All HLB group affiliates surged to their daily price limits on the 15th, hitting upper limits in unison. As concerns over manufacturing facilities that arose during the U.S. FDA approval process for the liver cancer drug 'Rivoceranib' were resolved, previously plummeting investor sentiment is showing signs of rapid recovery.

On this day, HLB closed at 34,700 won, up 29.9% from the previous trading day. Major affiliates including HLB Innovation (30.0%), HLB Pharmaceutical (30.0%), HLB Panzyn (30.0%), and HLB Therapeutics (30.0%), as well as HLB Life Sciences (29.8%), HLB Global (29.9%), HLB Genex (29.9%), HLB Pep (29.9%), and HLB Biostep (29.8%), all reached their price limits, showing a broad rally.

The direct catalyst for the surge was the FDA inspection result. HLB announced in a regulatory filing that its U.S. subsidiary Elevar Therapeutics received a letter notifying the completion of the FDA cGMP (Current Good Manufacturing Practice) inspection for the active pharmaceutical ingredient (API) manufacturing facility of Rivoceranib from its Chinese partner Hengrui Pharma.

The FDA determined that the facility generally complies with cGMP standards and classified the inspection result as 'Voluntary Action Indicated (VAI).' Notably, the letter included a statement that 'the VAI classification does not affect the evaluation of approval applications associated with the facility.'

Previously, HLB group stocks had experienced significant volatility, plunging together after the FDA issued a Complete Response Letter (CRL). With this VAI classification, the manufacturing facility uncertainty that the market had feared has been alleviated, leading to a broad buying spread across the entire group.

The market is paying close attention to the trading session on the 16th to see whether this rebound will be limited to a short-term technical bounce or mark the starting point of a trend reversal. The future Rivoceranib approval process and additional announcements from the company are cited as key variables that will determine the stock's direction.

[※ This article is not intended to solicit investment, and responsibility for investment decisions lies with the investor.]