近日，由中国医学科学院肿瘤医院国家新药（抗肿瘤）临床研究中心主任徐兵河院士牵头开展的汉曲优®（曲妥珠单抗，美国商品名：HERCESSI™，欧洲商品名：Zercepac®）国际多中心III期临床试验HLX02-BC01（临床试验号：NCT03084237；欧洲临床试验号：2016-000206-10）3年随访更新结果在乳腺癌领域专业期刊The Breast发表。随访分析结果表明，汉曲优®与原研曲妥珠单抗在未经系统治疗的HER2阳性转移性乳腺癌患者中具有相似的长期疗效、安全性和免疫原性，进一步验证了其临床等效性。
HLX02-BC01是一项在中国、菲律宾、波兰等89个中心同步开展的随机、双盲、国际多中心的III期临床研究，旨在评估国产曲妥珠单抗（汉曲优®）和原研曲妥珠单抗在未经系统治疗的HER2阳性转移性乳腺癌患者中的疗效、安全性和免疫原性。该研究共计入组了649例受试者，受试者按照1:1的比例随机分为两组，分别静脉注射给予汉曲优®联合多西他赛或欧洲市售（EU-）曲妥珠单抗联合多西他赛（初始剂量为8 mg/kg，随后每三周注射6 mg/kg，最多给药12个月）。研究的主要终点为24周的总缓解率（ORR24w），次要终点包括总生存期（OS）、无进展生存期（PFS）、安全性和免疫原性等。
本次发表的研究结果主要更新了PFS和OS等数据。结果显示，在3年随访中，汉曲优®组（n=324）中位PFS为11.7 个月， EU-曲妥珠单抗组（n=325）中位PFS为10.6个月，HR= 0.86 ，p = 0.158，与之前研究分析差异不大，两组间相似。汉曲优®组36个月的中位OS为37.3个月（95% CI 36.2-不可评估），EU-曲妥珠单抗组未达到（95% CI 34.2-不可评估），HR=0.86，p = 0.229，两组36个月的OS率分别为57.5%和54.0%，无显著差异。此外，汉曲优®与欧洲市售曲妥珠单抗在长期安全性和免疫原性方面的结果相似。研究结果充分证明，在全球各地区招募的HER2阳性转移性乳腺癌患者中，汉曲优®与原研曲妥珠单抗在长期疗效、安全性和免疫原性方面均无临床意义的差别。
汉曲优®是中美欧三地获批的国产单抗生物类似药，也是获批上市国家和地区最多的国产生物类似药。围绕该产品，复宏汉霖开展了一系列的头对头比对研究，包括质量对比研究、临床前研究、临床I期和国际多中心临床III期研究等，并于BioDrugs、Cancer Chemotherapy and Pharmacology、欧洲肿瘤内科学会（ESMO）、欧洲乳腺癌大会（EBCC）等国际生物医药领域知名期刊和学术舞台进行发表，充分证明了汉曲优®与原研曲妥珠单抗在质量、安全性和有效性方面高度相似。截至目前，汉曲优®已于中国、美国、英国、加拿大、法国、德国、瑞士、澳大利亚、芬兰、西班牙、阿根廷、沙特阿拉伯、泰国等50多个国家和地区获批上市，覆盖亚洲、欧洲、拉丁美洲、北美洲和大洋洲，对外授权覆盖约100个国家和地区，并进入中国、英国、法国和德国等国家医保目录，惠及全球超过23万名患者。
复宏汉霖深耕肿瘤治疗领域，针对肺癌、消化道肿瘤、乳腺癌等高发瘤种的治疗进行了全面布局，丰富的管线覆盖多款乳腺癌治疗产品，其中，公司小分子抗肿瘤药物汉奈佳®（奈拉替尼）用于HER2阳性早期乳腺癌的强化辅助治疗，可与汉曲优®实现序贯治疗，为HER2阳性早期乳腺癌患者提供了全新的治疗选择。公司自主研发的帕妥珠单抗生物类似药HLX11的上市注册申请（NDA）已在中国和美国获受理，用于治疗HER2阳性乳腺癌，并将有潜力与汉曲优®联合用药，为患者带来更全面、有效的治疗方案。此外，公司还引进了一款处于全球III期临床阶段的新型乳腺癌内分泌疗法lasofoxifene，可用于治疗ESR1突变的ER+/HER2-乳腺癌，并在2024年12月完成了中国首例患者给药。围绕乳腺癌，公司积极推进单药产品和联合疗法的临床研究，充分发挥管线产品间的协同效应，以期覆盖不同分型乳腺癌患者、不同疾病分期的全线治疗，为患者带去更佳的生存获益。
未来，复宏汉霖将持续推动汉曲优®在更多国家和地区的商业化落地，进一步深化该产品在全球市场的布局和影响力，同时加快探索创新治疗方案，持续提升乳腺癌患者的生存、生活质量，为全球患者带去更多高质量、可负担的治疗选择。
关于The Breast
The Breast是一本国际性的、多学科的学术期刊，专注于乳腺癌预防、诊断和治疗的转化和临床研究。该期刊涵盖了乳腺癌领域的广泛学科，包括流行病学、转化研究、筛查、治疗和护理等，为全球研究人员和临床医生提供了一个高质量的学术交流平台。
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，4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50多个分子，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，欧盟商品名：Hetronifly®）以及汉奈佳®（奈拉替尼）。公司亦同步就16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。
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.
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 4 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 over 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 the EU), 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 16 products, expanding its presence in major markets as well as emerging markets.
