Korean biotechnology firm’s stock plunges by 30 percent in wake of report HLB's logo (HLB) HLB's hopes of bringing its liver cancer treatment to the US market have suffered another blow after the US Food and Drug Administration issued a Complete Response Letter delaying approval, citing manufacturing compliance issues rather than concerns over the drug's clinical data.HLB said Friday that its US subsidiary, Elevar Therapeutics, received the CRL from the FDA regarding its new drug application for Rivoceranib, an anti-cancer therapy intended for use in the treatment of liver cancer.According to the company, the FDA's decision stemmed from observations made during a routine current Good Manufacturing Practice, or cGMP, inspection of a manufacturing facility operated by China's Jiangsu Hengrui Pharmaceuticals, where Rivoceranib is currently produced.Following the inspection of the Chinese site, the FDA issued a Form 483, a document detailing inspectional observations that may indicate deviations from manufacturing standards. HLB said the US agency explained that while the observations may not be directly related to the Rivoceranib application itself, the manufacturing site must address the cited issues before the application can be approved.The FDA also stated that approval cannot be granted until the facility demonstrates compliance with cGMP requirements. Depending on the outcome of corrective actions, the agency may conduct a preapproval inspection, or PAI, before making a final decision. HLB said both the cGMP inspection and any subsequent PAI must produce satisfactory results for the application to proceed.The manufacturing site received the Form 483 after a routine FDA cGMP inspection conducted in April. The final classification of the inspection has yet to be determined.HLB noted that it was the first on-site inspection of the Chinese facility since 2018. During the previous five FDA inspections, the site received four "no action indicated" classifications and one "voluntary action indicated" classification.The company said it and Elevar had not been informed in advance of either the routine inspection or the issuance of the Form 483 because the inspection was not conducted as a preapproval inspection tied to the Rivoceranib application.Following receipt of the CRL, Elevar has formally requested that Hengrui provide the Form 483, its responses to the FDA, and a timeline for completing corrective actions.HLB said it will analyze the FDA's observations and Hengrui's remediation plan before announcing a detailed strategy for resubmitting the 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," said Kim Dong-gun, CEO of Elevar Therapeutics."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.”As the latest decision marked the third regulatory setback for HLB's long-running effort to secure FDA approval for Rivoceranib, the shares of HLB plunged by 30 percent, the lower limit for a stock listed on Korea’s secondary tech-heavy bourse Kosdaq, to 36,600 won ($24.21) on the same day.