Target major indications for gastric cancer! Fu Hong Han Lin (02696) H drug's application for gastric cancer perioperative indications received priority review

Zhitong Finance App learned that on December 12, Fu Hong Han Lin (02696) announced that the company's self-developed innovative anti-PD-1 monoclonal H drug Hans-like® (Slulilizumab®, European trade name: Hetronifly®) combined with platinum-containing chemotherapy for post-operative adjuvant treatment for PD-L1-positive gastric cancer patients (NDA) was accepted by the National Drug Administration (NMPA) and included in the priority review and approval process.

Being included in the priority review means that the review period will be drastically shortened to 130 working days, marking an overall acceleration in the marketing process of H drug for perioperative treatment of gastric cancer. It is expected that H drug will become the first anti-PD-1 monoclonal antibody approved in this field in the world. Dr. Zhu Jun, executive director and CEO of Fu Hong Han Lin, said that it was accepted and included in the priority review, marking that H drug has officially entered the “fast track” for gastric cancer perioperative indications for gastric cancer.

According to information, gastric cancer is the most common malignant tumor in the world, and the incidence rate and death rate are among the highest. Currently, immunotherapy has progressed in advanced gastric cancer, but its application during the perioperative period (before and after surgery) is still lacking. There is no immunotherapy approved at this stage in China. Clinical needs are urgent, and there is an urgent need for new solutions that can effectively reduce recurrence and improve the cure rate.

The listing application is mainly based on the positive results of this critical study ASTRUM-006. The mid-term analysis results showed that the study met the pre-set efficacy standards. Compared with placebo chemotherapy, Hans-like® chemotherapy significantly improved event-free survival (EFS), the complete pathologic remission (PCR) rate increased significantly compared to the control group, the risk of recurrence was significantly reduced, and overall safety was manageable.

As Fuhong Hanlin's core anti-tumor drug, Hansform® has shown unique advantages in the treatment of various solid tumors with its differentiated mechanism. The drug not only has a stronger PD-1 endocytosis effect, can reduce PD-1 receptors on the surface of T cells and achieve rapid and potent immune activation; it also reduces PD-1 recruitment of the co-stimulant molecule CD28, thereby retaining CD28 signaling to a greater extent, enhancing downstream AKT protein activity, and promoting continuous T-cell activation.

Currently, H drug has been approved for the treatment of various indications such as squamous non-small cell lung cancer, and has been approved for marketing in more than 40 countries, covering nearly half of the world's population. At the same time, the phase III clinical study of sululizumab combined with chemotherapy for first-line treatment of metastatic colon cancer has also completed patient enrollment, and the data is expected to be released next year.