- The world’s first and only* anti-PD-1 monoclonal antibody approved for perioperative gastric cancer indication, filling a clinical treatment gap
- The world’s first postoperative “chemo-free” regimen for perioperative gastric cancer, replacing adjuvant chemotherapy with immunotherapy monotherapy, significantly reducing recurrence risk and making cure accessible
- Registration study ASTRUM-006 published in The Lancet and prominently featured at ASCO 2026, included in the CSCO guidelines
ShanghaiJune 9, 2026 /PRNewswire/ — Shanghai Henlius Biotech, Inc. (2696.HK) announced that the New Drug Application (NDA) for its self-developed anti-PD-1 monoclonal antibody, H drug Hansizhuang® (serplulimab, European trade name: Hetronifly®), has been officially approved by the National Medical Products Administration (NMPA) through a priority review procedure. The approval is for use in combination with oxaliplatin and tegafur/gimeracil/oteracil for neoadjuvant treatment of resectable gastric cancer with tumor PD-L1 expression CPS ≥5, followed by monotherapy adjuvant treatment after surgery. This NMPA approval makes H drug the world’s first and only* anti-PD-1 monoclonal antibody approved for perioperative gastric cancer treatment, filling a clinical treatment gap in this field. More groundbreakingly, this regimen achieves postoperative immunotherapy monotherapy replacing traditional adjuvant chemotherapy, significantly improving efficacy while effectively avoiding chemotherapy-related toxicities, greatly enhancing treatment compliance and tolerability for patients with locally advanced gastric cancer, leading perioperative gastric cancer treatment toward a precise and efficient era of clinical cure.
Dr. Jun Zhu, Executive Director and CEO of Henlius, stated:
“The approval of H drug for the perioperative gastric cancer indication marks another major milestone for Henlius in driving innovation through ‘first principles’ and deepening our focus on gastrointestinal tumors. The new postoperative ‘chemo-free’ regimen, designed from patient needs, not only highlights our deep expertise in tumor immunology but also brings new hope of cure for perioperative gastric cancer patients. Moving forward, we will continue to explore the clinical potential of our innovative pipeline, accelerate the global 2.0 strategy, and benefit patients in China and worldwide with high-quality innovative biologics.”
Professor Lin Shen, Principal Investigator of the Phase III clinical study ASTRUM-006 for H drug in perioperative gastric cancer and from Peking University Cancer Hospital, stated:
“Gastric cancer is a high-incidence tumor in China, and traditional intensive perioperative chemotherapy often leads to poor patient compliance due to toxic side effects. The serplulimab perioperative gastric cancer regimen successfully achieves postoperative ‘chemo-free’ treatment. This innovative ‘efficacy-enhancing and toxicity-reducing’ model significantly improves efficacy while balancing safety and patient tolerability. The approval of this indication for serplulimab effectively addresses long-standing clinical pain points, bringing higher-quality hope of cure for gastric cancer patients and further advancing domestic perioperative gastric cancer treatment toward precision, efficiency, and standardization.”
Breaking Clinical Pain Points, Setting a New Benchmark for Perioperative Gastric Cancer Treatment
Gastric cancer is a high-incidence malignant tumor globally, ranking among the top in both incidence and mortality rates. In China, the burden of gastric cancer is particularly prominent, with approximately 342,000 new cases and 249,000 deaths in 2024, ranking sixth and fourth among malignant tumors, respectively[1]. Currently, radical surgery is the core treatment for gastric cancer patients, but the risk of postoperative recurrence and metastasis remains high. Current perioperative treatment regimens primarily rely on chemotherapy or chemoradiotherapy, which have limitations in tumor regression effects and are associated with significant toxicities. In recent years, immunotherapy has been systematically reshaping the treatment landscape for gastric cancer. Immunotherapy combined with chemotherapy has become the standard first-line treatment for advanced gastric cancer, and its application is gradually being explored in perioperative settings. However, existing explorations mostly rely on a full-course immunotherapy combined with chemotherapy model, and the issue of chemotherapy-related toxicity remains unresolved. Furthermore, there are currently no approved perioperative immunotherapy drugs for gastric cancer in China, and there is an urgent clinical need for new treatment strategies that balance efficacy, safety, and treatment compliance.
The approval of H drug for the perioperative gastric cancer indication is primarily based on a randomized, double-blind, placebo-controlled, multicenter Phase III clinical study (ASTRUM-006). The study enrolled 588 patients with locally advanced gastric/gastroesophageal junction adenocarcinoma with positive PD-L1 expression (CPS ≥5) who met surgical conditions. Study data show that, as of August 19, 2025, in the PD-L1 CPS ≥5 population, compared with the chemotherapy control group, the regimen of serplulimab combined with chemotherapy as neoadjuvant therapy followed by serplulimab monotherapy as adjuvant therapy significantly prolonged event-free survival (EFS), with the risk of disease progression, recurrence, new other malignancies, or death assessed by BICR reduced by 33%. The pathological complete response (pCR) rate in the serplulimab group reached 21.6%, more than three times that of the control group, demonstrating excellent tumor regression capability. Additionally, the R0 resection rate was 96.7%, indicating a very high quality of radical surgery. Safety and tolerability evaluation results showed that the incidence of ≥Grade 3 treatment-related adverse events (TRAEs) was 46.6% in the serplulimab group and 58.5% in the control group, with permanent discontinuation due to TRAEs occurring in 6.5% and 10.5% of patients, respectively, indicating overall safety and good patient tolerability.
The breakthrough results of this study were prominently presented as an oral report at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting and simultaneously published in The Lancet (impact factor: 88.5), one of the world’s top four medical journals, making it the first perioperative gastric cancer immunotherapy clinical study to be published in The Lancet. Additionally, the Hansizhuang® perioperative gastric cancer regimen was included in the CSCO Guidelines for the Diagnosis and Treatment of Gastric Cancer (2026 Edition) in April of the same year. From recommendations in authoritative treatment guidelines to endorsement by the international academic community, this fully demonstrates the high recognition of this innovative perioperative “chemo-free” regimen by the global oncology community.
Differentiated Mechanism Empowers Global Layout, H Drug Continues to Lead Tumor Immunology Innovation
As an innovative humanized anti-PD-1 monoclonal antibody independently developed by Henlius, H drug possesses a unique differentiated pharmacological mechanism. Preclinical studies have shown that this drug not only has stronger PD-1 internalization effects, reducing PD-1 receptors on T cell surfaces[2] to achieve rapid and potent immune activation, but also reduces the recruitment of co-stimulatory molecule CD28 by PD-1, thereby preserving CD28 signaling to a greater extent[3]-[5], enhancing downstream AKT protein activity[6], and promoting sustained T cell activation. This differentiated mechanism provides strong pharmacological support for the anti-tumor effects in perioperative gastric cancer treatment.
Leveraging its unique mechanism advantages, H drug has been approved globally** for first-line treatment of 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 (nsqNSCLC), as well as perioperative gastric cancer treatment. It has been approved for marketing 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, in collaboration with global partners such as Accord and Abbott, continues to advance H drug’s overseas market access and commercialization. Since its first EU approval in February 2025, H drug has been launched and sold in 16 EU countries and has been included in national health insurance or public payment systems in 10 countries, including Austria, Denmark, Germany, Ireland, Italy, Spain, and Sweden, entering mainstream local healthcare systems.
Meanwhile, Henlius is continuously advancing H drug’s global clinical development plan, focusing on high-incidence cancers such as lung cancer and gastrointestinal tumors. From the world’s first anti-PD-1 monoclonal antibody approved for first-line treatment of small cell lung cancer to the world’s first and only* anti-PD-1 monoclonal antibody approved for perioperative gastric cancer, H drug is gradually building a global clinical value system covering a broader range of cancer types. To date, Henlius has initiated over 10 tumor immunotherapy combination studies for H drug globally, enrolling more than 5,700 patients, and has completed enrollment for bridging trials for ES-SCLC in the United States and Japan. In the field of gastrointestinal tumors, the Phase III international multicenter clinical study (ASTRUM-015) evaluating H drug combined with bevacizumab and chemotherapy for first-line treatment of metastatic colorectal cancer (mCRC) has completed global patient enrollment, potentially filling a clinical gap in immunotherapy for MSS mCRC.
The successful approval of the perioperative gastric cancer indication is an important milestone for Henlius in focusing on unmet clinical needs and deepening its presence in solid tumor treatment. Moving forward, the company will continue to expand H drug’s tumor treatment indication landscape, deepen the layout of perioperative precision treatment, and accelerate the global registration and commercialization process, benefiting tumor patients at home and abroad with high-quality, accessible innovative biologics.
*As of June 9, 2026
**Please refer to announcements from local drug regulatory authorities for approved indications in different countries or regions
About H drug Hansizhuang®
H drug Hansizhuang® is a recombinant humanized anti-PD-1 monoclonal antibody injection (generic name: serplulimab injection, European trade name: Hetronifly®). It is the world’s first anti-PD-1 monoclonal antibody approved for first-line treatment of small cell lung cancer (SCLC) and the first approved for perioperative gastric cancer indication. It has been approved for marketing in 50 countries and regions, including China, the United Kingdom, the European Union, Singapore, India, Switzerland, and Peru.
In March 2022, H drug was officially approved for marketing in China and has since been approved for the treatment of squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma (ESCC), non-squamous non-small cell lung cancer (nsqNSCLC), and gastric cancer (GC). With the approval of the gastric cancer indication, H drug becomes the world’s first treatment regimen to replace postoperative adjuvant chemotherapy with immunotherapy monotherapy in perioperative gastric cancer.
In terms of research progress, Henlius is comprehensively advancing H drug’s global clinical development plan. To date, over 10 tumor immunotherapy combination studies have been initiated globally, enrolling more than 5,700 patients. Among these, two international multicenter clinical trials have enrolled over 30% white patients, making H drug one of the anti-PD-1 monoclonal antibodies with extensive international clinical data. Bridging trials for ES-SCLC are being conducted simultaneously in the United States and Japan. In the field of colorectal cancer, the Phase III international multicenter clinical study ASTRUM-015 has completed patient enrollment. This study evaluates the efficacy and safety of H drug combined with bevacizumab and chemotherapy for first-line treatment of metastatic colorectal cancer (mCRC). Meanwhile, the latest data from its Phase II clinical study further highlights H drug’s potential to continuously expand clinical value in the field of malignant gastrointestinal tumors with high disease burden[7].
Key clinical study results for H drug have been published in renowned journals such as The Lancet, JAMA, Nature Medicine, and British Journal of Cancer. Additionally, H drug has been recommended by multiple authoritative guidelines, including the CSCO Guidelines for the Diagnosis and Treatment of Gastric Cancer, CSCO Guidelines for the Diagnosis and Treatment of Small Cell Lung Cancer, CSCO Guidelines for the Diagnosis and Treatment of Non-Small Cell Lung Cancer, CSCO Guidelines for the Diagnosis and Treatment of Esophageal Cancer, CSCO Guidelines for the Clinical Application of Immune Checkpoint Inhibitors, and Chinese Guidelines for Radiotherapy of Esophageal Cancer, providing important references for clinical tumor diagnosis and treatment. Overseas, H drug for the treatment of SCLC has also received orphan drug designation from regulatory agencies such as the U.S. FDA.
About Henlius
Henlius (2696.HK) is an international innovative biopharmaceutical company dedicated to providing high-quality, affordable biologics to patients worldwide, covering areas such as oncology, autoimmune diseases, and ophthalmic diseases. Since its establishment in 2010, the company has built a full-chain platform covering global R&D, clinical, registration, production, and commercialization, with nearly 4,000 employees globally and operations and branches in multiple locations, including China, the United States, and Japan. Leveraging the stable cash flow from biosimilars to support innovative R&D, Henlius is steadily entering the “Globalization 2.0” phase, continuously building a replicable and sustainable global growth model. As of early 2026, the company has 10 products approved for marketing in over 60 countries and regions globally, with 8 approved in China. In major Western biologics markets, Henlius has achieved multiple milestone breakthroughs, with 4 products approved by the U.S. FDA and 5 products approved by the European Commission, fully demonstrating that the company’s R&D system, quality management, and production capabilities have comprehensively met the highest international standards.
In terms of innovation-driven development, Henlius, leveraging its collaborative R&D system across Shanghai, the United States, and other locations, has built a diversified and platform-based innovation technology matrix covering cutting-edge directions such as immune checkpoint inhibitors, immune cell engagers (including multispecific TCEs), antibody-drug conjugates (ADCs), and AI-driven early R&D platforms. Currently, the company has over 50 early-stage innovative assets, of which approximately 70% have Best-in-Class potential, and is simultaneously advancing over 30 clinical studies globally. The core product H drug Hansizhuang® (serplulimab, European trade name: Hetronifly®), as the world’s first anti-PD-1 monoclonal antibody approved for first-line treatment of small cell lung cancer and the first approved for perioperative gastric cancer indication, is accelerating its global layout and has been approved for marketing in 50 markets. Meanwhile, multiple potential innovative assets, including PD-L1 ADC HLX43 and neo-epitope HER2 monoclonal antibody HLX22, are being comprehensively advanced in global pivotal clinical studies. Relying on a production system certified by GMP in China, Europe, and the United States, Henlius has built a biologics production platform with a total capacity of 84,000 liters, forming a stable supply network covering six continents. In the future, Henlius will always adhere to a patient-centered approach, focus on unmet clinical needs, continuously drive the transformation of innovation achievements into clinical value and patient accessibility, and create long-term and stable value in the global biomedical innovation ecosystem.
References
- 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.
- 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.