Polaris Group previously adopted a rolling submission approach for regulatory filing of its Biologic License Application (BLA) for ADI-PEG 20 to the U.S. Food and Drug Administration (FDA) on November 16, 2023 (U.S. time). ADI-PEG 20 is the systemic treatment of patients with malignant pleural mesothelioma (MPM) with non-epithelioid histology, in combination with a platinum agent and pemetrexed. The final portion of the BLA submission was completed on June 9, 2025 (U.S. time); Mass production date:NA.
Effect on company finances and business: It is expected that the U.S. FDA will accept the BLA for Pegargiminase (ADI-PEG 20) for review. Any other matters that need to be specified (the information disclosure also meets the requirements of Article 7, subparagraph 8 of the Securities and Exchange Act Enforcement Rules, which brings forth a significant impact on shareholders rights or the price of the securities on public companies): New drug name or code: ADI-PEG 20. Purpose: Based on the results of the successful phase 3 trial of ADI-PEG 20 in combination with a platinum agent, and pemetrexed which met both its primary and secondary objectives for progression free survival and overall survival, Pegargiminase (ADI-PEG 20) is an innovative enzyme-based drug designed to treat malignant pleural mesot Helioma(MPM).
Planned development stages: Complete U.S. FDA certification reviews on the ADI-PEG 20 product. Current development stage: File application/approved/disapproved/Each of clinical trials (include interim analysis): The Company has completely submitted a BLA to the U.S. FDA for Pegargiminase ("ADI-PEG 20") as a treatment for malignant pleural mesotHelioma. Once disapproved by competent authority or each of clinical trials (include Inter analysis) results less than statistically significant sense, the risks and the associated measures the Company may occur: NA.
After obtaining official approval or the results (include interim analysis) of statistically significant sense, the future strategy: NA. Accumulated investment expenditure incurred: Due to the potential for international collaboration on the ADI-Peg 20 product or considerations related to trade secrets, its not disclosed publicly to protect the interests of the Company and investors. Upcoming development plan: The U.S. FDA accepts application for market approval/incense.
Estimated date of completion: The final portion of the BL A submission includes the Chemistry, Manufacturing, and Controls (CMC) section. Because Pegargiminase (adI-PEG 20) For the treatment of MPM received orphan drug designation in the United States in 2016, the U.S. FDA would respond within 60 days of receiving the BLAC. The actual review timeline and approval status will be subject to official notification from the U.S. FDA.
Estimated responsibilities: None. Market situation: A. The global cancer incidence rate has been increasing year by year, and with the continuous growth of the population, the number of cancer patients is significantly rising. As a result, the cancer treatment market is expected to increase each year due to the growing number of cancer patients.
Malignant pleural mesothela is a highly aggressive and challenging cancer that affects the lining of the lungs. ADI-PEG 20 are a novel therapy that holds promise in the treatment of malignant pleural mesotELioma, a rare and aggressive form of cancer. The Company's development program for ADI-PEG20 is focused on demonstrating its safety and efficacy in addressing the pressing medical needs of patients facing this challenging condition.
Drug development is expected to be a novel therapy that holds promise of patients facing this challenging condition; Drug development is expected to be the most challenging condition.
