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Lotus Pharmaceuticals Receives Tentative US FDA Approval for Generic Drug

癌症用藥獲美FDA暫時審查許可

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Lotus Pharmaceuticals Receives Tentative US FDA Approval for Generic Drug
台灣美時化學製藥
Taiwan’s Lotus Pharmaceutical Co., Ltd. announced on January 16 that it had received tentative approval from the United States Food and Drug Administration for its Abbreviated New Drug Application for Nintedanib capsules.
台灣美時化學製藥股份有限公司於1月16日宣布其癌症用藥學名藥「Nintedanib膠囊」已通過簡易新藥申請程序(ANDA),並取得美國食品藥物管理局(FDA)暫時審查許可。
capsule(n.)膠囊
These capsules are a generic version of Boehringer Ingelheim’s Ofev, which is used to treat both the rare disease scleroderma—that affects the lungs and other organs—and lung cancer by promoting the function and health of patients’ lungs.
這款膠囊為百靈佳殷格翰Ofev的學名藥,用於治療會影響到肺部與其他器官的罕見疾病全身性硬化症以及肺癌,可改善患者肺部功能與健康。
treat(v.)治療treatment(n.)治療
Lotus CEO Petar Vazharov noted that the company is excited to receive the tentative approval from the US FDA for Nintedanib capsules as the multinational drugmaker is looking into enhancing its treatments for lung cancer as well as expanding its competitiveness in the US market.
美時製藥執行長Petar Vazharov指出,美時製藥積極研發治療肺癌的方法,同時也有意提高該公司在美國市場的競爭力,因此對於取得美國FDA的暫時審查許可感到欣喜。
competitiveness(n.)競爭力competitive(adj.)有競爭力的competitor(n.)競爭者
With the creation of a generic version of Boehringer Ingelheim’s medicine, Vazharov also hopes that this will be a step toward providing more affordable medicines to help cancer patients around the world.
隨著這款百靈佳殷格翰學名藥問世,Vazharov也希望朝向提供更平價的藥物邁進,以幫助全球各地的癌症患者。
afford(v.)負擔affordable(adj.)可負擔的
Given the US$1.8 billion in sales of Ofev in 2021, this move also looks to be a way for Lotus to capitalize on last year’s successful launch of its Lenalidomide capsules in the United States.
鑑於Ofev在2021年創下18億美元的銷售量,且美時製藥去年在美國成功推出血癌用藥Lenalidomide膠囊,預期美時製藥將可透過此舉獲利。
capitalize on…利用⋯⋯獲益、從⋯⋯獲利take advantage of利用launch(n.)推出

📚 重點單字片語

pharmaceutical(adj.)
製藥的;(n.)藥廠
pharmacy(n.)
藥房、配藥部
tentative(adj.)
試探性的、暫時性的
generic(adj.)
無專利的、未註冊的
generic drug
學名藥
brand drug
原廠藥
capsule(n.)
膠囊
treat(v.)
治療
treatment(n.)
治療
competitiveness(n.)
競爭力
competitive(adj.)
有競爭力的
competitor(n.)
競爭者
afford(v.)
負擔
affordable(adj.)
可負擔的
capitalize on…
利用⋯⋯獲益、從⋯⋯獲利
take advantage of
利用
launch(n.)
推出
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