Dive Brief:

简报：

GSK and Ionis Pharmaceuticals said their experimental hepatitis B medicine succeeded in two Phase 3 trials, offering patients what might be a “functional cure” for the disease.

GSK和Ionis制药公司表示，他们的实验性乙型肝炎药物在两项III期试验中取得了成功，为患者提供了可能的“功能性治愈”方法。

In

在

releases

发布

issued

发行

Wednesday, the companies didn’t provide details on the effects seen in the B-Well 1 and B-Well 2 studies. The drug, bepirovirsen, met the primary endpoint in both trials and “demonstrated a statistically significant and clinically meaningful functional cure rate,” the companies said.

周三，这些公司没有提供关于B-Well 1和B-Well 2研究中观察到的效果的详细信息。该药物bepirovirsen在这两项试验中达到了主要终点，“显示出具有统计学意义且临床效果显著的功能性治愈率”，这些公司表示。

Global regulatory filings are planned for the first quarter of this year based on the data, the companies said. Researchers plan to release the full results at a future medical meeting and in a peer-reviewed journal.

公司表示，基于数据，全球监管文件计划于今年第一季度提交。研究人员计划在未来的医学会议和同行评审期刊上发布完整结果。

Dive Insight:

深入洞察：

Health officials

卫生官员

estimate

估计

that more than 2 billion people around the world have been infected with the hepatitis B virus and

全世界有超过20亿人感染了乙型肝炎病毒并且

almost 300 million

几乎3亿

of those patients have developed chronic infections that can lead to cirrhosis and liver cancer. Infants exposed to the virus are

其中一些患者已经发展为慢性感染，这可能导致肝硬化和肝癌。接触过该病毒的婴儿

especially at risk

尤其处于危险之中

, with as many as 90% of those unvaccinated against it developing a chronic infection.

，其中多达90%未接种疫苗的人会发展为慢性感染。

Many patients with chronic hepatitis B end up taking antiviral drugs for life. With bepirovirsen, GSK and Ionis believe they can offer patients a six-month course of treatment that pushes the hepatitis B to undetectable levels. That

许多慢性乙型肝炎患者最终需要终身服用抗病毒药物。通过bepirovirsen，GSK和Ionis认为他们可以为患者提供一个为期六个月的疗程，将乙型肝炎降至无法检测的水平。

functional cure

功能性治愈

might allow patients to stay off medicine and still avoid the harmful effects of the virus.

可能让患者不用吃药，也能避免病毒的有害影响。

Analysts say they see a clear market demand for effective hepatitis B therapies; Gilead’s Vemlidy was

分析师表示，他们看到市场对有效的乙型肝炎疗法有明确的需求；吉利德的Vemlidy（替诺福韦艾拉酚胺）

on track

在正轨上

to top $1 billion in sales last year, based on third-quarter data. A little less than half of the drug’s revenue has come from the U.S., the world’s biggest pharmaceutical market.

去年，基于第三季度的数据，销售额达到了10亿美元。该药物约有不到一半的收入来自全球最大的医药市场——美国。

In the U.S., infections in infants, children and young people

在美国，婴儿、儿童和年轻人的感染情况

dropped 99%

下降了99%

after government health officials in 1991 began recommending universal vaccination for infants. But the Trump administration is now trying to dismantle that process. U.S. health officials this week

1991年政府卫生官员开始推荐婴儿普遍接种疫苗后，但特朗普政府现在正试图瓦解这一进程。美国卫生官员本周

reduced the number of universally recommended inoculations for children

减少了对儿童普遍推荐的疫苗接种数量

, axing hepatitis B shots from the list

，将乙型肝炎疫苗从名单中剔除

following the advice

遵循建议

of a committee

委员会的

overhauled by Health and Human Services Secretary Robert F. Kennedy Jr.

由卫生与公众服务部长小罗伯特·F·肯尼迪彻底改革

, a vaccine skeptic.

，一个疫苗怀疑论者。

Ionis developed bepirovirsen and

Ionis 开发了 bepirovirsen 并且

licensed it to GSK

将其授权给GSK

in 2019. The company is eligible to receive as much as $150 million more in payments for reaching certain regulatory and sales milestones as well as royalties of 10% to 12% on net sales if the drug reaches the market. For GSK, the successful study offers the possibility of another win for its pipeline after .

在2019年。如果该药物成功上市，该公司还有资格获得高达1.5亿美元的额外付款，用于达成特定的监管和销售里程碑，并在净销售额中获得10%至12%的特许权使用费。对于GSK来说，这项成功的研究为其产品线提供了另一个可能的胜利。

approval of a key asthma drug last month

上个月批准了一种关键的哮喘药物

.

。