In early trading on the 10th, HLB Group shares all plunged straight to the lower limit. Investor sentiment appears to have soured after approval by the U.S. Food and Drug Administration (FDA) for the liver cancer drug candidate "Rivoceranib" fell through.
As of 9:28 a.m. that day in the Korea Exchange, HLB(028300) was trading at 36,600 won, down 15,600 won (29.89%) from the previous session.
At the same time on the KOSDAQ market, HLB Panagene(046210), HLB Pharmaceutical(047920), HLB Life Science(067630), HLB Therapeutics(115450), and HLB bioStep(278650), among others, were also hitting the lower limit, with most HLB Group stocks recording declines.
The reason HLB Group stocks are plunging in tandem is analyzed to be the wave of sell orders on disappointment after word spread that HLB received a complete response letter (CRL) from the FDA regarding its liver cancer drug approval application.
HLB said its U.S. subsidiary Elevar Therapeutics received a CRL on the 9th (local time) from the FDA for the new drug application (NDA) for Rivoceranib.
The CRL stems from findings identified during a general cGMP (current good manufacturing practice) inspection of the Hansoh Pharmaceutical manufacturing facility included in the Rivoceranib NDA. The FDA said it will withhold approval of the Rivoceranib NDA until the issues at the facility are resolved and cGMP standards can be met.
It specified that even after cGMP-related matters are resolved, a pre-approval inspection (PAI) of the facility may be conducted again if necessary, and that approval is possible only if both the cGMP inspection and the PAI receive a determination of compliance.
The Rivoceranib–Camrelizumab combination therapy has now received a total of three FDA complete response requests: the first CRL in May 2024, the second last year, and the latest this time.