新药进展:治疗慢性咳嗽!中国生物制药自研1类新药P2X3受体拮抗剂获批临床

2021-12-22 生物探索 网络

 难治性慢性咳嗽是指经过全面检查仍无法明确病因,或经过常规治疗后咳嗽仍然没有明显缓解的咳嗽。根据相关数据,全球有5%-10%的成年人患有慢性咳嗽。

近日,据 CDE 官网信息,中国生物制药子公司北京泰德的 TCR1672 片在国内获批临床,用于治疗难治性慢性咳嗽。

 

TCR1672 是北京泰德自主研发的一款二代高选择性 P2X3 受体拮抗剂。针对这款产品,该公司采取中美双报策略,今年9 月 8 日已经向美国 FDA 递交了 IND申请并获受理。
 
P2X3 受体是嘌呤类受体家族中的配体门控离子通道。研究显示,P2X3 受体的过度活化与感觉神经元的超敏化 (hyper-sensitization)有关。损伤或感染引发的气道和肺部神经元超敏反应可引起过度、持续和频繁地咳嗽。此外 P2X3 受体还特异性表达在初级感受神经元上,其高表达和激活可以导致慢性疼痛模型动物的痛觉敏化,对生理性和病理性痛觉调节产生变化。
 
截至目前,全球尚无P2X3受体拮抗剂获批上市。在同类药物中,进展速度较快的是默沙东的gefapixant(MK-7264),该药也已经向FDA递交了NDA申请,用于治疗顽固性慢性咳嗽(RCC)或不明原因慢性咳嗽(UCC)成人患者。
 
TCR1672通过阻断三磷酸腺苷(ATP)启动P2X3受体产生的钙离子内流,从而发挥对其特异性抑制作用以起到治疗效果。目前,这种药物主要用于临床空白的两大适应症领域,治疗呼吸领域的难治性慢性咳嗽(RCC)成年患者及疼痛领域的子宫内膜异位症等复杂性内脏痛患者。除了这两个适应症领域,北京泰德还在探索其在神经病理性疼痛、癌性疼痛等领域的应用。
 
难治性慢性咳嗽是指经过全面检查仍无法明确病因,或经过常规治疗后咳嗽仍然没有明显缓解的咳嗽。根据相关数据,全球有5%-10%的成年人患有慢性咳嗽。难治性慢性咳嗽患者往往因咳嗽症状反复而就诊于多家医院,重复接受相关检查,并且服用各种药物,对患者的生活和工作质量产生不良影响的同时,给患者带来巨大的经济负担。因此,难治性慢性咳嗽是临床上亟待解决的难题。期待TCR1672能够早日获批上市,为广大有需要的患者带来治疗新希望。

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参考资料:

[1]https://med.sina.com/article_detail_100_2_110208.html

[2]https://mp.weixin.qq.com/s/ieyYQAPYzjhNdxXstlmXVA

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    2021-12-26 未来将来

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