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 - IFNα)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 - IFNα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 - IFNα). 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- IFNα. 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 Mar keting 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 combination treatment. The study’s primary efficacy endpoint isthe percentage of subjects with viral load been completed. Study results are expected, if positive, to support further approvals of ABX203,particularly in the Asia-Pacific region, where the majority of the patients with CHB reside. 查看信源地址。