产品速递 | 复宏汉霖PD-1抑制剂帕博利珠单抗生物类似药获批临床

2024年9月2日，复宏汉霖（2696.HK）宣布，公司自主开发的帕博利珠单抗生物类似药HLX17（重组抗PD-1人源化单克隆抗体注射液）的临床试验申请获得国家药品监督管理局（NMPA）批准，拟用于治疗黑色素瘤、非小细胞肺癌、食管癌、头颈部鳞状细胞癌、结直肠癌、肝细胞癌、胆道癌、三阴性乳腺癌、微卫星高度不稳定型或错配修复基因缺陷型肿瘤、胃癌等原研帕博利珠单抗在中国获批的所有适应症。

HLX17为复宏汉霖自主开发的帕博利珠单抗生物类似药。按照国家药品监督管理局发布的生物类似药指导原则的要求，并参考欧盟及美国生物类似药指导原则，经药学比对，临床前药理学、药效学、药代动力学和免疫原性研究证明，HLX17与原研帕博利珠单抗相似。

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，HLX17能够阻断PD-1与肿瘤细胞上的PD-L1、PD-L2间的相互作用，解除PD-1通路介导的免疫抑制，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。立足于公司在抗体药物领域的一体化平台优势，复宏汉霖加速免疫治疗药物的开发和布局，围绕PD-1/L1、CTLA-4、LAG-3、TIGIT等免疫检查点已打造出丰富的产品管线，不仅有望在更多适应症中取得突破，也为后续与公司其他产品的协同以及与创新疗法的联合奠定了坚实基础。

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。

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，3款产品在国际获批上市，24项适应症获批，3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50多个分子，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）以及汉奈佳^®（奈拉替尼），此外，创新产品汉斯状^®（斯鲁利单抗）已获批用于治疗微卫星高度不稳定（MSI-H）实体瘤、鳞状非小细胞肺癌、广泛期小细胞肺癌和食管鳞状细胞癌，并成为全球首个获批一线治疗小细胞肺癌的抗PD-1单抗。公司亦同步就16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。

IND Application of Henlius’ Pembrolizumab Biosimilar Approved by NMPA

Shanghai, China, September 2, 2024 - Shanghai Henlius Biotech, Inc. (2696.HK) announced the investigational new drug (IND) application for clinical trial of HLX17, a pembrolizumab biosimilar independently developed by the company, was approved by the National Medical Products Administration (NMPA) for the treatment of indications that reference pembrolizumab has been approved, including melanoma, non-small cell lung cancer, esophageal cancer, head and neck squamous cell cancer, colorectal cancer, hepatocellular carcinoma, biliary tract cancer, triple-negative breast cancer, microsatellite instability-high or mismatch repair deficient cancer, and gastric cancer, etc.

HLX17 is a pembrolizumab biosimilar independently developed by Henlius in accordance with the relevant guiding principles on biosimilar issued by the NMPA, and referencing the guidelines of European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA). The pharmacologic comparative study, and preclinical pharmacology study, pharmacodynamics, pharmacokinetics and immunogenicity studies have demonstrated that HLX17 is similar to the reference pembrolizumab.

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 has been continuously validated. HLX17 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. Based on the competitive edge of an integrated antibody drug R&D platform, Henlius has accelerated the development of immunotherapies and built a diversified product pipeline with high potential immune checkpoints including PD-1/L1, CTLA-4, LAG-3, TIGIT, etc., which are expected to show efficacy in multiple indications while laying a foundation for the synergy with in-house products of the company and other innovative therapies.

Looking forward, Henlius will maintain its focus on unmet medical needs and further broaden the company’s layout in more diseases areas, commit to bring high quality and affordable treatments 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. Up to date, 6 products have been launched in China, 3 have been approved for marketing in overseas markets, 24 indications are approved worldwide, and 3 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 over 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as backbone. Apart from the launched products 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) and HANNAIJIA (neratinib), the innovative product HANSIZHUANG has been approved by the NMPA for the treatment of MSI-H solid tumours, squamous non-small cell lung cancer (sqNSCLC) and extensive-stage small cell lung cancer (ES-SCLC), and esophageal squamous cell carcinoma (ESCC), making it the world’s first anti-PD-1 mAb for the first-line treatment of SCLC. What’s more, Henlius has conducted over 30 clinical studies for 16 products, expanding its presence in major markets as well as emerging markets.

联系方式

媒体：PR@Henlius.com

投资者：IR@Henlius.com