2025年12月19日，复宏汉霖（2696.HK）宣布，公司自主开发的纳武利尤单抗生物类似药HLX18（重组抗PD-1人源化单克隆抗体注射液）的新药临床试验（IND）申请已经获得美国食品药品监督管理局（FDA）许可，拟用于治疗多种已切除实体肿瘤。目前纳武利尤单抗已在多个国家和地区获批用于黑色素瘤（MEL）、恶性胸膜间皮瘤（MPM）、头颈部鳞状细胞癌（HNSCC）、尿路上皮癌（UC）等一系列适应症。根据IQVIA数据，纳武利尤单抗2024年度全球范围销售额为111.03亿美元。
近年来，免疫疗法为肿瘤治疗提供了新的途径，其独特的治疗优势和巨大潜力也陆续得以验证。通过与T细胞上的PD-1受体结合，纳武利尤单抗能够阻断PD-1与肿瘤细胞上的PD-L1、PD-L2的相互作用，解除PD-1通路介导的免疫应答抑制，包括抗肿瘤免疫应答，从而恢复T细胞对肿瘤的免疫监视和杀伤能力，使肿瘤调亡。HLX18是复宏汉霖严格按照中国、欧盟和美国等生物类似药法规开发的纳武利尤单抗生物类似药，经药学和非临床比对研究证明，HLX18与原研纳武利尤单抗相似。
在免疫肿瘤领域，复宏汉霖持续深化布局，形成以自主创新为引领、以生物类似药为有力补充的多层次产品体系。公司自主研发的抗PD-1单抗H药已在小细胞肺癌、胃癌围手术期治疗等多项核心适应症中展现明确的临床价值，并通过持续推进国际化临床研究与联合治疗探索，构建差异化竞争优势。在此基础上，公司依托在免疫肿瘤领域的系统性研发能力，持续推进覆盖PD-1/L1、CTLA-4等免疫靶点的多元化产品布局，围绕不同肿瘤类型和治疗场景构建互补式适应症组合，覆盖黑色素瘤、泌尿系统肿瘤、乳腺癌、淋巴瘤等多瘤种，并系统布局围手术期、一线治疗及联合治疗等关键治疗场景。其中，帕博利珠单抗生物类似药HLX17和伊匹木单抗生物类似药HLX13均已启动国际多中心I期临床研究并完成首例受试者给药；纳武利尤单抗生物类似药HLX18亦聚焦多项已确立免疫治疗价值的实体瘤适应症。多靶点免疫治疗产品在适应症定位与开发路径上的协同推进，进一步完善了公司现阶段在免疫肿瘤领域的整体产品矩阵，并为后续联合治疗及创新疗法探索奠定了坚实基础。
展开剩余86%未来，复宏汉霖将继续聚焦未满足的临床需求，持续拓宽公司在更多疾病领域的前瞻性布局，为全球患者带去高品质、可负担的创新治疗方案。
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，已在全球获批上市10款产品，5个上市申请分别获中国药监局和欧盟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）、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）、国内首个生物类似药汉利康（利妥昔单抗）、地舒单抗生物类似药Bildyos和Bilprevda，以及帕妥珠单抗POHERDY。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。
U.S. FDA Clearance of IND for Nivolumab Biosimilar HLX18
Shanghai, China, December 19, 2025 - Shanghai Henlius Biotech, Inc. (2696.HK) announced the investigational new drug (IND) application for its HLX18, a proposed nivolumab biosimilar independently developed by the company, was approved by the U.S. Food and Drug Administration (FDA) for the treatment of certain resected solid tumors. Nivolumab has been approved in various countries and regions for a range of different indications, such as for the treatment of melanoma (MEL), malignant pleural mesothelioma (MPM), head and neck squamous cell carcinoma (HNSCC), and urinary tract cancer (urothelial carcinoma, UC). According to IQVIA, the sales volume of nivolumab worldwide for the year 2024 was approximately USD11.103 billion.
Immune checkpoint inhibitors are playing a crucial part in immunotherapy, which has emerged in recent years as a novel approach to combating tumor cells and their distinct advantages and enormous potential have been continuously validated. HLX18 is a monoclonal antibody that binds to the PD-1 receptor expressed on T cells and blocks its interaction with PD-L1 and PD-L2, releasing PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response, thus restoring the T-cell immune surveillance of tumors and increasing its anti-tumour efficacy.
HLX18 is a nivolumab biosimilar developed by Henlius in accordance with the NMPA, EMA, FDA and other international biosimilar guidelines. Comparative pharmaceutical quality and non-clinical studies have demonstrated that HLX18 is similar to the reference nivolumab.
In the field of immuno-oncology, Henlius continues to deepen its strategic presence in immuno-oncology, establishing a multi-tiered product portfolio led by in-house innovation and complemented by biosimilars. Henlius’ self-developed anti-PD-1 monoclonal antibody, serplulimab, has demonstrated clear clinical value across multiple key indications, including small cell lung cancer and perioperative treatment of gastric cancer. Through the continued advancement of global clinical studies and combination therapy strategies, serplulimab is building a differentiated competitive profile.
Building on this foundation, Henlius leverages its integrated immuno-oncology R&D capabilities to advance a diversified portfolio covering multiple immune targets, including PD-1/L1 and CTLA-4. The company is developing complementary indication strategies across different tumour types and treatment settings, spanning MEL, urological cancers, breast cancer and lymphoma, while systematically addressing key clinical scenarios such as perioperative treatment, first-line therapy and combination regimens.
Among these programmes, the pembrolizumab biosimilar HLX17 and the ipilimumab biosimilar HLX13 have both initiated international multi-centre phase 1 clinical studies, with first patient dosing completed. Meanwhile, the nivolumab biosimilar HLX18 is focused on multiple solid tumour indications with well-established immunotherapy value. The coordinated advancement of multi-target immuno-oncology assets, differentiated by indication positioning and development pathways, further strengthens Henlius’ overall immuno-oncology portfolio and lays a solid foundation for future combination strategies and innovative therapeutic exploration.
Looking forward, Henlius will maintain its focus on unmet medical needs, further broaden the company’s layout in more disease areas, and strive to provide high-quality and affordable treatment options for 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. To date, 10 products have been approved for marketing across multiple countries and regions, and 5 marketing applications have been accepted for review in China 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 HANSIZHUANG (serplulimab, trade name: Hetronifly in Europe), the world’s first anti-PD-1 mAb for the first-line treatment of SCLC, HANQUYOU (trastuzumab, trade name: HERCESSI in the U.S., Zercepac in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANLIKANG (rituximab), the first China-developed biosimilar, denosumab Bildyos and Bilprevda, and pertuzumab Poherdy. What’s more, Henlius has conducted over 30 clinical studies for 19 products, expanding its presence in major markets as well as emerging markets.
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