Recently, the study results of HLX02-HV01 (Clinical Trial No.: NCT02581748), a phase 1 clinical trial of Henlius HLX02 HAN QU YOU^® (Trastuzumab, EU trade name: Zercepac^®), were published in Cancer Chemotherapy and Pharmacology, a well-known journal in the field of cancer therapy, and the study was led by Professor Zhang Quanying from the Second Affiliated Hospital of Soochow University. The publication of the results of the HAN QU YOU^® Phase 1 study indicates the recognition of the quality and data of the clinical study by peer review, which is an affirmation of the development level of high-quality biosimilars produced in China.

HLX02-HV01 is a two-stage Phase 1 clinical trial in healthy Chinese male subjects. The primary objective of the first stage was to evaluate the safety and tolerability of different doses of HAN QU YOU^®. The study showed that different doses of HAN QU YOU^® were well tolerated, and 6 mg/kg was determined as the test dose in the second stage. Phase II is a randomized, double-blind, three-arm, parallel-controlled trial to compare the PK profile, safety, and immunogenicity of HAN QU YOU^® with the trastuzumab innovator drugs marketed in China and the EU. The results showed that the safety and Pk profiles of HAN QU YOU^® and the trastuzumab innovator drugs marketed in China and the EU were equivalent in healthy Chinese male subjects. In this study, trastuzumab innovator drugs from two different sources were introduced as the reference drugs to conduct a rigorous and comprehensive comparison of the PK profiles between HAN QU YOU^® and the reference drugs, and the test results strongly supported the subsequent large-scale international multi-center phase III clinical study HLX02-BC01 (Clinical Trial No.: NCT03084237; European Clinical Trial No.: 2016-000206-10) to compare the efficacy, safety, and PK profile of HAN QU YOU^® and the trastuzumab innovator drugs in patients with HER2+ recurrent or metastatic breast cancer without systemic therapy.


As the first Chinese monoclonal antibody biosimilar approved both in China and Europe, HAN QU YOU^® has been developed in strict accordance with the relevant regulations of China and the EU on biosimilars, and a number of head-to-head comparative studies have been carried out with trastuzumab innovator drugs, including pharmaceutical comparative studies, non-clinical comparative studies and clinical comparative studies. Among them, the preclinical similarity study results of HAN QU YOU^® have been published in the BioDrugs, a well-established authoritative journal in the field of biomedicine, in 2020, this study has demonstrated the high structural and functional similarity between HLX02 and trastuzumab innovator drugs. The data of this phase 1 clinical study of HLX02 once again verified the similarity.

In July and August 2020, HAN QU YOU^® was successively approved for marketing by the European Commission and China National Medical Products Administration for the treatment of 1) HER2+ early breast cancer, 2) HER2+ metastatic breast cancer, and 3) HER2+ metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma, covering all approved indications of the innovator drug. At present, the commercialization of HAN QU YOU^® (EU trade name: Zercepac^®) has been accelerated. Following the issuance of the first prescription in China, HAN QU YOU^® has been covered by medical insurance in many cities including Shanghai, and is available in multiple hospitals. At the same time, the product has also been successfully launched in many European countries, and the commercialization layout in Europe keeps expanding. In addition, Henlius has worked with partners to accelerate the full coverage of HAN QU YOU^® in mainstream markets in Europe and the United States. In the future, Henlius will continue to lead the development of innovative biopharmaceuticals and provide affordable and effective treatment options for patients around the world with its well-established innovative R&D platform.

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About Cancer Chemotherapy and Pharmacology

Cancer Chemotherapy and Pharmacology mainly focuses on the experimental screening of new anti-cancer drugs, preclinical toxicology and pharmacology studies, monotherapy and combination therapy, as well as the results of clinical phase I, II and III trials of drugs. As an authoritative journal in the field, it addresses a wide range of pharmacological and oncological issues at the level of experimental and clinical research.


About Henlius

Henlius (2696. HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable and innovative biologics for patients worldwide with a focus on oncology, autoimmune diseases and others. 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. The Company has R&D centers in Shanghai, Taipei (China) and California (USA) to carry out production and quality control in line with global GMP standards, and has established a Shanghai-based manufacturing facility certificated by China and the EU GMP.

Henlius has pro-actively built a diversified and high-quality product pipeline covering over 20 innovative monoclonal antibodies (mAbs) and has continued to explore immuno-oncology combination therapies with proprietary HLX10 (anti-PD-1 mAb) as backbone. Up to now, the Company has successfully marketed Han Li Kang^® (rituximab), China's first biosimilar, HAN QU YOU^® (trastuzumab, Zercepac^® in the EU), China's first self-developed monoclonal antibody approved both in China and in the EU, and the application for marketing registration of HLX03 adalimumab and HLX04 bevacizumab is under review, of which HLX03 has obtained the qualification for Priority Review and is expected to be marketed this year. Henlius has simultaneously conducted more than 20 clinical trials worldwide on 10 products and 8 combination therapies, and the external authorization of the products comprehensively covers the mainstream biopharmaceutical markets in Europe and the United States, as well as many emerging countries.