Polaris Group withdraws MPM drug application, adjusts US subsidiary staff

Polaris Group spokesperson Shen Yi-chieh announced that the board of directors has decided to adjust key R&D product lines, including pausing the follow-up of human clinical trials for a new drug to treat leiomyosarcoma (LMS) and withdrawing the Biologics License Application (BLA) for malignant pleural mesothelioma (MPM) submitted to the US FDA. The company will also conduct personnel adjustments at its US subsidiaries. Polaris Group, a new drug development company, held a major information press conference today. Shen stated that regarding the MPM BLA application, despite supplementing data as requested by authorities during the review period, the company decided to voluntarily withdraw it based on overall business strategy and long-term commercialization plans. The company will conduct a deeper analysis of existing clinical trial data to evaluate the direction and strategy for the next phase of the project. Additionally, the Phase 3 multi-national, multi-center human clinical trial of Polaris Group's ADI-PEG 20 combined with Gemcitabine and Docetaxel for treating LMS will be paused following a review by the Data Safety Monitoring Board (DSMB). The company will follow the DSMB's recommendation to pause the trial and will subsequently optimize the subject population and trial design. In addition to strategic adjustments in R&D, Polaris Group has recently conducted a comprehensive review of its US subsidiary structure, evaluating the organizational structure and operational resource utilization of its Northern California subsidiary DRx and Southern California subsidiary PPI. She stated that considering current international and industrial environmental changes, capital utilization efficiency, and the group's long-term development strategy, the board has approved an organizational optimization and personnel adjustment plan for both DRx and PPI. Shen said the main purpose of the adjustment is to improve operational efficiency, reduce fixed cost burdens, and focus company resources on core business, key product development, and subsequent important operational goals to strengthen overall capital utilization efficiency. She emphasized that this adjustment will not affect the core functions and important operations of DRx and PPI; existing product development, quality system operations, and key business promotion will continue and will not be interrupted by the organizational adjustment. Polaris Group will ensure that necessary technical and operational functions are appropriately taken over and continued.