Polaris-KY(6550-TW) The Phase III clinical trial of its new drug ADI-PEG 20 for lung mesothelial cancer is expected to announce data this month, and funds will be placed in advance.
According to the notification from Precision Clinical, a clinical trial trustee research organization (CRO) company, Polaris expects to publish a preliminary efficacy analysis in mid-September, including the primary indicator of median overall survival (mOS), secondary indicators of median progression-free survival (mPFS) and statistical tests. P-value and other clinical trial data. CEO Chen Shaochen said that after completing the preliminary efficacy analysis, it will take some time to sort out complete clinical data before closing the case and submitting it to the FDA.
According to the Polaris plan, after the third quarter of the new drug for pulmonary mesothelial cancer has been unmasked and the data has been collated, it will submit an application for a drug certificate to the US FDA in the first quarter of next year, and have a chance to obtain a drug certificate by the end of 2023 at the earliest. It is carried out by means of zoning authorization or promotion.
According to the report of EvaluatePharma, a research institute, the market size of cancer drugs in 2019 is about 145.4 billion US dollars, and it is expected to climb to 311.2 billion yuan in 2026, with a compound annual growth rate of 11.5%.