The HLB group’s stock prices surged following the news that HLB’s new liver cancer drug, “Rivoceranib,” passed the Bioresearch Monitoring (BIMO) inspection in the FDA approval process. As reported on the 18th by the Korea Exchange, HLB’s stock price rose by 28.25%, reaching 79,900 won. Other HLB group stocks also saw significant increases, including HLB Pharmaceutical at its upper limit of 22,750 won and HLB Life Science (+28.16%), HLB Global (+25.68%), HLB Therapeutics (+23.87%), HLB Panagen (+20.99%), HLB Biostep (+20.49%), HLB Innovation (+15.95%), and HLB Science (+9.63%).
This surge is attributed to the FDA’s decision to issue a “No Action Indicated” (NAI) ruling from the BIMO results for the combination therapy of HLB’s Rivoceranib and Henlius Pharmaceutical’s “Camrelizumab.” BIMO is an FDA inspection process to ensure the reliability of clinical trial data and regulatory compliance, where FDA inspectors visit clinical sponsors, hospitals, and Clinical Research Organizations (CROs). FDA inspection results are classified into three categories: Official Action Indicated (OAI), Voluntary Action Indicated (VAI), and No Action Indicated (NAI).
Despite already receiving an NAI verdict after a BIMO inspection at Harbin Hospital in November last year, the FDA issued a Complete Response Letter (CRL) for manufacturing facilities (CMC) improvements in May, necessitating further BIMO inspections. Between September 28 and October 15, the FDA conducted additional BIMO inspections for the global Phase 3 trial sites of the Rivoceranib and Camrelizumab combination therapy, concluding with an NAI ruling, indicating the combination therapy passed BIMO.
HLB perceives this as bringing Rivoceranib closer to FDA approval, with the FDA having classified the review of the combination therapy as “Class 2.” A decision is expected within six months from the application date, suggesting a result could be announced by March next year, following HLB’s reapplication on September 20.
HLB Group CTO Han Yong-hae stated, “We’ve passed a significant milestone for liver cancer drug approval, and we’re thoroughly preparing for the final CMC inspection. With commercial preparation and pipeline expansion temporarily delayed, we will assess the situation critically and proceed proactively.”