慢性腎臟?。–KD）會(huì)導(dǎo)致腎性貧血，嚴(yán)重的腎性貧血會(huì)增加患者的死亡率。2017年10月18日FibroGen公司宣布國家食品藥品監(jiān)督管理總局（CFDA）已受理其提交的口服新藥羅沙司他（Roxadustat，F(xiàn)G-4592）的上市申請(qǐng)，如獲批準(zhǔn)，將成為全球第一個(gè)低氧誘導(dǎo)因子（HIF）脯氨酰羥化酶（PH）抑制劑類的首創(chuàng)新藥，中國將成為最先批準(zhǔn)的國家。羅沙司他是一種新型HIF-PH酶抑制劑，通過穩(wěn)定HIF，抑制其降解，從而激活相關(guān)基因的轉(zhuǎn)錄，產(chǎn)生相應(yīng)的生理反應(yīng)，發(fā)揮抗腎性貧血的作用，而且療效顯著，不良反應(yīng)少，給藥方便，可減少或規(guī)避鐵劑的使用。介紹羅沙司他的作用機(jī)制、藥動(dòng)學(xué)、臨床研究、不良反應(yīng)等研究進(jìn)展，為臨床應(yīng)用提供參考。

Chronic kidney disease (CKD) leads to renal anemia, and severe renal anemia increases mortality in patients with CKD. On October 18, 2017, FibroGen Inc. announces that CFDA has accepted the company's New Drug Application submitted recently for registration of Roxadustat which administered by oral. If approved, Roxadustat will be the first inhibitors of hypoxia-inducible factor (HIF) -prolyl hydroxylase (PH) enzyme available worldwide, China will be the first approval country for this first-in-class drug. Roxadustat is a new type of HIF-PH enzyme inhibitors, which can activate the transcription of related genes and produce a corresponding physiological response to treat renal anemia by stabilizing HIF to inhibit its degradation. Roxadustat has obvious efficacy, with low adverse reactions and convenient administration, which can reduce or avoid the use of iron. In this paper we introduce it's the mechanism, pharmacokinetics, clinical study, adverse reactions, potential application value of Roxadustat with view to promoting new drug information spreading and providing reference for clinical application.