Terrei Pearl mono-resistant wins 2nd indication, the first PD-1 drug approved for UC

On April 10, the State Drug Administration (NMPA) updated the status of the PD-1 single anti-Tilelli pearl single anti-injection (commodity name: Baczean ®) (acceptance number: CXSS1900025) to become "approved - pending certification"It marks the second major in the country since Terrei Pearl's resistance was approved for Hodgkin's lymphoma in December 2019Terelli Zhudan is the world's first cancer immunotherapy drug, and the first independently developed anti-cancer drug approved for listing in China, which was approved by NMPA on December 26, 2019 for the treatment of patients with relapsed or refractory classic Hodgkin's lymphoma who have undergone at least second-line system chemotherapyOn June 3, 2019, CDE accepted the second indications application for TerelliZumac, with the number: CXSS1900025, which seeks approval for the treatment of patients with pre-treated topical advanced or metastatic urinary tract cancerIn the same month, it was included in the priority reviewurinary tract cancer (UC) is the most common type of bladder cancerIt is estimated that there were about 80,000 new cases of bladder cancer in China in 2018, accounting for 27% of the world's new cases of bladder cancerCompared with the treatment of other tumors, China has made slow progress in UC treatment drugs, and is still mainly based on platinum-containing chemotherapyThis approval, so that The Tirelli Pearl mono-resistance became China's first approved UC indications PD-1 drugthe efficacy and safety ofTerelli-Z-monotherapy UC have been demonstrated in a key Phase II clinical study (CTR20170071)The study included 113 previously treated, PD-L1-positive localized advanced or metastatic UC patients with a median follow-up of 8 months, with a total remission rate (ORR) of 23.1% of 104 patients who met the conditions for efficacy assessment, 8 of which achieved complete remission (CR) and 16 patients with partial remission (PR)Safety and tolerance data are consistent with previous research findingsin addition to approved Hodgkin's lymphoma and urinary maltosis, Baiji Shenzhou is also accelerating the expansion of the terrei-pearl monoantigen in the meta-solid tumor and blood tumor indications layoutIt is understood that The Tireli Pearl mono-resistance has been carried out in 23 countries and regions around the world 15 registered clinical trials, of which 6 are international multi-center registered clinical trials, covering lung cancer, liver cancer, esophageal squamous cell carcinoma, stomach cancer and other high-risk cancerIn its 2019 financial results, Baiji Shenzhou said it plans to deliver sNDA in China in 2020 for the first-line treatment of scaly NSCLC patientsat present, the domestic has been approved 6 PD-1 monoantigen, Navuliu mono-resistance and Trepri mono-resistance is also being treated in UC research, in addition to the III clinical and II clinical stage The key clinical trial of Terri Pearl anti-resistance 4 domestic PD-1 monoantigens, previously only Hengrui Pharmaceutical's Carrey Pearl monoantigen has been approved for two indications, namely classic Hodgkin lymphoma and hepatocellular carcinoma Although the domestic PD-1 market time is late, but the market performance can not be underestimated In 2019, Treprieon achieved sales of 774 million yuan in 11 months, Xindili single resistance 10 months to achieve sales of 1.0159 billion yuan, Hengrui, although not disclosed the 2019 Carrey Pearl Single Resistance sales, but the network in less than half a year to achieve sales of 1 billion yuan domestic PD-1 inhibitor annual treatment costs
last month, terrei Zumai official prescription sales On March 2, Baiji Shenzhou announced the sale price and assistance program for the Terrei Pearl, with a minimum annual cost of about 10.69 million yuan The approval of the new indications has increased the competitiveness of the Telli-Zhu mono-resistance by a lot original title: Terrey Pearl won the second indication, the first PD-1 drug approved for UC