京新藥業(002020.SZ)簽約引進降血脂改良型複方新藥
格隆匯7月9日丨京新藥業(002020.SZ)宣佈,近日,公司與友霖生技醫藥股份有限公司(簡稱“友霖生技”)簽署《合作協議》,就降血脂改良型複方新藥在中國大陸(不含香港、澳門、台灣)進行研發、生產及商業化達成獨家合作。
根據產品在授權區域的銷售情況,公司按實際年淨銷售額向友霖生技支付相應的銷售分成。除非協議雙方約定提前終止,該協議將持續到在授權區域首次商業銷售許可產品起滿12年。
該次合作引進產品為降血脂改良型複方新藥,適應症為高膽固醇血癥。該產品由友霖生技開發,並運用獨特的“微粒技術”將兩種不同機制的降血脂藥物結合為複方製劑,劑型設計可提高藥物的穩定性,預期在降低低密度膽固醇(LDL-C)以及總膽固醇(TC)的治療效果上可優於單一藥物,並能減少病人同時服用多種藥物,提升服藥依從性,降低心血管疾病的風險,提高生活品質。該產品目前正在澳大利亞、新西蘭和台灣地區進行一項國際多中心的Ⅲ期臨牀研究,預計2021年下半年可完成。
米內網數據顯示,2020年降脂藥物在中國城市公立醫院銷售金額約79.3億元。簽約後公司將向友霖生技支付首付款、開發里程碑以及銷售里程碑等不超過2800萬元人民幣。
據悉,友霖生技是台灣一家依照PIC/SGMP、歐盟GMP及美國食品藥物管理局(FDA)21CFR國際標準所興建的全新藥廠,擁有多層次熱融藥物控制釋放等專利技術,專注於改良型新藥研發、臨牀試驗及製造。
公司聚焦精神神經和心腦血管領域積極打造核心競爭力,在心腦血管領域已有降血脂藥物辛伐他汀、瑞舒伐他汀鈣、匹伐他汀鈣等一系列產品,該次簽署合作協議引進此複方新藥將進一步豐富公司心腦血管管線產品,提升市場競爭力,對公司藥品業務產生積極影響。
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