Bepirovirsen Granted SENKU Designation in Japan for Chronic Hepatitis B
Bepirovirsen Granted SENKU Designation in Japan for Chronic Hepatitis B
- Designation expedites review of bepirovirsen as a potential treatment for people living with chronic hepatitis B (CHB)
- Designation based on strength of data from the B-Clear and B-Sure trials and need for innovative medicines to achieve functional cure
- SENKU follows US FDA Fast Track designation earlier this year
- 指定加快了对bepirovirsen作为慢性乙型肝炎(CHB)患者潜在治疗方法的审查
- 根据来自B-clear和B-sure试验的数据量以及实现功能性治疗对创新药物的需求进行认定
- SENKU 继今年早些时候被美国食品药品管理局指定为快速通道
GSK plc (LSE/NYSE: GSK) today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has granted SENKU (formerly known as SAKIGAKE) designation for bepirovirsen, an investigational antisense oligonucleotide (ASO) for the treatment of chronic hepatitis B (CHB). SENKU designation is granted based on the level of innovation, severity of disease, and prominent efficacy. The goal of SENKU designation is to increase early patient access to innovative medicines through an expedited review process to treat serious conditions and fill an unmet medical need.
葛兰素史克公司(伦敦证券交易所/纽约证券交易所代码:GSK)今天宣布,日本卫生、劳动和福利省(MHLW)已批准SENKU(前身为SAKIGAKE)对bepirovirsen的认定,这是一种用于治疗慢性乙型肝炎(CHB)的在研反义寡核苷酸(ASO)。SENKU 称号是根据创新水平、疾病严重程度和显著疗效授予的。SENKU称号的目标是通过加快审查程序,增加患者早期获得创新药物的机会,以治疗严重疾病并填补未满足的医疗需求。
The designation is based on results from the phase IIb B-Clear and B-Sure trials1,2 which evaluated the efficacy, safety and durability of response of bepirovirsen in people with CHB. A confirmatory phase III programme, B-Well, is ongoing. This is the second regulatory designation in 2024 for bepirovirsen, following the US Food and Drug Administration (FDA) Fast Track designation for bepirovirsen granted earlier this year. Further information is available at:
该称号基于IiB期B-clear和B-sure试验1,2的结果,该试验评估了bepirovirsen对Chb患者反应的疗效、安全性和耐久性。第三阶段的确认性计划正在进行中。这是继今年早些时候美国食品药品监督管理局(FDA)对bepirovirsen的快速通道认证之后,贝匹罗韦森在2024年获得的第二个监管指定。更多信息可在以下网址获得:
CHB affects 257 million people worldwide, and nearly 1 million people in Japan.3 Current treatment options provide a functional cure rate of less than 2-8% for pegylated interferon (PegIFN) and less than 1% for oral treatments (nucleoside/nucleotide analogues [NAs]).4 Functional cure occurs when the hepatitis B virus DNA and viral protein, hepatitis B surface antigen (HBsAg), are at levels low enough to be undetectable in the blood and can be controlled by the immune system without medication. Current therapies only suppress the virus and do not directly lower HBsAg, which is essential for functional cure.
Chb影响全球25700万人,日本有近100万人。3 目前的治疗方案对聚乙二醇化干扰素(pegiFN)的功能治愈率低于2-8%,口服治疗(核苷/核苷酸类似物 [NaS])的功能治愈率低于1%。4 当乙型肝炎病毒的DNA和病毒蛋白即乙型肝炎表面抗原(HbsAG)处于水平时,功能治愈就会发生低到足以在血液中检测不到,并且无需药物即可由免疫系统控制。目前的疗法只能抑制病毒,不会直接降低HbsAg,而HbsAg对于功能治愈至关重要。
Bepirovirsen is the only single agent in phase III development that has shown the potential to achieve clinically meaningful functional cure response when combined with oral NAs. Bepirovirsen is also being investigated as a potential backbone therapy in future sequential regimens to pursue functional cure in a broader population of patients with CHB.
Bepirovirsen是处于III期开发的唯一一种单一药物,它显示出与口服NA联合使用有可能实现具有临床意义的功能性治愈反应的单一药物。Bepirovirsen还被研究为未来序列疗法的潜在支柱疗法,以在更广泛的Chb患者群体中寻求功能性治愈。
About the B-Clear and B-Sure phase IIb trials
关于 B-clear 和 B-sure IIb 期试验
The B-Clear trial consisted of two parallel cohorts, one for patients receiving NA treatment and the other for patients who were not-on-NA. Further information is available at: .
B-clear试验由两个平行队列组成,一个针对接受NA治疗的患者,另一个针对未接受NA治疗的患者。更多信息可在以下网址获得:.
Longer term efficacy and durability of response is being investigated in the B-Sure trial, which follows participants from the B-Clear study for an additional 33 months and includes criteria for stopping NA therapy to evaluate the potential for functional cure in patients who successfully stop all medication and continue to demonstrate no serologic evidence of hepatitis B surface antigen (HBsAg) or HBV DNA.
B-sure试验正在研究长期疗效和反应的持久性,该试验对B-clear研究的参与者进行了另外33个月的跟踪,其中包括停止NA治疗的标准,以评估成功停止所有药物治疗但仍未显示出乙型肝炎表面抗原(HbsAG)或HBV DNA血清学证据的患者进行功能性治愈的可能性。
About B-Well 1 and B-Well 2 phase III trials
关于 B-well 1 和 B-well 2 三期试验
These two multi-centre, randomised, double-blind, placebo-controlled phase III trials (B-Well 1 and B-Well 2) assess the efficacy, safety, pharmacokinetic profile, and the durability of hepatitis B virus surface antigen (HBsAg) suppression with bepirovirsen treatment in nucleos(t)ide analogue (NA)-treated participants with chronic hepatitis B and baseline HBsAg <=3000 IU/ml. The primary endpoint of the trials is the number of participants achieving functional cure with baseline HBsAg ≤3000 IU/mL.
这两项多中心、随机、双盲、安慰剂对照的III期试验(B-well 1和B-well 2)评估了在接受核素(t)类似物(NA)治疗的慢性乙型肝炎和基线HbsAg
Further information is available on CT.gov at and .
有关更多信息,请访问Ct.gov,网址和。
About CHB
关于 CHB
Hepatitis B is a viral infection of the liver, caused by the hepatitis B virus, that can cause both acute and chronic liver disease.5 Chronic hepatitis B (CHB) is a long-lasting infection and occurs when the body's immune system is unable to fight off the virus and it persists in the blood and liver.5 CHB is a major global health issue, affecting 257 million people across the world,3 although only about 13% of these people have a diagnosis and only 3% receive treatment.6 CHB can progress to more serious conditions like cirrhosis and liver cancer, and more than a million people die from this infection every year.
乙型肝炎是一种肝脏病毒感染,由乙型肝炎病毒引起,可导致急性和慢性肝病。5 慢性乙型肝炎(CHB)是一种长期感染,发生在人体免疫系统无法抵抗病毒并持续存在于血液和肝脏中。5 Chb是一个重大的全球健康问题,影响全球25700万人,3 尽管其中只有大约 13% 的人得到诊断和只有 3% 的人接受了治疗。6 chB 可以发展为更严重的疾病,例如肝硬化和肝癌,而且不止于每年有数百万人死于这种感染。
About bepirovirsen (GSK3228836)
关于 bepirovirsen (GSK3228836)
Bepirovirsen is a triple action investigational antisense oligonucleotide (ASO), currently being evaluated in the B-Well phase III clinical trial programme for the treatment of CHB. Bepirovirsen is designed to recognise and destroy the genetic components (i.e. RNA) of the hepatitis B virus that can lead to chronic disease, potentially allowing a person's immune system to regain control. Bepirovirsen inhibits the replication of viral DNA in the body, suppresses the level of hepatitis B surface antigen (HBsAg) in the blood, and stimulates the immune system to increase the chances of a durable and sustained response.
Bepirovirsen是一种三重作用的研究性反义寡核苷酸(ASO),目前正在B-well III期临床试验计划中进行评估,用于治疗ChB。Bepirovirsen旨在识别和破坏乙型肝炎病毒的遗传成分(即RNA),这些成分可能导致慢性病,从而有可能使人的免疫系统重新获得控制权。Bepirovirsen抑制病毒DNA在体内的复制,抑制血液中乙型肝炎表面抗原(HbsAg)的水平,并刺激免疫系统以增加持久和持续反应的机会。
Bepirovirsen (previously known as 'ISIS 505358 or IONIS-HBVRX') was discovered by and jointly developed with Ionis Pharmaceuticals. Bepirovirsen is one of the ASO HBV programme assets in-licensed by GSK from Ionis Pharmaceuticals in August 2019.
Bepirovirsen(以前被称为 “ISIS 505358 或 IONIS-HBVRX”)由爱奥尼斯制药公司发现并共同开发。Bepirovirsen是葛兰素史克于2019年8月从爱奥尼斯制药公司获得许可的ASO HBV计划资产之一。
About GSK
关于葛兰素史克
GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com.
葛兰素史克是一家全球生物制药公司,其宗旨是联合科学、技术和人才,共同战胜疾病。要了解更多信息,请访问 gsk.com。
Cautionary statement regarding forward-looking statements
关于前瞻性陈述的警示声明
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D "Risk factors" in GSK's Annual Report on Form 20-F for 2023, and GSK's Q2 Results for 2024.
葛兰素史克提醒投资者,葛兰素史克做出的任何前瞻性陈述或预测,包括本公告中的前瞻性陈述或预测,都存在风险和不确定性,可能导致实际业绩与预期存在重大差异。这些因素包括但不限于葛兰素史克2023年20-F表年度报告第3.D项 “风险因素” 下描述的因素,以及葛兰素史克2024年第二季度业绩。