【友情轉(zhuǎn)發(fā)】KBP-7072 obtained QIDP and Fast Track Designations

2016年12月5日 | Filed under: 文獻(xiàn)綜合 | Posted by: 路人丙

(Jinan, China, and Princeton, NJ) KBP BioSciences, a clinical stage biopharma company announced today that the?U.S. Food and Drug Administration?(FDA) has granted Qualified Infectious Disease Product (QIDP) and Fast Track designations for KBP-7072, a new generation tetracycline for resistant bacterial infections.

KBP-7072 obtained the QIDP and Fast Track designations based on treatment of community-acquired bacterial pneumonia (CAP), which affects millions of people each year, more and more were due to resistant bacteria. “Bacteria resistant to multiple classes of antibiotics are becoming a real threat to human society.” said Dr. Zhenhua Huang, Chairman of KBP BioSciences. “We started our journey years ago with KBP-7072. QIDP and Fast Track designations are good confirmation for our work. ?KBP-7072 can be an important treatment for CAP and other bacterial infections in the future.”

The QIDP designation makes KBP-7072 eligible to certain incentives provided under the Generating Antibiotic Incentives Now Act (GAIN Act) of 2012, including Priority Review and eligibility for an additional five-year exclusivity under the Hatch-Waxman Act. Fast Track designation confers expedited development and regulatory review of drugs intended to treat serious or life-threatening conditions where there are significant unmet medical needs.

In addition to CAP, there are many infections which become life-threatening due to the increasing problem of drug-resistant bacterial pathogen. KBP-7072 is being developed for several indications.

About KBP-7072

KBP-7072 is a new generation broad spectrum antibiotics aimed at multi-drug resistant bacteria. In addition to major resistant strains such as MRSA, PRSP, and VRE, KBP-7072 is highly potent against Acinetobacter, a Gram negative pathogen. The bacterium is increasingly common in hospital and community settings causing high mortality rate. There is no effective mono- or combo-therapy for this deadly pathogen. KBP-7072 has good PK profile, available in both oral and injectable formulations, making it ideal for various infections. Phase I trial in the US showed that KBP-7072 was safe and generally well tolerated. The oral formulation has good drug exposure, and long half-life in human. No GI adverse events were observed at the highest dose tried.

About KBP BioSciences

KBP BioSciences is a clinical stage biotech company dedicated to research, development and commercialization of innovative medicines for the global market. The company’s three clinical stage compounds have all obtained US FDA IND approvals.

KBP has developed a deep pipeline focused on meeting unmet medical needs globally. The company devotes its resources in three therapeutic areas, inflammation & autoimmune diseases, organ protection, and antibiotics. KBP has built a proprietary R&D platform aimed at discovery and development of global first-in-class compounds. The platform consists of a compound library which is the basis of new compound discovery; a bacterium library aimed at multi-drug resistant bacteria; and in vivo pharmacology platform for screening and testing new compounds.

Headquartered in Jinan, China, KBP BioSciences established its US affiliate in Princeton, New Jersey, which is responsible for clinical development and registration. The management team has decades of combined experiences in drug development and registration. We work with a world-class scientific advisory board to advance new therapies for significant unmet medical needs.

Invented in China for the world.

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（濟(jì)南和普林斯頓）亨利醫(yī)藥今天宣布，美國食品藥品監(jiān)督管理局（FDA）已經(jīng)為KBP-7072（一種臨床階段的新一代抗耐藥性細(xì)菌感染的四環(huán)素）授予了合格傳染病產(chǎn)品（QIDP）和快速通道(Fast Track)認(rèn)證。

KBP-7072獲得這兩項(xiàng)認(rèn)證是基于其治療社區(qū)獲得性細(xì)菌性肺炎（CAP）的適應(yīng)癥。CAP傳播廣泛，影響巨大，每年有數(shù)百萬人罹患該病癥。亨利醫(yī)藥董事長黃振華博士說，“多重耐藥細(xì)菌正在成為人類社會的真正威脅，我們多年前開始KBP-7072的研發(fā)工作，QIDP和Fast Track 兩項(xiàng)認(rèn)證是對我們工作的良好認(rèn)可，KBP-7072 可能會成為治療社區(qū)獲得性細(xì)菌性肺炎及其他感染的重要手段。”

QIDP認(rèn)證來源于美國2012年鼓勵抗生素開發(fā)（GAINS）法案。經(jīng)QIDP認(rèn)證藥物享有多重優(yōu)惠政策，包括FDA優(yōu)先審批（Priority Review）以及Hatch-Waxman法案規(guī)定的附加5年行政保護(hù)期。FAST TRACK 是為針對嚴(yán)重和致命疾病的藥物提供優(yōu)惠政策，為有巨大未滿足臨床需求的治療領(lǐng)域提供新的治療手段。FAST TRACK認(rèn)證的藥物享有FDA加快的臨床和審批速度。

除了CAP，耐藥菌還造成許多其他感染，威脅患者生命。亨利醫(yī)藥正在開發(fā)KBP-7072其他多種以耐藥菌感染導(dǎo)致的適應(yīng)癥。

關(guān)于KBP-7072

KBP-7072是新一代針對耐藥細(xì)菌的廣譜抗生素，對包括MRSA、PRSP，VRE等主要耐藥菌均有很高的活性，在已有報(bào)道的化合物中對不動桿菌的活性最強(qiáng)。不動桿菌在臨床上的分離率越來越高，目前沒有有效的治療藥物，即使聯(lián)合用藥也無法解決現(xiàn)有的問題，導(dǎo)致死亡率高，對人類健康造成重大威脅。KBP-7072還有良好的PK特點(diǎn)，既可以口服給藥，也可以注射給藥，拓寬了適應(yīng)癥的范圍。已經(jīng)完成在美國的I期臨床，證明KBP-7072口服吸收好，半衰期長，安全性高，耐受性良好，即使在最高劑量下也未觀察到胃腸道副反應(yīng)。

關(guān)于亨利醫(yī)藥

山東亨利醫(yī)藥科技有限責(zé)任公司（KBP BioSciences）是一家致力于國際化創(chuàng)新藥物研發(fā)的公司。所有新藥均通過FDA申報(bào)，并且率先在美國開展臨床，迄今已經(jīng)有3個藥物獲得FDA 批準(zhǔn)進(jìn)入臨床試驗(yàn)。

亨利醫(yī)藥以臨床未滿足的需求為新藥的出發(fā)點(diǎn)，專注于包括炎癥和自身免疫性疾病、器官保護(hù)以及多重耐藥細(xì)菌感染為主的三個治療領(lǐng)域。公司經(jīng)過多年積累建立了三個技術(shù)平臺：化合物庫、菌種庫以及藥理實(shí)驗(yàn)技術(shù)平臺，化合物庫是得到具有獨(dú)特臨床特點(diǎn)新藥的分子基礎(chǔ)，菌種庫是找到治療臨床無藥可用的多重耐藥菌的生物基礎(chǔ)，藥理實(shí)驗(yàn)技術(shù)平臺是篩選獨(dú)有臨床特點(diǎn)藥物的生物基礎(chǔ)。三個技術(shù)平臺可以充分支持全球首創(chuàng)新藥（First-in-class）的國際化研究和開發(fā)。

亨利醫(yī)藥中國公司位于濟(jì)南，美國公司位于美國新澤西的普林斯頓，有資深的后期臨床以及注冊團(tuán)隊(duì)，負(fù)責(zé)公司新藥在美國的臨床開發(fā)以及注冊工作，并且在治療領(lǐng)域有全球頂級的專家團(tuán)隊(duì)共同參與，一起解決全球臨床未滿足需求。

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