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復星醫藥(02196.HK):口服新冠藥「Molnupiravir」臨床數據有限 尚未開始生產
阿思達克 01-24 08:27
藥品專利池組織向包括復星醫藥(02196.HK)在內的27家企業,授權生產口服抗新冠病毒藥物「Molnupiravir」仿製藥。復星醫藥(02196.HK)發公告指,附屬公司「上海復星醫藥產業發展」於本月7日與藥品專利池組織訂立分許可協議,該藥物的成本和相關定價暫無法確定,但鑑於該分許可旨在促進中低收入國家/地區獲得該藥物,預計在該分許可下該藥物的定價,將會低於中高收入國家的售價。 Molnupiravir由默沙東與Ridgeback Biotherapeutics LP合作開發。根據該協議,上海復星醫藥產業發展應按照年度淨銷售額的5%或10%向默沙東支付專利許可使用費,將自世衛宣布新型冠狀病毒不再被列為「國際關注的突發公共衛生事件」的次月起開始收取。 根據該協議 , 上海復星被授權在全球105個中低收入國家或地區開展生產該藥物的原料藥及成品藥、商品化,以及與之相關的權利,將在通過世衛預認證或經國際人用藥品註冊技術協調會相關成員機構批准的生產設施上進行生產。根據公開資料,該藥物只在包括英國、美國及日本在內的若干國家獲得有條件批准或緊急使用授權,公司指,由於該藥物有關的臨床數據有限,該藥物的臨床使用可能導致未曾報告的嚴重不良事件或意外不良事件,集團尚未開始生產該藥物,亦未取得任何有關該藥物的採購訂單。
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