HLB has provided a detailed explanation of the current status regarding market inquiries about a U.S. Food and Drug Administration (FDA) inspection. With the final approval decision for its liver cancer drug scheduled for July 23, market tension is running high.

Status of FDA Inspection and PDUFA Schedule According to the company, the FDA approval decision date (PDUFA Date) for HLB's liver cancer drug (ingredient name: camrelizumab) is July 23, U.S. time, while the cholangiocarcinoma drug is scheduled for September 27.

Initially, the market speculated that an FDA manufacturing and quality control (CMC) inspection should have already taken place based on the review schedule. However, it has been confirmed that no CMC inspection for camrelizumab has been conducted to date. Regarding this, HLB stated, "There has been no separate explanation or notification received from the FDA."

Complete Response Letter (CRL) Issue and Attention on RLI System Kanris Pharmaceutical, the developer of camrelizumab, has addressed all the issues pointed out in the Complete Response Letter (CRL) issued by the FDA last year. The company has since submitted the relevant data, and it is understood that the FDA has not requested any additional data submissions.

In particular, the market is focusing on the fact that the FDA has been actively utilizing the 'RLI (Reports in Lieue of Inspection)' system, which involves reviewing documents and data submitted by manufacturers instead of conducting on-site inspections. The system has reportedly seen increasing use in certain review processes since it was formalized as an official regulation last year. However, HLB drew a line, stating that it cannot be definitively concluded that the RLI system will be applied in the same way to the CMC review for camrelizumab.

"Waiting Calmly for Review Results"... Stock Price Volatility in Focus HLB stated, "Various possibilities exist until the FDA's final decision," adding, "For now, we are calmly waiting for the review results."

Investors are on high alert for the approval decision of the liver cancer drug scheduled for July 23 and the FDA's final judgment. In particular, whether an inspection takes place and the approval outcome are expected to serve as critical variables for HLB's corporate value and stock price movement going forward.

Meanwhile, as of the morning of the 17th, HLB's stock price is trading at 46,850 KRW, down 1,500 KRW from the previous trading day.

[※ This article was written with the assistance of AI. Investment decisions are the responsibility of the investor, and the content included in this article may change depending on market conditions.]