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Assembly Biosciences: A Horseman Of The HBV Core-Pocalypse?
Oct. 19, 2018 11:23 AM ET|
7 comments |
About: Assembly Biosciences, Inc. (ASMB), Includes: ABUS, BAYRY, BMY, CTRV, ENTA, GILD, JNJ, NVS, RHHBY
BZ Equity Research
BZ Equity Research
Long only, biotech, contrarian, Antiviral
(183 followers)
Summary
Assembly Biosciences is shaping up to be a major player in the future of Hepatitis B therapeutics.
It is currently at the forefront of the HBV core inhibitor race with its fast-tracked ABI-H0731 compound.
The new Chinese-domiciled entity (Assembly China) grants the company direct access to the largest HBV market in the world and allows the company to compete with industry heavyweights.
Its QD-based dosing regimen gives Assembly an upper hand in the race over many of its competitors and allows for the development of simple oral-based combination therapy regimens.
Assembly Biosciences: A Horseman Of The HBV Core-Pocalypse?
Oct. 19, 2018 11:23 AM ET | About: Assembly Biosciences, Inc. (ASMB), Includes: ABUS, BAYRY, BMY, CTRV, ENTA, GILD, JNJ, NVS, RHHBY
BZ Equity Research
BZ Equity Research
Long only, biotech, contrarian, Antiviral
(184 followers)
Summary
Assembly Biosciences is shaping up to be a major player in the future of Hepatitis B therapeutics.
It is currently at the forefront of the HBV core inhibitor race with its fast-tracked ABI-H0731 compound.
The new Chinese-domiciled entity (Assembly China) grants the company direct access to the largest HBV market in the world and allows the company to compete with industry heavyweights.
Its QD-based dosing regimen gives Assembly an upper hand in the race over many of its competitors and allows for the development of simple oral-based combination therapy regimens.
Assembly is a strong buy.
Introduction
Assembly Biosciences (ASMB) is a small-cap biotech company focused on the development of HBV therapeutics and microbiome-based therapies. The company has decidedly focused on a new and promising drug target which has already attracted many startup biotech companies and big pharma- the HBV core protein. With an FDA-fast track designation, Assembly has taken the lead position in the race to bring the world's first HBV core inhibitor to market. It's first-generation compound, ABI-H0731 is currently in phase 2a testing and has been shown to be safe and effective in early clinical testing.
There is no guarantee that Assembly will be the first-to-market with their HBV drugs but it is likely to be one of the major players in the core inhibitor space. In order to secure a future for themselves, Assembly's management team continues to expand their core inhibitor program in order to explore newer and more potent inhibitors. Furthermore, they have made great strides to enter the world's largest hepatitis B market in order to be able to compete with the likes of Roche (OTCQX:RHHBY) and Johnson & Johnson (JNJ).
As the battle for dominance continues in this hot field of HBV research, it becomes more and more evident that Assembly Biosciences will be one of the horsemen of the coming HBV core-pocalypse.作者: 齐欢畅 时间: 2018-10-20 15:37
文章参考来源：Assembly Biosciences Announces FDA Fast Track Designation Granted to ABI-H0731 for the Treatment of Hepatitis B Virus Infection作者: 齐欢畅 时间: 2018-10-20 17:16
享有与FDA更多会议交流的机会，以探讨药物研发计划并收集更多满足上市需求的数据More frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval;
收到更多FDA关于临床试验的设计和生物标记物等的选择的书面文件More frequent written communication from FDA about such things asthe design of the proposed clinical trials and use of biomarkers;
如果相关标准符合要求，则拥有优先审批权和加速批准权Eligibility for Accelerated Approval and Priority Review,ifrelevant criteria are met;
滚动式审，即药物申请公司可以提交已完成BLA或NDA章节，而不是常规的每一个章节均完成后才可进入审评。Rolling Review,which means that a drug company can submit completedsections of its Biologic License Application (BLA) or New Drug Application(NDA) for review by FDA,rather than waiting until every section of the NDA is completed before the entire application can be reviewed.BLA or NDA review usually does not begin until the drug company has submitted the entireapplication to the FDA。
