Polaris Group-KY announced that its new drug Pegargiminase (ADI-PEG 20), developed for the treatment of malignant pleural mesothelioma, has officially entered the substantive review stage with the U.S. FDA. This news drove the company’s stock to surge to its daily limit immediately after opening. If the FDA review and the planned U.S. inspection next February proceed smoothly, the drug could receive approval as early as the first half of next year, while discussions on U.S. market distribution licensing are expected to accelerate, potentially being finalized in Q1 2026.

Polaris Group conducted a rolling submission for Pegargiminase (ADI-PEG 20) over the course of 18 months, completing the required documentation. On the evening of August 1 (Taiwan time), the company held an Applicant Orientation Presentation (AOM) to provide a verbal briefing to FDA reviewers and respond to their questions following the submission.

On August 18, Polaris Group announced that it received formal notification from the FDA confirming that the submission has been accepted for review and deemed sufficiently complete to proceed to the substantive review stage. Observers expect the review process to take approximately one year, suggesting that drug approval could be granted in the first half of next year if everything goes smoothly.

JAANPYNG HSU, Chairman and CEO of Polaris Group, stated that the Biologics License Application (BLA) will be reviewed according to official FDA procedures, and any approvals will be based on formal communications from the FDA. Regarding manufacturing, a GMP inspection is planned for February next year. The team also plans to expedite licensing discussions for the U.S. and other markets, aiming to finalize agreements in the first quarter of 2026.

Malignant pleural mesothelioma is a highly aggressive and challenging cancer affecting the pleural lining of the lungs. Current treatments primarily include chemotherapy and immunotherapy. Pegargiminase differs from most existing therapies, employing a metabolic therapy approach in combination with adjunctive medications, rather than relying solely on chemotherapy, targeted therapy, or immunotherapy.

Resource: 北極星藥業-KY治惡性肺間皮癌新藥步FDA藥證實審，美國經銷授權拚加速