百济神州获得 PD-1 单抗 BGB- A317 的中国临床试验批件
北京，2016 年 9 月 12 日——百济神州（纳斯达克代码：BGNE）是一家专注于开发用于癌症治疗的创新分子靶向和肿瘤免疫药物的生物医药公司，其在研产品处于临床研究阶段。公司于今日宣布在研产品 PD-1 单抗 BGB-A317 获得了中国国家食品药品监督管理总局（CFDA）颁发的药物临床试验批件，用于治疗晚期实体肿瘤。中国大陆成为继澳大利亚、新西兰、美国和台湾地区之后 BGB-A317 获得临床试验许可的第五个地区。截至目前， 已经有 200 多名患者参与了 BGB-A317 的临床试验，BGB-A317 的临床 I 期剂量递增研究的初步数据也已于今年 6 月在美国临床肿瘤学会年会上进行了公布。
百济神州创始人之一、首席执行官兼董事长欧雷强表示：“BGB-A317 的临床试验批件，意味着百济神州 4 个临床阶段在研产品都已经可以在中国开展临床试验。国内医药市场持续稳健增长，对百济神州的发展至关重要。我们很高兴能获得这一批件，期待在中国大陆正式启动 BGB-A317 的临床试验，同时持续推进 BGB-A317的全球临床开发并提供最新临床数据。”
百济神州药政事务负责人闫小军表示：“BGB-A317 是国内自主研发的创新型生物药，在海外临床 I 期剂量递增试验中，我们已经积累了针对晚期实体肿瘤患者的安全有效性数据，这些数据为 BGB-A317 获得中国大陆临床试验批件提供了很好的支持。我们将继续与 CFDA 保持密切沟通，推动 BGB-A317 在国内的开发进程。”
关于BGB-A317
BGB-A317 是一种正处于临床试验阶段的人源化单克隆抗体，属于一种被称为“免疫关卡”抑制剂的新型肿瘤免疫制剂。BGB-A317的作用机制是与细胞表面的PD-1受体结合；后者是一种重要的免疫抑制分子，它可抑制T细胞的活化，从而降低免疫系统的作用。BGB-A317对PD-1有很高的亲和性和特异性，且通过生物工程技术特异性去除了和Fc γ受体I的结合能力，而后者是我们相信BGB-A317与目前获批的PD-1 抗体存在的差异性。BGB-A317正在开发作为单一疗法以及与其它治疗组合的疗法用以治疗各种癌症。
关于百济神州百济神州是一家全球性的、以研发为基础的生物科技公司，目前在中国大陆、美国、澳大利亚及台湾地区拥有超过 250名科学家、临床医学家和员工。公司专注于开发和推广靶向和免疫肿瘤治疗，在研产品线包括新型小分子靶向类和单克隆抗体类抗癌药物，并已有部分产品进入临床试验阶段。百济神州致力于通过寻找最优的肿瘤药物联合治疗方案， 使癌症患者的生存质量和生存期获得显著提高。
前瞻性声明
本新闻稿中包含一些按照《1995年美国私人证券诉讼改革法案》和其它联邦证券法做出的前瞻性声明，其中包括BGB-A317项目预期的临床开发和药政事务里程碑及相关计划。由于存在许多重要因素，真实结果可能与做出的前瞻性声明存在重大差别。这些因素包括：1. 百济神州能否证明其候选药物的有效性和安全性；2. 候选药物的临床试验结果可能不支持后期的开发；3. 管理机构可能会干涉临床试验的开始、时间进程和临床开发过程；4. 百济能否获得医药界的认可从而获得商业上的成功；5.百济神州能否为其技术和药物获得并维持知识产权的保护；6. 百济神州需依赖第三方开展临床前研究和临床试验；7. 百济神州较短的运营历史及能否为临床试验的进行获得更多资金，并完成其候选药物的开发和上市；8. 根据美国证券交易委员会《1933年证券法案》中第424(b)条规定备案的，百济神州最近一次在10-Q季度报告中“风险因素”章节全面、详细讨论的其他风险；9. 百济神州向美国证券交易委员会提交的后续备案中讨论到的一些潜在风险、不确定因素和其它重要因素。本新闻稿包含的所有信息都是在本新闻稿发表当日做出的，除非法律要求，百济神州没有义务更新这些信息。
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李聪 博士 +1 781-801-1800 ir@beigene.com media@beigene.com
BeiGene Receives Approval to Initiate Clinical Trials in China with PD-1 Antibody BGB-A317
BEIJING, Sept. 11, 2016 (GLOBE NEWSWIRE) -- BeiGene, Ltd. (NASDAQ:BGNE), a clinical-stage biopharmaceutical company focused on developing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, today announced that it has received Clinical Trial Application (CTA) approval from the China Food and Drug Administration (CFDA) to conduct clinical trials in China with investigational agent BGB-A317, a PD-1 antibody, for the treatment of advanced solid tumors. China is the fifth territory in which BGB-A317 has received approval to conduct clinical trials, in addition to Australia, New Zealand, the United States, andTaiwan. To date, BGB-A317 has been dosed in more than 200 patients, and preliminary data from the Phase I dose-escalation study of BGB-A317 were presented at the 2016 American Society of Clinical Oncology Annual Meeting in June.
“This event marks the receipt of regulatory clearance for all four of our clinical-stage molecules for initiation of clinical trials in China. The Chinese pharmaceutical market continues to grow robustly and is an important market for us. We are delighted to receive this clearance and look forward to commencing the development of BGB-A317 in China and updating the clinical data from the ongoing global study of BGB-A317,” said John V. Oyler, Founder, Chief Executive Officer, and Chairman.
“The CTA approval for BGB-A317 is supported by encouraging data from the Phase I dose-escalation trial in patients with advanced solid tumors conducted outside China. We will continue to communicate closely with the CFDA to continue advancing BGB-A317 along the domestic innovative drug development pathway,” said Wendy Yan, Head of Regulatory Affairs at BeiGene.
About BGB-A317
BGB-A317 is an investigational humanized monoclonal antibody that belongs to a class of immuno-oncology agents known as immune checkpoint inhibitors. It is designed to bind to PD-1, a cell surface receptor that plays an important role in downregulating the immune system by preventing the activation of T-cells. BGB-A317 has high affinity and specificity for PD-1, and we believe it is differentiated from the currently approved PD-1 antibodies with the ability to bind Fc gamma receptor I specifically engineered out. BGB-A317 is being developed as a monotherapy and in combination with other therapies for the treatment of various cancers.
About BeiGene
BeiGene is a global, clinical-stage, research-based biotechnology company focused on molecularly targeted and immuno-oncology cancer therapeutics. With a team of over 250 scientists, clinicians and staff in mainland China, the United States, Australia and Taiwan,BeiGene is advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for cancer. BeiGene is working to create combination solutions aimed to have both a meaningful and lasting impact on cancer patients.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the future clinical development and regulatory milestones of BGB-A317. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeiGene's ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials; BeiGene's ability to achieve market acceptance in the medical community necessary for commercial success; BeiGene's ability to obtain and maintain protection of intellectual property for its technology and drugs; BeiGene's reliance on third parties to conduct preclinical studies and clinical trials; BeiGene’s limited operating history and BeiGene's ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates, as well as those risks more fully discussed in the section entitled “Risk Factors” in the BeiGene’s most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeiGene's subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeiGeneundertakes no duty to update such information unless required by law.
（来源：百济神州官网新闻稿）