Jun 02, 2026｜2026
Featured in Both The Lancet and ASCO: Henlius’ Serplulimab Pioneers a New Perioperative Chemotherapy-Sparring Regimen for Gastric Cancer
Pioneering a new chemo-sparring regimen: The world’s first chemo-free perioperative regimen for gastric cancer, combined with adjuvant mono-immunotherapy, precisely targeting patients with PD-L1 CPS ≥5
Robust efficacy benefits: INV-assessed EFS, the primary endpoint, showed a significant improvement. Median EFS by BICR was also significantly prolonged in the serplulimab group (NR vs. 52.0 months; HR=0.67), translating into a 33% reduction in recurrence risk. The pCR rate reached 21.6% vs. 6.4%, more than tripling that of the control group.
Favorable safety profile: Grade ≥3 TRAEs (46.6% vs. 58.5%) and treatment discontinuation due to TRAEs (6.5% vs. 10.5%) were both lower with serplulimab than with placebo, supporting better tolerability and a favorable efficacy–safety profile.
Shanghai, China, June 2, 2026 — Henlius (2696.HK) announced that data from ASTRUM-006, a Phase 3 clinical study of its self-developed novel anti–PD-1 monoclonal antibody HANSIZHUANG(serplulimab, trade name in Europe: Hetronifly®) as neoadjuvant/adjuvant treatment for gastric cancer, were formally presented for the first time in an oral presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting and simultaneously published online in The Lancet (IF: 88.5), gaining recognition from two of the world’s most prestigious academic platforms. The study was led by Professors Jiafu Ji and Lin Shen from Peking University Cancer Hospital. Against the backdrop of persistently high recurrence rates in locally advanced gastric cancer and the substantial toxicities associated with conventional chemotherapy, ASTRUM-006 has established a new perioperative treatment approach for patients with PD-L1–positive resectable gastric cancer, enabling a postoperative chemotherapy-free strategy with immunotherapy alone, supported by compelling efficacy and a more favorable safety and tolerability profile.
Professor Lin Shen from Beijing Cancer Hospital, a leading principal investigator of the ASTRUM-006 study, stated: “ASTRUM-006 is the first study worldwide to validate the chemotherapy-free immunotherapy regimen for postoperative gastric cancer treatment. This regimen accurately identifies patients who can benefit from immunotherapy and optimizes the treatment strategy. It delivers a milestone improvement in survival outcomes with outstanding safety and tolerability. The findings have been published in The Lancet and presented at ASCO. We hope this innovative regimen with superior efficacy and reduced toxicity can be rapidly adopted in clinical settings to improve patients' survival and treatment experience."
Broad Efficacy Benefits with Breakthrough Improvements in EFS and pCR
According to the latest GLOBOCAN data, there were approximately 969,000 new cases of gastric cancer and 660,000 deaths worldwide in 2022, ranking fifth among all cancers in both incidence and mortality.1 At present, curative surgery remains the mainstay of treatment for gastric cancer, while optimization of perioperative treatment strategies (neoadjuvant/adjuvant therapy) has become critical to improving long-term survival outcomes.2 Although chemotherapy remains the current standard perioperative treatment for gastric cancer, the traditional full-course chemotherapy approach is still associated with a relatively high risk of recurrence and considerable toxicity, underscoring the urgent clinical need for more precise and effective treatment options.
ASTRUM-006 is a randomized, double-blind, multicenter Phase 3 study designed to evaluate the efficacy and safety of serplulimab plus chemotherapy versus placebo plus chemotherapy as neoadjuvant/adjuvant treatment for gastric cancer. The study enrolled patients with PD-L1–positive (PD-L1 CPS ≥5), histologically confirmed, previously untreated, and resectable gastric cancer or gastroesophageal junction (GEJ) adenocarcinoma. Patients were randomized in a 1:1 ratio to receive three cycles of neoadjuvant intravenous serplulimab (4.5 mg/kg) or placebo in combination with S-1 plus oxaliplatin (SOX), a standard perioperative chemotherapy regimen for gastric cancer in Asia. After surgery, patients continued with either adjuvant serplulimab monotherapy (for up to 17 cycles) or adjuvant chemotherapy (for up to 5 cycles), administered every 3 weeks (Q3W).
The primary endpoint was investigator-assessed event-free survival (EFS). Secondary endpoints included median EFS as assessed by blinded independent central review (BICR), pathological complete response (pCR) as assessed by investigators, and other key safety measures.
As of the data cutoff date of August 19, 2025, a total of 588 patients were enrolled in the intention-to-treat (ITT) population across 57 clinical centers in China and randomized 1:1 to the serplulimab group (n=292) or the placebo group (n=296). The median follow-up was 35.9 months. Baseline demographic and disease characteristics were well balanced and comparable between the two groups. The overall study population had relatively advanced disease at enrollment, with T4 primary tumors accounting for 60.6% and 60.8% of patients in the serplulimab and placebo groups, respectively. In terms of performance status, patients with an ECOG PS score of 1 comprised 46.6% of the serplulimab group and 47.0% of the placebo group. Overall, the baseline characteristics of the enrolled population were highly consistent with the real-world clinical profile of patients with locally advanced gastric cancer.
The study met its primary endpoint, with investigator-assessed event-free survival (EFS) showing a significant improvement in the serplulimab group. The median EFS was not reached in the serplulimab group, compared with 35.9 months in the control group (HR=0.73; 95% CI, 0.56–0.94; p=0.015), demonstrating a statistically significant difference. The benefit was further reinforced by BICR. Median EFS was also not reached in the serplulimab group versus 52.0 months in the control group (HR=0.67; 95% CI, 0.50–0.89; p=0.0061), corresponding to a 33% reduction in the risk of recurrence, disease progression, or death, further confirming the robustness of the efficacy findings.
In terms of pathological response, the pCR rate in the serplulimab group reached 21.6%, more than tripling that observed in the placebo group (6.4%), with a marked between-group difference (OR=3.95), indicating a substantially greater depth of tumor regression. Consistent benefit was also observed across subgroups defined by age, sex, performance status, tumor stage, Helicobacter pylori infection status, and PD-L1 expression levels. Overall survival (OS) data remain immature and follow-up is ongoing. Longer-term survival outcomes will be further evaluated as additional data become available.
Improved Efficacy with Reduced Toxicity: A Chemo-Free Approach Highlights Safety and Tolerability Advantages
ASTRUM-006 is the first study in the perioperative treatment of gastric cancer to demonstrate that a chemotherapy-free approach—consisting of neoadjuvant immunotherapy plus chemotherapy followed by adjuvant immunotherapy alone—can deliver significantly improved efficacy while substantially reducing the toxicities associated with conventional full-course chemotherapy, thereby achieving dual benefits in both efficacy and safety.
According to the overall safety data, compared with the placebo group, the serplulimab-based regimen not only improved efficacy but also significantly reduced treatment-related toxicity, with broad improvements across key safety endpoints. The incidence of grade ≥3 treatment-related adverse events (TRAEs) was 46.6% in the serplulimab group, markedly lower than 58.5% in the control group. The rate of treatment discontinuation due to TRAEs was also substantially lower in the serplulimab group (6.5% vs. 10.5%), indicating a meaningfully reduced risk of treatment interruption and further supporting the manageable safety profile and long-term treatment potential of serplulimab. In addition, detailed data published in The Lancet showed that during the adjuvant treatment phase, the incidence of grade ≥3 TRAEs was significantly lower in the serplulimab group than in the placebo group (16% vs. 34%), as was the incidence of TRAEs leading to permanent discontinuation of any study treatment (4% vs. 8%).
In the serplulimab group, patients received adjuvant immunotherapy alone after surgery, eliminating the need for conventional adjuvant chemotherapy and fundamentally reducing severe chemotherapy-related toxicities such as myelosuppression (including neutropenia, thrombocytopenia, and decreased white blood cell count), as well as nausea and vomiting. Meanwhile, immune-related adverse events, such as hypothyroidism, were predominantly mild to moderate in severity, contributing to better tolerability and improved quality of life for patients. This streamlined and efficient perioperative strategy addresses the long-standing challenges of substantial chemotherapy-related toxicity and poor treatment adherence, offering patients with PD-L1–positive gastric cancer a more favorable long-term treatment option.
The success of ASTRUM-006 marks a new milestone of high efficiency and low toxicity in the perioperative therapy of gastric cancer, with the potential to redefine global clinical diagnosis and treatment standards. Based on the positive data from the ASTRUM-006 study, in December 2025, the New Drug Application (NDA) for serplulimab combined with platinum-based chemotherapy as neoadjuvant treatment, followed by adjuvant treatment after surgery, for PD-L1 positive, operable gastric cancer patients, was accepted by the National Medical Products Administration (NMPA) and granted Priority Review. Previously, in November 2025, serplulimab was granted Breakthrough Therapy Designation by the CDE, becoming the first drug in the field of perioperative treatment for gastric cancer to receive this recognition. In April 2026, the perioperative gastric cancer regimen of serplulimab was included for the first time in the CSCO Clinical Guidelines for Gastric Cancer (2026 Edition).
Differentiated Mechanism, Accelerating Global Expansion
Serplulimab is the world’s first and by far the only anti-PD-1 mAb to achieve success in a Phase 3 registrational study for perioperative gastric cancer and the first anti-PD-1 mAb approved for the first-line treatment of SCLC*. 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 activation3—but also minimizes PD-1-mediated recruitment of the co-stimulatory molecule CD28, thereby preserving CD28 signaling,4-6 enhancing downstream AKT activity,7 and promoting sustained T-cell activation. Based on this differentiated mechanism, serplulimab has established a solid therapeutic advantage in the first-line treatment of high-incidence cancers such as lung cancer and gastrointestinal cancers. It has been approved for the treatment of squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC), ESCC, and non-squamous non-small cell lung cancer (nsqNSCLC)**. 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 and demonstrating extremely broad global application scenarios. Moreover, to date, serplulimab 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 and continuously enhancing its clinical value, commercial potential, and long-term accessibility.
The simultaneous presentation of ASTRUM-006 at ASCO and publication in The Lancet not only highlights the growing global leadership of China’s gastric cancer clinical research, but also breaks through the long-standing limitations of conventional perioperative chemotherapy in gastric cancer, establishing a new treatment paradigm characterized by precise patient selection, improved efficacy, lower toxicity, and a more streamlined regimen. With future regulatory approvals and broader clinical adoption, this serplulimab-based perioperative strategy is poised to reshape the treatment landscape for gastric cancer and benefit a broad population of patients with resectable gastric cancer.
*As of June 2, 2026.
**Approved indications may vary by country or region. Please refer to the announcements issued by the relevant local health authorities for approved indications in each market.
References
1. Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. 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.
2. 高梓茗，徐惠绵. 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.
3.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.
4.Hui E, et al. T cell costimulatory receptor CD28 is a primary target for PD-1-mediated inhibition. Science. 2017;355(6332):1428-1433.
5.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.
6.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.
7.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”).
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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.
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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:
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• 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:
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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.
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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.
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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.
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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:
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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.
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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.
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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?
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• To correct or supplement your personal information;
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• 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.
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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?
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Last updated: March 30, 2026
