Domestic anti-PD-1 therapy! Junshi bio Trepri monoantigen (Tuyi ®) urinary disease (UC) new indications application by the State Drug Administration to accept!

May 10, 2020 /
Biovalley BIOON / -- Junshi Bio recently announced that the State Drug Administration (NMPA) has accepted applications for new indications for treating patients with local progress ionized or metastatic urinary disease (UC) for the anti-PD-1 antibody drug Tripriem (commodity name: Tuyi) urinary tract cancer (UC) is the most common urinary system cancer worldwide Early surgery-based, for patients with non-surgical local progression or metastatic urinary tract cancer, platinum-based chemotherapy is its standard first-line treatment, with the decreasing sensitivity of chemotherapy, will lead to tumor recurrence and disease progression For patients with advanced urinary disease cancer who develop disease progressostins after this standard treatment, the current treatment methods are very limited it is worth mentioning that in April this year, , Baiji Shenzhou anti-PD-1 antibody drug Baczean ® (generic name: Treli-Jumono-resistant injection) was approved by NMPA for the treatment of uc
patients receiving advanced localized or metastatic PD-L1 high expression within 12 months of failure of chemotherapy containing platinum, including new or auxiliary chemotherapy At the end of December 2019, the Bacazean ® was approved by NMPA for the treatment of patients with recurrent or incurable classic Hodgkin's lymphoma (R/R cHL) who have undergone at least second-line system chemotherapy global, 11 PD-(L)1 treatments have been approved, eight of which have been approved in China Of the 11 treatments, six have been approved for urinary maltosin (UC) indications It is worth mentioning that Bacheran ® is the first anti-PD-(L)1 treatment approved for UC treatment in China (click on the image to view the larger picture) Junshi Bio's anti-PD-1 antibody drug Triprili monoantigen (commodity name: Tuyi) was approved by NMPA in December 2018 for sale, becoming China's first independently developed PD-1 monoantigen, the drug indications for: for the previous treatment of systemic system failure non-resectionable or transferable melanoma treatment The approval of Trepri monoantigen injection fills the gap of domestic PD-1 monoantigen, and more Chinese patients will have the opportunity to obtain the oncology immunotherapy at the international advanced level at the end of April this year, NMPA accepted a new indication slot application for the treatment of patients with recurrent/metastatic nasopharyngeal cancer (NPC) who had previously received a second-line and above system treatment It is also the world's first application for a new drug to treat recurrent/metastatic nasopharyngeal cancer the listing application for uc new indications, based on the POLARIS-03 study (NCT03113266), a key registered clinical study of open, single-arm, multi-center, phase II, aimed at assessing the safety and efficacy of patients with local progress or metastatic bladder urinary disease after the failure of the standard treatment of Triprimono resistance treatment, led by Professor Guo Jun of Beijing University Cancer Hospital and Professor Yan Yanwing of Shanghai Jiaotong University Medical School at the American Society of Clinical Oncology's Oncology Symposium on The Genitor system (ASCO GU) in February this year, the POLARIS-03 study published post-clinical analysis data for 151 patients with topical advanced or metastatic urinary tract cancer By the data cut-off date, the independent evaluation results showed that among the 148 patients who met the assessment criteria, the overall objective remission rate (ORR) was 25.7% , the ORR of PD-L1-positive patients (46 cases, 31.1%) reached 41.3%, the OS data were not yet mature, and the safety data were basically consistent with The Triprei single-resistance past reports Updated data for this study will be presented at the recent annual meeting of the International Conference of Academic Conferences asCO Dr Li Ning, ceo of Junshi Bio, said: "Following the listing of nasopharyngeal cancer indications last week, Trepri's mono-resistance reached another milestone, marking a new stage in the layout of our 'subdivision' of 'subdivisions' of melanoma , nasopharyngeal cancer, urinary skin cancer, etc Immune therapy has shown some advantages in the world for the of late-stage urinary system tumors PolarIS-03 is a Phase II clinical study of people with advanced urinary malcy cancer The results presented at this year's International Conference showed that, regardless of the patient's PD-L1 expression status, second-line treatment of Triprei monoantigen soutcomes has benefited as well as any PD-1/PD-L1 second-line treatment of advanced urinary disease We are actively working with regulators to provide more treatment options for patients with advanced urinary skin cancer as soon as possible (biovalleybioon.com) original origin: Junshi Bio, BioValley