HLB Liver Cancer Drug Fails to Secure US FDA Approval... Receives Request for Supplementary Information

On the morning of the 21st, Jin Yang-gon, chairman of HLB, appeared on the company's YouTube channel to explain the failure to obtain FDA approval for the liver cancer drug. Photo by HLB YouTube capture

HLB Group's liver cancer drug has once again failed to receive approval from the U.S. Food and Drug Administration (FDA).

On the 21st, HLB Group announced that it received a Complete Response Letter (CRL) from the U.S. FDA regarding the targeted anticancer drug 'Rivoceranib.' Jin Yang-gon, Chairman of HLB, stated on YouTube that morning, "The U.S. FDA has once again sent a CRL concerning the combination therapy of 'Rivoceranib,' which was submitted for new drug approval as a first-line treatment for liver cancer, and the Chinese pharmaceutical company Hansoh Pharmaceutical's immuno-oncology drug 'Camrelizumab.'

HLB's Rivoceranib is an oral targeted anticancer drug that selectively inhibits vascular endothelial growth factor receptor 2 (VEGFR-2), which is involved in tumor angiogenesis.

This drug attracted attention as it was expected to be the second domestic anticancer new drug to receive FDA approval, following Yuhan Corporation's lung cancer drug 'Leclaza,' which was approved by the FDA in August last year. If Rivoceranib obtains marketing authorization, it will become the first anticancer drug developed independently by a domestic company to receive FDA approval without technology export.

Chairman Jin explained on YouTube, "The first CRL in May last year involved two issues: Camrelizumab's CMC (Chemistry, Manufacturing, and Controls) and BIMO (Bioresearch Monitoring). However, this CRL is solely due to insufficient resolution of Camrelizumab's CMC issues." He added, "The CRL does not specify what the deficiencies are. Therefore, Hansoh Pharmaceutical will quickly engage with the FDA to identify the specific points that need to be addressed and respond accordingly."

He continued, "We have worked tirelessly over the past 10 months to achieve good results, so I believed this time we could deliver good news to our shareholders. However, it pains me to share disappointing news once again. We will not be discouraged and will overcome this challenge well."

Once HLB resubmits the New Drug Application (NDA) documents, the FDA will review them and notify the company of a new review schedule. Regarding the supplementary matters, the FDA may conduct an on-site reinspection or decide on approval based solely on document review.