HLB shares rose by more than 17% amid growing expectations for the U.S. approval of its liver cancer drug, riboceranib.
As of 2:57 PM on October 6, HLB was trading at 47,500 won, up 7,050 won (17.43%) from the previous trading day, according to the Korea Exchange.
The company announced that the U.S. Food and Drug Administration (FDA) has concluded its regular inspection of the manufacturing facility for riboceranib, classifying it as a Voluntary Action Indicated (VAI) status under current Good Manufacturing Practice (cGMP) standards.
HLB's U.S. subsidiary, Elevate Therapeutics, confirmed this outcome after receiving a letter from its partner, Anhui Zhifei Longcom Biopharmaceutical, on October 3. VAI indicates that while there were some issues noted, the company can voluntarily correct them without the need for formal regulatory action.
This conclusion alleviates some uncertainties regarding the manufacturing facility in the U.S. approval process for riboceranib, leading to expectations that HLB will expedite its New Drug Application (NDA) resubmission.
Currently, Elevate is finalizing the necessary materials for the NDA resubmission in collaboration with Anhui Zhifei Longcom and plans to submit the application as quickly as possible.
Meanwhile, shares of HLB Pharmaceuticals (up 29.97%) and HLB BioStep (up 29.91%) also surged, reflecting a strong performance across HLB's affiliated companies.
* This article has been translated by AI.
Copyright ⓒ Aju Press All rights reserved.