HLB Stock Plunges 30% After FDA Delays Rivoceranib Liver Cancer Treatment Approval Citing Manufacturing Issues
South Korean biotechnology firm HLB has faced a significant setback in its quest to bring its innovative liver cancer treatment, Rivoceranib, to the US market. The US Food and Drug Administration (FDA) issued a Complete Response Letter (CRL), delaying approval not due to concerns about the drug’s clinical data, but rather due to manufacturing compliance issues at its production facility.
On Friday, HLB confirmed that its US subsidiary, Elevar Therapeutics, received the CRL concerning its New Drug Application (NDA) for Rivoceranib. This anti-cancer therapy is specifically developed for the treatment of liver cancer, a critical area of unmet medical need.
The FDA’s decision, according to HLB, originated from observations made during a routine current Good Manufacturing Practice (cGMP) inspection. This inspection was conducted at a manufacturing facility operated by China’s Jiangsu Hengrui Pharmaceuticals, the site where Rivoceranib is currently produced.
Following the inspection of the Chinese production site, the FDA issued a Form 483. This document details specific inspectional observations that may indicate deviations from established manufacturing standards. HLB clarified that while the FDA indicated these observations might not be directly linked to the Rivoceranib application itself, the manufacturing facility must rigorously address all cited issues before the application can receive approval.
The FDA further emphasized that approval for Rivoceranib cannot be granted until the facility definitively demonstrates full compliance with stringent cGMP requirements. Depending on the successful resolution of these corrective actions, the agency may proceed with a preapproval inspection (PAI) before rendering a final decision. HLB stressed that both the initial cGMP inspection findings and any subsequent PAI must yield satisfactory results for the Rivoceranib application to advance.
The manufacturing site was issued the Form 483 following a routine FDA cGMP inspection that took place in April. The final classification of this particular inspection is still pending determination.
HLB highlighted that this recent assessment marked the first on-site inspection of the Chinese facility since 2018. Notably, during the five preceding FDA inspections, the site consistently received favorable classifications: four “no action indicated” and one “voluntary action indicated.”
The company also stated that neither HLB nor Elevar Therapeutics received prior notification regarding the routine inspection or the subsequent issuance of the Form 483. This was because the inspection was not conducted as a preapproval inspection specifically tied to the Rivoceranib application.
In response to the CRL, Elevar Therapeutics has formally requested that Jiangsu Hengrui Pharmaceuticals provide the detailed Form 483, its comprehensive responses to the FDA’s observations, and a clear timeline for completing all necessary corrective actions.
HLB announced its commitment to thoroughly analyze the FDA’s observations and Jiangsu Hengrui’s proposed remediation plan. Following this detailed assessment, the company intends to announce a comprehensive strategy for resubmitting the Rivoceranib application.
“The CRL does not identify any deficiencies related to the drug’s clinical efficacy or safety data, nor does it request additional clinical trials,” affirmed Kim Dong-gun, CEO of Elevar Therapeutics. This crucial point underscores that the drug’s core scientific merits remain unchallenged.
Kim Dong-gun added, “Because the primary issues are related to the manufacturing site’s cGMP inspection, we will work closely with the FDA to clarify the necessary procedures and pursue a resubmission as quickly as possible.” This statement reflects a strong commitment to swift resolution and getting the liver cancer treatment to patients.
This latest development represents the third regulatory setback in HLB’s prolonged journey to secure FDA approval for Rivoceranib. In response to the news, shares of HLB experienced a sharp decline, plunging by 30 percent—the lower limit for a stock listed on Korea’s secondary tech-heavy bourse Kosdaq. The stock closed at 36,600 won ($24.21) on the same day.
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