HLB(028300) failed in its third attempt to win U.S. Food and Drug Administration (FDA) approval for a new liver cancer drug, sending the stock to an intraday limit-down for a second straight session. The company began analyzing the cited manufacturing-facility issues identified as the cause of the denial and started preparing the reapplication process.
According to the Korea Exchange (KRX) on the 13th, HLB was trading at 25,650 won as of 3 p.m., down 29.92% from the previous session, hitting the intraday limit-down. It was the intraday limit-down for a second straight session following on the 10th.
Affiliates HLB Pharmaceutical(047920) also fell 27.65% to 6,200 won, and HLB Life Science(067630) dropped 25.96% to 1,651 won in transactions. HLB bioStep(278650) and HLB Therapeutics(115450) also fell 3.88% and 6.65%, respectively, widening losses across group stocks.
This week's sharp drop is seen as stemming from the FDA's issuance on the 10th of a complete response letter (CRL) to HLB's U.S. subsidiary Elevar Therapeutics regarding the new drug application (NDA) for the rivoceranib–camrelizumab combination therapy under development as a first-line liver cancer treatment.
HLB had sought approval for a first-line hepatocellular carcinoma treatment by combining its targeted anticancer therapy "Rivoceranib" with Jiangsu Hengrui's immunotherapy "Camrelizumab." This review was the third FDA approval attempt, following May 2023 and May 2024.
The FDA was reported to have identified issues during a current good manufacturing practice (cGMP) inspection of Jiangsu Hengrui's manufacturing facilities listed in the Rivoceranib NDA. The company said, as in the previous two instances, that no new issues were raised regarding the efficacy or safety of Rivoceranib.
HLB has begun follow-up procedures for reapplication. The company obtained "Form 483," issued during the FDA's manufacturing-facility inspection, and is analyzing the specific findings. Form 483 is a document by which the FDA notifies companies of deficiencies found during inspections of manufacturing facilities, serving as the basis for subsequent facility improvements and the approval process.
The company also asked its partner Jiangsu Hengrui for a response to Form 483 and related materials, including a corrective and preventive action (CAPA) plan. Based on the collected materials, it will conduct a comprehensive review of the FDA's requirements and Hengrui's improvement plan, then finalize the resubmission strategy and timeline.
The company plans to request a post-action letter (PAL), a procedure in which the FDA provides additional explanations to the applicant after issuing a CRL, to confirm the background of the issuance and specific requirements. It will then discuss remediation items and resubmission procedures through a "Type A meeting," the formal process for promptly consulting with the FDA when significant regulatory issues such as a rejection occur.
An HLB official said, "Through the PAL and Type A meeting, we will be able to clearly confirm the FDA's requirements and then explain the specific schedule," adding, "We will work closely with Elevar, Jiangsu Hengrui, and the FDA to resolve the manufacturing-facility issues as quickly as possible and concentrate all our capabilities to reapply for approval at the earliest possible date."