Hansoh Pharma's Zolbetuximab Receives BLA Acceptance for Gastric Cancer Treatment in China

On August 1st, Hansoh Pharma announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has accepted the biologics license application (BLA) for zolbetuximab. Zolbetuximab is an investigational first-in-class monoclonal antibody targeting Claudin18.2 (CLDN18.2) for the first-line treatment of locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma in patients who are CLDN18.2-positive and HER2-negative. Once approved, zolbetuximab will be the first treatment option targeting CLDN18.2 for the Chinese gastric cancer patient population.

This biologics license application is based on the results of two phase 3 clinical trials, GLOW and SPOTLIGHT. The GLOW trial evaluated the efficacy of zolbetuximab in combination with CAPOX (a combination chemotherapy regimen including capecitabine and oxaliplatin) compared to placebo in combination with CAPOX. The study included 145 patients from mainland China. The SPOTLIGHT trial evaluated the efficacy of zolbetuximab in combination with mFOLFOX6 (a combination chemotherapy regimen including oxaliplatin, folinic acid, and modified 5-fluorouracil) compared to placebo in combination with mFOLFOX6. The study included 36 patients from mainland China.

In both the GLOW and SPOTLIGHT trials, approximately 38% of the tumor patients who participated in the trials were determined to have CLDN18.2-positive expression based on validated immunohistochemical analysis.

Zolbetuximab is an investigational chimeric IgG1 monoclonal antibody targeting CLDN18.2, which is a transmembrane protein. It exerts its effect by binding to CLDN18.2 on the surface of gastric cancer cells. Preclinical studies have shown that this binding subsequently induces cancer cell death through the activation of two different immune system pathways - antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC). The safety and efficacy of zolbetuximab for the treatment of gastric, gastroesophageal, and pancreatic cancers are still under investigation and have not been determined. The approval and commercial launch of this investigational drug for its studied indications cannot be guaranteed by regulatory authorities.

Hansoh Pharma has reflected the impact of this application acceptance in its financial forecast for the current fiscal year ending March 31, 2024.