HLB(028300) group stocks hit the upper limit (the top of the daily price band) early on the 15th. The move came after news that issues in the U.S. approval process for HLB's liver cancer drug had been resolved.
As of 9:31 a.m. that day, HLB Pharmaceutical(047920) shares were up 30.00% (1,980 won) at 8,580 won on the KOSDAQ market, hitting the upper limit (the top of the daily price band).
HLB was also up 29.96% (8,000 won) at 34,700 won, hitting the upper limit.
HLB said in a news release that day that its U.S. subsidiary, Elevar Therapeutics, received a completion letter for a current good manufacturing practice (cGMP) inspection from the U.S. Food and Drug Administration (FDA) regarding the active pharmaceutical ingredient manufacturing site for Rivoceranib from its Chinese partner, Jiangsu Hengrui Pharmaceuticals.
Earlier, HLB said its U.S. subsidiary Elevar Therapeutics had received a complete response letter (CRL) from the FDA regarding approval of Rivoceranib.
HLB said it was determined that Hengrui's manufacturing facility, which produces the active pharmaceutical ingredient for Rivoceranib, was generally compliant with cGMP, and that the FDA inspection result was classified as a "voluntary action indicated" (VAI).