中國(guó)首個(gè)氘代藥物安泰坦正式獲批

关于安泰坦^®

安泰坦^®于2017年4月获得美国FDA批准，是FDA首次批准的氘代产品，也是针对与亨廷顿病有关的舞蹈病的历史上第二个药物^[6]。目前，该药已经在美国和中国两个国家获批，在美国的获批适应症包括与亨廷顿病（HD）有关的舞蹈病以及成人迟发性运动障碍（TD）。FDA对安泰坦^®的批准代表了HD患者的一个重要的新治疗选择，并强调了对这个服务不足的患者群体更多治疗资源的需求，TD适应症被批准为突破性治疗。我们相信，治疗迟发性运动障碍的医生会欣赏到该疗法的剂量灵活性，以及专注于直接治疗运动障碍而不破坏正在进行的基础疾病治疗的能力^[7]。

关于与亨廷顿病有关的舞蹈病获批临床试验^[8]

安泰坦^®获批用于治疗与亨廷顿病有关的舞蹈病，是基于一项90名患有明显亨廷顿病相关的舞蹈病患者参与的随机，双盲，安慰剂对照，多中心试验，主要临床评价指标为舞蹈病症状最高总评分（Total Maximal Chorea Score, TMC评分）。研究结果表明安泰坦^®：

• 具有显著的治疗效果：氘代丁苯那嗪组平均TMC评分改善幅度为4.4（安慰剂组1.9，P<0.0001），TMC评分提升6分以上的患者比例为33%（安慰剂组2%）。根据统一评定量表（Unified Huntington Disease Rating Scale, UHDRS），氘代丁苯那嗪组平均改善幅度为7.4（安慰剂组3.4，P=0.002）。
• 可显著提高治疗成功率：根据患者整体印象变化量表（Patient Global Impression of Change, PGIC），氘代丁苯那嗪组治疗成功率为51%（安慰剂组20%，P=0.002）；根据临床疗效总评量表（Clinical Global Impression of Change, CGIC），氘代丁苯那嗪组治疗成功率为42%（安慰剂组13%，P=0.002）。
• 具有良好的安全性，在开始治疗的患者中神经精神事件的发生率较低

关于成人迟发性运动障碍的临床试验^[9]

安泰坦^®获批用于治疗成人迟发性运动障碍，是基于两项III期随机、双盲、安慰剂对照、平行组研究的结果，研究结果证明安泰坦^®：

• 具有显著的治疗效果：治疗第12周氘代丁苯那嗪组的异常不自主运动量（Abnormal Involuntary Movement Scale，AIMS）评分改善幅度为3.3（安慰剂组1.5，P<0.001），AIMS评分提升50%以上的患者比例为33%（安慰剂组12%，P=0.007）。
• 可显著提高治疗成功率：在ARM-TD和AIM-TD研究的一项综合分析中，在第12周时，使用氘代丁苯那嗪的患者治疗成功的几率是使用安慰剂的患者的两倍多（2.1；P=0.005），并且使用氘代丁苯那嗪的患者的平均CGIC评分（48%）高于安慰剂（30%）
• 具有良好的安全性和耐受性。氘代丁苯那嗪对嗜睡、体重或心脏代谢因素的测量没有负面的影响。

关于梯瓦

梯瓦是一家总部位于以色列的全球性医药公司，是全世界最大的“药柜”之一，拥有超过1,800个分子化合物，35,000个产品。在美国，平均每7个处方就会用到1个梯瓦公司的产品，在过去的10年里，梯瓦公司为美国的医疗系统累计节省一共超过2150亿美金。我们的使命是成为全球仿制药和生物制药的领导者，提高和改善病患的生活质量。目前梯瓦在全球约有45,000名员工，在超过60个国家开展业务，2018年全年销售额接近190亿美金。

现在梯瓦已经来到中国，作为全球使命的一部分，梯瓦中国将会在未来的几年里大力拓展本土业务，我们计划在明年上半年上市第一款由我们创新研发的原研药品安泰坦^®, 以高品质药品为中国数百万患者提供帮助。在未来，梯瓦承诺会为中国的病患，以更快的速度带来更新更好的药物。

欲了解更多信息，请访问

www.tevapharm.com;
https://www.teva.cn/。

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 regarding the launch of AUSTEDO^® for treating Chorea associated with Huntington's Disease and Tardive Dyskinesia in adults in China, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to:

• uncertainty of the commercial success of AUSTEDO^®;
• uncertainty inherent in product development, including the receipt of approval for additional geographies and indications;
• our ability to successfully launch additional products in China;
• our ability to successfully compete in the marketplace, including: that we are substantially dependent on our generic products; consolidation of our customer base and commercial alliances among our customers; the increase in the number of competitors targeting generic opportunities and seeking U.S. market exclusivity for generic versions of significant products; competition for our specialty products, especially COPAXONE^®, our leading medicine, which faces competition from existing and potential additional generic versions, competing glatiramer acetate products and orally-administered alternatives; the uncertainty of commercial success of AJOVY^® or AUSTEDO^®; competition from companies with greater resources and capabilities; delays in launches of new products and our ability to achieve expected results from investments in our product pipeline; ability to develop and commercialize biopharmaceutical products; efforts of pharmaceutical companies to limit the use of generics, including through legislation and regulations and the effectiveness of our patents and other measures to protect our intellectual property rights;
• our business and operations in general, including: duration, and geographic reach of the COVID-19 pandemic and its impact on our business, financial condition, operations, cash flows, and liquidity and on the economy in general; interruptions in our supply chain, including due to potential effects of the COVID-19 pandemic on our operations and business in geographic locations impacted by the pandemic and on the business operations of our customers and suppliers; adequacy of and our ability to successfully execute and maintain the activities and efforts related to the measures we have taken or may take in response to the COVID-19 pandemic and associated costs therewith; implementation of our restructuring plan announced in December 2017; challenges associated with conducting business globally, including adverse effects of the COVID-19 pandemic, political or economic instability, major hostilities or terrorism; our ability to attract, hire and retain highly skilled personnel; our ability to develop and commercialize additional pharmaceutical products; compliance with anti-corruption sanctions and trade control laws; manufacturing or quality control problems; disruptions of information technology systems; breaches of our data security; variations in intellectual property laws; significant sales to a limited number of customers; our ability to successfully bid for suitable acquisition targets or licensing opportunities, or to consummate and integrate acquisitions; our prospects and opportunities for growth if we sell assets and potential difficulties related to the operation of our new global enterprise resource planning (ERP) system;
• compliance, regulatory and litigation matters, including: increased legal and regulatory action in connection with public concern over the abuse of opioid medications in the U.S. and our ability to reach a final resolution of the remaining opioid-related litigation; costs and delays resulting from the extensive governmental regulation to which we are subject or delays in governmental processing time including  due to modified government operations due to the COVID-19 pandemic and effects on product and patent approvals; the effects of reforms in healthcare regulation and reductions in pharmaceutical pricing, reimbursement and coverage; governmental investigations into S&M practices; potential liability for patent infringement; product liability claims; increased government scrutiny of our patent settlement agreements; failure to comply with complex Medicare and Medicaid reporting and payment obligations; and environmental risks;

and other factors discussed in our Quarterly Report on Form 10-Q for the first quarter  of 2020 and our Annual Report on Form 10-K for the year ended December 31, 2019, including in the sections captioned "Risk Factors” and “Forward Looking Statements.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.

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