Phase 3 Clinical Trial of HANSIZHUANG Plus Chemotherapy Meets Primary Endpoint in Neoadjuvant/Adjuvant Gastric Cancer, Greenlighting Early NDA Submission

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• The phase 3 clinical trial of HANSIZHUANG for perioperative gastric cancer treatment met its EFS primary endpoint, supporting an early New Drug Application (NDA) submission
• World-first regimen in gastric cancer that replaces adjuvant chemotherapy with mono-immunotherapy in the perioperative setting
• The ASTRUM-006 study demonstrated a significant improvement in event-free survival (EFS) and achieved a more than threefold higher pathological complete response (pCR) rate compared with the control arm, unlocking the potential for a cure

SHANGHAI, Oct. 9, 2025 /PRNewswire/ -- Shanghai Henlius Biotech, Inc. (2696.HK) announced that its self-developed innovative anti-PD-1 monoclonal antibody, HANSIZHUANG (serplulimab, Hetronifly^® in Europe), in combination with chemotherapy for the neoadjuvant/adjuvant monotherapy treatment of gastric cancer, has met the primary endpoint of Event-Free Survival (EFS) in an interim analysis of its phase 3 clinical study (ASTRUM-006). This outcome represents a breakthrough, making it the world-first regimen to replace adjuvant chemotherapy with mono-immunotherapy in the perioperative treatment of gastric cancer.

ASTRUM-006 is a randomized, double-blind, multi-centre phase 3 clinical study among patients with early-stage gastric cancer, aiming to compare the efficacy and safety of HANSIZHUANG or placebo in combination with chemotherapy as a neoadjuvant/adjuvant monotherapy treatment for patients with early-stage gastric cancer. According to the interim analysis conducted by the Independent Data Monitoring Committee (IDMC), the trial met its predefined efficacy criteria. Compared with placebo plus chemotherapy, HANSIZHUANG plus chemotherapy significantly prolonged EFS and achieved a more than threefold higher pathological complete response (pCR) rate compared with the control arm, with a significant reduction in the risk of recurrence. Furthermore, the combination regimen demonstrated a favorable safety profile, with no new safety signals identified. Based on this positive outcome, the IDMC has recommended an early NDA submission.

Professor Jiafu Ji from Beijing Cancer Hospital, a leading principal investigator of the ASTRUM-006 study, commented: "Surgery is the cornerstone of gastric cancer treatment, and perioperative therapy is critical to long-term survival. This study is the first to confirm the feasibility of replacing adjuvant chemotherapy with mono-immunotherapy in the postoperative setting. It not only opens a new path to consolidate surgical outcomes and reduce recurrence risk, but also paves the way for innovation in clinical practice."

Professor Lin Shen from Beijing Cancer Hospital, a leading principal investigator of the ASTRUM-006 study, stated: "The positive results from this study confirm the significant potential of serplulimab in the perioperative setting for gastric cancer. The innovative exploration of a 'chemotherapy-free, mono-immunotherapy' regimen during the adjuvant phase tangibly improves patients' quality of life, offering a new approach for optimizing clinical strategies."

Dr. Jason Zhu, Executive Director, and Chief Executive Officer of Henlius, said: "Gastrointestinal (GI) cancer is a core therapeutic area of dedicated focus for Henlius. The successful achievement of the primary endpoint in the phase 3 perioperative study of HANSIZHUANG in gastric cancer marks a pivotal breakthrough for the company. We are committed to actively advancing the translation of these findings into clinical practice, with the goal of bringing benefits to patients at the earliest opportunity. Concurrently, we will continue to accelerate the in-depth exploration and broad application of more innovative therapies."

Pioneering New Pathways in Gastric Cancer Perioperative Care

Gastric cancer represents a major global public health challenge. According to the latest GLOBOCAN statistics, there were approximately 969,000 new cases and 660,000 deaths worldwide in 2022, ranking it fifth in both incidence and mortality among all cancers. ^[1] While radical surgery remains the primary treatment modality, optimizing perioperative (neoadjuvant/adjuvant) strategies has become pivotal to improving long-term patient survival. ^[2]

In recent years, immunotherapy is fundamentally reshaping the treatment landscape for gastric cancer. While the combination of immunotherapy and chemotherapy has become the first-line standard for advanced disease, its potential in the perioperative setting is now a major focus of clinical investigation, with multiple trials underway to evaluate its efficacy and safety in this context. However, the field faces a dual challenge. On one hand, no immunotherapy has yet been formally approved for this specific indication, and only a limited number of phase 3 studies have successfully met their primary endpoints. On the other hand, in clinical practice, factors such as slow postoperative recovery and poor chemotherapy tolerance often prevent patients from completing adjuvant chemotherapy, thereby compromising their long-term survival outcomes. This significant unmet medical need underscores the urgent demand for novel treatment strategies that deliver both superior efficacy and improved tolerability.

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 ^[3]—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. The ASTRUM-006 study innovatively employed a "chemotherapy-free" serplulimab monotherapy strategy in the adjuvant setting. This approach maintained therapeutic efficacy while effectively circumventing toxicity related to conventional chemotherapy, significantly improved patients' quality of life, and provided a new clinical option. The success of this trial marks a pivotal shift in perioperative gastric cancer care—from a conventional intensity-driven paradigm toward a more refined "high-efficacy, low-toxicity" treatment model.

Delving into the Frontiers of GI Oncology

GI cancer is a strategically core therapeutic area for Henlius, with dedicated focus and extensive development. The company has built a diversified product portfolio spanning from immunotherapy to targeted agents, and from established targets to novel molecular modalities, addressing high-incidence GI cancers such as esophageal, gastric, and colorectal cancers. This portfolio forms a differentiated treatment system covering various molecular subtypes and disease stages.

In esophageal cancer, HANSIZHUANG received approval in China in September 2023 for the first-line treatment of esophageal squamous cell carcinoma (ESCC). Its efficacy and safety profile have earned it broad clinical recognition, rapidly establishing it as a key therapeutic option in this field. In the gastric cancer segment, Henlius demonstrates strong R&D depth and synergistic advantages. Beyond the positive outcomes achieved with HANSIZHUANG in the neoadjuvant/adjuvant setting, the company's internally developed, differentiated novel epitope HER2 mAb, HLX22, is challenging the current first-line standard of care for HER2-positive advanced gastric cancer through an international multi-centre, head-to-head phase 3 trial. In colorectal cancer, Henlius is actively advancing an international multi-centre phase 3 clinical study evaluating HANSIZHUANG-based combinations in the first-line treatment of metastatic CRC (mCRC). Concurrently, the company continues to push the boundaries of GI cancer treatment by developing next-generation therapies, such as the PD-L1-targeting ADC HLX43, now in clinical studies for advanced gastric/gastroesophageal junction adenocarcinoma and other tumors.

Looking ahead, Henlius will leverage its robust pipeline of innovative therapies and extensive global multi-centre clinical trial data to solidify its leadership in GI oncology. The company is dedicated to bringing a growing portfolio of high-quality therapeutic options to patients worldwide, addressing significant unmet needs across the globe.

About Henlius

Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases and ophthalmic diseases. To date, 9 products have been approved for marketing across multiple countries and regions, and 4 marketing applications have been accepted for review in China, the U.S. and the EU, respectively. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global innovation centre and Shanghai-based commercial manufacturing facilities certificated by China, the EU and U.S. GMP.

Henlius has pro-actively built a diversified and high-quality product pipeline covering about 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as the backbone. To date, the company's launched products include HANSIZHUANG (serplulimab, trade name: Hetronifly in Europe), the world's first anti-PD-1 mAb for the first-line treatment of SCLC, HANQUYOU (trastuzumab, trade name: HERCESSI in the U.S., Zercepac in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANLIKANG (rituximab), the first China-developed biosimilar, and denosumab BILDYOS and BILPREVDA. What's more, Henlius has conducted over 30 clinical studies for 19 products, expanding its presence in major markets as well as emerging markets.

SOURCE Henlius