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九芝堂(000989.SZ):全資子公司研發新藥啓動II期臨牀試驗

格隆匯5月26日丨九芝堂(000989.SZ)公佈,2025年5月24日,九芝堂股份有限公司全資子公司牡丹江友搏藥業有限責任公司(簡稱“友搏藥業”)與牽頭組長單位復旦大學附屬華山醫院和參研的四川大學華西醫院、中南大學湘雅醫院等全國26家臨牀試驗中心組織召開了關於開展“以注射用達託黴素爲對照,初步探索靜脈輸注不同劑量的YB211治療成人急性細菌性皮膚及皮膚結構感染受試者的有效性和安全性的隨機、盲法、陽性藥平行對照、多中心的Ⅱ期臨牀試驗”的項目啓動會。

YB211項目是具有全新化學結構的環脂肽類1類化藥新藥,其化合物、製備方法等核心技術均已獲得國際和國內發明專利授權與全球獨家許可。本藥品申請適應症爲對本品敏感的革蘭氏陽性病原菌所致的急性細菌性皮膚及皮膚結構感染(ABSSSI),其研發旨在提高環脂肽類抗菌藥物的安全性與有效性,爲臨牀提供一種新的選擇。

本臨牀試驗項目以注射用達託黴素爲對照,初步探索靜脈輸注不同劑量的YB211在成人急性細菌性皮膚及皮膚結構感染受試者的mITT(改良意向治療)人羣中TOC訪視(末次給藥後7~14天)時的臨牀療效。本試驗將分爲兩個部分進行:第一部分爲劑量探索研究,第二部分爲藥代動力學(PK)研究。

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