Polaris Pharmaceuticals (6550TW) held its 2021 Annual Meeting of Shareholders on (8/23) and announced that it will initiate the world’s first Phase III clinical trial of a single drug for liver cancer screened by genetic biomarkers. The Polaris research and development team analyzed the genes of patients who had participated in liver cancer clinical trials and found that patients with specific genetic markers for liver cancer had significant efficacy with ADI, which is a major discovery in liver cancer treatment. This clinical trial has been applied to the FDA more than a month ago, according to the rules of the FDA within one month without objection will automatically take effect, the company will recently discuss with the FDA, after obtaining the FDA’s advice will start the clinical trial.
During the meeting, the company also explained the progress of other clinical trials. CEO Shao-Chen Chen said that the unblinding of lung mesothelial cancer will be carried out in mid-August next year in accordance with the DSMB recommendation approved by the FDA. For soft tissue sarcoma, the Phase II trial will be a breakthrough drug due to its remarkable efficacy, and a Phase III clinical trial will be initiated.
Chairman Howard Chen said that Polaris has been conducting clinical trials with international pharmaceutical companies through the Anderson Cancer Medical Center in the U.S. The company has never ruled out the possibility of licensing or strategic cooperation with international pharmaceutical companies. The company cannot take the initiative to disclose the identity of the investor because the shareholding of the specific person has not reached the standard that must be announced in accordance with the law. The Yilan plant will be completed in the year after next and the U.S. plant will also be expanded. In response to the severe shortage of global biopharmaceutical production capacity in the future, Polaris will use biopharmaceutical foundries in the U.S., China and Taiwan for global deployment. In addition to supporting the company’s own ADI production needs, it will also produce Nanotein and mRNA-related biologics. Chairman Chen is very optimistic about the development potential of mRNA, which can be used not only in vaccine development but also in new biopharmaceuticals, and said that Polaris is gradually building up its mRNA technology team and has already mastered nearly 80% of mRNA-related technologies. Mr. Chiu has served TSMC for nearly 30 years and has served as the president of TSMC’s Tainan plant and the president of its mainland subsidiary. This seems to imply Polaris’ ambitious vision to move towards TSMC as a biopharmaceutical OEM.