HLB's shares fell sharply on July 13 after news that the U.S. Food and Drug Administration (FDA) did not approve its liver cancer drug, riboceranib, for combination therapy.
According to the Korea Exchange, as of 9:26 a.m., HLB's stock was trading at 29,000 won, down 7,600 won (20.77%) from the previous trading day. At the start of the session, shares dropped to as low as 27,800 won.
On July 10, HLB announced that its combination therapy of riboceranib and camrelizumab, developed as a first-line treatment for liver cancer, received a third Complete Response Letter (CRL) from the FDA, preventing it from obtaining product approval. This has raised uncertainties regarding the commercialization timeline in the U.S., leading to a deterioration in investor sentiment.
The latest CRL reportedly stems from issues identified during the cGMP inspection of HLB's Chinese partner, Jiangsu Hengrui Medicine. No new concerns regarding the efficacy or safety of the clinical trials were raised.
In response, HLB announced that it has officially begun the re-approval process. Its U.S. subsidiary, Elevate Therapeutics, has obtained Form 483 issued during the FDA inspection and is currently analyzing the detailed issues. HLB plans to receive corrective and preventive action (CAPA) plans and related materials from Jiangsu Hengrui to formulate its resubmission strategy.
* This article has been translated by AI.
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