SK Biopharmaceuticals’ independently-developed drug wins FDA approval

SK Biopharmaceuticals announced on Friday that its independently-developed new drug “XCOPRI” has won approval from the U.S. Food and Drug Administration (FDA).

This is the first time that a South Korean biopharmaceutical company independently took charge of the discovery, development and approval of a new drug without the help of foreign companies. With an aim of making biopharmaceuticals a core new growth engine following the footsteps of semiconductors, SK Group has made investments in the area for the past 20 years. Industry watchers say SK Group’s tenacious efforts have finally paid off.

It has been proven in clinical trials that XCOPRI prevents the onset of seizures for some epilepsy patients. The South Korean biopharmaceutical company is set to release the new drug in the U.S. market in the second quarter of next year. The pharmaceutical industry estimates that the annual sales of XCOPRI will exceed 1 trillion won.

The global sales of anti-epilepsy drug totaled 6.1 billion U.S. dollars last year, with American pharmaceutical companies taking up 54% (3.3billion dollars) of the market. In a company release, SK Biopharmaceuticals CEO Cho Jeong-woo revealed the company’s goal of becoming a fully integrated global pharmaceutical company that can discover, develop and deliver new treatment options for epilepsy and the central nervous system.


Dong-Il Seo dong@donga.com