Camrelizumab Approved for Nasopharyngeal Cancer in China... Crystal Holds Domestic Distribution Rights

[Asia Economy Reporter Hyunseok Yoo] CrystalGenomics announced on the 3rd that its domestically developed and licensed immuno-oncology drug 'Camrelizumab' has received marketing approval in China for nasopharyngeal carcinoma.

The China National Medical Products Administration (NMPA) approved the new drug application for Camrelizumab's indication for nasopharyngeal carcinoma on the 29th of last month (local time). This marks the fifth approved indication following classical Hodgkin lymphoma, hepatocellular carcinoma, non-small cell lung cancer, and esophageal cancer.

Camrelizumab is an immune checkpoint inhibitor (ICI) that inhibits 'PD-1', similar to Opdivo and Keytruda. CrystalGenomics exclusively holds the domestic development and licensing rights for Camrelizumab.

Currently, CrystalGenomics is preparing a bridging Phase 3 clinical trial (regulatory approval trial) in Korea, including translation of data and review of submission materials to the Ministry of Food and Drug Safety, to obtain approval for treating rare cancers such as esophageal cancer and lung cancer.

A CrystalGenomics representative stated, "Based on our collaboration with Hansoh Pharmaceutical, we aim to enter the domestic immuno-oncology market worth 200 billion KRW early with Camrelizumab."

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