康哲藥業(00867.HK)合作伙伴Zydus宣佈德度司他片新藥上市申請在印度獲批

2022年3月7日,康哲藥業(00867.HK)合作伙伴Zydus Lifesciences Ltd.(前稱Cadila Healthcare Ltd., "Zydus")宣佈,OxemiaTM(德度司他片)新藥上市申請(NDA)已獲印度藥品控制總署(DCGI)批准,成為印度同類首個口服治療慢性腎病(CKD)貧血的藥物。
根據Zydus官方新聞稿:
"德度司他片是一種口服、小分子低氧誘導因子脯氨酰羥化酶抑制劑(HIF-PHI)。德度司他片在兩項III期臨牀試驗(DREAM-D和DREAM-ND)中均達到改善血紅蛋白(Hb)的主要終點,且在CKD患者中顯示出良好的安全性、鐵調素下調、鐵動員改善和LDL-C降低。德度司他片的臨牀開發項目為印度針對CKD患者貧血同類藥物中最大的臨牀試驗之一,覆蓋1,200多名受試者。德度司他片為CKD貧血患者提供了一種便捷的口服治療選擇。
CKD是一種嚴重的進展性疾病,特徵為腎功能逐漸喪失,通常伴有貧血、心血管疾病(高血壓、心力衰竭和中風)、糖尿病等其他合併症,最終導致腎衰竭。CKD患者通常接受多種藥物治療,存在藥物間相互作用的安全風險。
據估計,印度有1.15億人、中國有1.32億人、美國有3,800萬人、日本有2,100萬人、西歐有4,100萬人患有慢性腎病(Lancet 2020;395:709-33)。預計到2040年,CKD將成為全球範圍內因病早亡最常見的原因之一。"
在中國,康哲藥業已通過技術轉移完成德度司他片試驗製劑的本地化生產。2021年6月,康哲藥業完成產品中國 I 期藥代動力學(PK)試驗,2022年1月,完成中國 III 期橋接試驗首例受試者給藥。
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