慢乙肝新药ABX203-(HeberNasvac)在古巴获得新药上市许可

慢乙肝新药 ABX203 HeberNasvac 在古巴获得新药上市许 可 专注于如 HIV AIDS 和慢性乙型肝炎等这类病毒性 疾病的抗病毒药物和治疗性疫苗研发并商业化的新兴领导 者 ABIVAX 及基因工程和生物科技中心 CIGB 全球生 物科技领导者 今日宣布 古巴监管部门 国家药品 医 疗器械和装备控制中心 CECMED 授予 CIGB 他们第一个 慢乙肝治疗性疫苗 ABX203 商品名 HeberNasvac 新药上市 许可申请 在临床试验期间 接受 ABX203 治疗的慢乙 肝患者 通过观察免疫反应显示 该治疗性疫苗可以帮助慢 乙肝患者克服免疫麻痹 这也是典型的乙肝慢性化机制 哈瓦那 CIGB 生物医学研究中心主任 Gerardo Guillen 博士 说道 目前对 ABX203 的研究为慢乙肝治疗性疫苗的概念提 供临床证据 ABX203 HerberNasvac 已经显示出了独一无二 的持续效应 它已经较聚乙二醇干扰素 PEG IFN 对慢乙 肝治疗到达了缩短持续用药时间和更好的耐受性 换句话说 数据显示 ABX203 通过标准治疗即给慢乙肝患者提供相当 的治疗优势 ABX203 拥有鼻喷剂型和皮下注射剂型两 种剂型 被设计成犹如强烈的机体细胞免疫反应似的诱导机 体产生对 HBsAg 的中和性血清抗体 而慢乙肝患者的机体 免疫反应通常非常弱或检测不到 该治疗性疫苗由从 HBV 表面抗原 HBsAg 和核心抗原 HBcAg 的 2 组重组蛋白 构成 ABIVAX 拥有包括亚洲 欧洲和非洲 80 多个国家 的 ABX203 商业开发和应用权 该授权由 CIGB 授予从 2013 年开始 完成所有的后续在古巴和孟加拉国进行的成功 I II 和 III 期临床试验 这些研究显示 ABX203 耐受性良好 并且具有跟 PEG IFN 具有相似的抗病毒效果 此外 其 对 HBV 病毒载量的效果也维持了非常长的一段时间 在短 期 更便捷的用药之后 该药独特的延长效用 提示 ABX203 提供了相当大的治疗优势并改善采用标准治疗的慢乙肝患 者依从性 ABIVAX CEO Hartmut Ehrlich 博士评论道 对于 ABX203 的营销授权被批准我们感到非常高兴 这代 表着 CIGB ABIVAX 一个重要的里程碑 更重要的 也是遭 受乙肝病毒感染的感染者的一个重大里程碑 我们期待这一 疗法能让数以亿计的需要每日服药 终身治疗以控制这破坏 性疾病的乙肝病毒感染者使用 CIGB 已成功推向市场的 记录 反映其产品良好质量标准 例如 他们针对乙肝的预 防性疫苗已经在超过 50 个国家的 2 亿人口中使用 拥有卓 越的国际知名度 更重要的 在古巴获得的首开先河授权 将允许由古巴监管部门获得的数据能够快速备案 在 ABIVAX 认为的某些关键国家的营销授权申请 此外 ABIVAX 目前正在实施他自己的针对 ABX203 的晚期 phase IIb III 临床试验 这一控制随机双盲试验已经完成了 276 名患者的全部入组 并在七个亚太国家和地区 澳大利亚 新西兰 台湾 香港 泰国 新加坡 韩国 的 40 个临床中心 实施 预期的结果将在 2016 年第四季度公布 在这项正 在进行的关键性研究中 其中一组患者接受 24 周的 ABX203 加上目前的标准疗法 核甘 酸 类似物 NUCs 而控制组则仅接受核甘 酸 类似物治疗 在经过 24 周的联 合治疗后所有的治疗都停止 该研究的首要有效终点 使 用 ABX203 24 周的治疗后病毒载量下降 40 IU mL 已经完 成 研究结果是可期待的 如为阳性 支持更进一步的 ABX203 批准 尤其是亚太国家 这也是主要的慢乙肝患者 居住地区 英文原文 ABX203 HeberNasvac Granted Cuban Marketing Authorization toTreat Chronic Hepatitis BParis France December 8th 2015 ABIVAX Euronext Paris FR0012333284 ABVX an emerging leader in developing and commercializing anti viral and vaccine therapies for diseases like HIV AIDS and chronic Hepatitis B CHB and the Center for genetic Engineering and Biotechnology CIGB a global leader in biotechnology today announced that CECMED the Cuban regulatory authorities granted the CIGB their first marketing authorization application for ABX203 a first in class therapeutic vaccine for treatment of CHB under the trade name HeberNasvac The immune responses observed in CHB patients receiving ABX203 during clinical testing clearly show that the therapeutic vaccine is able to help patients overcome the immune paralysis which is so typical for the chronic form of the disease said Gerardo Guillen PhD Director of Biomedical Research at the CIGB in Havana The previous studies with ABX203 provided clinical proof of the concept of therapeutic vaccination in chronic Hepatitis B ABX203 HerberNasvac has demonstrated a unique sustained effect which was achieved with a shorter duration of administration and better tolerability than peg interferon PEG IFN In other words the data indicate that ABX203 could deliver considerable therapeuticadvantages over standard treatments for patients suffering from CHB ABX203 is formulated as a nasal spray solution and as a solution for sub cutaneous injection and has been designed to induce neutralizing serum antibodies to HBsAg as well as strong cellular responses which are weak or undetectable in patients with CHB The therapeutic vaccine is composed of 2 recombinant proteins from the Hepatitis B virus HBV the surface antigen HBsAg and the nucleocapsid core antigen HBcAg ABIVAX owns development and commercial rights for ABX203 for more than 80 countries in Asia Europe and Africa These rights were licensed in 2013 from the CIGB following the completion of successful phase I I II and III clinical trials run in Cuba and Bangladesh These studies showed that ABX203 was well tolerated and had an antiviral effect similar to that of PEG IFN In addition the effect on HBV viral load was sustained for a longer period of time This unique prolonged efficacy aftershorter more convenient administration suggests that ABX203 offers considerable therapeutic advantages and improved compliance over standard treatments for CHB Professor Hartmut Ehrlich M D CEO of ABIVAX commented We are very pleased with this first Marketing Authorization Approval MAA approval for ABX203 It represents a significant milestone for the CIGB ABIVAX and most importantly patients suffering from chronic Hepatitis B We are looking forward to making this long lasting treatment available to the millions of patients who currently need daily life long treatment to control this devastating disease The CIGB has a track record of successful market introductions reflecting the quality and standard of their products For example their prophylactic vaccine for Hepatitis B is registered in more than 50 countries and more than 200 million doses have been administered leading to an international reputation for excellence Furthermore this first MAA in Cuba will allow rapid filing of the data used by the Cuban regulatory authorities for marketing authorization applications in some key ABIVAX countries Additionally ABIVAX is currently conducting its own late stage pivotal phase IIb III clinical trial with ABX203 This controlled randomized blinded study is already fully recruited 276 patients and is being conducted at over 40 clinical centers in seven Asia Pacific countries Australia New Zealand Taiwan Hong Kong Thailand Singapore and South Korea The results are expected to be reported in the fourth quarter of 2016 In this ongoing pivotal study one group of patients is receiving for 24 weeks ABX203 plus the current standard of care nucleotide analogues NUCs and the control group is receiving NUCs only All therapy is stopped after 24 weeks of