复宏汉霖：汉斯状欧盟获批上市，一线治疗广泛期小细胞肺癌

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。

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。

复宏汉霖长期对产品质量的严格要求亦为此次H药获EC批准奠定重要基础。2023年，H药相关生产场地和设施顺利通过欧盟GMP（Certificate of GMP Compliance of a Manufacturer）检查并获得欧盟GMP证书，为H药稳定、高质供应欧洲市场提供保障。公司建有徐汇基地、松江基地（一）及松江基地（二）三个生产基地，现有商业化总产能已达48,000升，实现全球产品常态化供应，全面覆盖中国、欧洲、拉丁美洲、中东北非、北美及东南亚。复宏汉霖现已建立一套符合国际质量标准的质量管理体系，覆盖从项目研发到物料管理、产品生产、质量控制、产品供应链管理以及产品上市后跟踪的全生命周期。此前，公司商业化生产基地及配套的质量管理体系已通过中国国家药监局、欧洲药品管理局（EMA）、美国食药监局（FDA）、欧盟质量受权人（QP）以及公司国际商业合作伙伴进行的多项实地核查及审计，获得中国、欧盟和美国GMP认证。

围绕H药，复宏汉霖携手全球商业合作伙伴Accord、KGbio和复星医药，全面布局美国、欧洲及众多新兴国家市场，对外授权覆盖70多个国家和地区。展望未来，复宏汉霖将与合作伙伴紧密协作，持续推进H药在更多国家和地区的获批上市进程，为全球更多患者提供更广泛的治疗选择。

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.

媒体：PR@Henlius.com

投资者：IR@Henlius.com