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标题: 腾盛博药在2022年亚太肝会议上公布BRII-835 (VIR-2218最新数据 [打印本页]

作者: newchinabok    时间: 2022-3-31 19:11     标题: 腾盛博药在2022年亚太肝会议上公布BRII-835 (VIR-2218最新数据

本帖最后由 newchinabok 于 2022-3-31 19:12 编辑

https://mp.weixin.qq.com/s/agZ1uLNawWKPXexMAc0tkA
作者: newchinabok    时间: 2022-3-31 19:13

http://notice.10jqka.com.cn/api/ ... de20.1648719999.pdf
作者: newchinabok    时间: 2022-3-31 19:14

https://m.10jqka.com.cn/20220331 ... ck_source=hyperlink
作者: newchinabok    时间: 2022-3-31 19:24

本帖最后由 newchinabok 于 2022-3-31 19:37 编辑

降1log值,举例hbsag100降到10,1000的降到100,3000降到300,(单用效果)。接受两次(间隔一月),两针药价患者可承受
作者: lancas    时间: 2022-3-31 19:41

上市干就完了
作者: newchinabok    时间: 2022-3-31 19:46

本帖最后由 newchinabok 于 2022-3-31 19:49 编辑
lancas 发表于 2022-3-31 19:41
上市干就完了

新药程序要走流程,药企比你还急,人民币在飞舞,急着嗷嗷叫,低hbsag和干挠素清不了0的人乐了,也急着嗷嗷叫,呵呵
作者: tim889    时间: 2022-4-1 15:18

不知道48周具体保持的怎么样了
作者: StephenW    时间: 2022-4-1 20:38

Brii Bio 在 APASL 2022 上展示中国慢性乙型肝炎患者的 BRII-835 (VIR-2218) 新数据
(PRNewsfoto/Brii Biosciences Limited)

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Brii Biosciences 有限公司

美国东部时间 2022 年 3 月 31 日 06:05
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新数据表明 BRII-835 (VIR-2218) 耐受性良好,在感染慢性乙型肝炎的中国患者中观察到血清 HBsAg 显着降低

北卡罗来纳州达勒姆和北京,2022 年 3 月 31 日 /美通社/ -- Brii Biosciences Limited(“Brii Bio”或“公司”,股票代码:2137.HK)是一家跨国公司,致力于开发针对未满足重大医疗需求的疾病的创新疗法需求和巨大的公共卫生负担,今天在 31 日公布了 BRII-835 (VIR-2218) 在中国慢性乙型肝炎病毒 (HBV) 感染患者中的 2 期随机、双盲、安慰剂对照试验的新数据2022 年亚太肝脏研究协会 (APASL) 会议将于 3 月 30 日至 4 月 3 日在韩国首尔举行。

数据表明,BRII-835 (VIR-2218) 是一种介导 RNA 干扰 (RNAi) 的在研小干扰核糖核酸 (siRNA),可导致中国慢性 HBV 患者乙型肝炎表面抗原 (HBsAg) 呈剂量依赖性降低接受两剂 BRII-835 (VIR-2218) 的感染者。在 HBeAg- 和 HBeAg+ 患者中观察到类似的 HBsAg 降低。此外,BRII-835 (VIR-2218) 具有良好的耐受性,所有治疗出现的不良事件 (TEAE) 均报告为轻度或中度,并且未观察到临床上显着的丙氨酸转氨酶 (ALT) 升高。

“在本试验中,两次剂量的 BRII-835 (VIR-2218) 后,在 HBeAg 和 HBeAg + 中国慢性 HBV 患者中观察到的血清 HBsAg 的剂量依赖性降低与之前在其他种族/民族群体中证实的发现一致,”说贾继东博士,北京首都医科​​大学北京友谊医院肝脏研究中心医学教授。 “在这些数据的支持下,我们认为 BRII-835 (VIR-2218) 等有效降低高 HBV 抗原负担的新型药物有可能成为慢性 HBV 感染患者功能性治愈方案的基石,从而促进消除应对这一重大的全球公共卫生威胁。”

“作为我们开发慢性 HBV 功能性治愈目标的一部分,我们很高兴该试验的数据继续支持 siRNA 作为联合治疗方案的支柱的潜力,这些方案正在几项正在进行的试验中进行评估,”李说闫,医学博士,博士,Brii Bio 首席医疗官。 “我们期待在今年晚些时候从这些试验中看到更多数据,其中 BRII-835 (VIR-2218) 正在与其他药物联合进行研究。”

摘要编号:L-OP-1324

口头报告题目: BRII-835 (VIR-2218)(一种 X 靶向 RNAi 治疗剂)每月两次给药对中国慢性 HBV 感染患者的安全性和抗病毒活性

主讲人:贾继东,医学博士,博士,首都医科大学教授,北京友谊医院肝脏研究中心主任,中国北京

    BRII-835 (VIR-2218) 在 16 名病毒抑制的中国非肝硬化慢性 HBV 感染患者中具有良好的耐受性,这些患者被分配每月接受两剂 BRII-835 皮下注射
    最后一次给药后 12 周,在接受 50 mg 和 100 mg 剂量 BRII-835 的患者中观察到的 HBsAg 平均降低分别为 HBeAg 患者的 1.02 log10 IU/mL 和 1.22 log10 IU/mL,以及 0.70 log10 IU/mL 和 1.15 HBeAg+ 患者分别为 log10 IU/mL
    在最后一次给药后 12 周达到 HBsAg 下降 > 1 log10 IU/mL 的所有患者中,血清 HBsAg 在第 48 周仍低于基线

关于 BRII-835 (VIR-2218)

BRII-835 (VIR-2218) 是一种研究性皮下给药的 HBV 靶向 siRNA,具有刺激有效免疫反应的潜力,并具有直接的抗 HBV 抗病毒活性。它是临床上第一个包含增强稳定化学加 (ESC+) 技术的 siRNA,以增强稳定性并最大限度地减少脱靶活性,这可能会导致治疗指数增加。 Brii Bio 于 2020 年从 Vir Biotechnology, Inc.(“Vir”)获得了在大中华地区开发和商业化 VIR-2218的独家权利。

同时,BRII-835 (VIR-2218) 正在与 BRII-179(一种重组治疗性疫苗)、PEG-IFN-α 和/或 VIR 联合进行三项额外的 2 期研究,分别由 Brii 和 Vir 赞助-3434(一种针对 HBV 的单克隆抗体)作为慢性 HBV 感染的功能性治愈方案。
作者: StephenW    时间: 2022-4-1 20:39

Brii Bio Presents New Data on BRII-835 (VIR-2218) in Chinese Patients with Chronic Hepatitis B at APASL 2022
(PRNewsfoto/Brii Biosciences Limited)

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Brii Biosciences Limited

Mar 31, 2022, 06:05 ET
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New data demonstrate BRII-835 (VIR-2218) was well tolerated with notable reductions in serum HBsAg observed in the Chinese patients infected with chronic hepatitis B

DURHAM, N.C. and BEIJING, March 31, 2022 /PRNewswire/ -- Brii Biosciences Limited ("Brii Bio" or the "Company", stock code: 2137.HK) a multi-national company developing innovative therapies for diseases with significant unmet medical needs and large public health burdens, today presented new data from a Phase 2 randomized, double-blind, placebo-controlled trial of BRII-835 (VIR-2218) in Chinese patients with chronic hepatitis B virus (HBV) infection, at the 31st Conference of Asian Pacific Association for the Study of the Liver (APASL) 2022, taking place virtually from March 30 to April 3 in Seoul, South Korea.

The data demonstrate that BRII-835 (VIR-2218), an investigational small interfering ribonucleic acid (siRNA) that mediates RNA interference (RNAi), results in dose-dependent reduction in hepatitis B surface antigen (HBsAg) in Chinese patients with chronic HBV infection who received two doses of BRII-835 (VIR-2218). Similar HBsAg reductions were observed in both HBeAg- and HBeAg+ patients. In addition, BRII-835 (VIR-2218) was well-tolerated, with all treatment emergent adverse events (TEAEs) reported as mild or moderate, and no clinically significant alanine transaminase (ALT) elevations were observed.

"The dose-dependent reduction in serum HBsAg observed in both HBeAg- and HBeAg+ Chinese chronic HBV patients in this trial after two doses of BRII-835 (VIR-2218) is consistent with previous findings demonstrated in other racial/ethnic groups," said Dr. Jidong Jia, Professor of Medicine at  the Liver Research Centre, Beijing Friendship Hospital, Capital Medical University in Beijing, China. "Supported by these data, we believe that novel agents like BRII-835 (VIR-2218) that effectively reduce the high HBV antigen burden has the potential to be the cornerstone of functional cure regimens for patients with chronic HBV infection, thereby facilitating the elimination of this major global public health threat."

"As part of our goal to develop a functional cure for chronic HBV , we are pleased that the data from this trial continue to support the potential of siRNA as the backbone of combination treatment regimens that are being evaluated in several ongoing trials," said Li Yan, M.D., Ph.D., Chief Medical Officer at Brii Bio. "We look forward to seeing more data later this year from these trials in which BRII-835 (VIR-2218) is being investigated in combination with other agents."

Abstract Number: L-OP-1324

Oral Presentation Title: Safety and antiviral activity of two monthly administrations of BRII-835 (VIR-2218), an X-targeting RNAi therapeutic, in Chinese patients with chronic HBV infection

Presenter: Jidong Jia, M.D., Ph.D., Professor of Medicine at Capital Medical University and Director of the Liver Research Centre at Beijing Friendship Hospital in Beijing, China

    BRII-835 (VIR-2218) was well-tolerated in 16 virally-suppressed Chinese patients with non-cirrhotic chronic HBV infection assigned to receive two doses of monthly subcutaneous injection of BRII-835
    12 weeks post last dose, the mean reductions in HBsAg observed in patients who received 50 mg and 100 mg doses of BRII-835 were 1.02 log10 IU/mL and 1.22 log10 IU/mL for HBeAg- patients and 0.70 log10 IU/mL and 1.15 log10 IU/mL for HBeAg+ patients, respectively
    In all patients achieving HBsAg decline > 1 log10 IU/mL at 12 weeks post last dose, serum HBsAg remained below baseline through Week 48

About BRII-835 (VIR-2218)

BRII-835 (VIR-2218) is an investigational subcutaneously administered HBV-targeting siRNA that has the potential to stimulate an effective immune response and has direct antiviral activity against HBV. It is the first siRNA in the clinic to include Enhanced Stabilization Chemistry Plus (ESC+) technology to enhance stability and minimize off-target activity, which potentially can result in an increased therapeutic index. Brii Bio licensed exclusive rights to develop and commercialize VIR-2218 for the greater China territory from Vir Biotechnology, Inc. ("Vir") in 2020.

Meanwhile, BRII-835 (VIR-2218) is being investigated in three additional Phase 2 studies, sponsored by Brii and Vir, respectively, in combinations with BRII-179 (a recombinant therapeutic vaccine), PEG-IFN-alpha and/or VIR-3434 (a monoclonal antibody targeting HBV) as a functional cure regimen for chronic HBV infection.
作者: newchinabok    时间: 2022-4-1 21:18

本帖最后由 newchinabok 于 2022-4-1 21:35 编辑
tim889 发表于 2022-4-1 15:18
不知道48周具体保持的怎么样了

这其实是vir的低配版,gsk可以降2.5~3log值,针数多些(药费更贵),vir高配版,6针也降的多,低配版其实适用于老年低hbsag,不用干挠素用asc22的患者和干挠素清不了零的人(新药对此类人最大利好),高表抗的人还不行,优点就是针少,药费便宜
作者: newchinabok    时间: 2022-4-1 21:22

本帖最后由 newchinabok 于 2022-4-1 21:24 编辑

vir,gsk其实对某些特别人群有意义。高hbsag,干挠素应答好的人,10000也能清零,根本不需要新药。干挠素应答不好,用了vir降到100也清不了零




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