遠大醫藥(00512.HK):全球創新的治療蠕形蟎瞼緣炎產品獲中國澳門藥監局批准上市
格隆匯5月25日丨遠大醫藥(00512.HK)公佈,集團用於治療蠕形蟎瞼緣炎的全球創新眼科藥物 GPN01768 (TP-03,洛替拉納滴眼液,0.25%)近日獲得中國澳門特別行政區政府藥物監督管理局 (澳門藥監局)批准上市,這是集團在眼科治療創新領域的又一項重要進展。該產品在澳門藥監局獲批為未來在粵港澳大灣區的獲批奠定了基礎,也有望進一步促進其在中國大陸的落地。
蠕形蟎是導致蠕形蟎瞼緣炎的根本原因,GPN01768 是一款對昆蟲和蛛形綱動物體內的 γ-氨基丁酸門控氯離子通道(GABA-Cl)具有選擇性的非競爭性拮抗劑,其通過選擇性抑制蠕形蟎體內的 GABA-Cl,使蟲體麻痺和死亡,進而治療蠕形蟎瞼緣炎。此外, GPN01768 具有高度親脂性,可促進其在蟎蟲棲息的睫毛毛囊油脂中的吸收。GPN01768 由 Tarsus Pharmaceuticals Inc. (Tarsus)開發,是首款也是唯一一款獲得美國食品藥品監督管理局(FDA)批准用於治療蠕形蟎瞼緣炎的產品。GPN01768 於 2024 年在美國取得約 1.8 億美元的收入,共計售出約 16.3 萬瓶;2025 年一季度,其在美國取得約 7830 萬美元的收入,較 2024 年四季度增長 18%。集團於2024年3月與 Tarsus 達成產品引進戰略合作協定,取得用於治療蠕形蟎瞼緣炎及蠕形蟎導致的瞼板腺功能障礙的眼用製劑 GPN01768 產品在大中華區(中國大陸、中國香港特別行政區、中國澳門特別行政區、台灣地區)的獨家開發、生產及商業化權益。此前,GPN01768 已於2024年12月向中華人民共和國國家藥品監督管理局遞交了新藥上市申請並獲得了受理。
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