This newspaper (Reporter Jin Wanxia) reported on October 9 that Shanghai Fuhong Hanlin Biotech Co., Ltd. (hereinafter referred to as " Fuhong Hanlin ") announced that the company's Phase III clinical study of its self-developed innovative PD-1 inhibitor Hanseluzumab (slulizumab) combined with chemotherapy for neoadjuvant/monoadjuvant treatment of gastric cancer has met the pre-set superiority criteria and the treatment regimen has a good safety profile. This is the world's first treatment regimen for gastric cancer in the perioperative (preoperative/postoperative) period to replace postoperative adjuvant chemotherapy with a single immunotherapy agent, achieving a major breakthrough in this field.
　　In light of these data, Henlius intends to advance its marketing authorization application for this indication. Dr. Zhu Jun, Executive Director and CEO of Henlius, stated, "Gastrointestinal cancer is a core area of focus for Henlius. We will actively promote the translation of our research findings to benefit patients as soon as possible, and continue to accelerate the in-depth exploration and widespread application of more innovative therapies."
　　While surgery is a core component of gastric cancer treatment, adjunctive treatments such as medication and chemotherapy before and after surgery (i.e., the perioperative period) directly impact patients' long-term outcomes. Professor Ji Jiafu of Peking University Cancer Hospital stated that this clinical study, for the first time, demonstrates the feasibility of replacing adjuvant chemotherapy with a single immunotherapy agent after gastric cancer surgery. This not only opens a new avenue for consolidating surgical outcomes and reducing the risk of recurrence, but also provides new insights into clinical practice.
　　Gastric cancer is a major global public health challenge. According to the latest GLOBOCAN statistics, there will be approximately 969,000 new cases of gastric cancer and 660,000 deaths worldwide in 2022. Its incidence and mortality rates rank fifth among all cancers .The treatment landscape for gastric cancer is being systematically reshaped. Immunotherapy combined with chemotherapy has become the standard first-line treatment for advanced gastric cancer. Several Phase III clinical trials are underway globally to validate the efficacy and safety of immunotherapy combined with chemotherapy in perioperative settings.
　　Digestive tract cancers are one of Henlius' core therapeutic areas of strategic focus and deep investment. In esophageal cancer, Hans-like was approved in China in September 2023 for the first-line treatment of esophageal squamous cell carcinoma (ESCC). Regarding gastric cancer, in addition to the positive results achieved with Hans-like in neoadjuvant/adjuvant settings, the company's independently developed, differentiated neo-epitope HER2 monoclonal antibody HLX22 is currently undergoing a multicenter, head-to-head, international Phase III clinical trial challenging the standard of care for first-line HER2-positive advanced gastric cancer. In colorectal cancer, the company is actively advancing a multicenter, Phase III clinical trial of Hans-like in combination with other therapies for the first-line treatment of metastatic colorectal cancer (mCRC). Furthermore, Henlius is also conducting clinical studies in advanced gastric/gastroesophageal junction adenocarcinoma, including the PD-L1 antibody-drug conjugate (ADC) HLX43.
　　Fuhong Hanlin stated that in the future, the company will rely on the multi-level innovative therapy matrix of its product pipeline and rich global multi-center clinical trial data to continue to deepen its leading position in the field of gastrointestinal tumors, and is committed to bringing more high-quality treatment solutions to the world to benefit a wider range of patient groups.
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