KOSPI-listed Kwangdong Pharmaceutical was strong early on the 20th. Buying appears to be concentrated on news that the presbyopia treatment "YUVEZZI," for which it holds exclusive domestic distribution rights, won approval from the U.S. Food and Drug Administration (FDA).
As of 9:27 a.m. on the day, Kwangdong Pharmaceutical was trading at 10,030 won, up 2,030 won (25.38%) from the previous session. Right after the open, the share price rose to 10,400 won, hitting a 1-year high and touching the upper limit (the top of the daily price band).
Kwangdong Pharmaceutical said on the 13th that YUVEZZI won U.S. FDA approval. YUVEZZI is a new drug developed by global biotech Tenpoint Therapeutics, and in Jan. 2024 Kwangdong Pharmaceutical signed an exclusive license agreement with Hong Kong drugmaker Zhaoke, which holds the drug's Asian distribution rights.
Kwangdong Pharmaceutical shares rose only 0.65% on the 13th, but as expectations grew for results from domestic sales, the stock finished at the upper limit on the next trading day, the 19th. The rally appears to be continuing today.
The company applied to the Ministery of Food and Drug Safety in September last year for item approval for the drug. While the domestic launch timing has not yet been set, industry views suggest it could reach the market within the year.
A Kwangdong Pharmaceutical official said, "The fact that YUVEZZI's efficacy and safety cleared the FDA's stringent approval standards is an encouraging development for the domestic introduction process," adding, "We will do our best with the remaining approval procedures and market launch preparations to provide a new treatment option for domestic medical professionals and presbyopia patients."