South Korea’s Aprogen said on Thursday it is in talks to acquire an FDA-approved Good Manufacturing Practice (cGMP) facility in the U.S. for finished biologics products in a move to facilitate its future entry into the local pharmaceutical market amid ‘America First’ policy in the U.S.

The plant adjacent to the largest city center in North Carolina and encompasses an area of about 230,000 square meters. It was completely renovated in 2015 and currently manufactures antibody and injection therapeutics on a floor area of about 7,500 square meters.

Aprogen wants to buy the site with its new shares instead of cash. Aprogen shares gained 3.75 percent to trade at 997 won ($0.71) at 1:45 pm on Thursday.

The U.S. plant recently completed process validation and pilot production of Aprogen’s biosimilar with drug substance from Aprogen Biologics’ Osong plant in Korea.

The company is planning to produce drug products in the U.S. for local distribution, while its Osong plant is responsible for production of drug substances for biosimilars and novel therapies. The acquisition, if realized, will also bring a competitive edge to Aprogen and Aprogen Pharmaceuticals in contract development and manufacturing business which is being studied.

Aprogen said it will manufacture drug products for Europe and other markets at Aprogen Biologics’ Osong plant, which is equipped with facilities capable of producing not only antibody and protein substances but also all injectable formulations (freeze-dried injection, water injection, pre-filling injection) with an annual production capacity of more than 3,000 kg.

By Pulse

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