Sep 12, 2019｜2019
Henlius and KG Bio Announce a Collaboration for Henlius Novel Anti-PD-1 mAb HLX10 in the Asia Pacific Region
Shanghai Henlius Biotech, Inc., a commercial-stage biopharmaceutical company focused on developing and commercializing antibodies for the treatment of tumor and auto-immune diseases (hereinafter referred to "Henlius"), and PT Kalbe Genexine Biologics (hereinafter referred to "KG Bio"), a holding subsidiary to PT Kalbe Farma, Tbk (hereinafter referred to "Kalbe Farma"), an Indonesian pharmaceutical company, today announced a collaboration for HLX10 – a recombinant humanized anti-programmed cell death (PD-1) monoclonal antibody injection independently developed by Henlius. With the collaboration, KG Bio will be granted exclusive rights to develop and commercialize HLX10 in the Asia Pacific territory including Philippines, Indonesia, Malaysia, Singapore, Thailand, Laos, Myanmar, Cambodia, Brunei and Vietnam. The payment reaches the total value of US$ 692 million including 1) upfront payment of US$10 million upon signing of the License Agreement; 2) commercial sales milestone payments not exceeding US$650 million depending on the level of accumulative net sales of relevant products; 3) regulatory milestone payments not exceeding US$22 million; 4) US$10 million to fund the trials of two combination therapies to be initiated by Henlius.
The collaboration is an important milestone of the global strategy for the expanded commercial presence of Henlius. Established in January 2016, KG Bio is a joint-venture between Kalbe Farma, one of the largest publicly-listed pharmaceutical companies in Southeast Asia and Genexine Inc. (hereinafter referred to "Genexine") of South Korea, focusing on clinical development and the commercialization of novel biologics and monoclonal antibodies in ASEAN, Asia Pacific and MENA. Benefiting from the extensive sales networking of Kalbe Farma and the innovative technology platform of Genexine, KG Bio is committed to delivering innovative biologic and immuno-oncology products, and better solutions in treating human diseases. Through the collaboration with KG Bio and Kalbe Farma, Henlius will strengthen its market access to Southeast Asia for HLX10 as a part of its international strategy through Kalbe Farma's extensive sales networking in the market with the aim of sharpening its global competitiveness and brand awareness in the field of immuno-oncology. With the long-term commitment to "affordable innovation", Henlius continues to provide patients in Southeast Asia access to high-quality, affordable and novel biological therapies.
"We are excited to achieve the collaboration on HLX10 and look forward to working with the experienced team at KG Bio and Kalbe Farma. Their extensive sales networking and in-depth coverage in Southeast Asian market will undoubtedly fuel the globalization of the development and commercialization for HLX10 in the market. There have been exponential gains in immuno-oncology in recent years through the development of immune checkpoint inhibitors such as anti-PD-1 and anti-PD-L1. However, not all patients benefit, and efforts should thus focus on improving the efficacy of immunotherapy through the use of combination approaches. Against such a backdrop, we differentiate ourselves with 'Global plus Combo' strategy. For 'Combo', we mean we advance immuno-oncology combination therapies with proprietary mAbs as backbones in combination with other therapies. For 'Global', we have global multi-center clinical trials ongoing in various countries and regions worldwide. We believe the collaboration will further strengthen the globalization of our immuno-oncology combination therapy," commented Scott Liu, Ph.D., the Co-Founder, President, and Chief Executive Officer of Henlius.
"We welcome warmly this collaboration with Henlius, through this we will be able to enrich the product portfolio of KG Bio in the field of immune-oncology. This collaboration of Kalbe with Henlius through KG Bio has the potential to drive the development of innovative biologics that are both high quality and affordable in Indonesia and other Southeast Asian countries," commented Sie Djohan, Director of Kalbe Farma and President Commissioner of KG Bio.
Looking forward, Henlius will proactively expand its global presence through continued strategic collaboration with international leading pharmaceutical companies, underscoring its mission to deliver quality products and effective treatment to patients worldwide.
About HLX10
HLX10 (recombinant humanized anti-PD-1 monoclonal antibody injection) is a noval mAb developed by Henlius independently. Currently, the global multi-center clinical trials for the treatment of various tumors are undergoing in different countries and regions such as Taiwan China and Mainland China. Concurrently, HLX01 is also being developed for the treatment of chronic hepatitis b infection.
Combination therapy has become main trend with the aim of improving the efficacy of anti-PD-1 products as mono-therapy. By virtue of high-caliber talents and integrated R&D platform, Henlius presses forward with the strategy of immune-oncology combination therapy with proprietary mAbs including HLX10 and HLX20 (recombinant humanized anti-PD-L1 monoclonal antibody injection) as backbones, among which, the combination therapy of HLX10 plus HLX 04 (bevacizumab biosimilar), HLX07 (recombinant anti-EGFR humanized monoclonal antibody injection) and chemotherapy are indicated for squamous cell carcinoma of the head and neck (SCCHN), locally advanced or metastatic esophageal squamous cell carcinoma (mESCC), locally advanced or metastatic squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC), metastatic non-squamous non-small cell lung cancer (nsNSCLC) , hepatocellular carcinoma (HCC) and so forth.
About Henlius
Henlius is a leading biopharmaceutical company in China with the vision to offer high-quality, affordable and innovative biologics for patients worldwide with a focus on oncology and autoimmune diseases. Since its inception in 2010, Henlius has built an integrated and efficient global R&D platform with key facilities in Shanghai, Taipei and California. The three R&D centers closely collaborate with each other to ensure a highly productive and cost-efficient R&D process. Starting from biosimilar, Henlius presses forward with novel mAb products and immuno-oncology combination therapies with proprietary anti-PD-1 and PD-L1 mAbs as backbone. Henlius establishes a diversified product pipeline of biosimilars, bio-innovative drugs and combination therapies, and builds an integrated platform covering the whole product lifecycle including R&D, commercial-scale production and commercialization.
Until now, in addition to one product launched commercially and two products under NDA/MAA review, Henlius has conducted over 20 clinical studies for 14 products and 6 combination therapies worldwide. HLX01, the first product of Henlius, has been granted approval by the NMPA as the first approved biosimilar in China. HLX03 (adalimumab injection) and HLX02 have their NDA under priority review by the NMPA. HLX02 is also the first China-manufactured biosimilar developed in a global setting. In June 2019, the MAA for HLX02 was accepted for review by EMA. Moreover, Henlius advances immuno-oncology combination therapies with proprietary mAbs including HLX10 (anti-PD-1 mAb) as backbone in combination with other mAbs including HLX04 (bevacizumab biosimilar) and HLX07 (anti-EGFR mAb). The global multi-center clinical trials are ongoing in various countries and regions worldwide.
About KG Bio
Kalbe Genexine Biologics (KG Bio) is a joint venture between Kalbe Farma of Indonesia and Genexine of South Korea. KG bio is focused on clinical development and the commercialization of novel biologics and monoclonal antibodies in ASEAN, Asia Pacific and MENA. Through innovative technological platform that ensures affordable and high-quality products, KG Bio aims to provide innovative biologic and immuno-oncology products, and better solutions in treating human diseases.
About Kalbe Farma
Kalbe Farma was established in 1966 and is one of the largest publicly-listed pharmaceutical companies in Southeast Asia. It has four main divisions include prescription pharmaceuticals, consumer health, nutritionals and distribution with over one million outlets. Kalbe Farma currently has more than 35 subsidiaries and 12 production facilities with international standards, supported by around 17,000 employees, spread in 76 branches across Indonesia. Since 1991, its shares have been listed on the Indonesia Stock Exchange (IDX: KLBF).
About Genexine, Inc.
Genexine, Inc., listed on KOSDAQ (095700) since 2009, is a leading biotherapeutics company focused on immuno-oncology and orphan disease. Genexine has a robust pipeline of products in the clinical stage, e.g. Hyleukin-7™, HyTropin (GX-H9), Papitrol (GX-188E), etc. based on long-acting Fc fusion technology and therapeutic DNA vaccine technology. Genexine has completed multinational phase II trials and is preparing to apply IND of US Phase III trial for HyTropin (long-acting human growth hormone, hGH-hyFc). Papitrol, a therapeutic DNA vaccine for HPV-associated diseases, is under Phase II in Europe and Korea for Cervical Intraepithelial Neoplasia (CIN) II/III. Founded in 1999, Genexine has over 180 employees, and half of them are scientists with MSc, or Ph.D. Genexine is located in Pangyo Techno Valley near Seoul, Korea.
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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: [email protected]
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: [email protected]
(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.
Terms of Use
This website (http:/) 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.
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Medical Information
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Privacy
Henlius respects your privacy. Please refer to our Privacy Notice for details.
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Last updated: March 30, 2026