HLB group stocks showed strength in after-hours trading on October 30, drawing renewed attention to the U.S. Food and Drug Administration (FDA) approval process for the group's liver cancer drug. Following the resubmission of the approval application on October 9, only the FDA's review classification remains outstanding. However, the review period and final approval status have not yet been determined, and no direct link has been confirmed between the after-hours stock price gains and approval-related expectations.

As of October 31, the biggest point of interest in HLB's liver cancer drug approval process is the FDA's classification of the resubmitted application.

■ Resubmission of Rivoceranib-Camrelizumab Combination Therapy... Procedure in Response to July CRL

On October 12, HLB announced through an 'Other Management Matters (Voluntary Disclosure)' that its U.S. subsidiary Elevar Therapeutics had submitted a new drug application resubmission to the FDA on October 9 local time for the rivoceranib-camrelizumab combination therapy, a first-line treatment for liver cancer. This resubmission was a procedure to respond to the Complete Response Letter (CRL) received from the FDA on July 9.

■ Class 1 Has a Two-Month Review Target, Class 2 Six Months

In the disclosure, HLB explained that after receiving the submission, the FDA will determine the review period and decide on approval based on the criteria for Class 1 and Class 2 classifications. The typical review target period is two months for Class 1 and six months for Class 2.

Based on a simple calculation from the October 9 resubmission date, the review target points would be December this year for Class 1 and April 2027 for Class 2. However, the actual target review completion date must be confirmed through official FDA notification.

■ Classification Does Not Itself Mean Approval or Rejection

Notably, even a Class 1 classification does not guarantee new drug approval. Likewise, a Class 2 classification does not mean rejection; it simply indicates that the review period for the resubmitted materials will be relatively longer.

■ Classification Notification Possible in Early-to-Mid November... Official Announcement Needed to Confirm Specific Schedule

On October 30, some HLB group stocks rose in after-hours trading. However, it has not been confirmed whether these gains were driven by expectations regarding the FDA's review classification. Considering the FDA's standard resubmission review procedures, notification regarding the review classification could come between early and mid-November. Nevertheless, the specific schedule must be confirmed through official announcements.

Ultimately, in HLB's liver cancer drug approval process, which review type the FDA applies and when it sets the target review completion date remain key variables going forward.

[This article was written with partial AI assistance. The FDA review timeline is an estimate based on standard regulations and may differ from the actual schedule. Stock investments carry the risk of principal loss, and investment decisions and responsibilities rest with the investor.]