Aprogen has reversed its plan to acquire a cGMP plant in the United States less than a day after the initial announcement, causing repercussions.
“We are examining various strategies, including the acquisition of a U.S. plant approved by the FDA, to respond to the U.S. government’s ‘made-in-America' policy according to the Executive Order of the National Biotechnology and Bio-manufacturing Initiative and to secure competitiveness in the U.S. biopharmaceutical markets, but has not decided anything in detail yet,” Aprogen said in disclosure of clarification on Thursday.
The company added, “We will re-announce the contents mentioned above when they are confirmed or within a month from then.”
Aprogen’s public notice contrasted with what it announced through a press release distributed several hours ago on the same morning.
In the initial news release, Aprogen said it would push to acquire a cGMP (current Good Manufacturing Practice) finished drug factory approved by the U.S. Food and Drug Administration.
According to Aprogen, the plant located in North Carolina has a site area of about 230,000 square meters (about 70,000 pyong) and is completely equipped with facilities for manufacturing antibody drugs and synthetic drugs injections.,
Aprogen said it is discussing paying for the sale of this factory with new Aprogen shares, not cash. It also emphasized the plant is manufacturing liquids and freeze-dried formulations of foreign pharmaceutical companies, such as the U.S. and Denmark.
The company also explained that it would prepare for the U.S. government’s “America-first principle in bio-industry” by acquiring the factory.
Aprogen also revealed its plan to produce the raw materials of biosimilars and new drugs at its Osong, South Chungcheong Province plant and make their finished products in the U.S. plant.
Due to the disclosure of clarification interpreted differently from the initial news release, industry watchers said they have no choice but to become suspicious of implementing the company’s plan announced earlier.
However, Aprogen said, “The public notice in question is an explanatory disclosure made at the request of the Korea Exchange, not reversing the press release.”