thirds of People（PPLI） receiving a diagnosis once it has reached an extensive stage.1With a five-year mortality rate above90%and most patients living less than a year after diagnosis with chemotherapy,even small extensions in survival could be meaningful to those affected and their loved ones.10,11
“This approval represents an important and long-overdue breakthrough for People（PPLI） living with extensive-stage small cell lung cancer and the families who support them,”said Paula Chadwick,Chief Executive of Roy Castle Lung Cancer Foundation.
“For decades,progress in treating small cell lung cancer has lagged far behind the advances seen in non-small cell lung cancer,where patients now benefit from a growing range of targeted and immunotherapy treatments.By contrast,People（PPLI） diagnosed with small cell lung cancer have faced limited options and devastating outcomes for far too long.”
“This aggressive disease progresses rapidly.That is why every additional month,every Milestone（MIST） and every precious moment gained through new treatment options matters so deeply.For families affected by this disease,that time is truly priceless.”
Serplulimab is a type of immunotherapy that helps the body’s own immune system recognise and attack cancer cells.12The treatment became the First（FFBC） anti-PD-1iNHIbitor in the United Kingdom approved by the Medicines and Healthcare products Regulatory Agency(MHRA)for those living with ES-SCLC.13
“Even with current standards of care,median survival for extensive-stage small cell lung cancer in England and Wales is approximately12months,with the majority of patients relapsing rapidly.The decision from NICE to recommend serplulimab is a step forward in expanding potential treatment options for patients facing this challenging cancer,”said Dr Giuseppe Banna,Consultant Medical Oncologist for Lung and Urology Tumours,Department of Oncology of Portsmouth Hospitals University NHS Trust.
“I am grateful to NICE for enabling eligible patients to have the option of accessing this treatment.Whilst extensive-stage small cell lung cancer will remain a difficult prospect for the clinical community to manage,this decision creates new possibilities and will allow us to provide patients with another immunotherapy through the NHS.”
The decision was supported by positive data from the global phase3ASTRUM-005clinical study.The safety profile of serplulimab was consistent with previous studies,with most common grade3adverse events including neutropenia(65.3%),leukopenia(33.7%),thrombocytopenia(23.1%),anaemia(19.8%),hyponatraemia(10%)and lymphopenia(5.1%).14"The inclusion of HETRONIFLY in the NHS following NICE recommendation is a strong validation of Henlius"commitment to bringing Innovative（IIPR） immunotherapies to patients worldwide.We are proud to partner with Accord to make HETRONIFLY available to the NHS,"added Darius Panaligan,Chief Commercial Officer,International（IGIC） Markets of Henlius."Our focus now is supporting timely access for eligible patients who can benefit from this treatment."
“At Accord Healthcare,we’re absolutely committed to supporting People（PPLI） living with lung cancer,”added Paul Tredwell,CEO of Accord Healthcare.“This recommendation means ES-SCLC patients will potentially have access to a treatment that has been shown to improve survival.”
“We will continue working with the NHS and oncology community to make sure those who could benefit from this treatment are able to access it as quickly as possible.”
About serplulimab Serplulimab is an anti-PD-1monoclonal antibody which is effective by blocking the PD-1receptor on immune cells which guides the immune system to identify and attack lung cancer cells.12The treatment became the UK’s First（FFBC） anti-PD-1iNHIbitor for those living with ES-SCLC to be approved by the Medicines and Healthcare products Regulatory Agency(MHRA).13The European Society of Medical Oncology(ESMO)assigned the treatment a score of four out of five in its Magnitude（MAGH） of Clinical Benefit Scale in ES-SCLC.15
About ASTRUM-005
In the study,serplulimab,in combination with chemotherapy,demonstrated significantly longer overall survival(OS)when compared with chemotherapy alone,with median OS of15.8months versus11.1months with placebo,with over20%of patients alive at4years.7,9
The safety profile of serplulimab was consistent with previous studies,with most common grade3adverse events including neutropenia(65.3%),leukopenia(33.7%),thrombocytopenia(23.1%),anaemia(19.8%),hyponatraemia(10%)and lymphopenia(5.1%).14
About Lung Cancer Lung cancer is the most common cancer worldwide in terms of incidence and mortality.According to GLOBOCAN2022,there were over2.48million new cases of lung cancer globally in2022,accounting for12.4%of all new cancer cases.16
Small cell lung cancer(SCLC),which accounts for15%to20%of all lung cancers,is characterised by high malignancy,early metastasis,rapid progression,and poor prognosis.Among SCLC patients,approximately30%to40%are diagnosed at a limited stage,while the remaining cases are in extensive stage.1,17
Within Europe,the prevalence of SCLC ranges from1to5per10,000People（PPLI）.11
Shanghai Henlius Biotech,Inc.(2696.HK)is a global,innovation-driven biopharmaceutical company committed to delivering high-quality,affordable biologic therapies to patients worldwide.The Company focuses on major disease areas including oncology,autoimmune diseases,and ophthalmic diseases.Founded in2010,Henlius has established an integrated,end-to-end biopharmaceutical platform encompassing global R&D,clinical operations,regulatory affairs,manufacturing,and commercialisation.The Company employs nearly4,000People（PPLI） globally and operates across multiple regions,including China,the United States,and Japan.Leveraging the stable cash flow generated from its biosimilar portfolio to support innovation,Henlius is steadily advancing into its“Globalisation2.0”phase,building a scalable and sustainable global growth model.Up to date,Henlius has achieved regulatory approvals for10products across over60countries and regions worldwide,including eight approvals in China.The Company has also reached multiple Milestone（MIST）s in major biopharmaceutical markets,with four products approved by the U.S.Food and Drug Administration(FDA)and five products approved by the European Commission(EC),reflecting its globally aligned R&D capabilities,quality systems,and manufacturing standards.
Driven by innovation,Henlius has built a Diversified（DHC）,platform-based technology ecosystem through coordinated R&D efforts across Shanghai,the United States,and other regions.Its innovation platforms span immune checkpoint iNHIbitors,immune cell engager technologies(including multispecific T cell engagers),antibody-drug conjugates(ADCs),and AI-enabled early discovery platforms.The Company currently has more than50early-stage Innovative（IIPR） assets,approximately70%of which are expected to be best-in-class,with over30clinical trials ongoing globally.Henlius’core product,serplulimab(trade name:Hetronifly in Europe),is the world’s First（FFBC） anti–PD-1mAb approved for First（FFBC）-line treatment of small cell lung cancer and for perioperative gastric cancer.Up to date,it has been approved in50markets worldwide with an accelerated globalisation process.In parallel,multiple high-potential Innovative（IIPR） assets—including the PD-L1ADC HLX43and the novel epitope anti-HER2mAb dulpatatug(HLX22)—are advancing through global pivotal clinical development.Supported by a biologics manufacturing network with a total capacity of84,000L and GMP certifications from regulatory authorities in China,Europe,and the United States,Henlius has established a stable global supply system serving six continents.Guided by a patient-centred mission,Henlius remains focused on addressing unmet medical needs and translating SCIentific innovation into meaningful clinical value and patient access,contributing sustainably to the global biopharmaceutical ecosystem.
About Accord Healthcare Headquartered in the United Kingdom,Accord Healthcare is one of the fastest growing pharmaceutical companies in Europe.Accord has one of the largest market footprints of any European generic and biosimilars companies,selling generic medicines in over80countries around the world.This global footprint enables us to deliver vital,affordable medicines to national health（NHI） systems supporting healthcare professionals to transform patient lives worldwide.
The approach of Accord is agile and inventive,always seeking to improve products and patients"access to them.Accord is driven to think differently and deliver more for the benefit of patients worldwide.
Accord has particular heritage and expertise in oncology.We have over54oncology-related treatments across its portfolio and further molecules in our pipeline,including several due for regulatory review over the next five years.As one of the largest suPPLIers of chemotherapy products in Europe,one in three oncology injectables are Accord products.We particularly focus on prevalent tumour types,including breast and prostate cancer,in additional to haematological and cancer supportive care.
Accord is also investing in the future of cancer care with a new research and development facility under Construction（ROAD） in the United Kingdom,to focus on biologics and vaccines,and further enable us to address patient needs at every step of their cancer treatment journey.
