長春高新(000661.SZ):金賽藥業獲綠葉利斯的明透皮貼劑產品內地獨家商業化權利
格隆匯12月22日丨長春高新(000661.SZ)宣佈,近日,公司控股子公司長春金賽藥業有限責任公司(簡稱“金賽藥業”)與綠葉製藥(02186.HK)的全資附屬公司Luye Pharma Switzerland AG(簡稱“綠葉瑞士”)共同簽署協議,綠葉瑞士同意授予金賽藥業在中國大陸進口、銷售、推廣、營銷與使用授權產品的獨家不可轉讓的、可分許可的永久商業化權利。
授權產品為利斯的明透皮貼劑單日貼(金斯明®)和多日貼(LY03013),各有兩個規格4.6mg/24小時和9.5mg/24小時,適應症為治療阿爾茨海默病的症狀。
其中,利斯的明透皮貼劑多日貼(LY03013)是綠葉製藥自主研發的改良型新藥,為每週經皮膚給藥兩次的貼劑產品,具有更低的使用頻率,能夠提高患者的用藥依從性。該產品已於2021年5月獲得歐盟多國上市許可資格,於 2021年9月獲得英國上市批准,並於2020年9月在中國獲批進行臨牀試驗。
利斯的明透皮貼劑單日貼是目前唯一通過FDA批准的治療阿爾茨海默病的貼劑產品,其原研為瑞士諾華製藥的艾斯能®,該次合作中所涉及的利斯的明透皮貼劑單日貼(金斯明®),是國內首個按一致性評價審評要求批准上市的利斯的明透皮貼劑單日貼產品。
據悉,綠葉製藥是致力於創新藥物的研發、生產和銷售的國際化製藥公司,在中樞神經和腫瘤領域已有多個創新制劑和創新藥在歐洲、美國、日本開展註冊及臨牀研究。綠葉瑞士為綠葉製藥在歐洲、中東和非洲地區的總部,負責集團中樞神經系統產品線在這些區域的商業化,並負責透皮貼劑產品的全球商業化。
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