CrystalGenomics Applies for Phase 3 Clinical Trial of Camrelizumab in Gastric Cancer

Exclusive Domestic Commercial Rights for Camrelizumab Upon Approval of Immunocheckpoint Inhibitor New Drug Developed and Licensed Domestically

[Asia Economy Reporter Hyungsoo Park] CrystalGenomics announced on the 20th that it has submitted an Investigational New Drug (IND) application for a Phase 3 clinical trial of 'Camrelizumab' for gastric cancer to the Ministry of Food and Drug Safety.

Camrelizumab is an immune checkpoint inhibitor that blocks PD-1, similar to Opdivo and Keytruda. CrystalGenomics holds the domestic development and licensing rights for Camrelizumab. The Phase 3 clinical trial for first-line treatment of gastric cancer will be conducted by comparing Camrelizumab alone or Camrelizumab combined with Rivoceranib to the existing standard treatment of capecitabine and oxaliplatin (CAPOX). Overall survival (OS) will be analyzed.

Hansoh Pharmaceutical is currently conducting a Phase 3 clinical trial for gastric cancer in China, aiming to recruit 885 patients. The strategy is to additionally recruit patients in Korea to achieve efficient clinical development and approval.

Camrelizumab received approval from the China National Medical Products Administration (NMPA) in May 2019 as a third-line treatment for classical Hodgkin lymphoma. Last year, its indications were expanded to second-line treatment for liver cancer in March, and first-line treatment for non-small cell lung cancer and second-line treatment for esophageal cancer in June.

A CrystalGenomics official stated, "Upon new drug approval for the Phase 3 clinical trial targeting gastric cancer, we will hold exclusive domestic commercial rights for Camrelizumab," adding, "We expect to have sufficient competitiveness in the domestic immune oncology market, which exceeds 200 billion KRW, including Keytruda and Opdivo."

This content was produced with the assistance of AI translation services.