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歌礼在 EASL ILC 2022 上宣布 ASC22(一种用于功能性治愈慢性乙 [复制链接]

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发表于 2022-6-16 15:41 |只看该作者 |倒序浏览 |打印
歌礼在 EASL ILC 2022 上宣布 ASC22(一种用于功能性治愈慢性乙型肝炎的皮下 PD-L1 抗体) IIb 期临床试验更新的口头报告

2022 年 6 月 16 日星期四上午 10:10·3 分钟阅读
在本文中:

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- ASC22 IIb 期研究的更新将在北京时间 2022 年 6 月 25 日星期六 14:15 举行的 International Liver Congress™ 2022 的口头会议上公布(摘要编号:OS091)

中国杭州和中国绍兴,2022 年 6 月 15 日 /美通社/ -- 歌礼制药股份有限公司(港交所代码:1672,“歌礼”)今天公布了 ASC22(恩伐利单抗)IIb 期临床试验的最新结果慢性乙型肝炎 (CHB) 将于 2022 年 6 月 25 日在欧洲肝脏研究协会 (EASL) 在伦敦举行的 2022 年国际肝脏大会™ (ILC 2022) 的口头平行会议上发表。

EASL 是世界领先的致力于肝病研究的医学协会。作为每年约有 10,000 名代表参加的年度旗舰活动,ILC 是全球最具影响力的肝病学研究大会之一,与全球社区分享进展、最佳实践和最新科学突破。今年ILC接收的1993篇摘要中,共有9篇中文摘要被录取为口头报告。歌礼关于慢性乙型肝炎功能性治愈的 ASC22 是唯一一项由中国生物技术发起的 HBV 相关研究,并被选中在 ILC 2022 上进行口头报告。

北京大学第一医院感染科、肝病中心主任王桂强教授将在ILC 2022上展示ASC22 IIb期研究的最新结果。在美国肝病研究协会(AASLD)举办的Liver Meeting® 2021上) 去年,王贵强教授还应邀与歌礼创始人、董事长兼首席执行官吴金子博士一起就ASC22 IIa和IIb期研究中期报告作了口头报告。

在全球范围内,慢性乙型肝炎仍然是一项未得到满足的医疗需求,中国约有 8600 万人,美国有 159 万人感染了乙型肝炎病毒 (HBV)[1]。核苷酸类似物(NAs)仅抑制HBV RNA逆转录为HBV DNA,不抑制HBV cccDNA转录为HBV RNA,因此对HBsAg无抑制作用。

将在 ILC 2022 上提交的摘要如下:

ALT 发作与 HBsAg 降低、血清清除和血清转换有关:慢性乙型肝炎患者接受 24 周皮下 PD-L1 Ab ASC22(Envafolimab)加核苷(酸)类似物治疗的 IIb 期研究的中期结果

演讲类型:口头演讲
摘要编号:OS091
会议:摘要会议:乙型肝炎新兴疗法
主讲人:北京大学第一医院感染科、肝病中心主任王桂强教授
演讲时间:2022年6月25日,星期六,14:15-14:30(北京时间)

*摘要可访问:https://easl.eu/event/internatio ... stract-information/

[1] Lim J K、Nguyen M H、Kim W R 等人。美国慢性乙型肝炎病毒感染流行情况[J].美国胃肠病学杂志 2020, 115(9): 1429-38。

关于歌礼

歌礼是一家在香港联合交易所(1672.HK)上市的创新研发驱动型生物科技公司,涵盖从发现开发到制造和商业化的整个价值链。在一支拥有深厚专业知识和良好业绩记录的管理团队的领导下,歌礼专注于从全球角度来看医疗需求未得到满足的三个治疗领域:病毒性疾病、非酒精性脂肪性肝炎 (NASH) 和肿瘤学。通过出色的执行,歌礼迅速推进其药物管线,旨在在全球竞争中处于领先地位。迄今为止,歌礼拥有利托那韦片、GANOVO®和ASCLEVIR®三个上市产品,以及20个在研药物在研。最先进的候选药物包括 ASC22(CHB 功能性治愈)、ASC10 和 ASC11(用于 COVID-19 治疗的口服小分子)、ASC40(复发性胶质母细胞瘤)、ASC42(PBC,原发性胆汁性胆管炎)和 ASC40(痤疮)。

欲了解更多信息,请访问 www.ascletis.com
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查看原文内容:https://www.prnewswire.com/news- ... -a-subcutaneous-pd- l1-antibody-for-functional-cure-of-chronic-hepatitis-b-at-easl-ilc-2022-301568835.html

消息来源 Ascletis Pharma Inc.

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发表于 2022-6-16 15:41 |只看该作者
Ascletis Announces Oral Presentation on Updates from Phase IIb Clinical Trial of ASC22, a Subcutaneous PD-L1 Antibody for Functional Cure of Chronic Hepatitis B at EASL ILC 2022

Thu, June 16, 2022 at 10:10 AM·3 min read
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- The updates of ASC22 Phase IIb study will be presented at the oral session during the International Liver Congress™ 2022 on Saturday, June 25, 2022 at 14:15, Beijing Time (Abstract Number: OS091)

HANGZHOU, China and SHAOXING, China, June 15, 2022 /PRNewswire/ --  Ascletis Pharma Inc. (HKEX:1672, "Ascletis") today announces that the latest results of the Phase IIb clinical trial of ASC22 (Envafolimab) in patients with chronic hepatitis B (CHB) will be presented at an oral parallel session of the International Liver Congress™ 2022 (ILC 2022) held by the European Association for the Study of the Liver (EASL) in London on June 25, 2022.

EASL is the world's leading medical association dedicated to liver diseases research. As the annual flagship event with approximately 10, 000 representatives participating every year, ILC is one of the most influential congresses on hepatology research globally where the advances, best practices and latest scientific breakthroughs are shared with the global community. Among the 1,993 abstracts accepted by ILC this year, nine Chinese abstracts have been admitted to oral presentation in total. Ascletis' ASC22 on CHB functional cure is the only China biotech-initiated, HBV-related study that has been selected for oral presentation at ILC 2022.

Professor Guiqiang Wang, Director of Infectious Diseases Department and Liver Disease Center of Peking University First Hospital, will present the latest results of ASC22 Phase IIb study at ILC 2022. At the Liver Meeting® 2021 by American Association for the Study of Liver Diseases (AASLD) last year, Professor Guiqiang Wang was also invited, along with Dr. Jinzi J. Wu, Founder, Chairman and CEO of Ascletis, to have an oral presentation on ASC22 Phase IIa and IIb study interim report.

CHB remains to be a significantly unmet medical need globally, with approximately 86 million people in China and 1.59 million people in the U.S. infected with hepatitis B virus (HBV)[1]. Nucleot(s)ide analogues (NAs) inhibit only reverse transcription of HBV RNA into HBV DNA and do not inhibit the transcription of HBV cccDNA into HBV RNA, thus have no inhibitory effect on HBsAg.

Abstract to be presented at ILC 2022 is as follows:

ALT flares were linked to HBsAg reduction, seroclearance and seroconversion: interim results from a phase IIb study in chronic hepatitis B patients with 24-week treatment of subcutaneous PD-L1 Ab ASC22 (Envafolimab) plus nucleos(t)ide analogs

Presentation Type: Oral Presentation
Abstract Number: OS091
Session: Abstract session: Hepatitis B emerging therapies
Presenter: Prof. Guiqiang Wang, Director of Infectious Diseases Department and Liver Disease Center of Peking University First Hospital
Presentation time: June 25, 2022, Saturday, 14:15-14:30 (Beijing Time)

*The abstract can be accessed at: https://easl.eu/event/internatio ... stract-information/

[1] Lim J K, Nguyen M H, Kim W R, et al. Prevalence of Chronic Hepatitis B Virus Infection in the United States [J]. The American journal of gastroenterology 2020, 115(9): 1429-38.

About Ascletis

Ascletis is an innovative R&D driven biotech listed on the Hong Kong Stock Exchange (1672.HK), covering the entire value chain from discovery and development to manufacturing and commercialization. Led by a management team with deep expertise and a proven track record, Ascletis focuses on three therapeutic areas with unmet medical needs from a global perspective: viral diseases, non-alcoholic steatohepatitis (NASH) and oncology. Through excellent execution, Ascletis rapidly advances its drug pipeline with an aim of leading in global competition. To date, Ascletis has three marketed products, i.e. ritonavir tablets, GANOVO® and ASCLEVIR®, and 20 drug candidates in its R&D pipeline. The most advanced drug candidates include ASC22 (CHB functional cure), ASC10 and ASC11 (oral small molecules for COVID-19 treatment), ASC40 (recurrent glioblastoma), ASC42 (PBC, primary biliary cholangitis), and ASC40 (acne).

For more information, please visit www.ascletis.com.
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View original content:https://www.prnewswire.com/news- ... 2022-301568835.html

SOURCE Ascletis Pharma Inc.

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发表于 2022-6-16 19:21 |只看该作者

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发表于 2022-6-16 21:58 |只看该作者
我都同意

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发表于 2022-6-17 00:15 |只看该作者
厉害,弯道超车。就目前来看,走在了所有外企的前面。全球有2b期报告的乙肝药企应该都是国内的。
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