[E-Daily Reporter Hyera Lee ] HLB INC. hit the daily price limit following news that the issues cited as reasons for the U.S. Food and Drug Administration (FDA) denying approval for HLB INC.’s new liver cancer drug “Riboceranib” have been resolved. However, it was reported that this will not affect the FDA’s evaluation of the currently pending approval application.
According to MP Doctor on the 15th, HLB INC.(028300)was trading at 34,700 won as of 9:09 a.m. that day, up 29.96% from the previous trading day. Following HLB INC.’s move to the daily price limit early in the session, other group stocks—including HLB GLOBAL Co., Ltd.(003580), HLB Therapeutics(115450), and HLB PHARMACEUTICAL(047920) —are also posting gains in the 20% range.
HLB INC.’s U.S. subsidiary, Eleva Therapeutics, announced on the 14th (local time) that it had received a “Seohan” from its partner, Hangzhou Pharmaceutical, confirming the completion of the FDA’s current Good Manufacturing Practice (cGMP) inspection of the active pharmaceutical ingredient (API) manufacturing facility for riboceranib. Seohan stated that the FDA determined the facility to be generally compliant with current cGMP standards and that the inspection results were classified as “VAI” (Very Acceptable).
Previously, the FDA had stated that the reason for holding up approval of the riboceranib and camrelizumab combination therapy was based on the results of a general cGMP inspection at Hangzhou Pharmaceutical’s Jinqiao site. This is a different issue from the problems with the camrelizumab manufacturing process, which were the reasons cited for the first and second delays in approval.
However, the company clarified that the Seohan explicitly stated, “The VAI classification itself does not affect the FDA’s evaluation of the current pending application associated with this manufacturing facility.”
HLB INC.’s stock has recently shown significant volatility in response to these developments. HLB INC.’s stock price hit the daily price limit down for two consecutive days on the 10th and 11th following news of the failed U.S. FDA approval.