HLB’s Rivoceranib Gains Momentum as FDA Issues VAI for China Production Site, Boosting Shares
HLB announced a significant development for its liver cancer treatment candidate, Rivoceranib, as the U.S. Food and Drug Administration (FDA) issued a Voluntary Action Indicated (VAI) notice following an inspection of its Chinese production facility. This positive outcome has rekindled optimism for potential FDA approval of the innovative anti-cancer therapy, leading to a strong rebound in HLB’s stock.
Elevar Therapeutics, HLB’s U.S. subsidiary, confirmed receipt of an FDA close-out letter related to the Current Good Manufacturing Practice (cGMP) inspection. The inspection was conducted at the manufacturing site of its partner, China’s Jiangsu Hengrui Pharmaceuticals, where Rivoceranib is produced.
According to HLB, the FDA letter explicitly stated, “An inspection classification of VAI for cGMP compliance will not directly negatively impact FDA’s assessment of any pending marketing applications referencing this facility.”
The FDA’s VAI assessment signifies that while minor issues or objectionable conditions were observed, they do not necessitate formal enforcement or legal action. This classification is considered a favorable outcome, positioned between a “No Action Indicated” (NAI), the best possible result, and an “Official Action Indicated” (OAI), which signals more serious deficiencies.
This positive development follows a challenging period for Elevar Therapeutics, which last week received a Complete Response Letter (CRL) from the FDA. The CRL denied the new drug application (NDA) for Rivoceranib, citing deficiencies identified during a cGMP inspection of a manufacturing site listed in the Rivoceranib NDA.
An HLB official expressed strong confidence, stating, “As the cGMP on-site inspection of Jiangsu Hengrui Pharmaceuticals’ manufacturing facilities, which was a core reason behind the CRL, has now concluded with a VAI notice, we believe the primary obstacles hindering the new drug application process have been largely addressed.”
The official further affirmed, “With the critical reason for the CRL now swiftly resolved, we are committed to resuming the new drug application process (for Rivoceranib) by cooperating closely and promptly with the FDA.”
The positive news had an immediate and significant impact on HLB’s stock performance. Shares of HLB, traded on Korea’s tech-heavy Kosdaq exchange, surged by 30 percent, hitting the daily upper limit at 34,700 won ($23.36) per share. This marked a sharp reversal for HLB shares, which had been declining since the announcement of the CRL last week.
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