Celltrion’s Cheongju plant passes FDA evaluation

Celltrion said Monday its Cheongju plant passed the US’ Food and Drug Administration’s additional inspection, opening up the path to a 1.2 trillion won ($985 million) human immunodecifiency treatment market.

Celltrion manufactures three-drug-in-one-tablet HIV treatment CT-G07 at its plant in Cheongju, North Chungcheong Province. The treatment is pending FDA approval for US commercialization.

FDA had carried out an on-site inspection of Celltrion’s Cheongju plant in January to check on a new technology that had not been included in the facility’s Current Good Manufacturing Practice. FDA observed no violation.

Celltrion said HIV treatments are the core of global chemical market, and that it has once again proven its capability to produce not only biologics but also chemical drugs.

Celltrion had started out as a biosimilar company, which produces copies of biologics drugs whose patents have expired. A biologics drug, which often involves large molecules containing tens of thousands of atoms, is much more costly than chemical drugs which are small molecules typically comprising around 100 atoms or fewer. However, in a bid to diversify its business portfolio, Celltrion had vowed to foray into the chemicals field, too.

The company already has two-drugs-in-one-tablet HIV treatment Temixys and generic antibiotics Linezolid in the US market.

As for CT-G07, Celltrion said it may begin commercial manufacturing as early as April, with hopes for 10 percent market domination to start off, and an eventual growth to 20 percent domination in due time.

By Lim Jeong-yeo (kaylalim@heraldcorp.com)