Leading the way to new and better cancer treatments

About Polaris

Polaris Group is a multinational biotechnology company focused on developing novel anti-cancer therapies.
Our lead drug candidate, Pegargiminase (ADI‑PEG 20), is a biologic in late-stage clinical development for a wide range of cancers, including hepatocellular carcinoma, mesothelioma, pancreatic cancer, non-small cell lung cancer, melanoma, acute myeloid leukemia and others.

Polaris Group is involved in every stage of the drug development process. Our family of companies harnesses structure-based drug design technology to create novel oncology therapies, conducts clinical studies at top-tier cancer centers worldwide and operates cGMP Production Facilities in Northern California and China.

Clinical Trials

Pegargiminase is in clinical development for numerous oncology indications.
Pre-Clinical Phase 1  Phase 2  Phase 3  BLA  
Mesothelioma
Phase 3 BLA Rolling Submission
Soft Tissue Sarcoma
Phase 3
Glioblastoma
Phase 1/2
Hepatic Cell Carcinoma
Phase 2/3
Acute Myeloid Leukemia
Phase 1
Nonalcoholic Steatohepatitis (NASH)
Phase 2

Development and Manufacturing Capabilities

Company News

English

Phase 1 Clinical Trial Results of ADI-PEG 20 in Acute Myeloid Leukemia by Polaris Group

2025/12/8-Polaris Group (TWSE:6550) is pleased to report the encouraging Phase 1 clinical trial results of its lead drug pegargiminase (ADI-PEG 20) in patients with acute myeloid leukemia (AML) that were presented at the annual meeting of the American Society of Hematology.

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English

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.

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English

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.

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English

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).

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