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On March 29, according to relevant websites, Junshi Bio-PD-1 Teriplimumab's third indication (acceptance number: CXSS2000018/19) has been changed to "under review" and is expected to be approved in the near future It is marketed for the treatment of locally advanced or metastatic urothelial carcinoma (UC) patients who have received previous treatment.
(Source: Yaozhi Data)
It is reported that the marketing application for this new indication is based on an open, single-arm, multi-center, phase II key registration clinical study (POLARIS-03), which aims to evaluate the failure of standard treatment for teriprizumab Safety and effectiveness in patients with locally advanced or metastatic bladder urothelial cancer.
According to the analysis data after the end of clinical enrollment published on ASCOGU in 2020, as of the data cut-off date, the independent evaluation results showed that among the 148 patients who met the evaluation criteria, the overall objective response rate (ORR) was 25.
Urothelial carcinoma (UC) (also called transitional cell carcinoma (TCC)) is currently the most common type of bladder cancer.
Currently, domestically produced PD-1 has been included in the 2020 National Medical Insurance Catalog.
PD-1/L1 has been listed and reported for production in China
(According to the public information, if there are any incompleteness, please leave a message to add)