226年3月2日，复宏汉霖(2696.HK)书记，公司自主树立的纳武利尤单抗生物雷同药HLX18(重组抗PD-1东谈主源化单克隆抗体打针液)的新药临床纯熟(IND)肯求已得回国药品监督措置局(NMPA)批准，拟用于疗多种已切除实体。此前，HLX18的IND肯求也已得回好意思国食物药品监督措置局(FDA)许可。

　　 HLX18是复宏汉霖严格按照、欧盟和好意思国等生物雷同药端正树立的纳武利尤单抗生物雷同药，经药学和非临床比对商讨解说，HLX18与原研纳武利尤单抗相同。当今纳武利尤单抗已在多个国和地区获批用于黑素瘤(MEL)、恶胸膜间皮瘤(MPM)、头颈部鳞状细胞(HNSCC)、尿路上皮(UC)等系列妥贴症。凭证IQVIA数据，纳武利尤单抗224年度全国规模销售额为111.3亿好意思元。

　　依托在疫域的系统研发智力，公司捏续进袒护PD-1/L1、CTLA-4等疫靶点的多元化产物布局，围绕不同类型和疗场景构建互补式妥贴症组合，袒护肺、消化谈、黑素瘤、泌尿系统、乳腺、淋巴瘤等多瘤种，并系统布局围手术期、线疗及合并疗等要津疗场景。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、胃围手术期疗等多项中枢妥贴症中展现明确的临床价值，并通过捏续进化临床商讨与合并疗探索，构建相反化竞争势。同期，管道保温施工公司树立的HLX43看成款潜在同类的广谱抗PD-L1ADC，已在NSCLC等实体瘤中展现出“、低毒”的初步临床疗，并已于近期在好意思国开动项针对晚期或升沉鳞状非小细胞肺(sqNSCLC)的II/III期多中心临床商讨。在HLX18除外，帕博利珠单抗生物雷同药HLX17和伊匹木单抗生物雷同药HLX13均已完成多中心I期临床商讨例受试者给药；达雷妥尤单抗生物雷同药HLX15(重组抗CD38全东谈主单克隆抗体)皮下打针剂型(HLX15-SC)的IND肯求亦已得回NMPA和FDA许可。

　　多靶点疫疗产物在妥贴症定位与树立旅途上的协同进，逾越完善了公司在疫域的全体产物矩阵，并为后续合并疗及篡改疗法探索奠定了坚实基础。以前，复宏汉霖将陆续聚焦未满足的临床需求，捏续拓宽公司在多域的前瞻布局，为全国患者带去品性、可职守的篡改疗案。

　　 NMPA Grants IND Approval for Henlius’Nivolumab Biosimilar HLX18Following U.S.FDA Clearance Shanghai遵义储罐保温施工队 , China,March2,226–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 USD11.13billion in224.

　　 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遵义储罐保温施工队 ,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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