Dr. Reddy's Signs Voluntary Licensing Agreement With Gilead Sciences To Manufacture And Commercialise Lenacapavir In India And Other Countries
Dr. Reddy's Signs Voluntary Licensing Agreement With Gilead Sciences To Manufacture And Commercialise Lenacapavir In India And Other Countries
Dr. Reddy's has been granted a non-exclusive voluntary licence to manufacture Lenacapavir and market it in 120 countries, for the current approved indication of HIV treatment in heavily treatment-experienced (HTE) adults with multi-drug resistant HIV. Dr. Reddy's will be responsible for technology transfer at its manufacturing site, conducting bioequivalence/clinical studies, product registration and launch in the agreed markets. Additionally, the agreement grants licence to Dr. Reddy's to manufacture and commercialise lenacapavir for the indication of prevention of HIV (PrEP) in 120 countries, if approved.Dr. Reddy's Laboratories Ltd. ((BSE: 500124, NSE: DRREDDY, NYSE:RDY, NSEIFSC: DRREDDY, along with its subsidiaries together referred to as "Dr. Reddy's")), today announced that it has entered into a royalty-free non-exclusive voluntary licensing agreement with Gilead Sciences Ireland UC for the manufacture and commercialisation of the drug, Lenacapavir, in India and 120 other countries.
印度紅房子實驗室有限公司（BSE：500124，NSE：DRREDDY，NYSE：RDY，NSEIFSC：DRREDDY及其子公司合稱爲「紅房子」）今天宣佈與吉利德科學愛爾蘭UC簽訂了一項免費非排他性自願許可協議，用於在印度和其他120個國家制造和商業化藥物Lenacapavir。
Lenacapavir is a United States Food and Drug Administration (USFDA) approved drug indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations. Additionally, Lenacapavir is currently under investigation for the prevention of HIV (PrEP) which is yet to be approved globally.
Lenacapavir是一種美國食品藥品監督管理局（USFDA）批准的藥物，用於治療人類免疫缺陷病毒型1（HIV-1）感染的重度治療經驗豐富的成年患者，對當前的抗逆轉錄病毒療法由於耐藥、不耐受性或安全考慮而失敗的患者。此外，Lenacapavir目前正在進行抗HIV（PrEP）的研究，尚未全球批准。
Gilead Sciences first launched Lenacapavir under the brand name Sunlenca in the United States and Europe markets in the year 2022. It is a first-in-class HIV-1 capsid inhibitor.
吉利德科學在2022年在美國和歐洲市場推出了以Sunlenca爲品牌名稱的Lenacapavir，這是一種第一類HIV-1衣殼抑制劑。
Dr. Reddy's has been granted a non-exclusive voluntary licence to manufacture Lenacapavir and market it in 120 countries, for the current approved indication of HIV treatment in heavily treatment-experienced (HTE) adults with multi-drug resistant HIV. Dr. Reddy's will be responsible for technology transfer at its manufacturing site, conducting bioequivalence/clinical studies, product registration and launch in the agreed markets. Additionally, the agreement grants licence to Dr. Reddy's to manufacture and commercialise lenacapavir for the indication of prevention of HIV (PrEP) in 120 countries, if approved.
紅房子已獲得製造Lenacapavir並在120個國家市場上銷售的非排他性自願許可證，用於治療具有多藥耐藥性HIV的重度治療經驗豐富（HTE）成年人的當前批准適應症。紅房子將負責在其製造地點進行技術轉移，進行生物等效/臨床研究，產品註冊和在約定市場上市。此外，協議還授予紅房子許可在120個國家制造和商業化Lenacapavir，用於治療HIV預防（PrEP）的適應症，如果獲得批准。
譯文內容由第三人軟體翻譯。