HLB has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the approval review for its first-line liver cancer treatment.

In a voluntary disclosure on the 10th, HLB announced that its U.S. subsidiary Elevar Therapeutics, Inc. received a CRL on July 9, 2026, local time, during the FDA review process for the rivoceranib and camrelizumab combination therapy, a first-line liver cancer treatment.

The FDA identified deficiencies at the relevant manufacturing facility following an inspection under Current Good Manufacturing Practice (CGMP) regulations. The agency notified that a re-inspection may be necessary to verify that the facility meets CGMP standards. However, the FDA explained that the findings identified during the inspection may not be directly related to Elevar Therapeutics' application itself.

HLB plans to proceed with a resubmission after Elevar Therapeutics promptly addresses the FDA's requirements. The disclosure decision date is based on the CRL receipt date of July 9, 2026, local time, and the company plans to make additional disclosures in the event of any significant changes in the future.