Camrelizumab 生物類似藥, PD-1 單克隆抗體-Camrelizumab Biosimilar, PD-1 Monoclonal Antibody代理/參數(shù)/廠家-二抗-艾美捷科技有限公司

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背景資料: Camrelizumab Biosimilar uses the same protein sequences as the therapeutic antibody camrelizumab.nnCamrelizumab is an IgG4κ humanized monoclonal antibody being investigated for hepatocellular carcinoma. It targets programmed cell death protein 1 (PD-1), a protein on the surface of cells, also known as CD279 (cluster of differentiation 279). Camrelizumab is being evaluated in the Phase 2/3 (NCT02989922) of patients with advanced hepatocellular carcinoma (HCC) in second-line after failure or intolerance to prior systemic treatment. The study has 2 arms in which patients will be intravenous administered 3 mg/kg SHR-1210 on day 1 every 2 weeks or every 3 weeks. The primary outcome measures are the overall response rate (ORR) and overall survival (OS) rates at 6 months with duration of response and OS at 2 years as secondary endpoints. The estimated enrollment is 220 patients, and the estimated primary completion date is December 2018. A randomized, open-label Phase 3 study (NCT03099382) is evaluating the efficacy of camrelizumab treatment compared to standard-of-care treatment (docetaxel or irinotecan) in patients with esophageal carcinoma. Patients are randomly assigned to receive either SHR-1210 (200 mg every 2 weeks) or the standard of care (docetaxel 75 mg/m2 on day 1 every 3 weeks or irinotecan 180 mg/m2 on day 1 every 2 weeks). This Phase 3 study has an estimated enrollment of 438 and an estimated primary completion date of June 2018.

保存建議: Store at 4°C 1 month, store at -20°C to -70°C 12 month. protected from prolonged exposure to light. Avoid freeze/thaw cycles.

其他: ProMab 生物技術(shù)公司通過(guò)整合生物信息學(xué)、分子生物學(xué)、蛋白質(zhì)表達(dá)、純化技術(shù)、基因克隆、微生物學(xué)和免疫學(xué)，利用新型高通量技術(shù)開(kāi)發(fā)重組蛋白、抗體和工程細(xì)胞系并將其商業(yè)化。專注于免疫治療領(lǐng)域，特別是 CAR-T/NK 細(xì)胞技術(shù)。ProMab 還開(kāi)發(fā)了一種新型的 mRNA 脂質(zhì)納米顆粒（mRNA-LNP）平臺(tái)，用于即用型試劑和定制研究服務(wù)，以推進(jìn)現(xiàn)有產(chǎn)品并擴(kuò)展到更多的研究領(lǐng)域。