信立泰(002294.SZ):JT“Enarodustat”獲批日本上市
格隆匯 9 月 28日丨信立泰(002294.SZ)公佈,近日,公司收到日本JAPANTOBACCO INC.(“JT”)通知,其擁有的創新化合物“Enarodustat”(2mg/4mg)在日本獲得生產和銷售許可。現就具體情況公告如下:
“Enarodustat”(恩那司他片)為JT擁有的抗腎性貧血口服小分子創新制劑,已開發的適應證為腎性貧血。JT於2019年11月在日本提交上市申請,2020年9月獲批上市。2019年12月,公司與JT簽訂協議,獲得“Enarodustat”相關知識產權、技術信息在腎性貧血適應證領域的中國市場獨家許可使用權。
相比較現有治療方法,恩那司他片改善貧血機制明確,既可促進內源性促紅細胞生成素的生成,也可改善鐵的利用;且具有良好的安全性和有效性,可顯著提高患者依從性。上市後將為患者提供更高效、安全的新治療選擇。根據日本的III期臨牀研究,證實了“Enarodustat”在非透析、腹膜透析和血液透析的腎性貧血患者中的安全性和有效性。此次“Enarodustat”在日本獲批上市,進一步論證了該產品的成藥性及臨牀價值。
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