HLB announced that the U.S. Food and Drug Administration (FDA) inspection of its finished pharmaceutical manufacturing facility for rivoceranib has been finally classified as 'VAI.' The company also disclosed its preparation status for resubmitting the new drug application for its liver cancer treatment. As of 9:16 a.m. today, HLB's share price stands at 45,500 won, down 400 won.

■ FDA Routine cGMP Inspection Finally Classified as 'VAI'

On the 6th, HLB announced through an official notice that the result of the FDA's routine current Good Manufacturing Practice (cGMP) inspection of the manufacturing facility has been finally classified as 'VAI' (Voluntary Action Indicated).

According to the company, VAI is a classification given when some observations are found during an inspection but the FDA judges that official regulatory action is not necessary. It is distinct from a case where no observations are found at all.

HLB explained that this result reflects Hanseo Pharmaceutical's ongoing efforts to resolve the inspection observations.

■ Elevar and Hanseo Pharmaceutical in Final Preparation for NDA Resubmission

Elevar and Hanseo Pharmaceutical are currently in the final stages of preparing the materials needed to resubmit the New Drug Application (NDA) for the liver cancer drug. The two companies plan to cooperate to resubmit the application to the FDA as quickly as possible. However, the notice did not include a specific resubmission date.

As the classification of the manufacturing facility inspection and the final drug approval are separate procedures, the resubmission schedule and the FDA's review outcome remain to be seen. HLB stated it will work to ensure the prompt resubmission of the liver cancer new drug and the smooth progress of the subsequent review.

[This article was written for informational purposes based on HLB's official notice and does not recommend buying or selling any particular stock. The manufacturing facility inspection result does not guarantee final approval of the new drug, and the application schedule and review outcome are subject to change. Investment decisions and their consequences are the responsibility of the investor. AI assistance was used in writing this article.]