HLB Fails to Receive US FDA Approval for Rivoceranib Liver Cancer Treatment


The logo of HLB
The logo of HLB

HLB has failed to secure approval from the U.S. Food and Drug Administration (FDA) for its “Rivoceranib + Camrelizumab,” which is under development as a first-line treatment for liver cancer.

On May 17, Chairman Jin Yang-gon of HLB announced via YouTube that its U.S. subsidiary, Eleva, received a complete response letter (CRL) from the FDA at 5:45 pm Eastern Time (6:45 am Korean Time), regarding the combination therapy of Rivoceranib and Camrelizumab, an anticancer drug made by Jiangsu Hengrui, HLB’s Chinese partner, under FDA product approval review.

Chairman Jin stated, “The FDA did not mention any problems related to Rivoceranib, but there were criticisms that the responses related to the Camrelizumab issue were not sufficient. It is difficult to predict. However, Jiangsu Hengrui received negative feedback regarding non-essential aspects of the chemistry manufacturing and controls (CMC) inspection during the review process, and the company reiterated its position multiple times, stating that it had adequately addressed and resolved the issues through modifications and enhancements. Nevertheless, I believe the Chinese firm’s response to criticism of its manufacturing process for Camrelizumab failed to fully satisfy the FDA.”

He continued, “There were issues with the bioresearch monitoring (BIMO) inspections, an FDA process to verify key sites where clinical trials were conducted, which couldn’t proceed due to travel restrictions during the COVID-19 period. This particularly affected our clinical participation in hospitals with a high proportion of Caucasian participants in Russia and Ukraine, the two countries currently in conflict, making inspections impossible. This is not our problem and it is deemed not to be a fundamental issue. It can be adequately demonstrated through other means.”

Chairman Jin expressed, “Although all of our employees have devoted their utmost efforts to obtain approval for the new drug, I feel devastated that the launch of the new drug has been delayed. However, I believe this delay will not be prolonged.” He added, “As the FDA has provided specific feedback and requested resubmission after addressing the deficiencies, we will expedite the resubmission process to obtain approval again shortly.”

On May 17, after the new liver cancer drug failed to secure approval, shares of nine listed companies under HLB Group all reached the lower limit. Consequently, the market capitalization of HLB Group evaporated by 5.03 trillion won in just one day.


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