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
- 指定加快了對bepirovirsen作爲慢性乙型肝炎(CHB)患者潛在治療方法的審查
- 根據來自B-clear和B-sure試驗的數據量以及實現功能性治療對創新藥物的需求進行認定
- SENKU 繼今年早些時候被美國食品藥品管理局指定爲快速通道
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.
葛蘭素史克公司(倫敦證券交易所/紐約證券交易所代碼:GSK)今天宣佈,日本衛生、勞動和福利省(MHLW)已批准SENKU(前身爲SAKIGAKE)對bepirovirsen的認定,這是一種用於治療慢性乙型肝炎(CHB)的在研反義寡核苷酸(ASO)。SENKU 稱號是根據創新水平、疾病嚴重程度和顯著療效授予的。SENKU稱號的目標是通過加快審查程序,增加患者早期獲得創新藥物的機會,以治療嚴重疾病並填補未滿足的醫療需求。
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:
該稱號基於IiB期B-clear和B-sure試驗1,2的結果,該試驗評估了bepirovirsen對Chb患者反應的療效、安全性和耐久性。第三階段的確認性計劃正在進行中。這是繼今年早些時候美國食品藥品監督管理局(FDA)對bepirovirsen的快速通道認證之後,貝匹羅韋森在2024年獲得的第二個監管指定。更多信息可在以下網址獲得:
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影響全球25700萬人,日本有近100萬人。3 目前的治療方案對聚乙二醇化干擾素(pegiFN)的功能治癒率低於2-8%,口服治療(核苷/核苷酸類似物 [NaS])的功能治癒率低於1%。4 當乙型肝炎病毒的DNA和病毒蛋白即乙型肝炎表面抗原(HbsAG)處於水平時,功能治癒就會發生低到足以在血液中檢測不到,並且無需藥物即可由免疫系統控制。目前的療法只能抑制病毒,不會直接降低HbsAg,而HbsAg對於功能治癒至關重要。
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是處於III期開發的唯一一種單一藥物,它顯示出與口服NA聯合使用有可能實現具有臨床意義的功能性治癒反應的單一藥物。Bepirovirsen還被研究爲未來序列療法的潛在支柱療法,以在更廣泛的Chb患者群體中尋求功能性治癒。
About the B-Clear and B-Sure phase IIb trials
關於 B-clear 和 B-sure IIb 期試驗
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試驗由兩個平行隊列組成,一個針對接受NA治療的患者,另一個針對未接受NA治療的患者。更多信息可在以下網址獲得:.
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試驗正在研究長期療效和反應的持久性,該試驗對B-clear研究的參與者進行了另外33個月的跟蹤,其中包括停止NA治療的標準,以評估成功停止所有藥物治療但仍未顯示出乙型肝炎表面抗原(HbsAG)或HBV DNA血清學證據的患者進行功能性治癒的可能性。
About B-Well 1 and B-Well 2 phase III trials
關於 B-well 1 和 B-well 2 三期試驗
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.
這兩項多中心、隨機、雙盲、安慰劑對照的III期試驗(B-well 1和B-well 2)評估了在接受核素(t)類似物(NA)治療的慢性乙型肝炎和基線HbsAg
Further information is available on CT.gov at and .
有關更多信息,請訪問Ct.gov,網址和。
About CHB
關於 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.
乙型肝炎是一種肝臟病毒感染,由乙型肝炎病毒引起,可導致急性和慢性肝病。5 慢性乙型肝炎(CHB)是一種長期感染,發生在人體免疫系統無法抵抗病毒並持續存在於血液和肝臟中。5 Chb是一個重大的全球健康問題,影響全球25700萬人,3 儘管其中只有大約 13% 的人得到診斷和只有 3% 的人接受了治療。6 chB 可以發展爲更嚴重的疾病,例如肝硬化和肝癌,而且不止於每年有數百萬人死於這種感染。
About bepirovirsen (GSK3228836)
關於 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是一種三重作用的研究性反義寡核苷酸(ASO),目前正在B-well III期臨床試驗計劃中進行評估,用於治療ChB。Bepirovirsen旨在識別和破壞乙型肝炎病毒的遺傳成分(即RNA),這些成分可能導致慢性病,從而有可能使人的免疫系統重新獲得控制權。Bepirovirsen抑制病毒DNA在體內的複製,抑制血液中乙型肝炎表面抗原(HbsAg)的水平,並刺激免疫系統以增加持久和持續反應的機會。
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(以前被稱爲 「ISIS 505358 或 IONIS-HBVRX」)由愛奧尼斯製藥公司發現並共同開發。Bepirovirsen是葛蘭素史克於2019年8月從愛奧尼斯製藥公司獲得許可的ASO HBV計劃資產之一。
About GSK
關於葛蘭素史克
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.
葛蘭素史克是一家全球生物製藥公司,其宗旨是聯合科學、技術和人才,共同戰勝疾病。要了解更多信息,請訪問 gsk.com。
Cautionary statement regarding forward-looking statements
關於前瞻性陳述的警示聲明
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.
葛蘭素史克提醒投資者,葛蘭素史克做出的任何前瞻性陳述或預測,包括本公告中的前瞻性陳述或預測,都存在風險和不確定性,可能導致實際業績與預期存在重大差異。這些因素包括但不限於葛蘭素史克2023年20-F表年度報告第3.D項 「風險因素」 下描述的因素,以及葛蘭素史克2024年第二季度業績。