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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.

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

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 Expands Sterile Injection Capacity to Supply Fully Synthetic Peptides & Specialty Injectables Globally Read More »

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.

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. Read More »

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).

Polaris Group’s Biologic License Application (BLA) for Pegargiminase (ADI-PEG 20) has officially entered the FDA substantive review stage. Read More »

Polaris Group Announces Subsidiary PPI In-Licensing Exclusive Partnership with Bioprofarma Bagó to introduce ADI-PEG20, an innovative First-in-Class arginine degradation for hard-to-treat cancers in Argentina and other LATAM markets

2025/7/22-Polaris Group (TWSE:6550) announces its US California subsidiary Polaris Pharmaceuticals Inc. (PPI) an exclusive licensing agreement with Bioprofarma Bagó (a fully owned subsidiary of GRUPO EMPRESARIAL BAGO) in Buenos Aires, Argentina to introduce ADI-PEG20 (ADZODI), a novel treatment for Malignant Pleural Mesothelioma (MPM) to the LATAM. This partnership is set to improve the treatment landscape by delivering innovative therapeutic solution aimed at improving patient outcomes across the region.

Polaris Group Announces Subsidiary PPI In-Licensing Exclusive Partnership with Bioprofarma Bagó to introduce ADI-PEG20, an innovative First-in-Class arginine degradation for hard-to-treat cancers in Argentina and other LATAM markets Read More »

Polaris Group Completes Rolling Submission of Biologic License Application (BLA) for ADI-PEG 20 with FDA to Treat Malignant Pleural Mesothelioma

2025/6/9-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).

Polaris Group Completes Rolling Submission of Biologic License Application (BLA) for ADI-PEG 20 with FDA to Treat Malignant Pleural Mesothelioma Read More »

Polaris Group commenced the ground-breaking ceremony for Zhunan plant today with Chairman & CEO Dr. Hsu sharing the 5-year dual-engine accelerated growth strategy

2025/4/15-On April 15th, 2025, Polaris Group-KY (6550) held a groundbreaking ceremony for the new plant with the expansion of 6 production lines at Zhunan. The attending guests and the ones sending their congratulations include Hsinchu Science Park Bureau, Longtai Construction, Hua Nan Bank, Taiwan Cooperative Bank, Shanghai Commercial & Savings Bank, Anxo Pharmaceutical, and many representatives from different industries. Chairman and CEO of Polaris Group Dr. Steve Hsu gave a ceremonial speech, mentioning that Polaris plans to invest a total of approximately NT$8 billion in phases to expand production capacity over the next five years (2025-2029), with the goal of reaching an annual output value of NT$100 billion with the dual engines after the full expansion with loaded capacity. The dual engine model includes (1) ADI-PEG20 (trade name ADZODI) for (a) malignant pleural mesothelioma (lung mesothelioma, MPM), (b) glioblastoma (brain cancer, GBM), leiomyosarcoma (LMS), acute myeloid leukemia (AML), and other indications (2) GLP-1 generics for diabetes, weight loss, and other indications.

Polaris Group commenced the ground-breaking ceremony for Zhunan plant today with Chairman & CEO Dr. Hsu sharing the 5-year dual-engine accelerated growth strategy Read More »

Polaris Group-KY (6550) Announces Subsidiary PPI Signed Exclusive Distribution Agreement with Er-Kim Pharmaceuticals to Commercialize Pegargiminase (ADZODI) for Malignant Pleural Mesothelioma (MPM) in Multiple EMEA Markets

2025/4/14-Polaris Group-KY (6550) announces today its US California subsidiary Polaris Pharmaceuticals Inc. (PPI) signed a distribution agreement with Er-Kim Pharmaceuticals, an international company specializing in the commercialization of novel therapies for pharmaceutical and biopharmaceutical companies. Polaris appointed Er-Kim as the exclusive partner to commercialize Pegargiminase (ADZODI) across 36 markets in the EMEA region (Central & Eastern Europe, Eurasia, North Africa and Mediterranean regions).

Polaris Group-KY (6550) Announces Subsidiary PPI Signed Exclusive Distribution Agreement with Er-Kim Pharmaceuticals to Commercialize Pegargiminase (ADZODI) for Malignant Pleural Mesothelioma (MPM) in Multiple EMEA Markets Read More »

Polaris Group-KY (6550) Announces Subsidiary PPI Signed Exclusive Partnership with Tabuk Pharmaceuticals to introduce ADI-PEG20 (ADZODI), an innovative First-in-Class arginine degradation innovative drug for hard-to-treat cancers in the Kingdom of Saudi Arabia and GCC Region

2025/4/14-Polaris Group-KY (6550) announces today its US California subsidiary Polaris Pharmaceuticals Inc. (PPI) signed an exclusive licensing agreement with Tabuk Pharmaceutical Manufacturing Company (a fully owned subsidiary of Astra Industrial Group, a listed company in Saudi Arabia) to introduce ADI-PEG20 (ADZODI), a novel treatment for Malignant Pleural Mesothelioma (MPM), to the 7 markets in Saudi Arabia and the GCC region. This partnership is set to improve the treatment landscape by delivering innovative therapeutic solution aimed at improving patient outcomes across the region.

Polaris Group-KY (6550) Announces Subsidiary PPI Signed Exclusive Partnership with Tabuk Pharmaceuticals to introduce ADI-PEG20 (ADZODI), an innovative First-in-Class arginine degradation innovative drug for hard-to-treat cancers in the Kingdom of Saudi Arabia and GCC Region Read More »

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