RedHill Biopharma Ltd. (NASDAQ:RDHL) (TASE:RDHL) 是一家专业生物制药公司，主要专注于开发并销售胃肠疾病和炎症性疾病及癌症治疗方面的处于后期临床试验阶段的专有口服小分子药物，该公司宣布RHB-104已从美国食品药品管理局（FDA）获得用于治疗非结核分歧杆菌（NTM）感染的合格感染病产品（QIDP）认证。QIDP认证是根据FDA的生成抗生素激励法案（GAIN）授权的，其目的旨在鼓励治疗严重或危及生命感染方面新抗生素药物的开发。
根据FDA的生成抗生素激励法案，QIDP认证会确保药物处于快速开发状态及优先审查阶段，进而可能会缩短FDA的新药申请审查时间，且如果获得批准的话，该药物还可在标准排他期基础上获得额外5年的美国市场专卖权。
NTM感染可发生在身体的任何一个部位，但肺部感染、淋巴结炎、皮肤和软组织感染则最为常见。在过去20年当中，全球范围内的NTM感染已与日俱增。受抗性开发风险影响，NTM的治疗时间通常比较长，且需要多药方案。
RHB-104针对克罗恩病的首项三期临床试验（MAP US研究）目前正在美国和另外的国家进行。越来越多的证据为克罗恩病和其他自身免疫疾病与易感患者的鸟分枝杆菌亚种副结合感染有关的假说提供了支援。
RedHill Biopharma Ltd介绍：
RedHill Biopharma Ltd. (NASDAQ/TASE: RDHL) 是一家总部位于以色列的专业生物医药公司，主要专注于开发并销售治疗肠胃疾病和炎症性疾病以及癌症方面的处于后期临床试验阶段的专有口服小分子药。RedHill已与Concordia就Donnatal®签署美国地区的联合促销协定，Donnatal®是一种用于治疗IBS和急性小肠结肠炎的处方口服辅助药物。RedHill目前处于临床阶段的产品管线包括：(i) RHB-105 -治疗幽门螺杆菌感染的口服混合药，首个三期试验获得成功；(ii) RHB-104 -治疗克罗恩病的口服混合药，正在进行首项三期试验以及治疗多发性硬化症的IIa期概念验证试验；(iii)BEKINDA™ (RHB-102) -日服一次的昂丹司琼口服药片制剂，正在美国进行治疗急性肠胃炎和慢性胃炎的三期试验，以及治疗腹泻型肠易激综合征的二期试验；(iv) RHB-106 -肠道准备药物胶囊，已经授权给Salix Pharmaceuticals Ltd.；(v) YELIVA™ (ABC294640) -二期阶段的口服SK2选择性抑制剂，是首创新药，靶向为多种肿瘤、炎症性和胃肠道适应症；(vi) MESUPRON® -处于二期试验阶段的口服蛋白酶抑制剂，是首创新药，靶向为胃肠和其他实体瘤；(vii) RIZAPORT™ (RHB-103) -利紮曲坦口服薄膜制剂，用于治疗急性偏头痛，正在与美国食品药品监督管理局讨论新药申请，2015年10月获准在德国上市。欲了解与本公司有关的更多资讯，请访问：www.redhillbio.com。
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company’s research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts; (ii) the Company’s ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials; (iii) the extent and number of additional studies that the Company may be required to conduct and the Company’s receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company’s therapeutic candidates; (v) the Company’s ability to establish and maintain corporate collaborations; (vi) the Company’s ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (vii) the interpretation of the properties and characteristics of the Company’s therapeutic candidates and of the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (viii) the implementation of the Company’s business model, strategic plans for its business and therapeutic candidates; (ix) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (x) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xi) estimates of the Company’s expenses, future revenues capital requirements and the Company’s needs for additional financing; (xii) competitive companies and technologies within the Company’s industry; and (xiii) the impact of the political and security situation in Israel on the Company’s business. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 20-F filed with the SEC on February 25, 2016. All forward-looking statements included in this Press Release are made only as of the date of this Press Release. We assume no obligation to update any written or oral forward-looking statement unless required by law.
注：该新闻稿的唯一官方版本是本公司以英文出版的。本摘要和意译版本仅为方便起见。
| 公司联络人： | 投资者关系联络人（美国） | |
| Adi Frish | Marcy Nanus | |
| 业务发展和许可高级副总裁 | 高级副总裁 | |
| RedHill Biopharma | The Trout Group | |
| +972-54-6543-112 | +1-646-378-2927 | |
| [email protected] | [email protected] |
