Mar 25, 2022｜2022
Henlius Receives NMPA Approval for its First Innovative Monoclonal Antibody HANSIZHUANG
Shanghai, China, March 25th, 2022 – Shanghai Henlius Biotech, Inc. (2696. HK) announced that its first self-developed innovative PD-1 inhibitor HANSIZHUANG (generic name: serplulimab injection) has been approved by the National Medical Products Administration (NMPA) for the treatment of adult patients with advanced unresectable or metastatic MSI-H (Microsatellite Instability-High) solid tumors that have failed to respond to previous standard treatments, providing an alternative treatment option for patients. Furthermore, it also empowers the domestic precision immunotherapy for tumors and promotes the high-quality development of China's biopharmaceutical industry.
Zhang Wenjie, Chairman, Executive Director, and CEO of Henlius, said, "I'm very glad to see the first indication of HANSIZHUANG was approved in China. As one of the pioneering PD-1 inhibitors for the 'pan-cancer' treatment of MSI-H solid tumors in China, HANSIZHUANG would give full play to its advantages in clinical practice to enable patients to live longer with more comfortable lives and accelerate the development of tumor immunotherapy. In addition, HANSIZHUANG is the fifth product launched by Henlius as well as a significant milestone in the company’s evolution toward Biopharma, which will actively drive Henlius to move forward, and inspire more innovative achievements centered on patient needs."
Professor Qin Shukui, one of the co-leading principal investigators of the pivotal phase II clinical study of HANSIZHUANG on MSI-H solid tumors, from the Tumor Center of Nanjing Jinling Hospital, said, "PD-1 inhibitor is one of the immune checkpoint inhibitors that has been explored in some diseases, which makes breakthroughs in many tumor treatments. The clinical research data of HANSIZHUANG for MSI-H solid tumors is outstanding and will actively improve the clinical efficacy and provide a new mindset and alternative option for the precision treatment for tumors in China."
Professor Li Jin, another co-leading principal investigator of the pivotal phase II clinical study of HANSIZHUANG on MSI-H solid tumors, from the Department of Oncology, Shanghai East Hospital, Tongji University, mentioned, "the approval of HANSIZHUANG brings new hope to patients with MSI-H solid tumors and better meets the demand of clinical treatment and medication of tumors. While promoting the development of domestic tumor treatment, this product plays a positive role in enhancing the recognition of 'pan-cancer' treatment and promoting the development of tumor precision immunotherapy."
"Pan-cancer" treatment benefits a broader patient population
The approval is mainly based on a single-arm, multi-center, pivotal phase II clinical study. The primary efficacy endpoint was objective response rate (ORR) assessed by independent radiological review committee (IRRC) per RECIST v1.1. As of July 10, 2021, 108 patients were enrolled, in which 68 patients with MSI-H confirmed by central laboratory or study sites were included in the main efficacy analysis population (MEAP). IRRC assessed ORR were 39.7% (95% CI: 28.03, 52.30; 3 CR, 24 PR) in MEAP. The study concludes that HANSIZHUANG monotherapy could bring significant benefits in the treatment of unresectable or metastatic MSI-H solid tumors that have failed to respond to previous standard treatments, met the primary endpoint criteria, and had good safety and tolerability. The results of this clinical study were first presented in oral at the 24th annual meeting of Chinese Society of Clinical Oncology (CSCO).
"Microsatellite" is a class of short tandem repeat DNA sequence in genes. It is called microsatellite instability (MSI) due to the change of microsatellite sequence length caused by insertion or deletion during DNA replication[1]. Many studies have shown that MSI is closely related to tumorigenesis, so in clinical practice, MSI is an important biomarker reference for the prognosis of some solid tumors and adjuvant treatment plans. MSI-H is one of the MSI types, in which two or more spots change, and commonly found in endometrial cancer, colorectal cancer, and gastric cancer, etc. These patients usually have high response to immune checkpoint inhibitors[2-3]. PD-1/PD-L1, important immunosuppressive molecules, have good therapeutic effect for patients with MSI-H solid tumors. It is estimated that there are more than 300,000 new MSI-H tumor patients in China every year[4], and some of them have no access to effective treatment. Furthermore, there are few PD-1 inhibitors approved for MSI-H advanced solid tumors in China currently. The clinical treatment demand is far from being met. Therefore, the advent of HANSIZHUANG is a "weapon" for the treatment of MSI-H solid tumors in China. It is expected to enhance the clinical diagnosis and tumor treatment with unique innovation and superior quality in clinical practice to achieve maximum benefit for patients and promote the construction of tumor prevention and treatment system.
Leverage the world-class quality to explore overseas market
With HANSIZHUANG as the backbone, Henlius conducts and accelerates various clinical trials with immuno-oncology combination therapies worldwide in a wide variety of high-incidence solid tumors, including lung cancer (LC), esophageal carcinoma, head and neck carcinoma, gastric cancer, etc., and covering the full range of first-line treatments of lung cancers. Up to date, more than 2,800 subjects have been enrolled worldwide for HANSIZHUANG clinical trials, which makes it a PD-1 inhibitor with one of the largest global clinical data pools and lays a solid foundation for future applications across the world. On the other hand, two global multi-center phase III clinical trials regarding sqNSCLC and ES-SCLC are conducted in China, Turkey, Poland, Georgia and other countries and regions, in which the Caucasian accounts for more than 30% of the total enrolled subjects, providing more diverse cases for clinical research. The NDA of the treatment for locally advanced or metastatic squamous non-small cell lung cancer (sqNSCLC) has been accepted by the NMPA and is expected to be approved in 2022. The global multi-center phase III study of HANSIZHUANG in combination with chemotherapy for the first-line treatment of ES-SCLC met the primary study endpoint of the overall survival (OS) with remarkable readouts. Its NDA in China and MAA in the EU are expected to be filed in 2022, making HANSIZHUANG potentially the world’s first PD-1 inhibitor for the first-line treatment of SCLC.
Henlius actively explores overseas commercialization of HANSIZHUANG, while proceeding its global multi-center clinical research. As early as 2019, the company forged a partnership with PT Kalbe Genexine Biologics（KG Bio）to grant it an exclusive license to develop and commercialize HANSIZHUANG in relation to a monotherapy and two combination therapies in 10 Southeast Asian countries. Going forward, Henlius will continue to expand global commercialization layout of HANSIZHUANG to reach out to more countries and regions, which urges this product to step on to the world PD-1 stage and benefits a broader patient population worldwide with its world-class quality.
In the future, Henlius will keep focusing on patient needs and inspire more "made-by-Henlius" products with efficient and innovative in-house capabilities, aiming to provide highest quality solutions and services for patients in China and across the world and to build a national brand in biopharmaceutical industry.
About HANSIZHUANG
HANSIZHUANG (recombinant humanized anti-PD-1 monoclonal antibody injection, generic name: serplulimab injection) is the first innovative monoclonal antibody developed by Henlius. It is approved by the NMPA for the treatment of MSI-H solid tumors. Henlius actively promotes HANSIZHUANG in conjunction with in-house products of the company and innovative therapies. It has successively obtained clinical trial licenses in China, the United States, the European Union and other countries and regions to initiate 9 clinical trials on immuno-oncology combination therapies of HANSIZHUANG worldwide in a wide variety of indications, such as lung cancer, esophageal carcinoma, head and neck squamous cell carcinoma and gastric cancer, etc., and covering the full range of first-line treatments of lung cancers. Up to date, the company has enrolled more than 2,800 subjects in China, Turkey, Poland, Georgia and other countries and regions, and the proportion of Caucasian is over 30% in two MRCTs, making HANSIZHUANG an anti-PD-1 mAb with one of the largest global clinical data pools. The NDA of the treatment for squamous non-small cell lung cancer (sqNSCLC) has been accepted by the NMPA and is expected to be approved in 2022. Furthermore, the global multi-center phase 3 clinical study of HANSIZHUANG in combination with chemotherapy in previously untreated extensive small-cell lung cancer (ES-SCLC) met the primary endpoint of overall survival (OS) with remarkable readouts and its NDA in China and MAA in the EU are expected to be filed in 2022, making this product potentially the world’s first anti-PD-1 mAb for the first-line treatment of SCLC.
参考文献
[1] Thibodeau S N, Bren G, Schaid D. Microsatellite instability in cancer of the proximal colon[J]. Science, 1993, 260(5109): 816-819.
[2] Michael J Overman, Ray McDermott, Joseph L Leach, et al. Nivolumab in patients with metastatic DNA mismatch repair deficient/microsatelliteinstability-high colorectal cancer (CheckMate 142): results of an open-label,multicenter, phase 2 study[J]. Lancet Oncology, 2017,18(9):1182-1191.
[3] Aurelien Marabelle, Dung T Le, Paolo A Asciert, et al. Efficacy of Pembrolizumab in Patients With Noncolorectal High Microsatellite Instability/Mismatch Repair-Deficient Cancer: Results From the Phase IIKEYNOTE-158 Study[J]. J Clin Oncol, 2020, 38(1): 1-10.
[4] Chen, W., et al., Cancer statistics in China, 2015. CA Cancer J Clin, 2016.
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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
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Last updated: March 30, 2026