China.com.cn Finance, November 20th - Henlius Biotech (2696.HK) announced today that its innovative PD-1 inhibitor, Hetronifly (slulimab, European brand name: Hetronifly), has been officially included in the Breakthrough Therapy List by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). It will be used in combination with chemotherapy for neoadjuvant/adjuvant treatment of gastric cancer, becoming the first perioperative treatment drug for gastric cancer to receive Breakthrough Therapy designation from the CDE.
Previously, H drug's Phase III clinical trial for this indication met its primary endpoint. As the world's first treatment regimen to replace postoperative adjuvant chemotherapy with immunotherapy during the perioperative period of gastric cancer, it is expected to bring patients a dual breakthrough in survival benefits and improved quality of life.

According to the "Drug Registration Management Measures" and the "Announcement of the National Medical Products Administration on Issuing Three Documents Including the <Breakthrough Therapy Drug Review Procedure (Trial)>" (Announcement No. 82 of 2020), the Breakthrough Therapy Drug Procedure applies to "diseases that seriously endanger life or severely affect quality of life, for which there are currently no effective treatments, and for which the drug can provide an effective means of prevention and treatment or has a more significant clinical advantage compared to existing treatments." For drugs included in the Breakthrough Therapy Drug Procedure, conditional approval and priority review applications can be submitted when applying for drug marketing authorization, provided that relevant conditions are met.
Data shows that stomach cancer is a highly prevalent malignant tumor worldwide, ranking fifth in both incidence and mortality among all cancers. In my country, in 2022, there were as many as 359,000 new cases and 260,000 deaths from stomach cancer, ranking fifth and third among malignant tumors, respectively.
Currently, radical surgery is the primary treatment for gastric cancer. However, clinical practice faces multiple challenges, including low surgical resection rates, a low proportion of radical resections, and high recurrence rates in patients with stage II or higher gastric cancer. Therefore, improving surgical resection rates and exploring effective treatment strategies beyond surgery have become key directions in gastric cancer treatment research. Against this backdrop, the role of neoadjuvant/adjuvant therapy in gastric cancer treatment is becoming increasingly prominent. Neoadjuvant therapy aims to reduce tumor stage, increase the complete tumor resection rate, and strive for maximum pathological remission; adjuvant therapy, on the other hand, focuses on eliminating minimal residual disease after surgery to reduce the risk of recurrence.
The Phase III clinical trial (ASTRUM-006) of H-drug combined with chemotherapy for neoadjuvant/adjuvant treatment of gastric cancer is the first Phase III registration clinical trial in my country to achieve positive results in the perioperative period of gastric cancer. It aimed to evaluate the clinical efficacy and safety of H-drug combined with chemotherapy compared to placebo combined with chemotherapy for neoadjuvant/adjuvant treatment of early-stage gastric cancer patients. Interim analysis results showed that H-drug combined with chemotherapy significantly prolonged event-free survival (EFS), achieved a pathological complete response (pCR) rate more than three times that of the control group, significantly reduced the risk of recurrence, and maintained manageable overall safety. This study pioneered a new "chemotherapy-free" adjuvant therapy model, effectively improving patients' chances of cure and achieving a better balance between efficacy and safety by avoiding chemotherapy-related toxicities, thereby greatly improving patient treatment adherence and quality of life.
Henlius stated that this Breakthrough Therapy Designation signifies authoritative recognition of the potential and clinical value of H drug in the perioperative treatment of gastric cancer, and is expected to accelerate its review and market launch process, filling a gap in immunotherapy in this field.The blank space.

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