• 分类：最新消息
• 作者：华讯知识产权
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• 发布时间：2020-12-24 10:09
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【概要描述】Bayer's new anti-tumor drug BAY 2416964 received clinical approval in China According to Center for Drug Evaluation (CDE) announcement, Bayer's clinical application for BAY 2416964 tablets submitted in category 1 of chemical drugs was accepted by CDE on October 16 and received on December 17 two clinical trials have implied permission and are intended to be developed for advanced malignant tumours. This is the first time the product has been approved for clinical use in China, which means that this drug candidate is about to start clinical studies in patients with advanced malignant tumors in China. The Aryl Hydrocarbon Receptor (AHR) is a protein in immune cells, which can play an immunomodulatory role according to the integrated signals of microorganism and amino acid metabolism in human body. Because AHR is highly expressed in a variety of tumors and has immunomodulatory effects, modulators targeting AHR are considered to be one of the new types of immunotherapy. At the same time, this type of therapy is expected to be combined with other drug categories to improve the therapeutic effect. BAY 2416964 is a potent, highly selective and cross-reactive AHR inhibitor that can exert a variety of anti-tumor immunomodulatory effects. It can block the transcription of CYP1A1 mediated by different AHR agonistic ligands, and can directly interact with AHR, and can inhibit ligand-induced AHR transport to the nucleus. Studies have shown that BAY 2416964 with different doses and different dosing frequencies can inhibit specific tumor models. Bayer is currently carrying out an exploratory study on the human dose of BAY 2416964 in patients with advanced cancer. This is an open-label, phase 1, dose escalation and expansion study conducted for the first time in humans to evaluate the safety, tolerability, maximum tolerated dose, pharmacokinetics, and efficacy of the AHR inhibitor BAY 2416964 Kinetics and tumor response profile, etc. Senator Roy Blunt wrote this paragraph in the 《Cancer Development Report 2016》in the United States: "When a family is healthy, there may be many conflicts and problems. But if one of them has cancer, you have only one problem to deal with , and that's the cancer itself." I hope that the follow-up clinical development of this product will progress smoothly and bring a new treatment option to cancer patients as soon as possible.