華東醫藥(000963.SZ)：擬引入ZORYVE®乳膏及ARQ-154，進一步補充自身免疫性及炎症性皮膚病領域的產品管線
格隆匯8月10日丨華東醫藥(000963.SZ)公佈，2023年8月10日，公司全資子公司中美華東與美國納斯達克上市公司Arcutis Biotherapeutics, Inc.(NASDAQ: ARQT)(“Arcutis”)簽訂了產品獨家許可協議。中美華東獲得Arcutis全球創新的羅氟司特外用製劑(包括羅氟司特乳膏劑ZORYVE®和羅氟司特泡沫劑ARQ-154)(“許可產品”)在大中華區(含中國大陸，中國香港、中國澳門和中國台灣)及東南亞(印度尼西亞、新加坡、菲律賓、泰國、緬甸、文萊、柬埔寨、老撾、馬來西亞和越南)(“許可區域”)的獨家許可，包括開發、註冊、生產及商業化權益。中美華東將向Arcutis支付3000萬美元首付款，最高不超過6425萬美元的開發、註冊及銷售里程碑付款，以及分級兩位數的淨銷售額提成費。
公吿顯示，ZORYVE®乳膏及ARQ-154的活性成分均為Roflumilast(羅氟司特)，是一種磷酸二酯酶-4 (PDE4)抑制劑。PDE4是一種細胞內酶，可增加促炎介質的生成並減少抗炎介質的生成，抑制PDE4可減輕炎症反應。PDE4與多種炎症性疾病有關，包括銀屑病，特應性皮炎和慢性阻塞性肺病等。
此次引入ZORYVE®乳膏及ARQ-154將進一步補充公司在自身免疫性及炎症性皮膚病領域的產品管線。截止目前 公司在自免疾病領域已擁有生物藥和小分子創新產品10餘款。其中，公司與參股企業荃信生物合作開發的烏司奴單抗生物類似藥HDM3001已正式遞交BLA申請；從Kiniksa引進的全球創新產品ARCALYST®在國內被列入《臨牀急需境外新藥名單(第一批)》，並計劃於2023年在中國正式遞交冷吡啉相關的週期性綜合徵(CAPS) BLA申請；與Provention Bio合作的全球創新產品HDM3002已正式獲得NMPA批准開展系統性紅斑狼瘡的Ⅱa期臨牀試驗。其中 ，ZORYVE®乳膏和ARQ-154作為外用製劑，有望與生物製劑烏司奴單抗生物類似藥HDM3001 (QX001S)共同為兒童及成人銀屑病患者帶來更多用藥選擇。
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