美国食品药品监督管理局（FDA）批准了葛兰素史克（GSK）开发的乙型肝炎治疗药物，为患者提供了停止长期治疗的机会10月20日，美国FDA宣布批准了英国制药公司葛兰素史克生产的乙型肝炎治疗药物Hibsago，使患有该疾病的患者在停止治疗后仍能够控制病毒。
US FDA approves GSK's hepatitis B drug, offering patients chance to stop long-term treatment Oct 20 - The US FDA said on Tuesday it had approved British drugmaker GSK's hepatitis B drug Hibsago, allowing patients with the liver infection a way to keep the virus under control after stopping treatment.
根据FDA的说法，这种名为贝皮罗韦森（bepirovirsen）的药物是首个获得FDA批准的用于慢性乙型肝炎治疗的反义寡核苷酸类药物。
The drug, chemically known as bepirovirsen, is the first FDA-approved antisense oligonucleotide for chronic hepatitis B, according to the agency.
在现任首席执行官卢克·米尔斯（Luke Miels）的领导下，葛兰素史克正致力于加快新药的研发和上市速度，以应对其畅销HIV药物的专利即将到期的问题。该公司预计该药物的年销售额将达到20亿英镑（约合26.8亿美元），并希望借此实现到2031年年营收超过400亿英镑的目标。
Under new CEO Luke Miels, GSK is aiming to speed up the develop and launch of new medicines ahead of looming patent expirations on its blockbuster HIV drugs. The company expects peak annual sales of more than £2 billion ($2.68 billion) for the drug and is central to its plans to reach more than £40 billion in annual revenue by 2031.
Hibsago已获得日本的批准，目前正处于中国和欧洲的监管审查阶段。该药物的研发权来自专注于罕见病治疗的Ionis Pharmaceuticals公司；Ionis公司有望在药物获得批准及其他监管里程碑达成时获得相应的奖励款项。
Hibsago has already secured approval in Japan and is under regulatory review in China and Europe. The drug was licensed from rare disease drugmaker Ionis Pharmaceuticals, which is eligible to receive milestone payments upon approval and other regulatory benchmarks.
临床试验显示，贝皮罗韦森帮助近五分之一的患者将乙型肝炎病毒载量降至无法检测的水平，并使他们至少六个月无需继续接受抗病毒治疗。
In clinical trials, bepirovirsen helped nearly one-in-five patients achieve undetectable levels of the hepatitis B virus and remain off antiviral treatment for at least six months.
乙型肝炎是一种严重的肝脏疾病，可能导致肝脏损伤甚至肝硬化。该病毒通过血液、唾液和精液等受污染的体液传播。全球有超过2.5亿人患有慢性乙型肝炎，而现有的标准治疗方法仅能让1%至4%的患者实现长期清除病毒（即达到医生所称的“功能性治愈”）。
Hepatitis B is a serious liver infection that can lead to liver damage and cirrhosis, or scarring of the liver. The virus spreads through infected bodily fluids such as blood, saliva and semen. More than 250 million people globally live with chronic hepatitis B, and current standard-of-care treatments help only 1% to 4% of patients clear the virus for a sustained period, or achieve what doctors call a functional cure.
核苷酸类似物是目前广泛使用的乙型肝炎治疗药物，患者通常需要终身服用这类药物来抑制病毒，但很难彻底根除病毒。
Nucleotide analogues, a widely used class of hepatitis B treatments, are often taken for life and suppress the virus but rarely eliminate it.
美国生物技术公司Aligos Therapeutics正在研发一种竞争性的乙型肝炎治疗药物——pevifoscorvir钠，该药物目前正处于中期临床试验阶段。
US biotech Aligos Therapeutics is developing a rival hepatitis B therapy, pevifoscorvir sodium, which is being evaluated in a mid-stage trial.
葛兰素史克（GSK）没有立即回应路透社关于其产品在美国的定价及市场销售情况的询问。
GSK did not immediately respond to a Reuters request for comment on US pricing and commercial availability.