Engchem Life Sciences Entrusts Hanmi Pharm with Manufacturing of COVID-19 Vaccine Bulk Material

[Asia Economy Reporter Jang Hyowon] Engchem Life Sciences announced on the 11th that it has signed a "technology transfer and facility preparation contract for the contract manufacturing of the ZyCoV-D vaccine" with Hanmi Pharmaceutical.

Engchem Life Sciences and Hanmi Pharmaceutical signed this "technology transfer and facility preparation contract for the contract manufacturing of the ZyCoV-D vaccine" following the "major terms agreement for the ZyCoV-D vaccine manufacturing project preparation" in December last year, based on the "ZyCoV-D manufacturing license technology transfer contract" between Zydus and Engchem Life Sciences.

This contract was signed for Engchem Life Sciences to outsource the manufacturing of the vaccine drug substance (DS) to Hanmi Pharmaceutical, aiming for technology transfer before commercial production and optimization of production facilities. Hanmi Pharmaceutical will perform process reproduction, production facility optimization, and assay method technology transfer to prepare for the main vaccine production upon Engchem Life Sciences' manufacturing outsourcing request.

Lee Hongkyun, Vice President of the Global Vaccine Business Division at Engchem Life Sciences, said, "Through the contract with Hanmi Pharmaceutical, we can officially start manufacturing the ZyCoV-D vaccine. The produced vaccine will be primarily supplied to major countries in Southeast Asia and South America with poor quarantine infrastructure, and we are currently rapidly preparing for regulatory approval according to priority. Additionally, we plan to gradually expand supply to countries with high vaccine demand."

Engchem Life Sciences plans to sign a main contract for commercial production with Hanmi Pharmaceutical as soon as technology transfer and production facility optimization are completed through this contract. Upon signing the main contract, full-scale production will commence immediately, and mass commercial production will begin from the second quarter of this year.

Son Kiyoung, Chairman of Engchem Life Sciences, emphasized, "Starting with this contract, from 2022 we will produce and sell more than 80 million doses annually of the pDNA COVID-19 vaccine. Engchem Life Sciences aims to supply advanced technology vaccines worldwide with pride in the 'Made in Korea' vaccine, contribute to resolving the COVID-19 pandemic by establishing a vaccine production hub, and leap forward as a global vaccine manufacturer."