Samsung Pharm Applies for Conditional Approval of PSP Treatment GV1001

Samsung Pharm announced on January 20 that it has applied to the Ministry of Food and Drug Safety for conditional approval of "GV1001," a treatment for progressive supranuclear palsy (PSP).

The application for conditional approval targets the progressive supranuclear palsy Richardson syndrome (PSP-RS) subtype as its indication. If conditional approval is granted, the company will be required to conduct clinical trials in accordance with the conditions set by the Ministry of Food and Drug Safety. In December of last year, Samsung Pharm secured the rights for clinical development and commercialization of the PSP treatment GV1001 in four major Asian countries, including Korea, through a technology transfer agreement with GemVax & KAEL.

Conditional approval is a system that allows the early market release of treatments for life-threatening cancers, other serious diseases, or rare diseases based on the results of Phase 2 clinical trials, on the condition that the results of Phase 3 clinical trials are submitted after launch.

The PSP treatment GV1001 was designated as an orphan drug in development by the Ministry of Food and Drug Safety in 2024. Samsung Pharm plans to ensure that the drug can be supplied quickly to medical sites if conditional approval is obtained.