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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).

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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.

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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).

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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.

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