RedHill Biopharma Ltd (RDHL)

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Kukbo Co., Ltd., a KOSPI-listed company, announced on the 28th that the US/Israel biotechnology company RedHill Biopharma's oral treatment for moderate/severe corona virus Opaganib will be approved for emergency use in the first half of the year.

Currently, the EUA (Emergency Use Authorization) procedure is the fastest in Colombia and there is very positive feedback, so emergency use approval is scheduled for mid-February. said. Additional data have been submitted to the US and EU, and it is known that the emergency approval process will soon begin through feedback from regulators.

Kukbo acquired a stake in Red Hill in November of last year and distributes oral COVID-19 treatments (Opaganib, RHB-107 (Upamostat)) and Talica® developed by Red Hill in Korea as well as major Asian regions. In the first quarter of this year, it has been given the right to preferential negotiation of the copyright contract, and signed a business performance service contract for Opaganib with LSK Global Pharma Service, a leading domestic clinical contract company (CRO) in December. Following the NDA Submission, the domestic emergency use approval procedure is in progress, and attention is focused on the result.

Red Hill's Opaganib is the only oral corona treatment that can treat severe and moderate COVID-19 patients. Compared to patients receiving standard treatment (remdesivir or dexamethasone), Red Hill's Opaganib reduced mortality in severe patients by 62%, It has published improved clinical results over time, and it is less burdensome and less burdensome to take compared to Pfizer's 'Paxrovid', which requires taking 30 tablets for 5 days by taking 2 tablets (1 tablet at a time) for 7 to 14 days. It is also known to have price competitiveness and is expected to attract attention.

In addition, Opaganib has demonstrated dual anti-inflammatory and antiviral activity targeting palliative cellular components, and as a sphingosine kinase-2 (SK2) selective inhibitor, it has been demonstrated to potentially minimize the possibility of viral resistance, thereby demonstrating superiority in the basal aspect. It has been proven, and it has been proven that the individual combination of Opaganib and RHB-107 (Upamostat) has a potential antitumor effect and antitumor effect on patients with cholangiocarcinoma, and has received a patent application from the US Patent and Trademark Office (USPTO).

Source: Global Economic Daily (http://www.getnews.co.kr)