Chong Kun Dang COVID-19 Treatment 'Napabeltan' Approved for Phase 3 Clinical Trial in Ukraine

First Overseas Approval for Global Clinical Trials in 8 Countries

Jongkundang Napabeltanju (Photo by Jongkundang)

[Asia Economy Reporter Kim Ji-hee] Chong Kun Dang announced on the 30th that it has received approval from the Ukrainian Ministry of Health for the Phase 3 clinical trial plan of the COVID-19 treatment drug 'Napabeltan' (active ingredient Nafamostat).

This clinical trial follows the approval of the Phase 3 clinical trial plan for Napabeltan by the Korean Ministry of Food and Drug Safety in April and marks the first overseas approval for the global clinical trial being conducted in eight countries, including Korea. Chong Kun Dang plans to conduct Phase 3 clinical trials starting in Ukraine, followed by Brazil, India, Thailand, Russia, Argentina, and Peru.

In the global Phase 3 clinical trial, Chong Kun Dang plans to evaluate the efficacy and safety of Napabeltan in 600 severe high-risk COVID-19 patients using a double-blind, multi-center, multi-national randomized allocation method. In Korea, the first patient was enrolled in July at Chilgok Kyungpook National University Hospital, and the trial is currently underway sequentially at a total of 14 institutions.

Last year, the Phase 2 clinical trial of Napabeltan conducted in Russia confirmed that among 104 severe COVID-19 patients, 36 patients with an early warning score of 7 or higher showed prevention of symptom worsening and improvement in treatment duration and treatment rate. The main ingredient of Napabeltan, 'Nafamostat,' works by inhibiting the activity of the spike protein common to the COVID-19 virus regardless of mutation status, thereby preventing cell infection. Accordingly, it is expected to respond to the spread of various mutant viruses such as Delta and Lambda, which have recently been spreading.

A Chong Kun Dang official stated, "To transition to 'With Corona,' not only vaccines but also treatments capable of responding to various mutations must be prepared," adding, "We plan to expand clinical trials to several countries including Ukraine, Brazil, India, and Peru to accelerate the development of treatments for severe high-risk patients."