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復宏漢霖-B(02696.HK)授出利妥昔單抗注射液獨家許可權利以於拉美地區銷售
格隆匯 12-05 20:40

格隆匯12月5日丨復宏漢霖-B(02696.HK)公佈,該公司與FARMA DE COLOMBIA S.A.S於近期訂立獨家許可協議,據此FARMA DE COLOMBIA在哥倫比亞、祕魯、厄瓜多爾及委內瑞拉獲授予HLX01的獨家許可及商業化權利。公司將根據許可的專有技術授予FARMA DE COLOMBIA一項不可轉讓、可分許可(受若干限制)的專有許可,該公司將收取簽約款項500,000美元,並於獲許可產品在哥倫比亞取得監管批准及在該地區的各個國家內商業化後收取里程碑款項。

HLX01(利妥昔單抗注射液)為美羅華生物類似藥。HLX01(漢利康)於2019年2月22日就非霍奇金淋巴瘤適應症自國家藥監局取得新藥藥證申請批准作商業化用途,成為中國首款根據《生物類似藥指導原則》獲批並以商業形式推出的生物類似藥。國家藥典委員會已批准HLX01(漢利康)在中國使用利妥昔單抗注射液作為通用名,其已被列入國家醫保目錄及國家基本藥物目錄。公司亦正就HLX01用於類風濕關節炎適應症在中國進行3期臨牀試驗。

據悉,FARMA DE COLOMBIA於1960年創立,在保健供應商的領域內具有高度正面的評價。FARMA DE COLOMBIA由Candoria Holding AG(總部設於瑞士楚格市)擁有,而Candoria Holding AG亦擁有設於厄瓜多爾、祕魯及委內瑞拉的附屬公司,並在中美洲及加勒比海地區商業化其產品。

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