Dec 12, 2025｜2025
China NMPA Accepts NDA and Grants Priority Review to Serplulimab for Neo-/Adjuvant Treatment of Gastric Cancer
The regulatory approval process for serplulimab has accelerated, making it poised to become the world’s first anti-PD-1 monoclonal antibody approved for perioperative treatment of gastric cancer.
Serplulimab is the first drug to receive Breakthrough Therapy Designation from the CDE for perioperative gastric cancer treatment, and the first to be granted Priority Review for this indication.
As the world’s first perioperative regimen for gastric cancer to replace adjuvant chemotherapy with immunotherapy monotherapy, it significantly reduces the risk of recurrence and increases the potential for cure.
Shanghai, China, December 12, 2025 — Shanghai Henlius Biotech, Inc. (2696.HK) announced that the New Drug Application (NDA) for its self-developed innovative anti-PD-1 monoclonal antibody HANSIZHUANG (serplulimab, trade name in Europe: Hetronifly®), in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by adjuvant treatment after surgery, for PD-L1 positive, operable gastric cancer patients, has been accepted by the National Medical Products Administration (NMPA) and granted Priority Review. This designation will shorten the regulatory review timeline to 130 working days, significantly accelerating the approval process for this indication. HANSIZHUANG is poised to become the world's first anti-PD-1 monoclonal antibody approved for perioperative treatment of gastric cancer.
Dr. Jason Zhu, Executive Director, and Chief Executive Officer of Henlius, said: “The NDA acceptance and priority review of serplulimab marks its formal entry onto a fast regulatory track for perioperative gastric cancer. As the world’s first innovative regimen in this setting to replace postoperative adjuvant chemotherapy with immunotherapy monotherapy, this approach will significantly improve patients’ quality of life and survival outcomes. We look forward to bringing this novel strategy to patients as soon as possible, offering them renewed hope for a cure.”
Gastric cancer is a major global health burden, ranking as the fifth most common cancer and the fifth leading cause of cancer-related death worldwide [1]. In China, it is particularly prevalent, with approximately 359,000 new cases and 260,000 deaths estimated in 2022, making it the fifth most frequently diagnosed cancer and the third leading cause of cancer mortality [2]. Radical surgery is the primary curative approach but is often limited by low rates of curative resection and high risks of postoperative recurrence. Therefore, optimizing perioperative therapeutic strategies is critical for improving patient outcomes [3-5]. Currently, perioperative chemotherapy or chemoradiotherapy constitutes the standard of care [6-8]. However, the efficacy of these regimens is constrained, and they are frequently associated with significant toxicity, contributing to persistently high recurrence rates. Although immunotherapy has transformed the treatment landscape for advanced gastric cancer, its application in the perioperative setting remains investigational, with no such therapies yet approved for this use in China. This gap underscores a significant unmet clinical need. Consequently, the development of novel treatment strategies capable of effectively reducing recurrence and enhancing cure rates is of paramount importance.
HANSIZHUANG is the world’s first and only anti-PD-1 monoclonal antibody with positive results from a phase 3 registrational trial in the perioperative treatment of gastric cancer. The NDA is primarily supported by the encouraging outcomes of the pivotal ASTRUM-006 study. ASTRUM-006 is a randomized, double-blind, multicenter, phase 3 clinical trial designed to evaluate the efficacy and safety of HANSIZHUANG combined with chemotherapy versus placebo combined with chemotherapy in the neoadjuvant/adjuvant treatment of gastric cancer. The interim analysis showed the study met its pre-specified primary endpoint of superiority. Compared to the control arm, the serplulimab-based regimen demonstrated a statistically significant and clinically meaningful improvement in Event-Free Survival (EFS) and a substantially higher pathological complete response (pCR) rate, significantly reducing the risk of disease recurrence, with a manageable safety profile. This study pioneers a novel, “chemotherapy-free” adjuvant treatment model following surgery, which not only significantly enhances efficacy but also improves patients’ quality of life. It marks a pivotal shift in the treatment paradigm for gastric cancer—from a sole focus on efficacy to a balanced emphasis on both efficacy and quality of life. Previously, HANSIZHUANG was granted BTD by the CDE for perioperative treatment of gastric cancer, becoming the first drug to receive this designation in this indication. Given that it meets the criteria for priority review, the CDE has agreed to include it in the Priority Review and Approval Procedure. Under relevant regulations, the regulatory review timeline for its NDA is set to be substantially shortened from the standard 200 working days to approximately 130 working days.
As a core oncology asset for Henlius, HANSIZHUANG demonstrates unique advantages in treating various solid tumors via its differentiated mechanism. The drug not only induces stronger PD-1 internalization—reducing PD-1 receptor presence on T cells for rapid and potent immune activation[9]—but also minimizes PD-1-mediated recruitment of the co-stimulatory molecule CD28, thereby preserving CD28 signaling [10-12], enhancing downstream AKT activity [13], and promoting sustained T-cell activation. To date, HANSIZHUANG has received marketing approvals for the treatment of multiple indications, including squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma (ESCC), and non-squamous non-small cell lung cancer (nsNSCLC). The drug has been launched in over 40 countries and regions, including China, the United Kingdom, Germany, Singapore, and India, reaching nearly half of the global population. Alongside this advance in gastric cancer, patient enrollment has been completed for a phase 3 trial evaluating serplulimab plus chemotherapy as first-line therapy for metastatic colorectal cancer, with data anticipated in the coming year.
Gastrointestinal (GI) cancers are a core strategic focus area for the company. Henlius is actively deepening our pipeline around key malignancies such as gastric, esophageal, and colorectal cancers. This effort is driven by a portfolio of innovative products, including HANSIZHUANG, HLX22 (a novel epitope-targeting anti-HER2 monoclonal antibody), and HLX43 (a PD-L1-targeting antibody-drug conjugate). Our goal is to build a comprehensive and leading treatment landscape for GI cancers. Remaining committed to our patient-first mission, Henlius will advance this breakthrough therapy toward market approval, aiming to accelerate patient access and improve clinical outcomes in gastric cancer.
【Reference】
[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 May-Jun;74(3):229-263.
[2] Han B, Zheng R, Zeng H, Wang S, Sun K, Chen R, Li L, Wei W, He J. Cancer incidence and mortality in China, 2022. J Natl Cancer Cent. 2024 Feb 2;4(1):47-53.
[3] 江良县,等. 新辅助化疗联合腹腔镜手术治疗进展期胃癌效果及患者生活质量情况观察[J].世界华人消化杂志,2018, 26(13):782-789.
[4] Knight G, Earle CC, Cosby R, et al. Gastric Cancer ,2013, 16(1):28-40.
[5] 高梓茗，等. 新辅助治疗与转化治疗——探索适合中国胃癌患者的围手术期治疗模式[J]. 中华医学信息导报，2021, 36(3): 17-17.
[6] Lordick F, Carneiro F, Cascinu S, et al. Gastric cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2022 Oct;33(10):1005-1020.
[7] National Comprehensive Cancer Network. NCCN clinical practice guidelines in oncology (NCCN guidelines): gastric cancer (Version 3.2025).
[8] Japanese Gastric Cancer Association. Japanese Gastric Cancer Treatment Guidelines 2021 (6th edition). Gastric Cancer. 2023 Jan;26(1):1-25.
[9] 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.
[10] Hui E, et al. T cell costimulatory receptor CD28 is a primary target for PD-1-mediated inhibition. Science. 2017;355(6332):1428-1433.
[11] 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.
[12] 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.
[13] 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@178xian.com
Cookies Policy
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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.
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Shanghai Henlius Biotech, Inc. (“Henlius”) is committed to improving the accessibility and user friendliness of its website for all visitors.
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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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Last updated: March 30, 2026
