Domestic pharmaceutical company HLB Group's stock is experiencing a sharp decline. This is believed to be affected by HLB Group's liver cancer new drug not receiving approval from the U.S. Food and Drug Administration (FDA). HLB challenged for a second FDA approval for commercialization but failed.
HLB's stock is trading at 46,500 won, down 19,900 won (29.97%) compared to the previous trading day, as of 9:03 a.m. on the 21st in the KOSDAQ market.
Stocks belonging to HLB Group, such as HLB Global, HLB Pharmaceutical, HLB Life Science, HLB Therapeutics, HLB bioStep, HLB Innovation, HLB PANAGENE, HLB Genex, and HLB Science, are also all declining.
According to HLB Group, the FDA sent a Complete Response Letter (CRL) regarding HLB's liver cancer new drug 'Riboceranib' on the 20th (local time). The company had applied for FDA approval for Riboceranib and the combination therapy with the immune anticancer drug 'Camrelizumab' from China as a first-line treatment for liver cancer. The FDA did not disclose the reasons for not making an approval decision.
Jin Yang-gon, chairman of HLB, noted through YouTube that day, "The CRL does not specify what the shortcomings are," adding, "Hangzhou Zhongmei is expected to swiftly contact the FDA to ascertain specifically what needs to be addressed before responding."
He further stated, "The first CRL in May last year involved two issues related to the CMC (Chemistry, Manufacturing, and Controls) of Camrelizumab and BIMO (Clinical Inspection), but this CRL is due to the reason that the CMC issues of Camrelizumab have not been sufficiently resolved." It appears that the content of the CRL has been simplified compared to the previous year.
He also said, "I believed that I could share good news with our shareholders, but it pains me to once again convey disappointing news," adding, "I will not be discouraged and will overcome this well."
HLB's Riboceranib competed for the position of 'the first domestically produced anticancer drug' which was approved by the FDA with Yuhan Corporation's lung cancer drug 'Lazertinib,' which received FDA approval in August last year. However, it has undergone subsequent procedures after receiving a CRL last year.