Henlius

Mar 11, 2021｜2021

First Patient Dosed in Phase II/III Clinical Trial of Henlius Anti-PD-1 mAb HLX10 Combined with Bevacizumab for the First-line Treatment of mCRC

Shanghai, China, March 11th, 2021 – Shanghai Henlius Biotech, Inc. (2696.HK) announced the first patient was dosed in a Phase II/III clinical trial (NCT04547166) of HLX10, a recombinant humanised anti-programmed cell death protein 1 (PD-1) monoclonal antibody (mAb) injection, in combination with HLX04 (bevacizumab) and chemotherapy for the first-line treatment of metastatic colorectal cancer (mCRC). Currently, there are few studies exploring immuno-oncology combination therapies in this patient population in China and this study is in a leading position in this area. Professor Ruihua Xu of Sun Yat-Sen University Cancer Center is the leading principal investigator of this study.

Immuno-oncology mAbs combination therapies based on proprietary products, expecting to benefit first-line mCRC patients

CRC is the second common malignancy and the fifth leading cause of cancer deaths in China. There are about 521,000 new diagnosed cases in 2018^[1] and the incidence increases with age. Metastasis happens frequently in colorectal cancers and the majority of patients with colorectal cancer are diagnosed at advanced stages^[2]. The most common sites for metastasis are liver, lung and abdominal cavity, among which liver metastasis is most frequently seen, and about 50% of mCRC patients suffer from liver metastasis^[3]. Currently, colorectal cancer treatment may include some combination of surgery, radiation therapy, chemotherapy and targeted therapy. Combining bevacizumab with chemotherapy is the standard first-line treatment for mCRC, which can significantly improve survival rates. The New Drug Application (NDA) of HLX04 has been accepted by the National Medical Products Administration (NMPA), potentially for the treatment of advanced, metastatic or recurrent non-small cell lung cancer and metastatic colorectal cancer.

Studies have indicated that anti-PD-1 mAbs are effective in treating mCRC^[4]. The exploration of HLX10 in combination with HLX04 in the first-line of mCRC treatment aims to benefit patients with immuno-oncology mAbs combination therapy as early as possible, further delaying the disease progression and improving the survival status of patients with mCRC. Moreover, HLX10 in combination with HLX04 is the first domestic mAbs combination therapy approved for clinical trials in China, which has been carried out late-stage clinical studies in non-small cell lung cancer and hepatocellular carcinoma previously.

Nine immuno-oncology mAbs combination therapies trials ongoing, “Combo+Global” differentiation advantages significant

HLX10 is a novel anti-PD-1 mAb independently developed by Henlius and has the potential to treat a variety of solid tumours. A differentiated strategy of "Combo + Global" is adopted by Henlius in the development of HLX10. Henlius fully leverages proprietary extensive pipeline across different categories of targets including tumour-specific target, angiogenesis target, immunotherapeutic target, etc. to conduct immune combination therapies. At present, HLX10 has been approved for clinical trials in Chinese mainland, the United States and Taiwan China successively. Two monotherapies and nine immuo-oncology combination therapies clinical trials with HLX10 are ongoing in Henlius pipeline. Many of them are global multi-centre clinical trials with a variety of solid tumours that cover lung cancer, gastric cancer, cervical cancer, colorectal cancer, hepatocellular carcinoma, esophageal carcinoma and head and neck carcinoma etc. What’s more, HLX10 on MSI-H/dMMR solid tumours has entered Phase 2 clinical trial, Henlius is expected to submit NDA based on its data on HLX10.

With the continuous development of "Combo+Global" strategy of HLX10 and diversified pipeline of innovative drug candidates of Company, Henlius is actively accelerating innovation transformation, improving innovation efficiency, and committing to bringing high-quality and affordable innovative biologics to patients around the world.

About NCT04547166

This is a multi-centre, randomised, double-blind, parallel-controlled, three-stage phase II/III study, aimed to evaluate HLX10 combined with HLX04 and chemotherapy (XELOX) versus placebo combined with Avastin^® and chemotherapy (XELOX), as first-line treatment for metastatic colorectal cancer (mCRC). Stage 1 is a single-arm safety run-in study primarily aimed to evaluate the safety and tolerability of HLX10 combined with HLX04 and chemotherapy as first-line treatment in mCRC patients. Stage 2 is a multicentre, randomised, double-blind, parallel-controlled phase II study whose primary objective is to compare the efficacy between two treatment groups through the evaluation of progression-free survival (PFS). Secondary objectives include the evaluation of other efficacy endpoints, pharmacokinetic profiles, safety, and tolerability. Stage 3 is a phase III study that will be conducted based on the phase II primary efficacy results, and it follows the study design and has the same primary and secondary objectives as phase II study.

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. 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 commercialisation. It has established global R&D centers and a Shanghai-based manufacturing facility certificated by China and the European Union (EU) Good Manufacturing Practice (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 date, Henlius has launched three mAbs developed independently: 汉利康^® (HLX01, rituximab), the first China-developed biosimilar, 汉曲优^® (HLX02, trastuzumab, Zercepac^® in the EU), the first China-developed mAb biosimilar approved both in China and in the EU and 汉达远^® (HLX03, adalimumab), the Company's first product indicated for autoimmune diseases. In addition, the New Drug Applications of HLX04 (bevacizumab) and HLX01 (rituximab) for the treatment of rheumatoid arthritis are under review, and Henlius has conducted over 20 clinical studies for 10 products and 9 combination therapies worldwide, expanding its presence in major market as well as emerging market.

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Cookies Policy

Accessibility

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:

• Your personal information provided to us voluntarily

When you subscribe to our news or announcements, contact us through the contact details or other interactive features made available on our website, a third-party platform or service linked or referred to on our website, or otherwise communicate with us in relation to our website, we may collect the personal information that you voluntarily provide, such as your name, contact details, organization, and the content of your inquiry or request, depending on the relevant page or function.

• Personal information collected by us independently through our website and other online channels

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:

• To know about and make decisions regarding the processing of your personal information;

• To access or copy your personal information;

• To correct or supplement your personal information;

• To delete your personal information;

• 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:

Address: 11/F, B8 Building, No.188 Yizhou Rd, Xuhui District, Shanghai

Tel.: 021- 33395800

Postal Code: 200233

Email: PR@czxwd.com

Cookies Policy

When you visit our website, we may place small data files known as “cookies” on your device. Cookies enable our website to recognize your browser and help us understand how visitors use the site.

Cookies and similar technologies used on this website may collect online identifiers, device information, browser information, IP address, and information about how you interact with the website. In certain circumstances, such information may constitute personal information or may be associated with you under applicable PRC laws and regulations. Information collected through cookies is used for purposes such as ensuring website operation, maintaining security, analyzing traffic and performance, remembering user preferences, and improving website content and user experience.

You may choose to accept or decline cookies by adjusting your browser settings or through any cookie banner or preference center made available on our website, if applicable. Please note that disabling cookies may affect the functionality of certain parts of the website.

For more information about how we process personal information, please refer to our Privacy Notice.

Some cookies may be provided by third parties. Where third-party cookies or similar technologies are used, such third parties may process the relevant information in accordance with their own privacy policies and applicable PRC laws and regulations.

Accessibility

Shanghai Henlius Biotech, Inc. (“Henlius”) is committed to improving the accessibility and user friendliness of its website for all visitors.

We strive to ensure that the content on our website can be accessed and used by individuals with diverse needs, including those who rely on assistive technologies. As our website continues to evolve, we recognize that accessibility is an ongoing effort, and we are continuously working to improve usability and accessibility across our digital platforms.

If you experience difficulty accessing any part of our website, or have suggestions on how we can enhance accessibility, we welcome your feedback. To help us respond effectively, please include the specific webpage address (URL) and a brief description of the issue encountered.

Email: PR@czxwd.com

(Please include “Website Accessibility” in the subject line)

Henlius will make reasonable efforts to review accessibility-related feedback and improve the overall online experience for all users. While we strive to improve accessibility, we do not guarantee that every page or feature will be fully accessible to every user in all circumstances.

This website (http://www.czxwd.com/) is developed and operated by Shanghai Henlius Biotech, Inc. (“Henlius”). Please read these Terms of Use carefully before accessing or using this website. By accessing, browsing or using this website, you acknowledge that you have read, understood and agreed to be bound by these Terms of Use and applicable PRC laws and regulations.

Henlius reserves the right to modify or update these Terms of Use at any time. Any updated version will be posted on this website with a revised “Last Updated” date. Please review them periodically for updates.

Prohibited Conduct:

You shall not infringe the lawful rights and interests of Henlius or any third party, nor interfere with or attempt to interfere with the normal operation, security, or integrity of this website by any means. Without limitation, you shall not use this website for any unlawful purpose, attempt unauthorized access to any part of the website or related systems, introduce malicious code, scrape or extract website content through automated means, or otherwise interfere with the website’s operation or security features.

All content on this website, including but not limited to text, data, logos, graphics, audio, video and other materials, is owned by Henlius or its respective rights holders, unless otherwise stated. Such content is protected by applicable Chinese and international copyright laws. This website and its content may be accessed and used only for lawful, personal, and non-commercial purposes. Without prior written consent, no entity or individual may copy, reproduce, republish, upload, post, transmit, distribute, modify, create derivative works from, mirror, or otherwise use such content for commercial or public purposes.

Disclaimers

To the fullest extent permitted by applicable PRC laws and regulations, Henlius makes no warranties or representations, express or implied, regarding the content of this website, including but not limited to accuracy, completeness, timeliness or suitability for any particular purpose. Henlius does not undertake any obligation to update the content of this website , except as otherwise required by applicable PRC laws and regulations.

You use this website and any information obtained from it at your own risk. To the fullest extent permitted by applicable PRC laws and regulations, Henlius shall not be liable for any loss or damage arising from the use or inability to use this website, including but not limited to system failures, computer viruses or data loss.

Medical Information

Nothing on this website constitutes medical advice, diagnosisor treatment recommendations. Medical decisions should always be made in consultation with qualified healthcare professionals. Any product-related or disease-related information provided on this website is provided for general informational purposes only and should not be construed as medical advice, diagnosis, or treatment recommendations; any product information is subject to the approved prescribing information and applicable local laws and regulations.

Third Party Websites

This website may contain links to third party websites for convenience. Henlius is not responsible for the content, availability, privacy practices, terms or use of such third-party websites. Access to third party websites is at your own risk.

Privacy

Henlius respects your privacy. Please refer to our Privacy Notice for details.

Governing Law

These Terms of Use shall be governed by the laws of the People’s Republic of China.

Last updated: March 30, 2026

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