GSK’s antisense-based drug for chronic hepatitis B (CHB), bepirovirsen, will get a rapid six-month review from the FDA when it is filed for approval, said the drugmaker this morning.

葛兰素史克（GSK）的慢性乙型肝炎（CHB）反义药物贝比罗维森（bepirovirsen）今晨表示，当其申请批准时，将得到FDA为期六个月的快速审查。

The fast-track designation from the US regulator recognises that bepirovirsen is the only single agent in phase 3 that has shown the potential to achieve a “functional cure” when combined with standard CHB therapies based on oral nucleoside or nucleotide analogue (NA) drugs, according to GSK.

根据GSK的说法，美国监管机构的快速通道指定认识到，贝比洛韦森是第三阶段中唯一一种与基于口服核苷或核苷酸类似物（NA）药物的标准CHB疗法联合使用时显示出“功能治愈”潜力的单一药物。

Hepatitis B affects almost 300 million people worldwide, according to GSK, and while NAs to treat it are available – such as Gilead’s polymerase inhibitor Viread (tenofovir) – there is still no curative treatment.

据葛兰素史克（GSK）统计，乙型肝炎影响全球近3亿人，虽然可以使用NA治疗，如吉列德的聚合酶抑制剂Viread（替诺福韦），但仍然没有治愈的方法。

A functional cure is said to have been achieved if a biomarker called hepatitis B surface antigen (HBsAg) is cleared from the blood and remains undetectable after stopping all treatment. Even when treated, CHB can progress to liver complications including cirrhosis and liver cancer, which results in almost a million deaths per year.

如果称为乙型肝炎表面抗原（HBsAg）的生物标志物从血液中清除，并且在停止所有治疗后仍无法检测到，则可以实现功能性治愈。即使接受治疗，慢性乙型肝炎也可能发展为包括肝硬化和肝癌在内的肝脏并发症，每年导致近100万人死亡。

However, it is estimated that only one in 10 patients is diagnosed worldwide and just 5% receive treatment..

然而，据估计，全世界只有十分之一的患者被诊断出来，只有5%的患者接受了治疗。。

Fast-track status has been granted to bepirovirsen largely on the back of the phase 2b B-Clear trial reported in 2022, which found that bepirovirsen was able to push HBsAg levels below the limit of detection in around 10% of patients at 24 weeks.

贝比洛韦森在2022年报道的2b期B-Clear试验的基础上获得了快速通道状态，该试验发现贝比洛韦森能够在24周内将约10%的患者的HBsAg水平推至检测限以下。

While that was a marked decline on an earlier readout of almost 30%, it is still approximately tenfold higher than can be expected with the current standard of care, according to GSK.

据葛兰素史克（GSK）称，虽然这比早期的近30%的读数明显下降，但仍然比目前的护理标准高出约十倍。

Data from the B-Clear study also showed that patients with low baseline HBsAg levels were most likely to benefit from treatment with bepirovirsen, with around a quarter of them achieving undetectable levels of the biomarker, suggesting it may be possible to target the drug to those most likely to benefit from it..

来自B-Clear研究的数据还显示，基线HBsAg水平低的患者最有可能从贝比洛韦森治疗中受益，其中约四分之一的患者达到了无法检测到的生物标志物水平，这表明有可能将药物靶向那些最有可能从中受益的人。。

GSK started the phase 3 B-Well programme for bepirovirsen last year and is also running a long-term extension to the B-Clear study, called B-Sure, which will follow patients for around three years.

葛兰素史克（GSK）去年启动了贝皮罗维森（Bepiroversen）的第三阶段B-Well项目，并正在对B-Clear研究（称为B-Sure）进行长期扩展，该研究将对患者进行大约三年的随访。

Analysts at William Blair have previously suggested that the market for a hepatitis B functional cure could be around the same size as for hepatitis C virus, which peaked at around $10 billion a year, but was a short-lived bonanza with sales falling sharply as the pool of eligible patients reduced.

威廉·布莱尔（WilliamBlair）的分析师此前曾表示，乙型肝炎功能性治疗的市场规模可能与丙型肝炎病毒的市场规模大致相同，丙型肝炎病毒每年的峰值约为100亿美元，但这只是一个短暂的发展，随着符合条件的患者数量减少，销售额急剧下降。

GSK has modelled peak sales of around £2 billion ($2.5 billion) for bepirovirsen if it reaches the market. It was licensed from Ionis as part of a two-drug deal in 2019, with GSK paying $25 million upfront with milestone payments taking the value of the deal up to $262 million.

葛兰素史克（GSK）预测，如果贝皮罗维森（Bepiroversen）上市，其最高销售额约为20亿英镑（25亿美元）。2019年，作为两种药物交易的一部分，它获得了Ionis的许可，葛兰素史克预付了2500万美元，里程碑付款使交易价值高达2.62亿美元。

Other drugs in development for CHB include Dicerna (now part of Novo Nordisk) and Roche’s siRNA candidate xalnesiran, which reported phase 2 data at the AASLD conference last year, and Arrowhead Pharma’s antisense oligonucleotide ARO-HBV.

其他正在开发的CHB药物包括Dicerna（现在是诺和诺德的一部分）和罗氏的siRNA候选药物xalnesiran，它们在去年的AASLD会议上报告了第二阶段的数据，以及Arrowhead Pharma的反义寡核苷酸ARO-HBV。

ARO-HBV was previously partnered with Johnson & Johnson until GSK acquired rights to the drug as a companion for bepirovirsen in a $1 billion deal signed last November.

ARO-HBV之前曾与强生公司合作，直到葛兰素史克（GSK）在去年11月签署的一项价值10亿美元的协议中获得该药物的权利，作为贝匹罗维森（bepirovirsen）的伴侣。