康哲藥業(00867.HK):獲得治療白癜風和特應性皮炎的產品蘆可替尼乳膏獨家許可權利
格隆匯12月2日丨康哲藥業(00867.HK)宣佈,於2022年12月2日,集團通過公司附屬公司—皮膚醫美業務公司("康哲美麗")與一家全球生物製藥公司Incyte(Nasdaq:INCY)("Incyte")就用於治療自身免疫性炎症皮膚病的蘆可替尼局部製劑("蘆可替尼乳膏"或"產品")訂立合作和許可協議("許可協議")。
根據許可協議,集團通過康哲美麗獲得在中國大陸、香港特別行政區、澳門特別行政區、台灣地區及東南亞十一囯(印尼、菲律賓、越南、泰國、緬甸、馬來西亞、柬埔寨、老撾、新加坡、東帝汶以及汶萊)("區域")研發、註冊及商業化產品的獨家許可權利,以及在區域內生產產品的非獨家許可權利。許可協議期限開始於許可協議生效日,自產品首次在區域內商業化起擁有十年的授權期限("授權期限")。授權期限屆滿後,根據許可協議約定的特定條件,許可協議期限可延長十年("初始延展授權期限")。初始延展授權期限屆滿後,根據許可協議約定的特定條件,雙方可另行協商許可協議的延長期限。
集團將向Incyte支付首付款,Incyte有權獲得額外潛在的開發註冊和商業化里程碑金以及基於許可產品在區域內淨銷售額的特許權使用費。此次合作將推動集團在皮膚治療領域的縱深發展,符合集團向皮膚醫美領域持續發展的戰略。蘆可替尼乳膏將與康哲美麗現有皮膚線產品產生協同效應,豐富皮膚疾病產品覆蓋,鞏固康哲美麗的影響力及競爭力。作為FDA批准的首個也是目前唯一一個局部外用JAK抑制劑,蘆可替尼乳膏極具創新意義。如在大中華區及東南亞獲批上市,將為區域內非節段型白癜風患者及中輕度AD患者帶來新的治療選擇,將滿足兼具安全性與療效外用藥物的臨牀需求。
集團深耕皮膚治療領域多年,在中國積累了豐富的皮膚科醫生、渠道和推廣團隊資源。集團將依託自身的臨牀開發及商業化優勢,儘快實現蘆可替尼乳膏於中國的上市銷售及市場覆蓋,造福更多患者。集團將持續多維度引進全球優質創新產品,將康哲美麗打造成為中國領先的皮膚醫美健康管理公司。
此次合作包括於上文所列載之東南亞十一國的產品權利,符合集團的東南亞業務發展戰略,不斷豐富東南亞產品矩陣,紮實推進對東南亞市場的佈局。依託具有專業經驗並紮根當地市場的核心管理團隊,集團將推動蘆可替尼乳膏於東南亞市場的開發註冊,儘快實現其商業落地並推動市場覆蓋,滿足東南亞市場對優質產品的巨大需求。集團將持續與全球生物製藥企業深入合作,搭建合作共贏、互惠互利的東南亞生物醫藥生態圈。
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