HLB announced in a regulatory filing on the 10th that it 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. On this news, HLB's stock price plummeted to the lower limit of 36,600 won in early trading. The drop of 15,600 won (29.89%) from the previous day erased the prior day's 2,800-won gain in a single day, sharply dampening investor sentiment.

According to HLB, its U.S. subsidiary Elevar Therapeutics received the CRL from the FDA during the approval review process for the combination therapy of rivoceranib and camrelizumab as a first-line liver cancer treatment.

The core issue in the CRL pertains to manufacturing facility concerns. According to the company, the FDA identified deficiencies at the relevant manufacturing facility during a Current Good Manufacturing Practice (CGMP) inspection. Accordingly, the FDA conveyed that a re-inspection may be necessary to confirm whether the facility meets CGMP standards.

However, it was reported that the FDA also noted that the issues identified during the inspection may not be directly linked to the approval application itself submitted by Elevar Therapeutics. In other words, rather than the clinical data or the substantive content of the application, the verification of the manufacturing and quality management system has emerged as the primary issue.

HLB stated that Elevar Therapeutics plans to promptly address the FDA's requirements and then proceed with the resubmission process for approval. The company added that it would make an additional disclosure if any material changes occur during the future approval review process.

The market views the receipt of this CRL as a significant short-term shock to HLB's stock price. Since expectations for the approval of the first-line liver cancer treatment had already been priced in, the possibility of a re-inspection and concerns about delays in the approval timeline have fueled selling pressure. Going forward, the focus is expected to center on the speed of compliance with the FDA's requirements and the results of the manufacturing facility re-inspection.

[※ This article was written with AI assistance and is based on the provided intraday market data. Stock prices and trading volumes may fluctuate in real time depending on market conditions, so investment decisions should be made carefully at one's own discretion after directly verifying the latest disclosures and market prices.]