Oct 12, 2019｜2019
The breakthrough of China-manufactured trastuzumab biosimilar (HLX02) for metastatic breast cancer︱Interview of Prof. Binghe Xu and Prof. Igor Bondarenko at ESMO Congress 2019
At the annual meeting of the European Society of Medical Oncology (ESMO Congress 2019)， the positive results of the phase 3 clinical trial of trastuzumab biosimilar HLX02 for metastatic breast cancer (HLX02-BC01) attracted the attention of many oncology experts. We interviewed Prof. Binghe Xu and Prof. Igor Bondarenko who were the Principal Investigators of this study， and summarised the conversations as followed.
Q1. The Phase 3 trial of HLX02 in the treatment of metastatic breast cancer has been presented at this ESMO conference. Could you please introduce its background and study design.
Prof. Igor Bondarenko: Metastatic breast cancer is a global cause of death in women. There are an estimated 2 million people diagnosed with breast cancer yearly with the mortality of about 71，300 people due to its pathology. High expression or amplification of the human epidermal growth factor receptor 2 (HER2) defines a distinct group of breast cancers， accounting for approximately 20% worldwide and resulting in more aggressive disease associated with poor prognosis. However， the tumour dependence on HER2 has also provided a target treatment. Thanks to the modern medications like trastuzumab， a humanised monoclonal antibody binding to a portion of the HER2， which became a real breakthrough over the last 15 years. While trastuzumab therapy has converted the unfavourable natural history of HER2-positive breast cancer into favourable clinical outcomes， the metastatic disease still remains incurable for most patients and approximately 50% of patients experience disease progression within 1 year of therapy for their advanced disease.
Although trastuzumab was initially evaluated and used in the first-line metastatic setting， it has become a common practice to continue trastuzumab therapy at progression， which improves patient outcomes. However， the use of trastuzumab has significant cost implications for patients and health care systems. That is why we participated in this HLX02-BC01 study， as well as other studies evaluating biosimilars with the potential of 3~5 times lower treatment price of cost savings. Personally， I’ve seen this Phase 3 blinded results of the investigator evaluation on the overall response rate for the two treatment groups (docetaxel in combination with either the standard treatment or the Henlius investigational product， HLX02) which were considerably similar. I would like to say my congratulations to our partners in China， and great achievement with positive results from this trial.
Prof. Xu: The introduction of trastuzumab in combination with chemotherapy has significantly improved clinical outcomes for patients with HER2-positve breast cancer; however， its high manufacturing cost has driven up prices resulting in limited access to this effective therapy. HLX02 was developed as a biosimilar of Herceptin® in consultation with China NMPA and EMA to support global development. Following the stepwise clinical approach for the development of biosimilar， we previously reported the clinical PK and safety bioequivalence between HLX02， EU-sourced trastuzumab and CN-sourced trastuzumab.
At this ESMO conference， we report the multi-national， randomised， double-blind Phase 3 study investigating the efficacy and safety profiles of HLX02 and EU-sourced trastuzumab in combination with docetaxel in HER2-overexpressing recurrent or previously-untreated metastatic breast cancer has met the primary endpoint of best overall response rate (ORR) after eight cycles of therapy (Week 24， ORR24). We also report the results of the interim analysis including secondary efficacy endpoints of CBR， DCR， DoR， PFS， OS， and safety outcome
Q2. Please tell us something more about the positive results of HLX02-BC01 study presented at this ESMO Congress meeting， and your comments on the positive results as well.
Prof. Xu: Sure. The use of HLX02 compared with EU-sourced trastuzumab results in an equivalent ORR at week 24. The primary outcome was ORR， which was 71.0% (HLX02) and 71.4% (EU-sourced trastuzumab) with no statistical difference observed (p=0.952) between the groups， and the ORR difference (-0.4; 95% CI: -7.4% to 6.6%) was also within the predefined margin (13.5% and -13.5%). With no new safety signals in comparison with EU-sourced trastuzumab， all secondary efficacy and safety analyses supported the biosimilarity of HLX02 and reference trastuzumab.
The positive results of the interim analysis supported the NDA and MAA submissions to China NMPA and EMA， respectively. HLX02 is the first China-manufactured trastuzumab biosimilar which developed in accordance with NMPA and EMA guidelines and maybe the first potential Chinese biosimilar being approved outside of China.
Prof. Igor Bondarenko: I think it is important to mention that this Phase 3 trial has employed the randomised and double-blind study design with high international good clinical practice (GCP) - International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) standards for evidence-based medicine. We know the primary outcome was ORR at week 24， which was approximately 71.0% in both treatment groups. The primary efficacy results from this study are quite similar to the ORR at week 25 (62.5% for PF-05280014 group; 66.5% for Herceptin group) in the Trazimera’s Pfizer study and the ORR at week 24 (69.6% for MYL-1401O group; 64.0% for Herceptin group) in the Ogivri’s Mylan study， which are the two recent trastuzumab biosimilar studies in metastatic breast cancer. At my clinic， I enrolled 22 patients into the study and we do not observe any differences between the two treatment groups in general.
It is my understanding that the submission of the marketing authorisation application (MAA) with the results from this interim analysis has been accepted by the European Medicines Agency (EMA) for review. And maybe I don’t know the details， but I know that Henlius has also filed new drug application of HLX02 in China and received priority review by the NMPA. Therefore， the results from this study are good news to many patients and countries， not only China， because access to trastuzumab might be limited for various reasons in different country， such as lack of drug funding or treatment costs.
Q3. In the recent NCCN breast cancer guidelines， biosimilar drugs have also been recommended. What do you think of the significance of this update? How does biosimilar drug like HLX02 will affect clinical practice?
Prof. Xu: We know that great progress has been made in the treatment of HER2-positive breast cancer， but there are still many patients who are unable to get adequate treatment because of the high drug prices. During the development of NCCN guidelines， the committee was asked to develop them in a cost-insensitive manner. The committee was supposed to come up with what they thought to be the best clinical care. But if the same exact high-quality clinical care could be delivered at a lower cost， it’s going to allow for continued innovation and improvement in the marketplace. The extremely high prices of most biological products have forced to look for alternative options such as the development of biosimilar products.
A biosimilar is highly similar to and has no clinically meaningful differences in safety and efficacy from the reference product. The availability of safe and effective trastuzumab biosimilar HLX02 may improve access to this critical therapy. Furthermore， HLX02 may generate savings for healthcare systems， particularly because HER2-targeted drugs may be administered for extended periods of time and in combination with other systemic therapies. The availability of HLX02 may address the unmet needs of patients and clinicians.
Prof. Igor Bondarenko: You know there’s no need for all of the patients to be treated with either biosimilar or originator. Physicians might decide not to prescribe the originators in situations where such medications have regulatory approval but they are not funded or reimbursed. Reimbursement of anti-HER2 therapy also varies across Europe， which might create disparities in accessing trastuzumab. That’s why NCCN presented their position on biosimilars couple years ago， not only for Chinese but for patients worldwide. I had participated in eight biosimilar studies in breast cancer， lung cancer， lymphoma. To date， results from some of these trials have only been disclosed at international oncology congresses and these biosimilars are highly similar to the reference products. The regulatory framework for biosimilars provides a more tailored pathway for approval compared with the originators that relies on a rigorous assessment of similarity. I believe that HLX02 will bring positive impact on clinical practice based on the results from this study that both HLX02 and the reference trastuzumab are highly similar. As a result， HLX02 might provide a lower-cost alternative to the reference trastuzumab and has the potential to generate cost savings.
Q4. The positive results of the interim analysis supported its submissions to China NMPA and EMA， thus HLX02 is coming to the market. How can we make better use of this biosimilar in the future?
Prof. Xu: HLX02 is the first and only potential Chinese trastuzumab biosimilar being approved by EMA. Clinicians need to understand what are biosimilars and how to incorporate HLX02 in a way that continues to add value to their patients and provide optimum care. Initiating treatment with an approved trastuzumab biosimilar is as safe and effective as initiating treatment with the reference product. However， questions have been raised about switching between a reference product and its biosimilar or between biosimilars of the same reference product， although no issues have been identified thus far with switching from a reference product to its biosimilar. Henlius plans to conduct post-marketing surveillance study addressing the impact of switching between reference product to HLX02.
Prof. Igor Bondarenko: Over the last few years， biosimilars have generated great interest worldwide as effective alternatives to the reference biologics. Biosimilars have been integral to clinical practice in the European Union for almost a decade. Several trastuzumab biosimilars have also recently approved in Europe. In Ukraine， we may not be at the front lines in research but we assist in the development of biosimilars for other companies and we paid attention to the many companies from Korean， China and so on. These biosimilars are highly similar to the originator products “notwithstanding minor differences in clinically inactive components and have no clinically meaningful differences in safety， purity or efficacy compared with the reference products”. The introduction of a lower-cost biosimilar such as HLX02 to my country could make trastuzumab cost-effective and support decisions for drug funding and reimbursement， thereby improving patient access to HER2 therapy for treatment of HER2-positive breast cancer.
So， what can I also remember about this study (HLX02-BC01) - the important note is that Henlius is really reaching very high international standards. This is a study involving many centres in China， Ukraine， Philippines and Poland. Our research staff have done excellent job strictly adhering to high international standards in the design and implementation of the study. I believe that this study carried out at such high GCP/ICH standards may also meet the market approval requirements from European and other countries.
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Privacy Policy
Introduction
Shanghai Henlius Biotech, Inc., and, where applicable, its affiliates and subsidiaries (collectively, “we” , “us” or “our”) attach great importance to the protection of your privacy and personal information. This Privacy Notice (this “Policy”) is formulated in accordance with applicable PRC laws and regulations governing the protection of personal information in the People’s Republic of China (“PRC”).
This Policy applies when: (1) you browse or use our website and other online resources (such as our WeChat official accounts); (2) subscribe to our news or announcements; or (3) contact us through the contact details or other interactive features made available on our website, or otherwise interact with us through our website.. The purpose of this Policy is to explain how and why we process your personal information, the types of personal information involved, applicable retention periods, your rights, and the measures we take to protect personal information. Please read this Policy carefully to ensure that you fully understand its content.
In certain business scenarios, we may provide additional explanations regarding the processing of your personal information through separate agreements, privacy statements, or personal information notices. In the event of any inconsistency, such documents shall prevail. For example, where a recruitment function is provided through a third-party platform or service, the relevant third party privacy policy or notice may also apply.
For the purposes of this Policy, “personal information” refers to all kinds of information related to identified or identifiable natural persons, excluding anonymized information.
We collect, use, store, transfer and otherwise process personal information in strict compliance with applicable PRC laws and regulations of the People’s Republic of China.
Our website may contain links to third party websites for your convenience. We do not control, and are not responsible for, the privacy practices of such third parties. We encourage you to review their privacy policies before using those websites.
If you have any questions or concerns regarding this Policy or our processing of personal information, please contact us using the details provided below.
This Policy will help you understand:
I. How we collect your personal information
II. How we use your personal information
III. How we entrust, share, transfer and publicly disclose your personal information
IV. Cross border transfer of personal information
V. How we store your personal information
VI. Security measures
VII. Your rights
VIII. Personal information of minors
IX. Updates to this Policy
X. How to contact us
I. How do we collect your personal information?
In addition to our employees, we may process personal information of the following persons:
• Visitors and users of our website;
• Healthcare Professionals;
• Investigators of clinical trial institutions and personnel of contract research organizations in clinical trials;
• Subjects of clinical trials and their relatives;
• Consumers/patients and their relatives using our products or services;
• Staff of business partners (including vendors, distributors, partners, etc.); and
• Our applicants.
We may process personal information of website visitors and individuals who contact or interact with us through our website or other online resources. Depending on the relevant page, function, or interaction, separate privacy notices, consents, platform privacy policies, contracts, or other notices may apply.
Based on the context in which you interact with us, we may collect personal information by the following means and on the legal bases permitted by applicable PRC laws and regulations, including your consent, the necessity for entering into or performing a contract, compliance with legal obligations, protection of life, health or property, public health needs, or other circumstances permitted by law:
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When you visit our website, most of our services do not require any registration, and you can visit our website without telling us who you are. However, some pages or functions may require you to provide certain personal information. If you choose not provide such information as we request, you may not be able to access certain content or functions or we may not be able to respond to your inquiry, request or subscription. Please refer to the relevant page or notice for further details about the categories of personal information collected in a specific scenario.
• Personal information we collect from vendors or business partners
In the course of our daily business operations, we may collect personal information from our vendors or business partners. We require our vendors and business partners to comply with the requirements of the personal information protection laws and regulations of the PRC and to lawfully provide us with personal information. If you are an employee or representative of one of our vendors or business partners, we may collect personal information such as your name and contact details for the purpose of establishing business contacts and cooperations.
• Personal information we collect from publicly available sources
We may collect personal information of medical and healthcare professionals from such publicy available sources, such as the official websites of medical institutions and the official websites of competent government departments, and process such information within a reasonable scope and for lawful purposes. For example, for the purpose of lawful academic or professional interaction with healthcare professionals, we may collect the name, gender, employer, position, practitioner registration information, academic title, degree, educational background, specialty expertise, and profile information, where such information has been lawfully made public.
Our website may include links, contact details, QR codes, or references to third-party platforms or services. Where you choose to interact with us through such third-party platforms or services, the relevant third party may also process your personal information in accordance with its own privacy policy and applicable law, and we encourage you to review such policy before submitting your information.
II. How do we use your personal information?
We may use your personal information for the following purposes:
• Operating, maintaining and improving our website and other online resource;
• Researching, developing, providing and continuously improving our products and services;
• Conducting and managing daily business;
• Academic interaction with healthcare professionals;
• Responding to your inquiries, requests, or communications sent through our website or the contact details made available on our website;
• Providing subscription services for our news, announcements, or investor-related updates;
• Managing and maintaining our relationship and communications with business contacts who reach us through our website;
• Recruiting and human resource management;
• Internal compliance management，audit，record-keeping; and
• Complying with applicable PRC laws and regulations, for example, monitoring and reporting adverse events for purposes of performing drug quality management responsibilities, providing medical information and dealing with product complaints, etc..
We will process personal information only to the extent necessary for the relevant purpose. Where required by applicable law, we will obtain your consent or separate consent before processing your personal information or sensitive personal information. Where a third-party platform or service is used in connection with a particular function, the relevant third party may process your personal information in accordance with its own privacy policy and applicable law.
III. How do we entrust, share, transfer and publicly disclose your personal information?
1. Entrustment
We may entrust our business partners with the processing of your personal information for the purpose(s) described in this Policy. We will enter into appropriate confidentiality, data processing and security agreements with such entrusted parties and require them to process personal information in accordance with our instructions , this Policy and applicable PRC laws and regulations.
2. Sharing and public disclosure
For the purpose(s) described in this Policy, we will share or publicly disclose your personal information only where permitted by applicable PRC laws and regulations and, where required, after obtaining your consent or separate consent. Such circumstances may include:
• Sharing your personal information among our affiliates and subsidiaries where necessary for legitimate business, management, compliance, or operational purposes;
• Sharing your personal information with vendors or business partners (such as conference service providers, travel service providers, data service providers, banking or insurance institutions, other professional service organizations, to the extent necessary for the relevant purpose); and
• Disclosing your personal information to the extent that it is permitted or required by applicable PRC laws and regulations or for the purpose of assisting with investigations by judicial, regulatory or law enforcement authorities.
• other circumstances permitted by applicable PRC laws and regulations.
If you submit your information through or in connection with a third-party platform or service referred to on our website, the relevant third party may independently process your personal information in accordance with its own privacy policy and applicable law.
3. Transfer
We will not transfer your personal information to any other company, entity or individual unless otherwise permitted by applicable law and, where required, after obtaining your consent. Further, in the event of a merger, acquisition, insolvency, reorganization, division, dissolution, bankruptcy, or similar transaction, we will require the new processor of your personal information to continue to be bound by this Policy or we will require the new processor to obtain your consent again.
IV.How do we provide your personal information across borders?
In principle, personal information that we collect and generate in the course of our operations within the territory of the PRC will be stored within the PRC. In certain circumstances, it may be necessary for us to provide your personal information to recipients outside the PRC in connection with our business operations, website functions, or communications, where permitted by applicable PRC laws and regulations. As required by applicable laws and regulations regarding the protection of personal information, we will provide you with the required notice and obtain your separate consent before providing your personal information across any border, unless otherwise permitted by law. We will use lawful cross-border transfer mechanisms to transfer your personal information oversea and will take necessary measures to ensure that the oversea recipients provide a level of protection required by applicable PRC laws and regulations.
You may obtain more information about cross-border transfers of personal information and oversea recipients through the contact methods referred to in this Policy.
V. How do we store your personal information?
We will retain your personal information for the minimum period necessary to achieve the purposes described in this Policy ,unless a longer retention period is required or permitted by applicable PRC laws and regulations. Upon expiration of the applicable retention period, we will promptly delete or anonymize your personal information in accordance with applicable PRC laws and regulations. Our criteria for determining the period for which personal information shall be retained include:
• Applicable laws, regulations and other relevant requirements;
• The period of time needed for us to provide services, maintain business relations or interact with you; and
• The period of time needed for us to perform relevant agreements or fulfil the purposes described in this Policy.
VI. What security measures do we take to protect your personal information?
In accordance with applicable PRC laws, regulations, and the requirements of relevant national standards, we take reasonable and appropriate security and precautionary measures to protect the personal information we process against unauthorized access, public disclosure, use, modification, destruction or loss of data. However, you are also responsible for taking appropriate measures to protect the security of the devices, systems, and networks you use when accessing our website or communicating with us.
VII. Your rights
In accordance with the requirements of the applicable PRC laws and regulations, you may have the following rights in respect of your personal information:
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• To access or copy your personal information;
• To correct or supplement your personal information;
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• To request for explanation of rules regarding processing of personal information; and
• To change the scope of your consent or revoke your consent , where processing is based on your consent.
If you wish to exercise your rights with respect to personal information, you may contact us through the contact information listed in this Policy and we will respond to any request in accordance with applicable relevant laws and regulations. When you exercise the above rights, we may verify your identity to safeguard the security of your personal information. Subject to applicable PRC laws and regulations, there may be circumstances where we are unable to respond to all or part of your request.
VIII. How do we process the personal information of minors?
For the purposes of this Policy and in accordance with applicable PRC laws and regulations, our products, websites and services are not targeted at minors under the age of 14. Minors under the age of 14 should not provide personal information to us without the consent of a parent or legal guardian.
If a minor's personal information is collected with the consent of a parent or legal guardian, we will process the information only when permitted by law, with the express consent of the parent or legal guardian, or necessary for the protection of the minor. If we discover that we have collected personal information without obtaining verifiable prior consent of a parent or legal guardian, we will seek to delete the data as soon as possible.
IX. Updates of the Policy
We may revise our Privacy Policy from time to time. We will post the updated version on our website and update the “Last Updated” date above or below this Policy.
Last updated: March 30, 2026.
X. How to contact us?
If you have any questions, comments or suggestions concerning this Policy, or any questions or concerns about our processing of your personal information, you may contact us in the following ways:
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Last updated: March 30, 2026
