Immune Checkpoint Inhibitor 'Camrelizumab' Designated as Orphan Drug by US FDA... Crystal Holds Domestic Distribution Rights

[Asia Economy Reporter Hyunseok Yoo] CrystalGenomics announced on the 28th that camrelizumab, an anticancer drug developed and licensed domestically from China’s Hansoh Pharmaceutical, has been designated as an orphan drug in the United States.

The U.S. Food and Drug Administration (FDA) designated camrelizumab as an orphan drug for the indication of hepatocellular carcinoma on the 27th (local time).

Camrelizumab is an immune checkpoint inhibitor that blocks PD-1. CrystalGenomics exclusively holds the domestic development and licensing rights for camrelizumab.

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

The FDA orphan drug designation is a system that supports the development and approval of treatments for rare and intractable diseases or life-threatening conditions. Designation as an orphan drug provides benefits such as tax reductions, exemption from application fees, and seven years of market exclusivity upon approval.

Camrelizumab was first approved in 2019 by China’s National Medical Products Administration (NMPA) as a third-line treatment for classical Hodgkin lymphoma, and subsequently received additional approvals in March last year for second-line treatment of liver cancer, in June for first-line treatment of non-small cell lung cancer, and for second-line treatment of esophageal cancer.

A CrystalGenomics official stated, "Based on our collaboration with Hansoh Pharmaceutical, we plan to enter the domestic immune-oncology market worth 200 billion KRW with camrelizumab, a drug validated for various indications."

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