FDA approval for South Korean firm's MAb drug substances plant

The US Food and Drug Administration has licensed the first monoclonal antibody (MAb) drug substance at its second plant, the world's largest single plant, operated by Samsung BioLogics (XKRX:207940), a contract manufacturer of biologic drugs under South Korea’s Samsung Group, in Songdo, Incheon.

Shares of Samsung Biologics gained 8.6% to 377,500 won on the news.

With the first license of its second plant from the FDA, Samsung BioLogics is now able to manufacture commercial biologics drug substance at its second plant in addition to its first plant which has 30,000 liters of capacity.