[Asia Economy Reporter Hyunseok Yoo] APRG, a subsidiary of Gold Pacific, has completed the production of active pharmaceutical ingredients (API) for conducting overseas clinical trials of its COVID-19 treatment in India in just over a month and is now preparing for full-scale clinical trials.
On the 30th, APRG announced that it had completed the production of the API for the overseas clinical trials of its COVID-19 treatment candidate substance, ‘APRG64’.
This API production was for conducting Phase 1 clinical trials approved by India’s Central Drugs Standard Control Organization (CDSCO) on the 8th, and APRG had already signed a contract with Genencell on the 16th for the production of the API.
A company official explained, “From the approval of Phase 1 clinical trials by India’s CDSCO to the signing of the API production contract and completion of production, everything was completed within just one month,” adding, “Only the production of the finished pharmaceutical product remains before entering Phase 1 clinical trials.” He further added, “The rapid progress of the clinical trials was based on a solid consortium composed of experts from various fields dedicated to developing COVID-19 treatments.”
In August, APRG signed a consortium agreement with Genencell, Korea Pharma, Korea Institute of Drug Development, and Kyung Hee University Industry-Academic Cooperation Foundation to jointly develop a COVID-19 treatment based on APRG64.
Among them, the development and production of the API were led by Genencell, and Korea Pharma will take over this API to complete the production of the finished pharmaceutical product APRG64, which will be used in the Phase 1 clinical trials next month, completing all preparations for the start of Phase 1 clinical trials in December. Genencell will conduct the Phase 1 clinical trials in India, aiming to complete them in the first half of next year.
In particular, once this Phase 1 clinical trial is completed, Phase 2 clinical trials will be conducted under the full leadership of APRG in both Korea and India. A company official explained, “Phase 2 clinical trials, which evaluate the therapeutic efficacy and appropriate dosage and administration of the drug, are more complex than Phase 1 trials. Especially in India, where COVID-19 patients are rapidly increasing, if the evaluation results of Phase 2 are excellent, there is a high possibility of being exempted from Phase 3 clinical trials through the fast-track system and proceeding directly to product launch, making it extremely important.”
Meanwhile, in August, APRG signed a technology transfer contract for ‘APRG64’ with the research team led by Professor Kang Se-chan, director of the Biomedical Research Center (BMRI) at Kyung Hee University, acquiring all rights related to new drug development as well as exclusive domestic and international distribution rights.
© The Asia Business Daily(www.asiae.co.kr). All rights reserved.
