摘要：复宏汉霖（2696.HK）宣布，公司自主研发的抗PD-1单抗 H药 汉斯状（斯鲁利单抗，欧洲商品名：Hetronifly）已于近期相继获英国药品和保健品监管局（MHRA）和印度中央药品标准控制组织（CDSCO）批准，用于广泛期小细胞肺癌（ES-SCLC）的一线
- H药 汉斯状是全球首个获批一线治疗ES-SCLC的抗PD-1单抗，迄今惠及逾110,000位患者
- H药 汉斯状目前已在近40个国家和地区获批上市，包括中国、欧洲、印度和东南亚多个国家
- 欧洲和印度的商业化由Intas及其子公司Accord Healthcare负责
复宏汉霖（2696.HK）宣布，公司自主研发的抗PD-1单抗 H药 汉斯状（斯鲁利单抗，欧洲商品名：Hetronifly）已于近期相继获英国药品和保健品监管局（MHRA）和印度中央药品标准控制组织（CDSCO）批准，用于广泛期小细胞肺癌（ES-SCLC）的一线治疗，由合作伙伴Intas及子公司Accord Healthcare负责该产品在当地的推广，商品名为Hetronifly。
此次获批主要基于ASTRUM-005研究，该研究在全球开设了128个试验中心，入组585例受试者，在2025年美国临床肿瘤学会（ASCO）年会上，ASTRUM-005研究公布了研究结束分析结果，数据显示中位随访达42.4个月，斯鲁利单抗联合化疗组的4年总生存率（OS）为21.9%（95% CI：17.6–26.6%），证实了该免疫治疗方案对ES-SCLC患者的长期生存获益。
肺癌是全球癌症相关死亡的首要原因之一[1]。小细胞肺癌（SCLC）约占肺癌总数的15%，是肺癌中侵袭性最强的亚型，治疗选择有限。H药 汉斯状为全球首个获批用于一线治疗小细胞肺癌的抗PD-1单抗。英国医药和健康产品管理局（MHRA）医疗质量与准入执行署署长Julian Beach表示：“斯鲁利单抗是英国首个且唯一获批用于小细胞肺癌治疗的抗PD-1单抗，为这一恶性肺癌类型的患者提供了新的治疗选择。这类患者当前治疗手段有限，预后较差，该药物的获批具有重要意义。”[2]在印度，肺癌在癌症发病率和死亡率中均位列第4位，2022年新发病例超过81,000例，死亡人数逾75,000人[1]。根据联合国人口基金发布的《2025年世界人口状况报告》，印度人口预计将达到14.6亿，仍为全球人口第一大国[3]。庞大的人口基数与日益增长的医疗需求也进一步突显了提升创新药可及性的紧迫性。此次H药双国获批，同步进入主流成熟市场英国与新兴市场印度，借助Intas及Accord Healthcare在当地成熟的市场准入能力和销售网络，有望加快H药在当地的覆盖进程，缓解该领域的迫切临床需求，为更多患者带来实质性的治疗获益，进一步拓展这款创新免疫治疗方案的全球可及性。
在 Accord，我们始终致力于支持癌症患者。MHRA批准Hetronifly上市，为对抗广泛期小细胞肺癌这一最具侵袭性的肺癌类型之一提供了新的治疗选择。这一里程碑反映了我们持续推动为难治疾病提供创新特药的承诺。复宏汉霖首席商务发展官兼高级副总裁
曹平表示
Hetronifly在英国和印度的获批，不仅代表公司全球化战略的持续推进，更是我们‘以患者为中心’承诺的切实践行。我们正持续拓展H药在全球市场的覆盖，致力于让高质量的创新药惠及更多患者
作为复宏汉霖全球化战略的重要支点，H药正持续加速其全球布局。截至目前，H药已在中国、印度尼西亚、新加坡、德国等近40个国家和地区获批上市，累计惠及患者超过11万人。其在小细胞肺癌治疗方面的潜力已获得国际广泛认可，包括获得美国FDA、欧盟委员会和瑞士Swissmedic授予的小细胞肺癌（SCLC）孤儿药资格，英国创新许可与准入通道合作组织授予的创新通行证资格认定，以及韩国MFDS授予的广泛期小细胞肺癌（ES-SCLC）孤儿药资格。目前，公司正在美国和日本开展头对头桥接研究，对比H药与当前广泛期小细胞肺癌一线标准治疗方案阿替利珠单抗，以进一步支持其全球注册申报。
未来，公司将持续践行“以患者为中心”的使命，携手全球合作伙伴，共同推进创新药物的可及性，让更多患者共享生命质量的提升。
关于复宏汉霖
复宏汉霖（2696.HK）是一家国际化的创新生物制药公司，致力于为全球患者提供可负担的高品质生物药，产品覆盖肿瘤、自身免疫疾病、眼科疾病等领域，已有6款产品在中国获批上市，4款产品在国际获批上市，5个上市申请分别获中国药监局、美国FDA和欧盟EMA受理。自2010年成立以来，复宏汉霖已建成一体化生物制药平台，高效及创新的自主核心能力贯穿研发、生产及商业运营全产业链。公司已建立完善高效的全球创新中心，按照国际药品生产质量管理规范（GMP）标准进行生产和质量管控，不断夯实一体化综合生产平台，其中，公司商业化生产基地已相继获得中国、欧盟和美国GMP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，涵盖约50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，欧洲商品名：Hetronifly）以及汉奈佳（奈拉替尼）。公司亦同步就19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 UK and India for the First-Line Treatment of Extensive-Stage Small Cell Lung Cancer
- Serplulimab is the world’s first anti-PD-1 mAb approved for the first-line treatment of ES-SCLC and has reached over 110,000 patients
- It has been approved in nearly 40 countries including China, Europe, India and multiple Southeast Asian countries
- Commercialisation in Europe and India is led by Intas and its subsidiary Accord Healthcare
Henlius (2696.HK) announced that its self-developed anti-PD-1 monoclonal antibody (mAb) serplulimab (trade name in Europe: Hetronifly) has been approved in both the United Kingdom and India for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC). Commercialisation in the UK and India will be led by Henlius’ partner Intas and its subsidiary Accord Healthcare.
The approvals were primarily based on the results of the global phase 3 clinical study ASTRUM-005, which enrolled 585 patients across 128 trial sites worldwide. At the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, the results from the final analysis of ASTRUM-005 were presented, showing a median follow-up of 42.4 months and a 4-year overall survival (OS) rate of 21.9% (95% CI: 17.6–26.6%) for the serplulimab plus chemotherapy group. These results further confirm the long-term survival benefit of this immunotherapy-based regimen for patients with ES-SCLC.
Lung cancer remains the leading cause of cancer-related death globally[1]. Small cell lung cancer (SCLC), one of the most aggressive subtypes, accounts for approximately 15% of all lung cancer cases and is associated with limited treatment options. Hetronifly is the world’s first anti-PD-1 monoclonal antibody approved for the first-line treatment of SCLC. Julian Beach, Interim Executive Director of Healthcare Quality and Access at the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), commented: “As the first and only anti-PD-1 monoclonal antibody approved in the UK for small cell lung cancer, this marks an important new treatment option for patients with this aggressive type of lung cancer who currently have limited choices and face a poor prognosis.” [2]In India, lung cancer ranks fourth in both incidence and mortality among cancers. In 2022, over 81,000 new cases and more than 75,000 deaths were reported[1]. According to the State of World Population 2025 report by the United Nations Population Fund (UNFPA), India’s population is projected to reach 1.46 billion, reaffirming its position as the most populous country in the world[3]. The growing demand for healthcare resources highlights the urgent need to improve access to innovative therapies.The approvals of Hetronifly in the UK and India—representing a mature, mainstream biologics market and emerging market, respectively—underscore a significant milestone in expanding the therapy’s global reach. Leveraging the local expertise and commercial networks of Intas and Accord Healthcare, Hetronifly is expected to accelerate market penetration and address unmet medical needs in both regions, bringing tangible clinical benefits to more patients.
Regarding the UK approval, Paul Tredwell, Executive Vice-President, EMENA, Accord Healthcare said: “At Accord, we are dedicated to supporting patients with cancer. The MHRA’s approval of Hetronifly provides a new treatment option in the fight against extensive-stage small cell lung cancer — one of the most aggressive forms of lung cancer. This milestone reflects our ongoing commitment to providing novel specialty medicines for difficult-to-treat conditions.”
Ping Cao, Chief Business Development Officer and Senior Vice President of Henlius, said: “The approvals of serplulimab in the UK and India not only represent continued progress in our globalisation strategy, but also reflect our concrete commitment to putting patients first. We are steadily expanding the global reach of the product, aiming to bring high-quality innovative therapies to more patients around the world.”
As a core product of Henlius’ globalisation strategy, serplulimab has now been approved in nearly 40 countries and regions including China, Indonesia, Singapore, Germany, the UK and India, reaching over 110,000 patients worldwide. Its potential in SCLC has been widely recognised, with orphan drug designations granted by the US FDA, the European Commission, and Swissmedic for SCLC; Innovation Passport Designation from the U.K. Innovative Licensing and Access Pathway Steering Group (ILAP); and orphan drug designation from South Korea’s MFDS for ES-SCLC.
Henlius is currently conducting head-to-head bridging trials in the US and Japan comparing serplulimab with atezolizumab—the current standard of care for ES-SCLC—to further support global regulatory filings. Looking ahead, the company will continue to collaborate with global partners to enhance accessibility and bring more life-changing therapies to patients worldwide.
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 5 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 about 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 (serplulimab, trade name: Hetronifly in Europe), 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 19 products, expanding its presence in major markets as well as emerging markets.
来源：动态宝
