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]。

关于亨廷顿病有关的舞蹈病获批临床试验^[8]

安泰坦^®批用于治疗与亨廷顿病有关的舞蹈病是基于一项由90例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、多中心试验的结果。该研究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。

• 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。

• uncertaintyof the commercial success of AUSTEDO;
• uncertaintyinherent in product development, including the receipt of approval foradditional geographies and indications;
• our ability to successfully launch additionalproducts in China;
• ourability to successfully compete in the marketplace, including: that we aresubstantially dependent on our generic products; consolidation of our customerbase and commercial alliances among our customers; the increase in the numberof competitors targeting generic opportunities and seeking U.S. marketexclusivity for generic versions of significant products; competition for ourspecialty products, especially COPAXONE®, our leading medicine,which faces competition from existing and potential additional genericversions, competing glatiramer acetate products and orally-administeredalternatives; the uncertainty of commercial success of AJOVY® orAUSTEDO®; competition from companies with greater resources andcapabilities; delays in launches of new products and our ability to achieveexpected results from investments in our product pipeline; ability to developand commercialize biopharmaceutical products; efforts of pharmaceuticalcompanies to limit the use of generics, including through legislation andregulations and the effectiveness of our patents and other measures to protectour intellectual property rights;
• ourbusiness and operations in general, including: duration, and geographic reachof 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 theCOVID-19 pandemic on our operations and business in geographic locationsimpacted by the pandemic and on the business operations of our customers andsuppliers; adequacy of and our ability to successfully execute and maintain theactivities and efforts related to the measures we have taken or may take inresponse to the COVID-19 pandemic and associated costs therewith; implementationof our restructuring plan announced in December 2017; challenges associatedwith conducting business globally, including adverse effects of the COVID-19pandemic, political or economic instability, major hostilities or terrorism; ourability to attract, hire and retain highly skilled personnel; our ability todevelop and commercialize additional pharmaceutical products; compliance with anti-corruptionsanctions 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 numberof customers; our ability to successfully bid for suitable acquisition targetsor licensing opportunities, or to consummate and integrate acquisitions; ourprospects and opportunities for growth if we sell assets and potentialdifficulties related to the operation of our new global enterprise resourceplanning (ERP) system;
• compliance,regulatory and litigation matters, including: increased legal and regulatoryaction in connection with public concern over the abuse of opioid medicationsin the U.S. and our ability to reach a final resolution of the remainingopioid-related litigation; costs and delays resulting from the extensivegovernmental regulation to which we are subject or delays in governmentalprocessing time including  due tomodified government operations due to the COVID-19 pandemic and effects onproduct and patent approvals; the effects of reforms in healthcare regulationand reductions in pharmaceutical pricing, reimbursement and coverage;governmental investigations into S&M practices; potential liability forpatent infringement; product liability claims; increased government scrutiny ofour patent settlement agreements; failure to comply withcomplex Medicare and Medicaid reporting and payment obligations;and environmental risks;