2026年3月20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)申请已获得中国国家药品监督管理局(NMPA)批准，拟用于治疗多种已切除实体肿瘤。此前，HLX18的IND申请也已获得美国食品药品监督管理局(FDA)许可。
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。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。
依托在免疫肿瘤领域的系统性研发能力，公司持续推进覆盖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，覆盖肺癌、消化道肿瘤、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。公司自主研发的抗PD-1单抗H药汉斯状(斯鲁利单抗)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。同时，公司开发的HLX43作为一款潜在同类最优的广谱抗肿瘤PD-L1ADC，已在NSCLC等实体瘤中展现出“高效、低毒”的初步临床疗效，并已于近期在美国启动一项针对晚期或转移性鳞状非小细胞肺癌(sqNSCLC)的II/III期国际多中心临床研究。在HLX18之外，帕博利珠单抗生物类似药HLX17和伊匹木单抗生物类似药HLX13均已完成国际多中心I期临床研究首例受试者给药；达雷妥尤单抗生物类似药HLX15(重组抗CD38全人单克隆抗体)皮下注射剂型(HLX15-SC)的IND申请亦已获得NMPA和FDA许可。
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。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。
NMPA Grants IND Approval for Henlius’Nivolumab Biosimilar HLX18Following U.S.FDA Clearance Shanghai, China,March20,2026–Shanghai Henlius Biotech,Inc.(2696.HK)announced that the investigational new drug(IND)application for HLX18,a proposed nivolumab biosimilar independently developed by the company,has been approved by the China National Medical Products Administration(NMPA)for the treatment of certain resected solid tumors.Previously,the IND application for HLX18was also cleared by the U.S.Food and Drug Administration(FDA).
HLX18is a nivolumab biosimilar developed by Henlius in accordance with biosimilar regulatory guidelines in China,the European Union,and the United States.Comparative pharmaceutical quality and non-clinical studies have demonstrated that HLX18is similar to the reference product nivolumab.
Nivolumab has been approved in multiple countries and regions for a range of indications,including melanoma(MEL),malignant pleural mesothelioma(MPM),head and neck squamous cell carcinoma(HNSCC),and urothelial carcinoma(UC).According to IQVIA,global sales of nivolumab reached approximately USD11.103billion in2024.
Leveraging its integrated R&D capabilities in immuno-oncology,Henlius continues to advance a diversified portfolio covering multiple immune targets,including PD-1/L1and CTLA-4.The company is developing complementary indication strategies across different tumour types and treatment settings,spanning lung cancer,gastrointestinal cancers,melanoma,urological cancers,breast cancer,and lymphoma,while systematically addressing key clinical scenarios such as perioperative treatment,first-line therapy,and combination regimens.
Henlius’self-developed anti-PD-1monoclonal antibody,serplulimab,has demonstrated clear clinical value in 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.
In addition,HLX43,a potentially best-in-class pan-tumour antibody-drug conjugate(ADC)candidate targeting PD-L1,has shown promising preliminary clinical efficacy characterized by encouraging efficacy and manageable safety profile in solid tumors including non-small cell lung cancer(NSCLC).Recently,a global multicenter phase2/3clinical study evaluating HLX43for advanced or metastatic squamous NSCLC(sqNSCLC)has been initiated in the United States.
Beyond HLX18,the pembrolizumab biosimilar HLX17and the ipilimumab biosimilar HLX13have both completed first patient dosing in their respective international multicenter phase1clinical studies.Meanwhile,the investigational new drug application for HLX15-SC,a subcutaneous formulation of the daratumumab biosimilar HLX15(a recombinant anti-CD38fully human monoclonal antibody),has also been cleared by both the NMPA and the FDA.
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 ahead,Henlius will continue to focus on unmet medical needs,expand its forward-looking pipeline across more disease areas,and strive to provide high-quality and affordable treatment options for patients worldwide.
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