• 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.

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