Shanghai, China, June 25, 2026 — Shanghai Henlius Biotech, Inc. (2696.HK) today announced that its independently developed investigational ipilimumab biosimilar HLX13 (recombinant anti-CTLA-4 fully human monoclonal antibody injection) has completed first patient dosing in the United States in its international multicenter phase 1 clinical study (HLX13-HCC102). The study had previously achieved first patient dosing in China. This milestone marks continued progress in HLX13’s global clinical development and demonstrates the company’s ability to conduct quality international multicenter studies through its in-house global clinical operations. Henlius is advancing the global clinical development and regulatory advancement of multiple pipeline products, including HLX13.

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 assessments 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 and 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.

This study is an international multicenter, randomized, double-blind, parallel-controlled phase 1 clinical study to evaluate the pharmacokinetic (PK) characteristics, safety, efficacy, and immunogenicity of HLX13 compared with its reference product YERVOY^®, each in combination with OPDIVO^® (INN: 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 maintenance monotherapy with OPDIVO^® administered every 4 weeks. The primary objective of this study is to evaluate the PK similarity of HLX13 and YERVOY^® in the target patient population. 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, or area under the serum concentration-time curve from time 0 to infinity at steady-state (AUCinf) after the 4th dose. Secondary endpoints include other PK parameters, efficacy assessments, safety and immunogenicity.

Looking ahead, Henlius will continue to focus on unmet medical needs, leveraging its integrated global R&D and clinical development capabilities to expand its presence across therapeutic areas and deliver high-quality, affordable treatment options to patients worldwide.