[E-Daily Reporter Hyera Lee ] HLB INC.(028300)is trading at its daily lower price limit shortly after the market opened. This follows the failure of “Riboceranib,” a new drug candidate for liver cancer, to receive approval from the U.S. Food and Drug Administration (FDA).
According to MP Doctor on the 10th, as of 9:06 a.m. that day, HLB INC.(028300)was trading at 36,600 won, down 29.89% from the previous trading day. In addition, HLB PANAGENE(046210), HLB PHARMACEUTICAL(047920), HLB Life Science(067630), and HLB Therapeutics(115450) also plummeted to their daily trading limits.
This is believed to be due to a wave of sell-offs triggered by HLB INC.’s announcement earlier today that it had received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application (NDA) for a new liver cancer drug.
According to HLB INC., its U.S. subsidiary, Eleva Therapeutics, received a CRL from the FDA on the 9th (local time) regarding the New Drug Application (NDA) for riboceranib.
This CRL stems from findings identified during a routine cGMP (Current Good Manufacturing Practice) inspection of the Hengrui Pharmaceuticals manufacturing facility listed in the riboceranib NDA. The FDA stated that it cannot approve the riboceranib NDA until the issues at the manufacturing facility are resolved and compliance with cGMP standards is confirmed. Furthermore, the CRL noted that even after the cGMP-related issues are resolved, the FDA may conduct a Pre-Approval Inspection (PAI) of the facility if necessary, and that new drug approval is contingent upon satisfactory results from both the cGMP inspection and the PAI.
Consequently, the riboceranib and camrelizumab combination therapy has now received three requests for supplemental information from the FDA—following the first CRL in May 2024 and the second CRL last year.
Kim Dong-geon, CEO of Eleva, stated, “We have not identified any specific concerns regarding clinical efficacy or safety data in this CRL, nor any requests for additional clinical trials.” He added, “Since the main requests for supplemental information relate to the cGMP inspection of the manufacturing facility, we will consult closely with the FDA to confirm the necessary procedures and proceed with a resubmission as soon as possible.”