羅欣藥業(002793.SZ)：引進布地奈德溶液型鼻噴劑產品大中華區獨家權益
格隆匯10月21日丨羅欣藥業(002793.SZ)宣佈，公司子公司山東羅欣藥業集團股份有限公司(簡稱“山東羅欣”)與奧地利Marinomed Biotech AG(簡稱“Marinomed”)於2021年10月20日簽署了《許可協議》，就引進Budesolv®(布地奈德溶液型鼻噴劑)產品達成協議，山東羅欣將獲得該產品在大中華區(包括中國大陸、香港和澳門特別行政區、台灣地區)獨家開發、生產和商業化的權利。
協議簽署後，山東羅欣將向Mrinomed公司支付總計200萬美元的首付款。山東羅欣將根據研發里程碑和銷售里程碑，向Mainomed公司支付總計不超過2000萬美元的里程碑付款。根據Budesolv®在授權區域的銷售情況，山東羅欣將根據實際年淨銷售額分級向Mainomed支付相應比例的銷售提成。
Budesolv®為糖皮質激素布地奈德新型劑，屬於激素類鼻噴霧劑，是首個基於Marinomed公司的專有技術平台Marinosolv®開發的水溶型鼻噴劑，Budesolv®已成功完成歐洲上市申請所必需的關鍵性III期臨牀。
Budesolv®是採用Marinomed的專利技術開發的水溶性、無防腐劑的布地奈德鼻噴溶液，本產品開發用於過敏性鼻炎的治療。關鍵性III期臨牀試驗證實，與市售的Rhinocort® Aqua 64(布地奈德混懸型鼻噴劑)相比，用藥劑量降低了85%，療效不劣於Rhinocort® Aqua 64，起效更快，給藥3小時症狀明顯緩解。
過敏性鼻炎是發病率高、病程長、易反覆發作的慢性疾病。數據顯示，過去6年間中國過敏性鼻炎患病率從11.1%升高到了17.6%(數據來自《國際過敏和鼻科學論壇》)。
Budesolv®為糖皮質激素布地奈德新型劑，目前國內外暫未上市銷售。根據IQVIA及米內網數據，2020年度激素類鼻噴霧劑全球市場規模為21.5億美元(以出廠價計算)，國內百張牀位以上醫院及零售藥店市場規模合計為13.05億元人民幣。
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