Jul 29, 2020｜2020
Challenge Dilemmas in the Treatment of SCCHN, Henlius Innovative Combination Therapy Dosed the First Patient in a Phase 2 Clinical Trial
Shanghai, China, July 29, 2020-Shanghai Henlius Biotech, Inc. (2696.HK) announced that the first patient was dosed in Chinese mainland in a Phase 2 clinical trial of HLX10, a recombinant humanised anti-programmed cell death protein 1 (PD-1) monoclonal antibody (mAb) injection, in combination with HLX07, a recombinant anti-epidermal growth factor receptor (EGFR) humanised monoclonal antibody injection, for the treatment of recurrent or metastatic squamous cell carcinoma of head and neck (SCCHN). This is the second mAb combination therapy of Henlius which received clinical trial approval from the National Medical Products Administration (NMPA) and also the first mAb combination therapy developed for the treatment of SCCHN that has entered into clinical trial stage.
Challenge dilemmas in the treatment of SCCHN and lead its innovative combination therapy development
Head and neck cancer is the 5th most prevalent cancer worldwide，with more than 500,000 newly diagnosed cases each year[1]. Moreover, the incidence of this health problem is higher in China than other countries and regions[2], and an increasing population of patients has being diagnosed. There are varied origins for Head and neck cancer. Except of eyes, brain, ears, thyroid and esophagus, tumors originating from other head and neck tissues or organs are all considered as head and neck cancer. Accounting for nearly 90% patients[3], SCCHN is the most common type of head and neck cancer and the majorities of SCCHN patients show EGFR over-expression[4].
Before the emergence of immunotherapy, the anti-EGFR receptor antibodies and chemotherapies were used as major effective therapeutic modalities in SCCHN while their clinical benefits proved to be limited and problems of resistance of EGFR targeting have been found. In recent years, though more and more clinical evidence has suggested that significant benefits were observed in some advanced SCCHN patients with monotherapy of immune checkpoints inhibitor, there is still a large proportion of the patients who response poorly to this therapy. Innovative therapies are strongly needed to further improve the survival benefits of advanced SCCHN patients. As immune-regulatory mechanism of EGFR antibody gradually been discovered[5], novel combination therapies of anti-EGFR monoclonal antibody and immune checkpoint inhibitor may provide a breakthrough to solve the treatment dilemmas of SCCHN.
HLX10 is a novel anti-PD-1 monoclonal antibody independently developed by Henlius and has exhibited better pharmacokinetics, pharmacodynamics properties, favourable safety, tolerability profile and anti-tumor activity in preclinical and early clinical research. HLX07 is the first bio-better independently developed by Henlius. On the basis of cetuximab, a series of optimisation processes, e.g. humanisation, affinity maturation and stable cell line construction, have been conducted for HLX07 to reduce the immunogenicity and increase the affinity of the product. In preclinical animal model tests, HLX07 exhibited better anti-tumor activities than cetuximab in variety of xenograft models including human head and neck cancer xenograft. In December 2019, the investigational new drug (IND) applications for the combination therapy of HLX10 and HLX07 has been approved by the National Medical Products Administration(NMPA), for the treatment of recurrent or metastatic head and neck squamous cell carcinoma.
The clinical trial which just dosed the first patient is an open-label, Phase 2 clinical study to evaluate the clinical efficacy and safety in HLX10 combined with HLX07 in patients with advanced recurrent or metastatic head and neck squamous cell carcinoma. The study primarily aims to assess objective response rate (ORR) at week 16 and the safety profile of HLX10 in combination with HLX07. Secondary objectives include evaluating other efficacy endpoints, immunogenicity and pharmacokinetics file. Exploratory objective includes identifying biomarkers for therapeutic response and/or drug resistance. Were the clinical trial of this combination therapy for SCCHN went well, it will hopefully break through the limitations of established therapeutic modalities and lead to a new and more effective treatment options for patients with SCCHN.
Comprehensive international layout and quickly implementation of combination therapies focusing on HLX10
To maximize the clinical potential of HLX10, a differentiated strategy of "Combo plus Global" is adopted by Henlius in the development of HLX10. Currently, more than 10 clinical trials has been conducted to explore the efficacy of HLX10, in which several of them are phase 2/3 pivotal trials that can be potentially used to submit New Drug Application of HLX10. In addition to SCCHN, Henlius has actively explored the efficacy of HLX10 in a variety of solid tumours covering lung, gastric and uterine cancer and hepatocellular and esophageal carcinoma etc. It is worth mentioning that HLX10 in combination with HLX04, a bevacizumab biosimilar developed by Henlius independently has been approved for the treatment of advanced solid tumors in September 2018, making it the first domestic mAbs combination therapy that has received IND approval in China.
The manufacturing and development of HLX10 is strictly in accordance with international standards and its manufacturing facility based in Shanghai has passed on-site inspections and/or audits conducted by EU QP. The position of HLX10 to be a global product and to benefit patients around the world will become a major differentiation advantage of HLX10. Besides Chinese mainland, HLX10 has been approved for clinical trials in the United States and Taiwan China successively, with multiple international clinical trials accounting for a high proportion in all of the clinical trials being conducted of HLX10. With the initiation of multiple international clinical trials and the enrollment of patients in overseas trial sites, the pace of HLX10 to enter international market will be accelerated.
Apart from conducting international trials of HLX10, Henlius also actively seeks for international cooperation opportunities with the aim to benefit more patients in the world, especially patients in emerging markets. Henlius has reached a collaboration agreement with PT Kalbe Genexine Biologics (KG Bio), upon which KG Bio is granted exclusive rights to develop and commercialize HLX10 in relation to its first monotherapy and two combination therapies in 10 Southeast Asian countries.
Self-developed extensive portfolio forwards affordable diversified immune-oncology combination therapies
The combination of in-house innovative mAbs has significant advantages in the development of combination immunotherapy, which can greatly reduce time and cost in the development process. Fully leveraging innovative in-house capabilities, Henlius has built an extensive pipeline across different categories of targets including tumour-specific target, angiogenesis target, immunotherapeutic target, etc. to make affordable and extensive combination therapies possible. Meawhile, the relevant data and insights on PD-(L)1 and EGFR pathway and on structure-activity relationship of anti-PD-1 and anti-EGFR antibodies that can be accumulated during the development of combination therapy of HLX10 and HLX07 will lay the foundation for Henlius' future endeavours in the development of bispecific antibodies with PD-1 and EGFR target.
【参考文献】
[1] Fitzmaurice C, Allen C, Barber R M, et al. Global, regional, and national cancer incidence, mortality, years of life lost, years lived with disability, and disability-adjusted life-years for 32 cancer groups, 1990 to 2015: a systematic analysis for the global burden of disease study[J]. JAMA oncology, 2017, 3(4): 524-548.
[2] Chen W , Zheng R , Baade P D , et al. Cancer statistics in China, 2015[J]. CA: A Cancer Journal for Clinicians, 2016, 66(2):115-132.
[3] Sanderson RJ, Ironside JA. Squamous cell carcinomas of the head and neck. BMJ. 2002;325(7368):822‐827.
[4] Ang KK, Andratschke NH, and M. L, Epidermal growth factor receptor and response of head-andneck carcinoma to therapy. Int J Radiat Oncol Biol Phys., 2004 3 1;58(3):959–65.
[5] Concha-Benavente F and Ferris RL, Oncogenic growth factor signaling mediating tumor escape from cellular immunity. Curr Opin Immunol, 2017 45: p. 52–59.
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Privacy Policy
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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:
• 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@lshhqj.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.
Contact us:
Email: PR@lshhqj.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.
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This website (http://www.lshhqj.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.
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Last updated: March 30, 2026