HLB group stocks rise simultaneously
HLB “US FDA main review is going smoothly without any particular problems”
With the news that HLB’s liver cancer treatment is imminent to be approved by the U.S. Food and Drug Administration (FDA), HLB group stocks are trading strongly in early trading on the 29th.
At 9:15 on this day, HLB is trading at 68,700 won, up 5.37%. In addition, group stocks such as HLB Therapeutics (+20.52%), HLB Life Sciences (+13.85%), and HLB Pharmaceuticals (+10.66%) are also trading upward.
HLB is seeking first-line treatment approval from the FDA for a combination treatment of liver cancer treatment candidate ‘rivoceranib’ and China’s Hengxi Pharmaceutical’s ‘camrelizumab’.
The only thing left to do before FDA approval is the FDA’s final review at the end of March, where the FDA will conduct a final document review. If there are no problems, it will be 9 steps to new drug approval.
An HLB official said, “No special issues were raised in the two previous document review meetings with the FDA, and the factory inspection was completed without any problems, so considering everything, we are confident that the new drug will be approved.”
After the review in March, the FDA plans to decide whether to approve rivoceranib by May 16.
Reporter Kim Dong-hagi hdk@wowtv.co.kr
