HLB Chairman Increases Stock Holdings Before FDA Decision

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created on 03/11/2025 3:28:52 PM
modified on 03/11/2025 3:28:52 PM

[Seok Ji-hoen, Edaily Reporter] As HLB’s liver cancer drug awaits approval from the U.S. Food and Drug Administration (FDA), HLB Group Chairman Jin Yang-gon has been steadily increasing his stake in the company’s affiliates.

HLB’s liver cancer drug successfully completed its global Phase 3 clinical trial and had anticipated FDA approval in May 2024. However, due to a Complete Response Letter (CRL) issued over a Chemistry, Manufacturing, and Controls (CMC) issue involving Hansoh Pharmaceutical, the approval process was delayed. HLB is now making another attempt at securing approval. Under the Prescription Drug User Fee Act (PDUFA), the FDA is expected to announce its decision by March 20 (Eastern Time), or March 21 (KST).

If approved, this would mark the first instance of a Korean company independently completing all clinical trials and development without licensing out the technology, leading to an FDA-approved cancer drug. Previously, Yuhan’s Lazertinib was licensed out to Janssen, which later obtained approval for its lung cancer treatment.

On the other hand, if the approval is postponed or denied, HLB’s stock is expected to face temporary declines. As the decision date approaches, market volatility has increased. Amid this uncertainty, Jin has continued to purchase shares of HLB affiliates, drawing industry attention.

Jin first bought 210,000 shares of HLB BioStep in November 2024, while the FDA review was ongoing. In December, he purchased 81,000 shares of HLB Genex.

His stock acquisitions have accelerated in 2025. In January, he bought 100,000 shares of HLB Innovation and over 100,000 shares of HLB Genex. In February, he acquired 75,200 shares of HLB BioStep and 130,000 shares of HLB Innovation. In March, he continued purchasing, acquiring 18,000 shares of HLB BioStep as of the previous day.

Jin’s continuous stock purchases suggest his confidence in the FDA review process nearing its final stage.

A company representative stated, “While we are optimistic about FDA approval, no one can predict the final decision. Chairman Jin’s stock purchases appear to be a responsible management decision, focusing on increasing his stake in affiliates where he holds relatively lower ownership.”