[Asia Economy Reporter Jang Hyowon] Genencell, a subsidiary of Sejong Medical, announced on the 23rd that it has signed a main contract with Ordi Pharma FZ-LLC in the United Arab Emirates (UAE) for the exclusive distribution rights of the oral COVID-19 treatment ‘ES16001’ in the Middle East and Turkey.
Both companies agreed on the production, regulatory approval, distribution, and supply strategies for ‘ES16001’ and signed the exclusive distributorship agreement on the 20th.
Ordi Pharma has shown great interest not only in the COVID-19 treatment but also in other pipelines of Genencell and its affiliates, and discussions for subsequent commercialization are also underway.
Professor Kang Sechan of Kyung Hee University (College of Life Sciences, Dean of the Institute of Biotechnology / concurrently serving as a director of Genencell), who leads the Genencell Technology Management Committee, and his delegation visited DEM Pharma, the parent company of Ordi Pharma, located in the Atasehir district of Istanbul, Turkey, from the 19th to the 20th.
Professor Kang Sechan and his team inspected the GMP (Good Manufacturing Practice) certified production facilities and research institutes, and met with Deniz Demir, CEO of DEM Pharma, and Gharehgozloo A, co-founder of Ordi Pharma, to finalize the contract.
Initially, in Turkey, the strategy is to obtain regulatory approval as an over-the-counter (OTC) herbal medicine without additional clinical trials, and later acquire prescription drug approval based on interim results from the ongoing multinational Phase 2/3 clinical trials conducted by Genencell. Regarding local manufacturing through domestic production and technology transfer, further discussions will be held with Korea Pharma, Genencell’s production partner.
Ordi Pharma plans to sell 150,000 doses in Turkey alone by the first half of next year and expects to continuously expand the market even after COVID-19 becomes endemic. Additionally, the Middle Eastern countries including Kuwait, Saudi Arabia, Oman, Iran, and Iraq will enter the market using the same approach as Turkey. Depending on the multinational clinical trial results, conditional approvals will be applied for each country, and if necessary, bridging clinical trials (additional local clinical trials) will be conducted under Ordi Pharma’s supervision.
Within 15 days of signing this contract, Ordi Pharma is expected to send local regulatory approval and business plans to Genencell. Based on this, both companies will finalize the agreed pricing policy and Turkish brand within 45 days.
Regarding this, Lee Seongho, CEO of Genencell, said, “Professor Kang Sechan, the original technology developer, personally met with the representatives of Ordi Pharma and its parent company to explain the strengths of our treatment and concluded the contract,” adding, “We will do our best to complete the remaining contract procedures to achieve the milestone of the first export of a domestically developed COVID-19 treatment.”
Meanwhile, at the contract meeting, Professor Kang Sechan introduced not only Genencell’s pharmaceuticals but also health functional food ingredients, medical devices from the major shareholder Sejong Medical, and the cooperative relationships and pipelines with Korea Pharma, the shareholder and production partner, and its affiliate APRG. They also agreed to explore additional exports and joint research. In particular, Ordi Pharma showed great interest in Genencell’s eye health functional ingredients and APRG’s oral virus antibody formation enhancer.
‘ES16001’ is a new drug candidate based on a novel material extracted from the domestic native plant Dambalsu, and clinical trials for COVID-19 and shingles are currently underway in South Korea.
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