[Market Focus] HLB Rises on FDA's Lack of Safety or Efficacy Concerns for Liver Cancer Drug, Eyes Resubmission This Year

HLB is showing strong performance. This is believed to be due to news that the original Complete Response Letter (CRL) for the combination therapy of the liver cancer drug "Rivoceranib + Camrelizumab (Rivocamrel)" released by the U.S. Food and Drug Administration (FDA) did not raise any concerns about the safety or efficacy of Rivoceranib itself.

As of 10:55 a.m. on September 5, HLB was trading at 42,200 won, up 6.97% from the previous day.

According to a media outlet, the FDA has disclosed the original CRL for HLB's liver cancer drug "Rivoceranib + Camrelizumab (Rivocamrel)" combination therapy. This is the first time the specific reasons for the non-approval in March have been officially clarified.

The FDA reportedly pointed out issues related to Hansoh Pharmaceutical's plant management (CMC), and also noted that Rivoceranib cannot be approved as a standalone treatment while Camrelizumab has not yet received official approval. However, there were no particular concerns raised regarding the safety or efficacy of Rivoceranib itself.

In response, HLB stated that it will do its best to resubmit the application within this year.

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