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Phase 1 Clinical Trial Results of ADI-PEG 20 in Acute Myeloid Leukemia by Polaris Group
Polaris Group (TWSE: 6550) is pleased to announce that its lead drug pegargiminase (ADI-PEG 20) which is already under FDA review for a new drug application for the treatment of malignant pleural mesothelioma is also showing remarkable progress in the treatment of acute myeloid leukemia (AML). The latest encouraging data from its Phase 1 clinical trial were officially presented on December 6, 2025, at the annual meeting of the American Society of Hematology.
GENOVIOR, Key Subsidiary of the Company Expands Sterile Injection Capacity to Supply Fully Synthetic Peptides & Specialty Injectables Globally
Genovior Biotech (“Genovior”) announced today the expansion of its sterile injectable manufacturing capacity, enabling large-scale commercial production of fully synthetic peptide medicines and specialty sterile dosage forms for global markets.
GENOVIOR, Key Subsidiary of the Company and MNR Therapeutics announce an non-exclusive agreement for the commercialization of Fulvestrant in the Gulf Cooperation Council (GCC) region.
2025/11/21-GENOVIOR and MNR Therapeutics announce an non-exclusive agreement for the commercialization of Fulvestrant in the Gulf Cooperation Council (GCC) region.
Polaris Group’s Biologic License Application (BLA) for Pegargiminase (ADI-PEG 20) has officially entered the FDA substantive review stage.
2025/8/18-Polaris Group (The Company, TWSE:6550) 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).