Polaris Group (TWSE:6550) held its 2021 Annual General Meeting on August 23, announcing the launch of the world’s first Phase III clinical trial for a single-agent liver cancer treatment using genetic biomarker screening. The Polaris R&D team analyzed the genes of patients who had previously participated in liver cancer clinical trials and discovered that liver cancer patients with specific genetic markers demonstrated significant therapeutic efficacy when treated with ADI. This represents a major breakthrough in liver cancer treatment. The clinical trial application was submitted to the FDA over a month ago. Per regulations, it automatically becomes effective if the FDA raises no objections within one month. The company will soon discuss with the FDA and initiate the trial upon receiving its recommendations.
During the meeting, the company also provided updates on other clinical trials. CEO Chen Shao-Chen stated that the lung mesothelioma trial will unblind earlier than planned, in mid-August next year, following recommendations from the FDA-approved Data Safety Monitoring Board (DSMB). An application will then be submitted to the FDA promptly, with the goal of obtaining marketing approval in 2023. The soft tissue sarcoma trial, demonstrating highly significant efficacy in Phase II, has the potential to qualify for Breakthrough Therapy designation and will proceed to Phase III.
Chairman Chen Hongwen noted that Polaris has initiated co-development clinical trial collaborations with major international pharmaceutical companies through the University of Texas MD Anderson Cancer Center. The company remains open to licensing or strategic partnerships with global pharmaceutical giants, and any developments will be disclosed in a timely manner in accordance with the principle of information symmetry. Regarding investor inquiries about whether the specific parties in this private placement are affiliated with international pharmaceutical giants, Chairman Chen cautiously noted that since their shareholding does not meet the threshold requiring mandatory disclosure, the company cannot proactively reveal their identities. Chairman Chen Hongwen also outlined Polaris’ future CDMO strategic layout during the meeting. The Yilan plant is scheduled for completion the year after next, while the U.S. facility will undergo expansion. To address the anticipated severe global shortage of biopharmaceutical production capacity, Polaris will establish a global footprint through its biopharmaceutical contract manufacturing operations in the U.S., China, and Taiwan. Beyond supporting the company’s own ADI production needs, the facilities will also manufacture Nanotein and mRNA-related biologics. Chairman Chen expressed strong confidence in mRNA’s development potential, noting its applicability not only in vaccine development but also in novel biologics. He stated Polaris is progressively building an mRNA technology team, having already mastered nearly 80% of mRNA-related technologies, and will soon possess comprehensive mRNA technical capabilities. The shareholders’ meeting also approved the appointment of Mr. Ying-Cheng Chao as an independent director. With nearly three decades of service at TSMC, Mr. Chao previously served as Plant Manager of TSMC’s Tainan facility and General Manager of its mainland China subsidiary. He possesses extensive practical experience in factory production management and multinational operations. This move appears to signal Polaris’s ambition to become the TSMC of the biopharmaceutical contract manufacturing industry.