TEL AVIV, Israel & PARSIPPANY, N.J.--(BUSINESS WIRE)--Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced results from a Phase 3 study evaluating the efficacy and safety of AJOVY for the prevention of migraine in adult Chinese patients..

以色列特拉维夫和新泽西州帕西帕尼（BUSINESS WIRE）--Teva Pharmaceuticals，Teva Pharmaceuticals Industries Ltd.（纽约证券交易所和塔斯社：Teva）的美国附属公司，今天宣布了一项评估AJOVY预防中国成年患者偏头痛的有效性和安全性的3期研究结果。。

In the study, AJOVY achieved primary endpoint and all secondary endpoints, significantly reducing the number of migraine days experienced per month, demonstrating superior efficacy over placebo. All key secondary endpoints were also met including measures for early onset of efficacy during the first month, responder rate analysis defined as 50% reduction of migraine days and reduction of acute headache medication use over 3 months after first use.

在这项研究中，AJOVY达到了主要终点和所有次要终点，显着减少了每月经历的偏头痛天数，显示出优于安慰剂的疗效。所有关键的次要终点也得到了满足，包括第一个月内早期起效的措施，应答率分析定义为偏头痛天数减少50%，首次使用后3个月内急性头痛药物使用减少。

Study data also show AJOVY was safe and well tolerated with no emerging safety signals. This data is consistent with the previous Phase 3 data for AJOVY which was approved for the preventive treatment of migraine in adults in the U.S. in 2018 and in the EU in 2019..

研究数据还显示，AJOVY安全且耐受性良好，没有出现安全信号。该数据与之前的AJOVY第三阶段数据一致，该数据于2018年在美国和2019年在欧盟被批准用于预防成人偏头痛。。

In China, an estimated 14.3% of non-elderly adults are living with migraine.1 From this population, approximately 52.9% will visit hospitals and only 13.8% of them will be diagnosed with migraine.2

在中国，估计有14.3%的非老年人患有偏头痛。1在这一人群中，大约52.9%的人会去医院，只有13.8%的人会被诊断出患有偏头痛。2

“Migraine and its debilitating symptoms impact people around the world, and these study results from Chinese migraine patients reinforce AJOVY as a proven preventive medicine that can safely and effectively help reduce the burden of migraine,” said Eric Hughes, MD, PhD, Executive Vice President of Global R&D and Chief Medical Officer at Teva.

Teva全球研发执行副总裁兼首席医疗官埃里克·休斯（EricHughes）博士说：“偏头痛及其使人衰弱的症状影响着世界各地的人们，这些来自中国偏头痛患者的研究结果强化了阿霍维作为一种经证实的预防药物，可以安全有效地帮助减轻偏头痛的负担。”。

'China has the largest migraine population worldwide,3 and Teva is committed to research on a global scale that helps address unmet need where it exists and ensure that the role of treatment innovations like AJOVY are better understood.”.

“中国是世界上偏头痛人数最多的国家，3特瓦致力于在全球范围内进行研究，以帮助解决其存在的未满足需求，并确保更好地了解阿佐维等治疗创新的作用。”。

Migraine attacks cause disabling pain, nausea, vomiting and sensitivities to light and sound, resulting in serious effects on the ability to complete daily tasks. The burden of migraine and the fear of the next one can lead to a significant negative impact on quality of life, including family, social and professional relationships.

偏头痛发作会导致致残性疼痛，恶心，呕吐以及对光和声音的敏感性，从而严重影响完成日常任务的能力。偏头痛的负担和对下一次偏头痛的恐惧可能会对生活质量产生重大的负面影响，包括家庭、社会和职业关系。

People who experience migraine are more likely to suffer from anxiety and depression compared to healthy individuals.4.

与健康人相比，偏头痛患者更容易患焦虑和抑郁。

AJOVY is a humanized monoclonal antibody (mAb) which selectively binds the calcitonin gene-related peptide (CGRP).

AJOVY是一种人源化单克隆抗体（mAb），可选择性结合降钙素基因相关肽（CGRP）。

In the Phase 3 double-blind study in China, 365 adult participants were randomized 1:1:2 to receive AJOVY subcutaneously 225mg once-monthly for three months or a single dose of 675mg once-quarterly or placebo.

在中国的第三阶段双盲研究中，365名成年参与者以1:1:2的比例随机接受AJOVY皮下注射225mg，每月一次，持续三个月，或每季度一次单剂量675mg或安慰剂。

'For the many millions of migraine patients in China,1 there is a need for preventive treatment options that may help reduce the number of migraine days they experience and support the alleviation of the incapacitating symptoms migraine can cause,” said Shengyuan Yu, MD, PhD, Director and Professor, Department of Neurology, Chinese PLA General Hospital.

中国人民解放军总医院神经内科主任兼教授余盛元博士说：“对于中国数百万偏头痛患者来说，1需要预防性治疗方案，这可能有助于减少他们经历的偏头痛天数，并有助于缓解偏头痛可能引起的失能症状。”。

'These Phase 3 data indicate that fremanezumab has the potential to significantly improve life quality of the patients with migraine in China.”.

“这些3期数据表明，fremanezumab有可能显着改善中国偏头痛患者的生活质量。”。

In the study, AJOVY was safe and well tolerated with no safety signals observed. The most common treatment-related (≥5%) AEs were injection site reactions.

在这项研究中，AJOVY是安全的，耐受性良好，没有观察到安全信号。最常见的治疗相关（≥5%）AE是注射部位反应。

Additional findings from this study are planned for presentation at a medical meeting later this year.

这项研究的其他发现计划在今年晚些时候的医学会议上发表。

About AJOVY Phase 3 Study in China

关于AJOVY在中国的第三阶段研究

This multicenter, randomized, double-blind, placebo-controlled study is evaluating the efficacy, safety and tolerability of fremanezumab injection for subcutaneous use as a treatment in patients (ages 18-70 years) with episodic or chronic migraine vs placebo. The study enrolled 365 patients who were randomized to receive a subcutaneous injection of fremanezumab once-monthly or once-quarterly, or placebo in a 1:1:2 ratio.

这项多中心，随机，双盲，安慰剂对照研究正在评估皮下注射fremanezumab治疗发作性或慢性偏头痛患者（18-70岁）与安慰剂相比的疗效，安全性和耐受性。该研究招募了365名患者，他们被随机分配每月或每季度皮下注射一次fremanezumab，或以1:1:2的比例接受安慰剂。

The primary objective is to demonstrate the efficacy of fremanezumab administered as once-monthly and once-quarterly subcutaneous injections to adult Chinese participants with migraine. The secondary objectives are to further demonstrate the efficacy of fremanezumab administered as once-monthly and once-quarterly subcutaneous injections and to evaluate the safety and tolerability of fremanezumab administered as once-monthly and once-quarterly subcutaneous injections.

主要目的是证明fremanezumab每月一次和每季度一次皮下注射给成年偏头痛患者的疗效。次要目标是进一步证明每月一次和每季度一次皮下注射fremanezumab的疗效，并评估每月一次和每季度一次皮下注射fremanezumab的安全性和耐受性。

The study consists of a screening visit, a baseline period (4 weeks), a 12-week double-blind treatment period, a 12-week open-label treatment period when all patients receive 225mg of AJOVY monthly, and a follow-up period lasting 3 months after the last dose of treatment. The open label phase of the trial is still ongoing..

该研究包括筛查访问，基线期（4周），12周双盲治疗期，12周开放标签治疗期（所有患者每月接受225mg AJOVY），以及持续3个月的随访期最后一剂治疗后。试验的开放标签阶段仍在进行中。。

About AJOVY▼ (fremanezumab-vfrm) injection

关于AJOVY▼ （fremanezumab vfrm）注射液

AJOVY is indicated for the preventive treatment of migraine in adults. AJOVY is available as a 225 mg/1.5 mL single dose injection in a pre-filled syringe or, in some countries, in a pre-filled pen. Two dosing options are available: 225 mg once monthly administered as one subcutaneous injection (monthly dosing), or 675 mg every three months (quarterly dosing), which is administered as three subcutaneous injections.

AJOVY适用于成人偏头痛的预防性治疗。AJOVY可在预先填充的注射器中或在某些国家，在预先填充的笔中以225 mg/1.5 mL的单剂量注射方式提供。有两种给药选择：每月一次225毫克，作为一次皮下注射（每月给药），或每三个月675毫克（每季度给药），作为三次皮下注射给药。

AJOVY can be administered either by a healthcare professional or at home by a patient or caregiver..

AJOVY可以由医疗保健专业人员管理，也可以由患者或护理人员在家管理。。

About Teva

关于Teva

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a global pharmaceutical leader with a category-defying portfolio, harnessing our generics expertise and stepping up innovation to continue the momentum behind the discovery, delivery, and expanded development of modern medicine. For over 120 years, Teva's commitment to bettering health has never wavered.

Teva Pharmaceutical Industries Ltd.（纽约证券交易所和塔斯社：Teva）是一家全球制药领导者，拥有挑战类别的投资组合，利用我们的仿制药专业知识并加快创新，以继续推动现代医学的发现，交付和扩展发展。120多年来，特瓦对改善健康的承诺从未动摇过。

Today, the company’s global network of capabilities enables its ~37,000 employees across 58 markets to push the boundaries of scientific innovation and deliver quality medicines to help improve health outcomes of millions of patients every day. To learn more about how Teva is all in for better health, visit www.tevapharm.com..

如今，该公司的全球能力网络使其在58个市场的约37000名员工能够推动科学创新的界限，并提供优质药物，以帮助每天改善数百万患者的健康状况。要了解更多关于Teva如何改善健康的信息，请访问www.tevapharm.com。。