KB News Desk
Rivoceranib’s Chinese production site gets VAI from FDA; HLB shares rebound sharply
HLB said Wednesday it received a Voluntary Action Indicated notice from the US Food and Drug Administration after the American authorities had conducted an on-site inspection of the Chinese production site for liver cancer therapy candidate Rivoceranib, reigniting the hopes of getting the FDA’s greenlight for the anti-cancer treatment.
According to HLB, its US subsidiary Elevar Therapeutics had received a close-out letter from the FDA regarding the current Good Manufacturing Practice, or cGMP, inspection from its partner firm, China’s Jiangsu Hengrui Pharmaceuticals, where Rivoceranib is currently produced.
HLB said the letter stated that the VAI classification does not affect the FDA’s ongoing review of the approval application related to the Chinese site.
A VAI assessment by the FDA indicates that minor issues or objectionable conditions were found but they do not require formal enforcement or legal action. It is regarded as a middle-class result in between the best result, known as No Action Indicated, or NAI, and the worst result, known as Official Action Indicated, or OAI.
Last week, Elevar Therapeutics received a Complete Response Letter from the FDA denying the new drug application for Rivoceranib. The US regulator said the decision was related to deficiencies identified during a cGMP inspection of a manufacturing site listed on the Rivoceranib NDA.
“As the cGMP on-site inspection of Jiangsu Hengrui Pharmaceuticals’ manufacturing facilities, which was the reason behind the CRL, was concluded in a VAI notice, we believe that the key issues causing trouble in the new drug application process have been mostly resolved,” an HLB official said.
“With the CRL reason immediately being resolved, we will do our best to resume the new drug application process (for Rivoceranib) by swiftly cooperating with the FDA.”
The stock price of HLB, which is listed on Korea’s secondary tech-heavy bourse Kosdaq, surged by 30 percent to hit the upper limit for a daily increase, reaching 34,700 won ($23.36) per share. Prior to Wednesday’s report, HLB shares had been falling since last week’s CRL announcement.
