HLB's shares hit the lower limit after news that its liver cancer drug, Riboceranib, failed to receive approval from the U.S. Food and Drug Administration (FDA).
As of 11:40 a.m. on July 10, HLB's stock was trading at 36,600 won, down 15,600 won (29.89%) from the previous trading day.
At the same time, HLB Pharmaceuticals (-29.98%), HLB Life Science (-29.87%), and HLB Therapeutics (-29.82%) also recorded the lower limit. Additionally, shares of HLB Global (-27.37%), HLB Innovation (-26.06%), HLB Panajin (-25.86%), HLB Biostep (-26.57%), HLB Genex (-20.60%), and HLB Pep (-15.06%) all experienced significant declines.
The sharp drop in investor sentiment was triggered by a disclosure from HLB's U.S. subsidiary, Elevate Therapeutics, which announced it received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application (NDA) for the combination therapy of Riboceranib and Camrelizumab as a first-line treatment for liver cancer.
According to the company, the CRL was not due to the efficacy or clinical results of Riboceranib itself, but rather issues identified during the FDA's inspection of the manufacturing facility of China's Jiangsu Hengrui Medicine, which was included in the application. The FDA stated that approval would only be possible once the identified issues at the manufacturing facility are resolved and compliance with current Good Manufacturing Practices (cGMP) is confirmed.
This marks the third attempt for approval following submissions in May 2024 and 2025. HLB has requested documentation and improvement plans related to the FDA inspection from Jiangsu Hengrui, but the market anticipates that the need for corrective actions at the manufacturing facility will delay the approval timeline.
* This article has been translated by AI.
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