National Treasure Signs Contract with CRO Company for Oral COVID-19 Treatment Regulatory Approval Assistance

[Asia Economy Reporter Jang Hyowon] Kospi-listed company Gukbo announced on the 15th that it has signed a service contract with clinical research organization (CRO) LSK Global Pharma Services to handle tasks such as approval and licensing for the oral COVID-19 treatment Opaganib.

Last month on the 8th, Gukbo acquired shares of the US/Israel biotechnology company RedHill Biopharma and was granted the first negotiation rights for the distribution rights contract covering RedHill’s oral COVID-19 treatments Opaganib and RHB-107 (Upamostat), as well as the Helicobacter pylori treatment Talicia, not only for domestic distribution but also for major Asian regions.

LSK Global Pharma Services, established in March 2000, is a leading domestic clinical research organization (CRO) that supports all areas related to clinical trials, including phase 1 to 3 clinical trials for approval, investigator-initiated trials, phase 4, PMS, observational studies, and post-approval clinical trials, as well as consulting related to new drug development. As of June, it is known to have conducted approximately 1,351 diverse clinical trials, including about 153 global clinical trials and approximately 759 approval clinical trials, and has also been conducting clinical trials for various COVID-19 vaccines, treatments, and diagnostic kits.

The oral COVID-19 moderate/severe treatment Opaganib received feedback from the US FDA in January 2022, and the European Union’s EMA is expected to receive preliminary review results by the end of this year. The oral COVID-19 mild treatment RHB-107 (Upamostat) is currently undergoing phase 2/3 clinical trials, with phase 2 results scheduled to be announced in the first quarter of 2022.

A Gukbo official stated, “We are pleased to work together with LSK Global Pharma Services on approval tasks for Opaganib, for which we secured first negotiation rights from RedHill. Through this, we will share all data as strategic partners with RedHill and review procedures such as domestic and overseas emergency use authorization and expedited review.” He added, “Starting with this contract, we will further strengthen collaboration between the two companies, and Gukbo will aggressively target the Asian medical market to become a game changer.”

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