复宏汉霖伊匹木单抗生物类似药I/III期临床研究于中国完成首例受试者给药

2025年5月16日，复宏汉霖（2696.HK）宣布，公司自主研制的伊匹木单抗生物类似药HLX13（重组抗CTLA-4全人单克隆抗体注射液）的I/III期临床研究（NCT06841185）在中国完成首例受试者给药。复宏汉霖已于2025年4月与Sandoz达成授权许可合作，授予Sandoz对HLX13在美国、欧洲42个国家和地区、日本、加拿大及澳大利亚的独家商业化权益。

关于NCT06841185

本研究为一项多中心、随机、双盲、平行对照1/3期临床研究，旨在评估HLX13与其原研药YERVOY^®（美国市售和欧盟市售）在既往未经治疗的不可切除的晚期肝细胞癌（HCC）患者中的药代动力学（PK）特征、有效性、安全性和免疫原性相似性。合格的受试者将按2:1:1的比例随机分配至三组，在前4个周期，受试者每3周接受一次HLX13、美国市售的YERVOY^®或欧盟市售的YERVOY^®治疗，三组均联合纳武利尤单抗。随后每4周接受一次纳武利尤单抗治疗，最多10个周期。主要PK终点为从给药前至首次给药后21天的血药浓度-时间曲线下面积（AUC0-21d）和稳态给药间隔内血药浓度-时间曲线下面积（AUCss）；主要有效性终点为由独立放射学审查委员会（IRRC）根据实体肿瘤临床疗效评价标准（RECIST v1.1）评估的直至第24周的最佳客观缓解率（ORR）。次要终点包括其他PK参数、其他有效性评估、安全性及免疫原性。

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，4款产品在国际获批上市，5个上市申请分别获中国药监局、美国FDA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）、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^®）以及汉奈佳^®（奈拉替尼）。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。

About NCT06841185

This study is a multicentre, randomized, double-blind, parallel-controlled Phase 1/3 clinical study to evaluate the similarity of pharmacokinetic (PK) profiles, efficacy, safety, and immunogenicity among HLX13 and its reference product YERVOY^® (US-sourced and EU-sourced) as treatment for patients with unresectable advanced hepatocellular carcinoma (HCC) who have not received prior systemic therapy. Eligible subjects will be randomized in a 2:1:1 ratio to receive HLX13, US-sourced YERVOY^® or EU-sourced YERVOY^®. During the initial 4 treatment cycles, subjects across all study groups received the investigational product every 3 weeks in combination with nivolumab. Thereafter, nivolumab is administered every 4 weeks for up to 10 cycles. The primary PK endpoints are the area under the serum concentration-time curve from time 0 to 21 days (AUC0-21d) and the area under the serum concentration-time curve within a dosing interval at steady state (AUCss). The primary efficacy endpoint is the best objective response rate (ORR) assessed by the Independent Radiology Review Committee (IRRC) as per Response Evaluation Criteria In Solid Tumours version 1.1 (RECIST v1.1) up to Week 24. Secondary endpoints include other PK parameters, other efficacy assessments, safety, and immunogenicity.

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, 4 have been approved for marketing in overseas markets, and 5 marketing applications have been accepted for review in China, the U.S. 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 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), HANSIZHUANG (serplulimab, trade name: Hetronifly^® in Europe), the world’s first anti-PD-1 mAb for the first-line treatment of SCLC, and HANNAIJIA (neratinib). What’s more, Henlius has conducted over 30 clinical studies for 19 products, expanding its presence in major markets as well as emerging markets.