Cinda Bio's Cindy Dilly Single Anti-Injection (Dabershu) has been officially approved for listing by the State Drug Administration
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Last Update: 2020-06-10
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Source: Internet
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Author: User
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recently, Cinda Bio's PD-1 monoclonal antibody Sindili monoantigen (commodity name: Dabershu) was officially approved by the NationalMedicines(http://Regulatory Authority to treat at least second-line system chemotherapy recurrent or incurable classic classic Hodgkin's lymphoma, which is also the first PD-1 mono-
drug (http://for Hodgkin's lymphoma indicationit is understood that the approval is based on a study called ORIENT-1, which is a multi-center, Phase II registered study to assess the efficacy and safety of Sindilli monoantigen in recurrent or refractory classic Hodgkin lymphoma (r/r cHL), a total of 96 cases of relapsed or refractory cHL patients, is by far the largest number of relapsed or refractory cHL studies in Chinaassessed by IRRC, 96 patients with 24 weeks ofanalysis(http://results showed that the objective remission rate (ORR) was 79.2%, the disease control rate (DCR) was 97.9%, which reached the preset statistical targethttp://
;, Sindilli mono-anti-injection is also promoting the development of other indications, clinicaltrial(http://more than 20, including first-line non-small cell lung cancer, first-line lung squamous cancer, second-line lung squamous cancer, EGFR TKI Treatment of failed EGFR mutation-positive non-small cell lung cancer, first-line stomach cancer, first-line liver cancer, first-line esophageal cancer, second-line esophageal cancer, etc., more than 1000 Chinese and foreign cancer patients have participated in Sindili mono-anti-injection-related clinical trials,
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