Polaris Pharmaceuticals-KY held a groundbreaking ceremony on April 15 for its new plant at the Zhunan site. Chairman and CEO Steve Hsu stated that the facility, designed for producing GLP-1 peptide active pharmaceutical ingredients (APIs), will house six production lines and is expected to begin operations in 2028 following regulatory inspections. Polaris plans to invest approximately NT$8 billion over the next five years, in phases, to expand production capacity. Once fully operational at full capacity, the company aims to achieve annual output value of NT$100 billion through its dual growth engines.
Originally focused on developing metabolic anticancer therapies, Polaris Pharmaceuticals’ core project has been the development of ADI-PEG 20 (brand name ADZODI), targeting indications such as malignant pleural mesothelioma (MPM), glioblastoma (GBM), leiomyosarcoma (LMS), and acute myeloid leukemia (AML). In September 2022, the company announced statistically significant results from its Phase III clinical trial evaluating ADI-PEG 20 in combination with chemotherapy drugs cisplatin and pemetrexed for advanced MPM.
By the end of 2023, Polaris expanded into the GLP-1 peptide API market through the acquisition of Genovior Biotech, marking its transition into a dual-engine strategy combining oncology drug development with peptide manufacturing.
Steve Hsu noted that Polaris will expand its manufacturing facilities in the U.S., Taiwan, and mainland China to support regional ADZODI supply. For the indications of MPM and GBM alone, the company plans to scale up to an annual capacity of 3.6 million injectable doses. The company is targeting marketing approval for ADZODI in MPM by the end of this year, with commercial sales expected to begin in 2026. International collaborations currently cover Saudi Arabia, the GCC region, and 36 markets across EMEA (Central and Eastern Europe, Eurasia, North Africa, and the Mediterranean). Partnerships in Asia and South Asia are actively being pursued.
Hsu also revealed that Polaris plans to raise NT$2 billion in capital by mid-2025, backed by strong support and confidence from major shareholders. In preparation for the dual-engine growth strategy, the group is actively recruiting and training skilled technical and managerial personnel. Additionally, Polaris will continue investing in the development of new drugs and generics, including next-generation ADI-PEG 20 and diabetic ulcer healing therapies, spanning from starting materials to APIs and formulations. The goal is to protect and enhance stakeholder interests and create a mutually beneficial ecosystem.
According to Hsu, the global GLP-1 market—including semaglutide and tirzepatide used for diabetes and weight loss—is valued at US$44.725 billion as of 2024. According to forecasts from Debon Securities, the global GLP-1 market for type 2 diabetes and obesity could reach US$90 billion by 2030, with US$35–40 billion attributed to type 2 diabetes drugs and US$50–55 billion to obesity medications.
Resource: 北極星GLP-1新廠動土 未來五年投80億擴產能攻千億市場
