Recently, the updated 3-year follow-up results of the international multicenter Phase 3 clinical trial HLX02-BC01(NCT03084237 and EudraCT: 2016-000206-10) of HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac® in Europe), led by Academician Binghe Xu, director of the National New Drug (Antitumor) Clinical Research Center of Cancer Hospital Chinese Academy of Medical Sciences, were published in the professional breast cancer journal The Breast. The follow-up analysis results demonstrated that HANQUYOU exhibited comparable long-term efficacy, safety, and immunogenicity to the reference trastuzumab in patients with previously untreated HER2-positive metastatic breast cancer, further validating their clinical equivalence.
HLX02-BC01 is a randomized, double-blind, international multicenter Phase 3 clinical study conducted across 89 centers in China, the Philippines, Poland and other countries. The study aimed to evaluate the efficacy, safety, and immunogenicity of the domestically developed trastuzumab (HANQUYOU) compared to the reference trastuzumab in previously untreated HER2-positive metastatic breast cancer patients. A total of 649 subjects were enrolled and were randomized in a 1:1 ratio to receive either HANQUYOU or the European Union (EU)-sourced trastuzumab in combination with docetaxel (initial dose of 8 mg/kg, followed by 6 mg/kg every 3 weeks for up to 12 months). The primary endpoint was the overall response rate up to week 24 (ORR24w), with secondary endpoints including overall survival (OS), progression-free survival (PFS), safety, and immunogenicity.
The published results primarily updated PFS and OS. The findings showed that during the 36-month follow-up period, the median PFS for the HANQUYOU group (n=324) was 11.7 months, and the median PFS for the EU-trastuzumab group (n=325) was 10.6 months, HR= 0.86 ，p = 0.158, showing little difference from the previous study analysis and indicating similarity between the two groups. The median OS for the HANQUYOU group at 36 months was 37.3 months (95% CI 36.2-not evaluable), while the median OS for the EU-trastuzumab group was not reached (95% CI 34.2-not evaluable), HR=0.86，p = 0.229. The 36-month OS rates for the two groups were 57.5% and 54.0% respectively, with no significant difference observed. Furthermore, HANQUYOU demonstrated long-term safety and immunogenicity profiles comparable to those of the EU-sourced trastuzumab. These results conclusively demonstrate that, among HER2-positive metastatic breast cancer patients recruited globally, HANQUYOU and the reference trastuzumab exhibit no clinically meaningful differences in long-term efficacy, safety, and immunogenicity.
HANQUYOU is the first China-developed monoclonal antibody biosimilar to receive approval in China, the U.S., and Europe, making it the most widely approved Chinese biosimilar across multiple countries and regions. Henlius has conducted a series of head-to-head comparative studies for this product, including quality comparison studies, preclinical studies, Phase 1 clinical trials, and international multicenter Phase 3 clinical trials. The results have been published in renowned international biomedical journals and conferences such as BioDrugs, Cancer Chemotherapy and Pharmacology, the European Society for Medical Oncology (ESMO), and the European Breast Cancer Conference (EBCC). These data robustly demonstrate that HANQUYOU is highly comparable to the reference trastuzumab in terms of quality, safety, and efficacy. To date, HANQUYOU has gained marketing approval in over 50 countries and regions, including China, the U.S., the U.K., Canada, France, Germany, Switzerland, Australia, Finland, Spain, Argentina, Saudi Arabia, and Thailand, spanning Asia, Europe, Latin America, North America, and Oceania. The product has also been licensed in approximately 100 countries and regions and has been included in the national medical insurance catalogs of countries such as China, the UK, France, and Germany, benefiting over 230,000 patients globally.
Henlius has been deeply committed to the field of oncology, with a comprehensive portfolio targeting high-incidence cancers such as lung cancer, gastrointestinal tumors, and breast cancer. Its robust pipeline includes multiple breast cancer treatments, among which HANNAIJIA (neratinib), approved for the extended adjuvant treatment of HER2-positive early breast cancer, can be used in sequential therapy with HANQUYOU, offering a new treatment option for HER2-positive early breast cancer patients. The company’s self-developed pertuzumab biosimilar, HLX11, has had its New Drug Application (NDA) accepted in China and the U.S. for the treatment of HER2-positive breast cancer. It has the potential to be used in combination with HANQUYOU, providing patients with a more comprehensive and effective treatment regimen. Additionally, the company has acquired a novel endocrine therapy for breast cancer, lasofoxifene, which is currently in global Phase 3 clinical trials, targeting ESR1-mutated ER+/HER2- breast cancer. The first patient in China was dosed in December 2024. Henlius is actively advancing clinical studies on both monotherapies and combination therapies, leveraging the synergistic effects among its pipeline products. This strategy aims to address the full spectrum of breast cancer patients across different stages and subtypes, providing comprehensive treatment options and thereby maximizing clinical benefits to patients.
Moving forward, Henlius will accelerate the commercialization of HANQUYOU in more countries and regions, further expanding its global market presence and influence. The company will also continue to advance its commercialization efforts while actively exploring innovative treatment options. These initiatives aim to improve survival rates and quality of life for breast cancer patients, as well as provide global patients with more high-quality and affordable treatment options.
About The Breast
The Breast is an international, multidisciplinary academic journal focusing on translational and clinical research in breast cancer prevention, diagnosis, and treatment. The journal covers a wide range of disciplines in the field of breast cancer, including epidemiology, translational research, screening, treatment, and care, providing a high-quality academic exchange platform for researchers and clinicians worldwide.
