李氏大藥廠(00950.HK)：Intrarosa多中心、隨機、雙盲、並行組別第III期臨牀試驗的首名中國患者已經入組
格隆匯9月13日丨李氏大藥廠(00950.HK)公吿，於2021年9月13日，公司全資附屬公司兆科藥業（合肥）有限公司的Intrarosa多中心、隨機、雙盲、並行組別第III期臨牀試驗的首名中國患者已經入組。Intrarosa為Endoceutics,Inc.特許授權的產品，用於治療外陰陰道萎縮（VVA）。
Intrarosa一直行銷於美國、加拿大及歐洲。目前於中國進行的第III期試驗旨在比較Intrarosa相對安慰劑對中國人羣的安全性與療效。主要研究終點為比較兩個試驗組別於第1日與第85日的性交疼痛嚴重分數（以VASQ得出）變化。將合共入組418例患者。是項研究由復旦大學附屬婦產科醫院的隋龍教授牽頭，合共28間中心將會參與是項研究。預期入組完成時間為2022年第三季。
據悉，Intrarosa是唯一一種獲美國食品藥品監督管理局（FDA）及歐洲藥品管理局（EMA）批准供日常局部使用的不含雌激素類固醇，用於治療因絕經而出現的VVA。Intrarosa的產品資料並無任何包裝（安全）警吿，有別於其他獲FDA認證用於治療VVA的藥物，全部均印有包裝警吿。Intrarosa含有普拉睾酮（又名脱氫表雄酮(DHEA)）。普拉睾酮為一種非活性內源性類固醇，會內部轉化為雄激素及雌激素，幫助修復陰道纖維組織，從表層和副基底細胞的百分比以及酸礆值改善可見一斑。
Endoceutics為一間加拿大私營藥業公司，從事婦女健康及激素敏感癌症的預防及治療。於Intrarosa在2016年11月獲美國FDA認證用於治療因絕經而出現的中等至嚴重程度性交疼痛（一種VVA徵狀），以及在2018年1月及2019年11月分別獲歐洲藥品管理局及加拿大衞生部認證用於治療絕經女性的VVA後，Endoceutics現時致力於協助合作伙伴將此項創新產品作全球商業化，推進產品管線。
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