South Korea’s leading bio-pharmaceutical company Celltrion Inc. said on Monday that it has received marketing authorization from the U.S. Food and Drug Administration for its oral antiviral medication Temixys tablets used for Human Immunodeficiency Virus (HIV) infection treatment.
According to Celltrion, the FDA last week gave green light for Temixys, a new drug that combines ingredients of Zeffix (lamivudine), an original antiviral agent developed by British pharmaceutical company GlaxoSmithKline plc, and Viread (tenofovir), an antiviral medicine developed by Gilead Sciences Inc., a research-based biopharmaceutical company.
The latest approval comes after Celltrion launched drug development in 2016 and filed for marketing approval to the FDA in January. The Korean company has already received approval from the Ministry of Food and Drug Safety to export the drug last month.
With the approval by the U.S. FDA, Celltrion plans to sell Temixys tablets in the U.S. from early next year with an aim to dominate the market by supplying medicines at affordable prices to local patients with HIV infection struggling to receive treatments due to expensive medicines and insurance fees.
Celltrion shares closed Monday 2.2 percent up at 229,000 won.
The U.S. HIV treatment market is estimated to reach 24 trillion won ($21.3 billion), of which 3.3 trillion won is taken up by Gilead Sciences’ Truvada. Celltrion is expected to expand presence also by securing supplier qualification from world’s HIV treatment procurement agencies.
An unnamed official from Celltrion said that the company will put out efforts to supply high-quality treatments to Acquired Immune Deficiency Syndrome patients at the earliest possible following the latest FDA approval.
The U.S. launch of Temixys, meanwhile, is the first outcome of Celltrion’s Global Chemical Project aimed at developing chemical drugs. The company had newly set up a chemical development team and promoted projects to become a bio-pharmaceutical firm equipped with global-level portfolio.
By Kim Byung-ho and Lee Eun-joo
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