On June 9, 2026, the New Drug Application (NDA) for the anti-PD-1 monoclonal antibody H drug, Hansizhuang® (serplulimab, European brand name: Hetronifly®), developed by HENLIUS (02696), was officially approved by the National Medical Products Administration (NMPA) through a priority review pathway. The approval is for use in combination with oxaliplatin and tegafur, gimeracil, and oteracil potassium (S-1) for neoadjuvant treatment, followed by monotherapy adjuvant treatment after surgery, in patients with resectable gastric cancer whose tumors express PD-L1 with a Combined Positive Score (CPS) ≥5.
This NMPA approval makes the H drug the first and only* anti-PD-1 monoclonal antibody globally approved for the perioperative treatment of gastric cancer, addressing a significant unmet clinical need in this field. More innovatively, this regimen achieves the replacement of traditional adjuvant chemotherapy with postoperative immunotherapy monotherapy. It significantly enhances efficacy while effectively avoiding chemotherapy-related toxic side effects, greatly improving treatment compliance and tolerance for patients with locally advanced gastric cancer, and ushering in a new era of precise and efficient clinical cure for perioperative gastric cancer treatment.
The global commercial footprint and deepening research pipeline of the H drug have once again become a market focus. Its commercial value and future growth potential are being reassessed, with the potential to reshape the landscape of gastric cancer treatment.
Dr. Zhu Jun, Executive Director and Chief Executive Officer of HENLIUS, stated: "The approval of the H drug for the perioperative gastric cancer indication is another major milestone for HENLIUS, adhering to the 'first principles' to drive innovation and deepening our commitment to gastrointestinal cancers. The new postoperative 'chemotherapy-free' regimen, developed from patient needs, not only demonstrates our profound expertise in tumor immunotherapy but also brings new hope for a cure to patients with perioperative gastric cancer. In the future, we will continue to explore the clinical potential of our innovative pipeline, accelerate the advancement of our Globalization 2.0 strategy, and benefit patients in China and globally with high-quality innovative biologics."
Addressing Clinical Challenges and Setting a New Standard
Gastric cancer is a highly prevalent malignant tumor globally, ranking among the top in both incidence and mortality rates. The burden is particularly significant in China, with approximately 342,000 new cases and 249,000 deaths in 2024, ranking sixth and fourth, respectively, among all malignancies. 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 involve chemotherapy or chemoradiotherapy, which have limitations in tumor shrinkage effects and often involve noticeable toxic side effects.
In recent years, immunotherapy has been systematically reshaping the treatment landscape for gastric cancer. Immunotherapy combined with chemotherapy has become the first-line standard for advanced gastric cancer, and its application is gradually expanding into perioperative settings. However, existing explorations mostly rely on a model of continuous immunotherapy combined with chemotherapy, and the issue of chemotherapy-related toxicity has not been effectively resolved. On the other hand, there are currently no approved immunotherapy drugs for perioperative gastric cancer treatment in China, creating a clinical need for new treatment strategies that balance efficacy, safety, and treatment compliance.
The approval of the 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 a total of 588 patients with PD-L1 positive (CPS≥5), resectable locally advanced gastric or gastroesophageal junction adenocarcinoma.
Study data showed that as of August 19, 2025, in the PD-L1 CPS≥5 population, compared to the chemotherapy control group, the regimen of serplulimab combined with chemotherapy for neoadjuvant treatment followed by serplulimab monotherapy for adjuvant treatment significantly prolonged Event-Free Survival (EFS). The risk of disease progression, recurrence, new primary malignancies, or death, as assessed by Blinded Independent Central Review (BICR), was 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 shrinkage capability. Additionally, the R0 resection rate was 96.7%, indicating a high quality of surgical radicality.
Safety and tolerability evaluation results showed that the incidence of Grade ≥3 Treatment-Related Adverse Events (TRAEs) in the serplulimab group and the control group was 46.6% and 58.5%, respectively. The incidence of permanent treatment discontinuation due to TRAEs was 6.5% and 10.5%, respectively, indicating overall manageable safety and good patient tolerability.
Leveraging its unique mechanism of action, the H drug has been approved globally** for multiple indications, including first-line treatment for 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 treatment for gastric cancer.
In terms of market breadth, the H drug's commercial reach has extended to approximately 50 countries and regions, including China, the United Kingdom, the European Union, Singapore, India, Switzerland, and Peru, initially covering nearly half of the global population. Through collaboration with international partners such as Accord and Abbott, the company continues to promote the drug's market access and commercialization overseas.
In terms of market depth, particularly in the European market with its mature reimbursement environment, the H drug has achieved critical breakthroughs. Since its first approval in the EU in February 2025, the drug has been launched for sale in 16 EU countries. More notably, in 10 countries including Austria, Denmark, Germany, Ireland, Italy, Spain, and Sweden, the H drug has been successfully included in local health insurance or public payment systems, entering the mainstream healthcare coverage.
Deepening the Pipeline to Build a Differentiated Global Clinical Value System
While accelerating commercialization, HENLIUS continues to advance the global clinical development of the H drug, focusing on high-incidence cancers such as lung and gastrointestinal cancers. From being the first anti-PD-1 monoclonal antibody globally approved for first-line treatment of small cell lung cancer to the first and only* anti-PD-1 monoclonal antibody approved for the perioperative gastric cancer indication, the 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 the H drug globally, enrolling a cumulative total of more than 5,700 patients. Bridging trials for ES-SCLC are being conducted concurrently in the United States and Japan, with all subject enrollment completed.
In the field of gastrointestinal cancers, the Phase III international multicenter clinical study (ASTRUM-015) evaluating the H drug combined with bevacizumab and chemotherapy for first-line treatment of metastatic colorectal cancer (mCRC) has completed global patient enrollment. This study holds the potential to address the clinical gap for immunotherapy in microsatellite stable (MSS) mCRC.
Professor Shen Lin from Peking University Cancer Hospital, the principal investigator of the Phase III ASTRUM-006 study for perioperative gastric cancer, stated: "Gastric cancer is a prevalent tumor in China. Traditional high-intensity perioperative chemotherapy often leads to poor patient compliance due to toxic side effects. The serplulimab perioperative gastric cancer regimen successfully achieves postoperative 'chemotherapy-free.' This innovative model of 'enhancing efficacy while reducing toxicity' significantly improves efficacy while balancing safety and patient tolerability. The approval of this indication for serplulimab effectively addresses a long-standing clinical challenge, brings higher-quality hope for a cure to gastric cancer patients, and will further promote the advancement of perioperative gastric cancer treatment in China towards precision, efficiency, and standardization."
The successful approval of this perioperative gastric cancer indication marks a significant milestone for HENLIUS in focusing on unmet clinical needs and deepening its commitment to solid tumor treatment. In the future, the company will continue to expand the H drug's oncology treatment indications, deepen its layout in perioperative precision therapy, and simultaneously accelerate global registration and commercialization processes. The goal is to benefit domestic and international cancer patients with high-quality, accessible innovative biologics.
*As of June 9, 2026.
**Approved indications may vary by country or region; please refer to announcements from local drug regulatory authorities.
Comments