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)