购宝钱包(中国)

Jun 23, 2026｜2026
Henlius’ Serplulimab Marks Third Publication in a Leading International Journal, with Small Cell Lung Cancer Long-Term Survival Data Published in JAMA Oncology and a 4-Year OS Rate of 21.9%

Recently, the end-of-study analysis results from ASTRUM-005, a study of Henlius’ self-developed anti-PD-1 monoclonal antibody(mAb) HANSIZHUANG (serplulimab, trade name in Europe: Hetronifly®) in combination with chemotherapy for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC), were published in the internationally renowned oncology journal JAMA Oncology (impact factor: 23.9). The publication also reported patient-reported outcomes (PROs) data for the first time. The final analysis confirmed that serplulimab delivers durable and clinically meaningful survival benefits for patients with ES-SCLC, accompanied by a contemporaneous editor’s note that highly recognized the durable clinical benefit this study brings to patients with ES-SCLC. The relevant long-term follow-up data were first presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, and their publication in a top-tier journal now provides high-level evidence to inform global clinical practice, further reinforcing its leading position in the field of immunotherapy for small cell lung cancer.


In September 2022, the interim analysis of ASTRUM-005 was published in JAMA, becoming the first clinical immunotherapy study in small cell lung cancer worldwide to appear in the journal. In 2025, updated data analyses and biomarker exploration results were published in Cancer Communications. In addition, key data from ASTRUM-005 were presented at the ASCO Annual Meetings in 2022, 2024, and 2025, achieving coordinated dissemination through both major academic conferences and top-tier journals. This four-year academic journey, with three appearances in leading international journals, not only highlights the robustness of the study data but also reflects broad recognition from the global academic community.


4-Year OS Rate Reaches 21.9%, Further Validating Durable Long-Term Benefit

Lung cancer remains the most commonly diagnosed cancer and the leading cause of cancer-related death worldwide, with approximately 2.5 million new cases and 1.8 million deaths reported globally in 2022.1 Small cell lung cancer (SCLC), the most aggressive subtype of lung cancer, accounts for around 15% of all lung cancer cases.2 Approximately two-thirds of patients with SCLC are diagnosed at the extensive stage, and the 5-year survival rate remains only 7%.2,3


ASTRUM-005 is a randomized, double-blind, international multicenter, placebo-controlled Phase 3 clinical trial designed to evaluate the efficacy and safety of serplulimab in combination with chemotherapy (carboplatin plus etoposide) as first-line treatment for ES-SCLC. Conducted across 114 investigational sites in 6 countries, the study enrolled 585 previously untreated patients with ES-SCLC. Based on the ASTRUM-005 results, serplulimab has been approved in 50 countries and regions, including China, the United Kingdom, the European Union, Singapore, India, Switzerland, and Peru, for the first-line treatment of ES-SCLC, making it the world’s first anti-PD-1 mAb approved for this indication. It has also received orphan drug designation from the U.S. FDA and other regulatory authorities, addressing a significant unmet clinical need.


As of the data cutoff date of May 7, 2024, with a median follow-up of 42.4 months, the long-term follow-up results demonstrated durable survival benefits with the serplulimab-based regimen:


  • Overall Survival (OS): Median OS reached 15.8 months in the serplulimab group, representing an extension of 4.7 months versus 11.1 months in the chemotherapy control group, with a 40% reduction in the risk of death (HR=0.60, 95% CI: 0.49–0.73, P<0.001). Long-term survival outcomes were particularly notable, with a 4-year OS rate of 21.9% in the serplulimab group—more than triple that of the chemotherapy group (7.2%).

  • Tumor Response and Disease Control: Median progression-free survival (PFS) was 5.8 months in the serplulimab group versus 4.3 months in the chemotherapy group (HR=0.47, P<0.001). The objective response rate (ORR) improved to 68.9%, and median duration of response (DOR) was 6.8 months, both markedly superior to the control arm, suggesting that more patients achieved deeper and more durable tumor responses.

  • Safety and Quality of Life: No new safety signals were identified during long-term follow-up. The incidence of grade ≥3 treatment-related adverse events was comparable between the serplulimab and chemotherapy groups (35.0% vs 29.1%). Meanwhile, PRO data showed that the serplulimab regimen prolonged survival without compromising patients’ quality of life.


As an innovative anti-PD-1 mAb independently developed by Henlius, serplulimab is distinguished by a differentiated mechanism. Preclinical studies have proven that serplulimab not only induces stronger PD-1 internalization—reducing PD-1 receptor presence on T cells for rapid and potent immune activation4—but also minimizes PD-1-mediated recruitment of the co-stimulatory molecule CD28, thereby preserving CD28 signaling,5-7 enhancing downstream AKT activity,8 and promoting sustained T-cell activation.


Leveraging its unique mechanistic advantages, serplulimab has achieved breakthroughs in both lung cancer and gastric cancer. It is the world’s first anti-PD-1 mAb approved for first-line treatment of SCLC, and also the first and only* anti-PD-1 mAb approved for the perioperative treatment of gastric cancer. To date, serplulimab has been approved globally** for first-line treatment of squamous non-small cell lung cancer (sqNSCLC), ES-SCLC, esophageal squamous cell carcinoma (ESCC), and non-squamous non-small cell lung cancer (nsqNSCLC), as well as perioperative treatment of gastric cancer. Key clinical studies of serplulimab have been successively published in leading international medical journals, highlighting the strong value and leadership of its evidence base. In lung cancer, beyond the ASTRUM-005 study, results from the ASTRUM-004 study in first-line sqNSCLC and the ASTRUM-002 study in first-line nsqNSCLC were published in Cancer Cell and The Lancet Respiratory Medicine, respectively. In gastrointestinal cancers, the ASTRUM-006 study in perioperative gastric cancer and the ASTRUM-007 study in first-line ESCC were published in The Lancet and Nature Medicine, respectively, further reinforcing the academic influence of serplulimab across multiple tumor types.


At the same time, Henlius continues to advance the global clinical development of serplulimab across high-incidence cancers, including lung cancer and gastrointestinal malignancies. In lung cancer, serplulimab now covers the full spectrum of first-line treatment for advanced lung cancer. Beyond already approved indications, patient enrollment has been completed in an international multicenter Phase 3 trial evaluating serplulimab in combination with chemotherapy and concurrent radiotherapy as first-line treatment for limited-stage SCLC (LS-SCLC). In addition, bridging studies for ES-SCLC being conducted in parallel in the United States and Japan have also completed enrollment. In gastrointestinal cancer, global enrollment has been completed in the international multicenter Phase 3 study ASTRUM-015, which is evaluating serplulimab in combination with bevacizumab and chemotherapy as first-line treatment for metastatic colorectal cancer (mCRC), with the potential to address an unmet need for immunotherapy in patients with MSS mCRC.


In addition, serplulimab continues to make breakthroughs internationally, with its commercial footprint expanding rapidly. Up to date, it has been approved in 50 countries and regions including China, the United Kingdom, the European Union, Singapore, India, Switzerland, and Peru, covering nearly half of the global population. Henlius, together with its regional partners including Accord and Abbott, has continued to advance market access and commercialisation efforts for serplulimab in overseas markets. Since receiving its first approval in the European Union in February 2025, to date, serplulimab has been commercially launched in 16 European countries and has been included in reimbursement or public healthcare coverage systems in 10 countries, including Austria, Denmark, Germany, Ireland, Italy, Spain, and Sweden, thereby gaining access to mainstream healthcare systems in these markets.


*As of June 22, 2026

**Approved indications may vary by country or region. Please refer to the prescribing information and approvals issued by the relevant local regulatory authorities.


References

1. Bray F, Laversanne M, Sung H, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024;74(3):229-263. doi:10.3322/caac.21834

2. Rudin CM, Brambilla E, Faivre-Finn C, Sage J. Small-cell lung cancer. Nat Rev Dis Primers. 2021;7 (1):

3. doi:10.1038/s41572-020-00235-0 3. American Cancer Society. Cancer facts & figures. Accessed December 26, 2025. http://www. cancer.org/content/dam/cancer-org/research/ cancer-facts-and-statistics/annual-cancer-factsand-figures/2021/cancer-facts-and-figures-2021. Pdf

4.Issafras H, et al. Structural basis of HLX10 PD-1 receptor recognition, a promising anti-PD-1 antibody clinical candidate for cancer immunotherapy. PLoS One. 2021;16(12):e0257972.

5.Hui E, et al. T cell costimulatory receptor CD28 is a primary target for PD-1-mediated inhibition. Science. 2017;355(6332):1428-1433.

6.Patsoukis N, et al. Interaction of SHP-2 SH2 domains with PD-1 ITSM induces PD-1 dimerization and SHP-2 activation. Commun Biol. 2020;3(1):128.

7.Fenwick C, et al. Tumor suppression of novel anti-PD-1 antibodies mediated through CD28 costimulatory pathway. J Exp Med. 2019;216(7):1525-1541.

8.Primavera E, et al. Computer-Aided Identification of Kinase-Targeted Small Molecules for Cancer: A Review on AKT Protein. Pharmaceuticals (Basel). 2023;16(7):993.



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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@xxzsbj.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@xxzsbj.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.xxzsbj.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.

 

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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