National Treasure Investor Redhill: "Oral COVID-19 Treatment Expected to Receive Emergency Use Authorization in Colombia and Russia"

[Asia Economy Reporter Jang Hyowon] KOSPI-listed company Kukbo announced on the 28th that Opaganib, an oral COVID-19 treatment for moderate to severe cases developed by the US/Israel-based biotechnology company RedHill Biopharma, is scheduled to receive emergency use authorization (EUA) in Colombia and Russia during the first half of the year.

Currently, the EUA process is progressing fastest in Colombia, with positive feedback received, and emergency use authorization is expected by February. In Russia, clinical trials have been completed, and EUA is expected within the first quarter, according to RedHill. Additional data has been submitted to the US and EU, and it is known that the emergency approval process will soon begin based on regulatory feedback.

Last November, Kukbo acquired shares in RedHill and was granted the first negotiation rights for distribution contracts covering not only the domestic distribution of RedHill’s oral COVID-19 treatments (Opaganib, RHB-107 (Upamostat), and Talicia) but also distribution in major Asian regions. In December, Kukbo signed a service contract with LSK Global Pharma Services, a leading domestic clinical research organization (CRO), for work related to Opaganib, and is currently proceeding with the domestic emergency use authorization process following the NDA submission in the first quarter.

RedHill’s Opaganib is an oral COVID-19 treatment capable of treating moderate and severe patients. Clinical results have shown a 62% reduction in mortality among severe patients compared to those receiving standard treatments (Remdesivir or Dexamethasone), as well as improvements in indoor air quality and average time to discharge. Compared to Pfizer’s Paxlovid, which requires taking 30 pills over 5 days (2 pills per day, 1 pill per dose for 7?14 days), Opaganib has a lower pill burden and is also known to have price competitiveness.

A Kukbo official stated, “Opaganib, an oral treatment whose safety has been proven and is preparing for emergency use authorization, is expected to play a true ‘Game Changer’ role in ending the pandemic by being rapidly supplied not only to the domestic market but also to overseas markets.”

Meanwhile, RedHill Biopharma is a Nasdaq-listed emerging specialized biopharmaceutical company based in the US. It currently commercializes and sells three FDA-approved products: Movantic, Talicia, and Aemcolo, and is developing six new drugs, including an oral COVID-19 treatment.