CanaryBio Strengthens Regulatory Affairs Team to Prepare for BLA Submission

[Asia Economy Reporter Jang Hyowon] Canaria Bio (CEO Hanik Na) announced on the 11th that it has strengthened its Regulatory Affair team to prepare the Biologics License Application (BLA).

As part of the reinforcement plan, Canaria Bio recruited Director Hajong Lee, who previously worked in the Regulatory Affair teams at Celltrion and Merck and was currently serving in the Regulatory Affair team at Nexton Bio, as the head of the Regulatory Affair team.

Team Leader Hajong Lee earned his degree from Northern Illinois University and worked at Celltrion for six years, handling the new drug approval process for the autoimmune disease treatment Remsima. Afterwards, he gained experience in new drug approval by communicating with major regulatory agencies worldwide such as KFDA, FDA, and EMA while working at Merck, Eutilex, and Nexton Bio.

CEO Hanik Na expressed expectations, saying, “Team Leader Hajong Lee has successful experience obtaining new drug approval at Celltrion. As a talent with a success DNA, he will play a pivotal role in the FDA and EMA approval of oregovomab.”

Oregovomab, designated as a Fast Track development item by the FDA, is currently undergoing clinical trials at 152 sites across 16 countries, and the company plans to submit the Biologics License Application (BLA) to the FDA in 2025.

CEO Hanik Na stated, “Until now, the Regulatory Affair team has handled regulatory tasks such as submitting Investigational New Drug (IND) applications and modifying clinical protocols. Going forward, we will conduct gap analysis to fill in missing data so that we can submit the BLA immediately after the clinical trials conclude. We have already received a list of additional data requests from the FDA to be submitted when applying for new drug approval,” and added, “We will further strengthen the Regulatory Affair personnel to thoroughly prepare for the BLA.”