Zenesel Signs Middle East Licensing Agreement for Oral COVID-19 Treatment 'ES16001'

Export to UAE Ordipharma

Currently conducting multinational Phase 2 and 3 clinical trials
Separately exploring OTC drug entry into the Middle East

Deniz Demir, CEO of DEM Pharma, Kang Se-chan, Dean of Kyung Hee University Graduate School of Biotechnology (Director of Genensel), and Garegozlu, Co-founder of Ordipharma (from left), are posing for a commemorative photo after signing the main contract for the exclusive rights of ES16001 in the Middle East and Turkey.

[Asia Economy Reporter Chunhee Lee] Genensel announced on the 23rd that it signed a main contract on the 20th with Ordipharma of the United Arab Emirates (UAE) for the exclusive rights in the Middle East and Turkey for 'ES16001,' an oral COVID-19 treatment under development.

The contract was finalized during a visit on the 19th-20th to DEM Pharma, the parent company of Ordipharma located in Istanbul, Turkey, by Professor Kang Se-chan, Dean of Kyung Hee University Graduate School of Biotechnology (Professor of Life Sciences), who also serves as a director of Genensel and leads the Genensel Technology Management Committee.

Professor Kang and his delegation inspected the Good Manufacturing Practice (GMP) certified production facilities and research labs, and met with Deniz Demir, CEO of DEM Pharma, and Garegozlu, co-founder of Ordipharma, to conclude the contract.

Currently, Genensel is conducting multinational Phase 2 and 3 clinical trials to evaluate the efficacy and safety of ES16001. ES16001 is a new drug candidate based on a novel material extracted from the leaves of the Korean native plant, Dampaulsu, which Genensel is developing as a treatment for COVID-19 and shingles.

Phase 2 clinical trials of ES16001 are underway with approximately 100 participants in Korea and 300 in India, totaling 400 subjects. After completing Phase 2, the plan is to proceed with multinational Phase 3 trials targeting around 700 participants.

However, both parties have strategized to obtain approval for ES16001 as an over-the-counter (OTC) herbal medicine in Turkey without additional clinical trials, and to acquire prescription drug (ETC) approval based on interim results from Phase 2 and 3 trials. Regarding manufacturing, the product will be produced domestically and locally through technology transfer, with further discussions planned with Korea Pharma, Genensel’s production partner.

Ordipharma plans to sell 150,000 units in Turkey by the first half of next year. Additionally, they intend to enter Middle Eastern markets such as Kuwait, Saudi Arabia, Oman, Iran, and Iraq using the same approach as in Turkey. Depending on clinical results, conditional approvals will be sought for each country, and if necessary, bridge clinical trials (additional local clinical trials) will be conducted under Ordipharma’s supervision.

Genensel CEO Lee Sung-ho said, “Professor Kang Se-chan, the developer of the original technology, personally met with the representatives of Ordipharma and its parent company to explain the strengths of our treatment and finalize the contract. We will do our best to complete the remaining contracts to achieve the milestone of the first export of a domestically developed COVID-19 treatment.”

Genensel also stated, “Ordipharma showed great interest not only in the COVID-19 treatment but also in other pipelines of Genensel and its affiliates,” and plans to pursue follow-up commercialization discussions.

At the contract meeting, Professor Kang introduced not only Genensel’s pharmaceuticals but also health functional food ingredients, medical devices from Sejong Medical, the largest shareholder, and the cooperative relationships and pipelines with Korea Pharma, a shareholder and production partner, and its affiliate APRG. Through this, they plan to explore additional exports and joint research opportunities.