[Special Stock] HLB Gains for Second Day Following US FDA Recommendation to Reapply for Liver Cancer Drug Review

HLB has been on the rise for the second consecutive day. This is attributed to news that the U.S. Food and Drug Administration (FDA) has recommended the submission of a reexamination application for Hanseo Pharmaceutical's camrelizumab, a combination drug with HLB's liver cancer new drug 'Rivoceranib.'

As of 10:22 AM on the 4th, HLB is trading at 81,700 KRW, up 6.51% compared to the previous day.

On the 2nd (local time), HLB announced that during a meeting in the U.S. to resume the approval review of the liver cancer new drug, the FDA strongly recommended submitting a reexamination application. The FDA delivered an official document (PAL·Post Action) regarding the CMC (Chemistry, Manufacturing, and Controls) issues of camrelizumab.

The meeting included HLB, HLB's subsidiary Elevate Therapeutics, and Hanseo Pharmaceutical. According to HLB, the document contained the FDA's position that Hanseo Pharmaceutical has no additional documents to submit related to the camrelizumab CMC inspection. Hanseo Pharmaceutical can submit the Biologics License Application (BLA) to the FDA reflecting the supplementary CMC materials already submitted twice.

This content was produced with the assistance of AI translation services.