Gold Pacific Subsidiary Signs API Contract for COVID-19 Treatment Phase 1 Trial... 'India Clinical Trial to Start Within the Year'

[Asia Economy Reporter Jang Hyowon] Gold Pacific subsidiary APRG has signed a contract for the production of active pharmaceutical ingredients (APIs) to conduct overseas clinical trials for a novel coronavirus disease (COVID-19) treatment. This contract is for conducting Phase 1 clinical trials recently approved by the Indian 'Central Drugs Standard Control Organization,' and Genensel plans to complete the production of APIs within this month.

On the 16th, APRG announced that it had signed a contract with Genensel for the production of APIs to conduct Phase 1 clinical trials in India for the COVID-19 treatment candidate substance 'APRG64.'

Through this contract, Genensel plans to complete the production of APIs by October. Based on this, Korea Pharma plans to produce the finished pharmaceutical products to be used in the Phase 1 clinical trials scheduled to be conducted in India in November.

It was explained that once the production of finished pharmaceutical products is completed, the Phase 1 clinical trials in India can proceed immediately. Therefore, starting from this contract, the development of COVID-19 treatments through APRG's overseas clinical trials is expected to gain significant momentum.

A Gold Pacific official stated, "Because companies involved in all stages are already part of the COVID-19 treatment development consortium, it is possible to produce APIs for clinical trials within a short period of about two months." He added, "The COVID-19 treatment being developed by APRG not only has excellent efficacy but also can progress rapidly in clinical trials, attracting attention from global pharmaceutical companies and industry stakeholders."

He continued, "APRG plans to start Phase 1 clinical trials in India within this year and complete them by March next year," and said, "Following Phase 1, it is expected that Phase 2 clinical trials can be conducted simultaneously in India and domestically in the first half of next year."

The COVID-19 treatment candidate substance 'APRG64' being developed by APRG is described as having a dual function of preventing intracellular infection of the COVID-19 virus and treating infection after it occurs, showing more than 50 times the therapeutic effect compared to Remdesivir.

Meanwhile, APRG has formed a consortium for COVID-19 treatment development with Kyung Hee University Industry-Academic Cooperation Foundation, Genensel, Korea Pharma, and Korea Institute of Drug Development, and this Phase 1 clinical trial in India marks the first step of the consortium.

This content was produced with the assistance of AI translation services.