Henlius' Serplulimab (anti-PD-1 mAb) Granted Breakthrough Therapy Designation by China NMPA for Neo-/Adjuvant Treatment for Gastric Cancer

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• The first CDE-designated Breakthrough Therapy for perioperative gastric cancer, promising accelerated patient access.
• The world's first gastric cancer perioperative regimen replacing chemotherapy with immunotherapy alone in the adjuvant setting has met primary endpoints in its phase 3 clinical trial, significantly reducing recurrence risk and improving cure rates. 
• No immunotherapy has been approved globally for gastric cancer perioperative treatment – HANSIZHUANG is poised to address this unmet medical need.

SHANGHAI, Nov. 20, 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 neo-/adjuvant treatment for gastric cancer, has been officially granted the Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). This marks the first gastric cancer perioperative drug to receive the CDE's BTD. Previously, the phase 3 clinical trial of this therapy met its primary endpoints. As the world's first perioperative gastric cancer treatment regimen replacing chemotherapy with immunotherapy alone in the adjuvant setting, it demonstrates potential to deliver dual breakthroughs in survival benefits and quality of life for patients.

In accordance with the relative measures of Administration of Drug Registration and the Announcement of the NMPA on the Release of Three Documents including the Working Procedures for Review of Breakthrough Therapeutics (Trial) (No. 82 of 2020), the BTD procedure is designed to expedite the development and review of therapies that are intended for treatment of a seriously debilitating or life-threatening condition for which there is no existing treatment and where preliminary evidence indicates advantages of the therapy over available treatment options. According to the CDE, drug candidates with BTD may be eligible for conditional approval and priority review when submitting a New Drug Application (NDA).

Gastric cancer is a highly prevalent malignant tumor worldwide, ranking fifth in both incidence and mortality among all cancers ^[1]. In China, the number of new cases and deaths from gastric cancer reached 359,000 and 260,000 respectively in 2022, ranking fifth and third among all malignant tumors ^[2], reflecting a substantial disease burden. Currently, radical surgery remains the primary treatment for gastric cancer. However, clinical practice faces multiple challenges, including low rates of surgical resection, a limited proportion of radical resections, and high postoperative recurrence rates in patients with stage 2 or higher disease. Therefore, improving resection rates and exploring effective non-surgical treatment strategies have become key research directions in gastric cancer management ^[3]. Against this backdrop, the role of neoadjuvant/adjuvant therapy has become increasingly prominent ^[4]. Neoadjuvant therapy aims to downstage tumors, increase the rate of complete resection, and achieve maximal pathological response. Adjuvant therapy, on the other hand, focuses on eliminating minimal residual disease after surgery to reduce the risk of recurrence. Currently, chemotherapy or chemoradiotherapy represents the mainstream perioperative treatment strategy for gastric cancer ^[5-7]. Nevertheless, recurrence rates remain high. Additionally, many patients experience interruptions in adjuvant therapy due to slow postoperative recovery or poor tolerance to chemotherapy, which directly affects their long-term survival outcomes.

The ASTRUM-006 trial—a phase 3 study evaluating HANSIZHUANG combined with chemotherapy as neo-/adjuvant treatment for gastric cancer—is the first perioperative Phase 3 registration study in China to report positive results, It aims to assess the clinical efficacy and safety of HANSIZHUANG plus chemotherapy compared with placebo plus chemotherapy as neoadjuvant, followed by HANSIZHUANG monotherapy as adjuvant therapy, in patients with early-stage gastric cancer. Interim analysis results demonstrated that the combination of HANSIZHUANG and chemotherapy significantly extended event-free survival (EFS) and achieved a pathological complete response (pCR) rate more than three times that of the control group, significantly reducing the risk of recurrence with an overall manageable safety profile. The study pioneers a novel "chemotherapy-free" adjuvant treatment model. This approach not only enhances the potential for cure but also achieves a superior balance between efficacy and safety by avoiding chemotherapy-related toxicities, thereby substantially improving patient treatment adherence and quality of life. Currently, no immunotherapy is approved globally for the perioperative treatment of gastric cancer. As a multicenter clinical trial initiated by a Chinese company and led by Chinese investigators, ASTRUM-006 fully demonstrates China's innovative capacity and leadership in the field of oncology. The recent granting of BTD authoritatively recognizes HANSIZHUANG's potential and clinical value in the perioperative setting of gastric cancer, which is expected to accelerate its regulatory review and market approval, potentially filling the current gap in immunotherapy for this indication.

Going forward, Henlius will fast-track this innovative therapy to market, bridging a clinical breakthrough into tangible survival benefits. We are committed to bringing new hope to patients through a superior treatment option.

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, 10 products have been approved for marketing across multiple countries and regions, and 3 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, denosumab Bildyos^® and Bilprevda^®, and pertuzumab Poherdy^®. What's more, Henlius has conducted over 30 clinical studies for 19 products, expanding its presence in major markets as well as emerging markets.

To learn more about Henlius, visit https://www.henlius.com/en/index.html and connect with us on LinkedIn at https://www.linkedin.com/company/henlius/.

SOURCE Henlius