RedHill Biopharma Ltd. (纳斯达克： RDHL) (特拉维夫股票交易所：RDHL) (“RedHill” 或“公司”), 是一家专业生物制药公司，主要专注于开发幷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。本公司今天宣布美国食品药品监督管理局已经授予YELIVA® (ABC294640)治疗胆管癌的孤儿药认证。
孤儿药认证使得RedHill开发胆管癌药物YELIVA® (ABC294640)的多项激励措施，幷且产品获批上市之后，将享有七年的市场独占权。
YELIVA®治疗晚期不可切除肝内和肝外胆管癌患者的二a期试验计划在2017年第三季度启动。
胆管癌是一种高度致命性的恶性肿瘤，强烈需要更加高效的系统性治疗。患者五年相对存活率在2%到30%之间，取决于肿瘤类型和诊断时的阶段。
YELIVA®治疗晚期实体瘤的一期试验成功达到了主要和次要终点。参与一期试验的三名胆管癌患者，其中一名获得了持续部分应答，其他两位病情稳定时间延长。
RedHill正在推进YELIVA®的多个一/二期临床试验，靶向为多种肿瘤和炎症适应症，其中一些项目得到美国国家癌症研究所对Apogee Biotechnology和美国大学的拨款支持。
YELIVA®为专有的首创口服鞘氨醇激酶-2（SK2）选择性抑制剂，具有抗癌和抗炎症活性。
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，主要专注于开发幷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推广协议，Donnatal®是一种用于治疗肠易激综合征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) -利扎曲坦口服薄膜制剂，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 successfully market Donnatal®, (vi) the Company’s ability to establish and maintain corporate collaborations; (vii) 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; (viii) 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; (ix) the implementation of the Company’s business model, strategic plans for its business and therapeutic candidates; (x) 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; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; and (xii) estimates of the Company’s expenses, future revenues capital requirements and the Company’s needs for additional financing; (xiii) competitive companies and technologies within the Company’s industry. 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 23, 2017. 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发布的英文原版稿件。本摘要和翻译版本仅为方便阅读之目的。
公司联络人：
Adi Frish
业务发展和许可高级副总裁
RedHill Biopharma
+972-54-6543-112
[email protected]
投资者关系联络人（美国）：
Marcy Nanus
高级副总裁
The Trout Group
+1-646-378-2927
[email protected]
