奧賽康(002755.SZ)：子公司引進Shield Therapeutics新一代口服鐵劑麥芽酚鐵膠囊
格隆匯1月8日丨奧賽康(002755.SZ)公佈，公司的子公司江蘇奧賽康藥業有限公司(下稱“江奧”)與英國Shield Therapeutics Plc.公司(下稱“Shield Therapeutics”)於2020年1月8日簽署《授權協議》，根據該協議，江奧獲得Shield Therapeutics用於成人鐵缺乏症(有無貧血症狀均可)治療的新一代口服鐵劑產品麥芽酚鐵膠囊及其未來可拓展的劑型、適應症等在中國(包括中國大陸、香港特別行政區、澳門特別行政區、台灣，下同)的獨家開發、生產和市場推廣權益。
該協議的具體財務條款為：(1)首付款協議簽署後，江奧將向Shield Therapeutics支付總計1140萬美元的首付款；(2)開發里程金麥芽酚鐵膠囊獲中國藥監局批准後，江奧將向Shield Therapeutics支付總計1140萬美元的開發里程金；(3)銷售里程金根據產品在授權區域達成的特定銷售目標，江奧將向Shield Therapeutics支付總計不超過4000萬美元的銷售里程金；(4)銷售提成根據產品在授權區域的銷售情況，江奧將根據實際年淨銷售額向Shield Therapeutics支付10%-15%的銷售提成。
麥芽酚鐵膠囊由Shield Therapeutics研發，2016年、2019年先後被歐洲藥品管理局(EMA)和美國食品藥品管理局(FDA)批准用於成人鐵缺乏症(有無貧血症狀均可)治療。商品名分別為Feraccru®(歐盟市場)、Accrufer™(美國市場)。
Feraccru®Accrufer™的活性成分麥芽酚鐵(ferric maltol)是一種非鐵鹽、穩定的新型複合物，具有獨特的吸收機制，對於基於鐵鹽的補鐵藥物不耐受的患者，Feraccru®Accrufer™是理想的替代療法。在一系列III期臨牀對照試驗中，Feraccru®Accrufer™已被證實是一種穩定、耐受性良好、高效的治療成人鐵缺乏症(有無貧血症狀均可)的口服藥物。
此外，在AEGIS-H2H臨牀試驗中，Feraccru®Accrufer™與靜脈注射補鐵療法相比，在血紅蛋白提升方面達到非劣效性標準。這意味着，缺鐵性貧血患者可能無需使用靜脈注射鐵劑，Feraccru®Accrufer™有望改變鐵缺乏症患者的治療模式。
世界衞生組織(WHO)指出，缺鐵是世界上最常見和最普遍的營養失調。在美國鐵劑處方市場每年超過10億美元。在中國由於缺鐵引起的貧血等疾病發病率在20%以上，婦女、老人、慢性腎病患者、心衰患者、克羅恩病患者更是鐵缺乏症的高發人羣。中國目前鐵劑市場規模已超過30億元，抗貧血藥鐵劑潛在用户至少有2億人，潛在市場規模預估超過200億元。
公司表示，此次合作引進新一代口服鐵劑麥芽酚鐵膠囊，有助於豐富公司及子公司江奧產品管線佈局，提升公司及子公司江奧的核心競爭力，符合公司戰略發展的需要。
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