复宏汉霖伊匹木单抗生物类似药国际多中心临床研究完成首例受试者给药

2025年11月25日，复宏汉霖（2696.HK）宣布，公司自主开发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）的国际多中心I期临床研究（HLX13-HCC102）在中国完成首例受试者给药。此前，该研究的新药临床试验（IND）申请已经获得美国食品药品监督管理局（FDA）和中国国家药品监督管理局（NMPA）许可，拟用于一线治疗不可切除肝细胞癌。

HLX13是复宏汉霖严格按照中国、欧盟和美国等生物类似药法规自主研发的伊匹木单抗生物类似药，已有的药学相似性比对研究、临床前研究数据表明，HLX13与原研药伊匹木单抗相似或无明显差异。目前，原研药伊匹木单抗（YERVOY^®）作为全球首个CTLA-4抑制剂，已在多个国家和地区获批上市，适应症包括联合纳武利尤单抗用于黑色素瘤、肝细胞癌等一系列适应症。2025年4月，复宏汉霖与Sandoz达成授权合作，授予其对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。

HLX13-HCC102为一项多中心、随机、双盲、平行对照I期临床研究，旨在评价HLX13或其原研药YERVOY^®（美国市售）分别联合OPDIVO^®（欧盟市售，通用名：纳武利尤单抗），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、安全性、疗效和免疫原性的相似性。合格的受试者将按1:1的比例随机分配至两组，在前4个周期，受试者每3周接受一次HLX13或YERVOY^®联合OPDIVO^®治疗，随后每4周接受一次OPDIVO^®单药维持治疗。主要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）和第4次给药后稳态给药间隔内血药浓度-时间曲线下面积（AUCss）。次要终点包括其他PK参数、有效性评估、安全性及免疫原性。

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，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。

First Subject Dosed for Phase 1 Clinical Trial of Henlius’ Proposed Ipilimumab Biosimilar

Shanghai, China, November 25, 2025 - Shanghai Henlius Biotech, Inc. (2696.HK) announced that the first subject was dosed for a phase 1 multi-centre clinical trial (HLX13-HCC102) of the company's independently developed investigational ipilimumab biosimilar HLX13 in China. Previously, the investigational new drug (IND) applications of HLX13-HCC102 have been approved by the U.S. Food and Drug Administration (FDA) and the National Medical Products Administration (NMPA) as a first-line treatment for patients with unresectable hepatocellular carcinoma.

HLX13 is a biosimilar of ipilimumab independently developed by Henlius in accordance with international biosimilar guidelines, including those of National Medical Products Administration (NMPA), EMA and FDA. Henlius has conducted preliminary comparative analytical assessment and a series of head-to-head preclinical studies to evaluate the similarity of HLX13 and the reference product ipilimumab. The results demonstrated a high similarity or no significant difference between HLX13 and the reference product ipilimumab. The reference product of HLX13, YERVOY^®, the world’s first CTLA-4 inhibitor, has been approved in various countries and regions in combination with nivolumab for the treatment of metastatic melanoma and hepatocellular carcinoma, among other indications. In April 2025, Henlius entered into a license agreement with Sandoz, granting Sandoz exclusive commercialization rights for HLX13 in the United States, 42 European countries and regions, Japan, Canada, and Australia.

HLX13-HCC102 is a multicenter, randomized, double-blind, parallel-controlled Phase 1 clinical study to evaluate the similarity in pharmacokinetic (PK) profiles, safety, efficacy, and immunogenicity between HLX13 and its reference product YERVOY^® (US-sourced), each in combination with OPDIVO^® (EU-sourced, generic name: nivolumab), in patients with previously untreated, unresectable advanced hepatocellular carcinoma (HCC). Eligible subjects will be randomly assigned to two groups at a 1:1 ratio. Subjects will receive HLX13 or YERVOY^® in combination with OPDIVO^® once every 3 weeks for the first 4 cycles, followed by OPDIVO^® monotherapy administered every 4 weeks as maintenance treatment. The primary endpoints are area under the serum concentration-time curve from time 0 to 21 days (AUC0-21d) after the 1st dose and the area under the serum concentration-time curve within a dosing interval at steady-state (AUCss) after the 4th dose. Secondary endpoints include other PK parameters, efficacy assessments, safety, and immunogenicity.

Looking forward, Henlius will maintain its focus on unmet medical needs and further broaden the company’s layout in more disease areas, commit to bring high quality and affordable treatments for patients worldwide.

*YERVOY^® is a registered trademark of Bristol-Myers Squibb (US)

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 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 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.