OSAKA, Japan & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Takeda (TSE:4502/NYSE:TAK) today announced that LIVTENCITY® (maribavir) has been approved by the Japanese Ministry of Health, Labour and Welfare (MHLW) for post-transplant cytomegalovirus (CMV) infection/disease that is refractory to existing anti-CMV therapies.4 LIVTENCITY is the first and only post-transplant anti-CMV treatment approved in Japan that targets and inhibits pUL97 kinase and its natural substrates.1.

日本大阪和马萨诸塞州剑桥。-（商业新闻短讯）--武田（东京证交所：4502/纽约证交所：TAK）今天宣布，LIVTENCITY®（马里巴韦）已获得日本厚生劳动省（MHLW）的批准，用于移植后巨细胞病毒（CMV）感染/疾病，对现有的抗CMV治疗无效[4]。LIVTENCITY是日本批准的第一种也是唯一一种针对和抑制pUL97激酶及其天然底物的移植后抗CMV治疗。

“We are pleased by the approval of LIVTENCITY in Japan, which will provide the transplant community with a new option for treatment of post-transplant CMV infection in patients refractory to other therapies,” said Yasushi Kajii, Head, R&D Japan Region at Takeda. “A diagnosis of CMV infection can be particularly challenging for patients, and serious complications such as increased organ rejection and hospitalization rates can occur, when not successfully treated.

武田日本研发部负责人Kajii Yasushi说：“我们对日本LIVTENCITY的批准感到高兴，这将为移植界提供一种新的选择，用于治疗其他疗法难治的患者的移植后CMV感染。”。“巨细胞病毒感染的诊断对患者来说尤其具有挑战性，如果治疗不成功，可能会出现严重的并发症，如器官排斥反应增加和住院率增加。

We believe LIVTENCITY has the potential to help address the challenges faced by people with post-transplant CMV and transform the treatment landscape for patients in Japan.”.

我们相信LIVTENCITY有可能帮助解决移植后巨细胞病毒患者面临的挑战，并改变日本患者的治疗格局。”。

The approval is primarily based on the results of the Phase 3 SOLSTICE trial (NCT02931539), which evaluated the safety and efficacy of LIVTENCITY versus alternative antiviral treatments for patients with CMV infection/disease refractory* to prior therapies who underwent hematopoietic stem cell transplant (HSCT) or solid organ transplant (SOT), and the Japanese Phase 3 open-label study in patients with CMV infection, including those with refractory* CMV infection who underwent HSCT or SOT (NCT05137717)..

该批准主要基于3期SOLSTICE试验（NCT02931539）的结果，该试验评估了对接受造血干细胞移植（HSCT）或实体器官移植（SOT）的先前治疗的CMV感染/疾病难治性*患者的存活率与替代抗病毒治疗的安全性和有效性，以及日本对CMV感染患者（包括接受HSCT或SOT的难治性*CMV感染患者）的3期开放标签研究（NCT05137717）。。

In the SOLSTICE trial (maribavir n=235, alternative treatments n=117), maribavir showed statistically significant improvement when compared to alternative antiviral treatments at the end of Week 8 for the primary endpoint of confirmed CMV viremia clearancea in post-transplant (HSCT or SOT) adults with refractory* CMV infection.5 Of the 234 patients included in the safety evaluation, adverse reactions (related cases) were observed in 141 patients (60.3%).5.

在SOLSTICE试验（马里巴韦n=235，替代治疗n=117）中，与第8周末的替代抗病毒治疗相比，马里巴韦在移植后确诊的CMV病毒血症清除的主要终点（HSCT或SOT）成人难治性*CMV感染中显示出统计学显着的改善。在安全性评估中包括的234名患者中，141名患者（60.3%）观察到不良反应（相关病例）。

An open-label, multicenter, single-arm study was conducted to evaluate the efficacy and safety in Japanese patients in post-transplant (HSCT or SOT) adultsc (41 randomized, including 3 subjects with CMV infection refractory* to the most recently administered anti-CMV agent). The primary endpoint of CMV viremia clearanceb at the end of Study Week 8 was achieved in 33.3% of patients with refractory* CMV infection.4 Of 41 subjects included in the safety evaluation, adverse reactions (related events) were observed in 36.6% (15 subjects).

进行了一项开放标签，多中心，单臂研究，以评估日本患者在移植后（HSCT或SOT）成人SC中的疗效和安全性（41名随机分组，包括3名CMV感染难治*的受试者最近服用的抗CMV药物）。在研究第8周结束时，33.3%的难治性*CMV感染患者达到了CMV病毒血症清除的主要终点。在安全性评估的41名受试者中，有4名观察到36.6%的不良反应（相关事件）（15名受试者）。

4.

4.

About LIVTENCITY

关于LIVTENCITY

LIVTENCITY (maribavir), an orally administered (tablet) anti-CMV compound, is the first and only antiviral agent that targets and inhibits the CMV-specific UL97 protein kinase and thus its natural substrates.1 As of June 2024, LIVTENCITY is approved in more than 30 countries for post-transplant CMV refractory* to prior therapies, including such major markets as Japan, the United States, Canada, Australia, the European Union and China..

LIVTENCITY（maribavir）是一种口服（片剂）抗CMV化合物，是第一种也是唯一一种靶向和抑制CMV特异性UL97蛋白激酶及其天然底物的抗病毒药物。1截至2024年6月，LIVTENCITY在30多个国家被批准用于移植后CMV难治性*的先前治疗，包括日本，美国，加拿大，澳大利亚，欧盟和中国等主要市场。。

LIVTENCITY Product Overview in Japan

LIVTENCITY日本产品概述

Product Name

产品名称

LIVTENCITY 200 mg tablets.

LIVTENCITY 200 mg片剂。

Generic Name

通用名称

Maribavir

马里巴韦

Indications

适应症

The post-transplant cytomegalovirus (CMV) infection/disease that is refractory to existing anti-CMV therapies.

移植后巨细胞病毒（CMV）感染/疾病，对现有的抗CMV治疗无效。

Precautions concerning indications

关于适应症的注意事项

This drug should be administered to post-transplant patients with CMV infection/disease who have responded inadequately to other therapies.

这种药物应该用于对其他疗法反应不足的CMV感染/疾病的移植后患者。

Efficacy and safety have not been studied in patients with CMV infection of the central nervous system and CMV retinitis. Based on nonclinical studies, this drug is expected to cross the blood-brain barrier but has low potential to enter the central nervous system.

尚未研究中枢神经系统CMV感染和CMV视网膜炎患者的疗效和安全性。根据非临床研究，这种药物有望穿过血脑屏障，但进入中枢神经系统的可能性很低。

Dosage and Administration

剂量和给药

Usually, the recommended dosage for adultsc is 400 mg of maribavir to be administered orally twice daily.

通常，成人SC的推荐剂量为400毫克马里巴韦，每天两次口服。

About Takeda’s SOLSTICE Trial

The TAK-620-303 (SOLSTICE) trial (NCT02931539, EudraCT 2015-004725-13) was a Phase 3 global, multicenter, randomized, open-label, active-controlled trial to assess the efficacy and safety of maribavir treatment compared to investigator-assigned treatment (alternative antiviral therapies) in 352 HSCT and SOT recipients with CMV infections that were refractory* or resistant to one or a combination of the alternative antiviral therapies: ganciclovir, valganciclovir, foscarnet, or cidofovir.

TAK-620-303（SOLSTICE）试验（NCT02931539，EudraCT 2015-004725-13）是一项3期全球，多中心，随机，开放标签，主动对照试验，用于评估与研究者指定治疗（替代抗病毒治疗）相比，马里巴韦治疗的有效性和安全性。352名HSCT和SOT受试者患有CMV感染，这些感染对更昔洛韦，缬更昔洛韦，膦甲酸钠或西多福韦的一种或多种替代抗病毒治疗具有难治性*或耐药性。

Adult patients underwent a 2-week screening period, followed by randomization 2:1 to maribavir (n=235) (400 mg, twice daily) or alternative antiviral treatments (n=117) (as dosed by the investigator) for up to 8 weeks. After completion of the treatment period, subjects entered a 12-week follow-up phase.5 The trial’s primary efficacy endpoint was confirmed CMV viremia clearance a at the end of Week 8.

成年患者接受为期2周的筛查期，然后以2:1的比例随机分配至马里巴韦（n=235）（400 mg，每日两次）或替代抗病毒治疗（n=117）（由研究者给药）长达8周。治疗期结束后，受试者进入12周的随访阶段。试验的主要疗效终点是在第8周结束时确认CMV病毒血症清除率为a。

The key secondary endpoint was confirmed CMV viremia clearance and CMV infection symptom control† at the end of Study Week 8 with maintenance of this treatment effect through Study Week 16.5.

关键的次要终点是在研究第8周结束时确认CMV病毒血症清除率和CMV感染症状控制†，并在研究第16.5周维持这种治疗效果。

About Cytomegalovirus (CMV)

关于巨细胞病毒（CMV）

CMV is a beta herpesvirus that commonly infects humans; serologic evidence of prior infection can be found in 40-100% of various adult populations.6 CMV typically resides latent and asymptomatic in the body but may reactivate during periods of immunosuppression. Serious disease may occur in individuals with compromised immune systems, which includes patients who receive immunosuppressants associated with various types of transplants including HSCT or SOT.5,7 Out of the estimated 200,000 adult transplants per year globally, CMV is one of the most common viral infections experienced by transplant recipients, with an estimated incidence rate between 16-56% in SOT recipients and 30-80% in HSCT recipients.7,8.

CMV是一种通常感染人类的β疱疹病毒；。免疫系统受损的个体可能会发生严重疾病，其中包括接受与各种类型移植（包括HSCT或SOT）相关的免疫抑制剂的患者[5,7]。在全球每年估计的200000例成人移植中，CMV是移植受者最常见的病毒感染之一，SOT受者的发病率估计在16-56%之间，HSCT受者的发病率估计在30-80%之间[7,8]。

In transplant recipients, reactivation of CMV infection can lead to secondary infections and serious consequences, including graft loss and, in extreme cases, can be fatal.2,3,5

在移植受者中，巨细胞病毒感染的重新激活可导致继发感染和严重后果，包括移植物丢失，在极端情况下可能致命。2,3,5

About Takeda

关于武田

Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines.

武田致力于为人们创造更好的健康，为世界创造更美好的未来。我们的目标是在我们的核心治疗和业务领域发现并提供改变生命的治疗方法，包括胃肠道和炎症、罕见疾病、血浆衍生疗法、肿瘤学、神经科学和疫苗。

Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet.

与我们的合作伙伴一起，我们的目标是通过我们动态多样的渠道改善患者体验，并推进治疗选择的新前沿。作为总部位于日本的领先的基于价值观、研发驱动的生物制药公司，我们以对患者、人民和地球的承诺为指导。

Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit www.takeda.com..

我们在大约80个国家和地区的员工是由我们的目标驱动的，并以两个多世纪以来定义我们的价值观为基础。有关更多信息，请访问www.takeda.com。。

LIVTENCITY Safety Information

LIVENCITY安全信息

Contraindications

禁忌症

Contraindications include Hypersensitivity to the active substance or to any of the excipients and co‑administration with ganciclovir or valganciclovir.

禁忌症包括对活性物质或任何赋形剂的超敏反应以及与更昔洛韦或缬更昔洛韦的联合给药。

Special warnings and precautions for use

特殊警告和使用注意事项

Some maribavir pUL97 resistance-associated substitutions confer cross-resistance to ganciclovir and valganciclovir. CMV DNA levels should be monitored, and resistance mutations should be investigated in patients who do not respond to treatment. Treatment should be discontinued if maribavir resistance mutations are detected..

。应监测CMV DNA水平，并应调查对治疗无反应的患者的耐药突变。如果检测到马里巴韦耐药突变，应停止治疗。。

LIVTENCITY is not expected to be effective in treating CMV CNS infections (e.g. meningo‑encephalitis).

LIVTENCITY预计不会有效治疗CMV中枢神经系统感染（例如脑膜脑炎）。

LIVTENCITY has the potential to increase the concentrations of immunosuppressants that are cytochrome P450 (CYP)3A/P-gp substrates with narrow therapeutic margins (including tacrolimus, cyclosporine, sirolimus and everolimus). The plasma levels of these immunosuppressants must be frequently monitored throughout treatment with LIVTENCITY, especially following initiation and after discontinuation of LIVTENCITY, and doses should be adjusted, as needed..

LIVTENCITY有可能增加免疫抑制剂的浓度，这些免疫抑制剂是细胞色素P450（CYP）3A/P-gp底物，具有狭窄的治疗边缘（包括他克莫司，环孢素，西罗莫司和依维莫司）。在整个治疗过程中，必须经常监测这些免疫抑制剂的血浆水平，特别是在开始和停止存活后，并且应根据需要调整剂量。。

The concomitant use of LIVTENCITY and certain medicinal products may result in known or potentially significant medicinal product interactions, some of which may lead to:

同时使用LIVTENCITY和某些药品可能会导致已知或潜在的重要药品相互作用，其中一些可能导致：

possible clinically significant adverse reactions from greater exposure of concomitant medicinal products.

伴随药品的更多暴露可能导致临床上显着的不良反应。

reduced therapeutic effect of LIVTENCITY.

降低了活力的治疗效果。

Sodium content: This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium‑free’.

钠含量：该药品每片含有少于1 mmol钠（23 mg），即基本上“无钠”。

Pregnancy & Breast-feeding: LIVTENCITY is not recommended during pregnancy and in women of childbearing potential not using contraception. Breast‑feeding should be discontinued during treatment with LIVTENCITY.

怀孕和母乳喂养：不建议在怀孕期间和不使用避孕措施的有生育潜力的女性服用LIVTENCITY。。

Interactions

Effect of other medicinal products on maribavir: Co-administration of maribavir with strong cytochrome P450 3A (CYP3A) inducers rifampicin, rifabutin or St. John’s wort is not recommended. If co-administration of maribavir with other strong or moderate CYP3A inducers (e.g., carbamazepine, efavirenz, phenobarbital and phenytoin) cannot be avoided, the maribavir dose should be increased to 1 200 mg twice daily.

其他药物对马里巴韦的影响：不建议将马里巴韦与强细胞色素P450 3A（CYP3A）诱导剂利福平，利福布汀或圣约翰草共同给药。如果不能避免将马里巴韦与其他强或中度CYP3A诱导剂（例如卡马西平，依非韦伦，苯巴比妥和苯妥英钠）共同给药，则应每天两次将马里巴韦剂量增加至1200 mg。

No dose adjustment is needed when maribavir is co‑administered with CYP3A inhibitors..

。。

Effect of maribavir on other medicinal products: If dose adjustments of concomitant medicinal products are made due to treatment with maribavir, doses should be readjusted after treatment with maribavir is completed.

马里巴韦对其他药品的影响：如果由于马里巴韦治疗而对伴随药品进行剂量调整，则应在马里巴韦治疗完成后重新调整剂量。

Co-administration of maribavir with valganciclovir and ganciclovir is contraindicated.

禁止将马里巴韦与缬更昔洛韦和更昔洛韦联合给药。

Concomitant administration of maribavir and medicinal products that are sensitive substrates of CYP1A2 with a narrow therapeutic window (e.g., tizanidine and theophylline) should be avoided due to the risk for lack of efficacy of CYP1A2 substrates.

由于CYP1A2底物缺乏疗效的风险，应避免同时服用马里巴韦和作为CYP1A2敏感底物且治疗窗口狭窄的药物（例如替扎尼定和茶碱）。

When the immunosuppressants tacrolimus, cyclosporine, everolimus or sirolimus are co-administered with maribavir, immunosuppressant levels should be frequently monitored throughout treatment with maribavir, especially following initiation and after discontinuation of maribavir and dose adjusted, when needed..

当免疫抑制剂他克莫司、环孢素、依维莫司或西罗莫司与马里巴韦联合使用时，应在整个马里巴韦治疗过程中经常监测免疫抑制剂水平，特别是在开始和停用马里巴韦后，并在需要时调整剂量。。

Caution should be exercised when maribavir and sensitive P-gp substrates (e.g., digoxin, dabigatran) are co‑administered. Serum digoxin concentrations should be monitored, and dose of digoxin may need to be reduced, as needed (see Table 1).

当联合使用马里巴韦和敏感的P-gp底物（例如地高辛，达比加群）时，应谨慎行事。应监测血清地高辛浓度，并根据需要减少地高辛的剂量（见表1）。

Co‑administration of maribavir with sensitive BCRP substrates such as rosuvastatin, is expected to increase their exposure and lead to undesirable effects.

马里巴韦与敏感的BCRP底物（如瑞舒伐他汀）共同给药，预计会增加其暴露量并导致不良反应。

Adverse Reactions

不良反应

Very common

非常常见

(≥1/10)

(≥1/10)

Taste disturbance, Diarrhoea, Nausea, Vomiting, Fatigue

味觉障碍、腹泻、恶心、呕吐、疲劳

Common

普通

(≥1/100 to <1/10)

（≥1/100至<1/10）

Headache, Abdominal pain upper, Decreased appetite, Immunosuppressant drug level increased, Weight decreased

头痛，腹痛上身，食欲下降，免疫抑制剂水平升高，体重下降

The most commonly reported serious adverse reactions were diarrhoea (2%) and nausea, weight decreased, fatigue, immunosuppressant drug level increased, and vomiting (all occurring at < 1%).

最常报告的严重不良反应是腹泻（2%），恶心，体重减轻，疲劳，免疫抑制剂药物水平升高和呕吐（均发生在1%以下）。

Please consult the LIVTENCITY (maribavir) approved label before prescribing, particularly in relation to dosing and treatment monitoring.

在开处方之前，请咨询LIVTENCITY（maribavir）批准的标签，特别是与剂量和治疗监测有关的标签。

For Japan, please consult the LIVTENCITY Japan Package Insert.

对于日本，请参阅LIVTENCITY Japan Package Insert。

For the European Union, please consult the Summary of Products Characteristics (SmPC).

对于欧盟，请参阅产品特性摘要（SmPC）。

For China, please consult the LIVTENCITY China Package Leaflet.

对于中国，请参阅LIVTENCITY China套餐传单。

For full U.S. Prescribing Information, including the approved indication and important safety information, please visit: https://content.takeda.com/?contenttype=pi&product=liv&language=eng&country=usa&documentnumber=1

有关完整的美国处方信息，包括批准的适应症和重要的安全信息，请访问：https://content.takeda.com/?contenttype=pi&product=liv&language=eng&country=usa&documentnumber=1

Important Notice

重要注意事项

For the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction.

就本通知而言，“新闻稿”是指武田制药有限公司（“武田”）就本新闻稿讨论或分发的本文件、任何口头陈述、任何问答环节以及任何书面或口头材料。本新闻稿（包括任何口头简报以及与之相关的任何问题和答案）不打算，也不构成、代表或构成在任何司法管辖区内购买、以其他方式获取、认购、交换、出售或以其他方式处置任何证券的任何要约、邀请或邀约的一部分，也不构成任何投票或批准的邀约、邀请或邀约的一部分。

No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction).

本新闻稿不向公众发售任何股份或其他证券。除非根据经修订的《1933年美国证券法》注册或豁免，否则不得在美国境内发行证券。本新闻稿（连同可能向接收方提供的任何进一步信息）的发布条件是，本新闻稿仅供接收方参考（不用于评估任何投资、收购、处置或任何其他交易）。

Any failure to comply with these restrictions may constitute a violation of applicable securities laws. The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general.

任何不遵守这些限制的行为都可能构成对适用证券法的违反。武田直接和间接拥有投资的公司是独立的实体。在本新闻稿中，通常提及武田及其子公司时，“武田”有时是为了方便起见。

Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies..

同样，“我们”、“我们”和“我们的”也用于指代一般的子公司或为其工作的人。如果识别特定公司没有任何有用的目的，也可以使用这些表达。。

Forward-Looking Statements

前瞻性声明

This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could”, “anticipates”, “estimates”, “projects” or similar expressions or the negative thereof.

本新闻稿和与本新闻稿相关的任何材料可能包含有关武田未来业务、未来地位和经营成果的前瞻性声明、信念或意见，包括武田的估计、预测、目标和计划。不受限制，前瞻性陈述通常包括“目标”，“计划”，“相信”，“希望”，“继续”，“期望”，“目标”，“打算”，“确保”，“将”，“可能”，“应该”，“将”，“可能”，“预期”，“估计”，“项目”或类似表达或其负面影响。

These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations, including global health care reforms; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic, on Takeda and its customers and suppliers, including foreign governments in countries in which Takeda operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to div.

这些前瞻性陈述基于对许多重要因素的假设，包括以下因素，这些因素可能导致实际结果与前瞻性陈述中明示或暗示的结果产生重大差异：围绕武田全球业务的经济情况，包括日本和美国的一般经济状况；竞争压力和发展；适用法律法规的变更，包括全球医疗保健改革；新产品开发固有的挑战，包括临床成功的不确定性以及监管机构的决策及其时间安排；新产品和现有产品商业成功的不确定性；制造困难或延误；利率和货币汇率波动；关于上市产品或候选产品的安全性或有效性的索赔或担忧；健康危机（如新型冠状病毒大流行）对武田及其客户和供应商（包括武田经营所在国的外国政府）或其业务其他方面的影响；与被收购公司进行并购后整合的时机和影响；潜水的能力。

Medical Information

医疗信息

This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development..

本新闻稿包含的产品信息可能并非在所有国家都可用，也可能以不同商标、不同适应症、不同剂量或不同强度提供。此处所含内容不应视为任何处方药（包括正在开发的处方药）的招揽、促销或广告。。

* Including a subgroup with genotypic resistance to alternative antiviral treatments.

*包括对替代抗病毒治疗具有基因型抗性的亚组。

a Defined as confirmed CMV DNA concentration below the lower limit of quantification (<LLOQ; i.e., <137 IU/mL) in two consecutive samples separated by at least five days.

a定义为在间隔至少五天的两个连续样品中确认的CMV DNA浓度低于定量下限（<LLOQ；即<137 IU/mL）。

b Defined as confirmed CMV DNA concentration below the lower limit of quantification (<LLOQ; i.e., <34.5 IU/mL) in two consecutive samples separated by at least five days.

b定义为在间隔至少五天的两个连续样品中确认的CMV DNA浓度低于定量下限（<LLOQ；即<34.5 IU/mL）。

c Defined as > 15 years old

c定义为>15岁

† CMV infection symptom control was defined as resolution or improvement of tissue-invasive disease or CMV syndrome for symptomatic patients at baseline, or no new symptoms for patients who were asymptomatic at baseline.

†CMV感染症状控制定义为基线时有症状患者的组织浸润性疾病或CMV综合征的消退或改善，或基线时无症状患者无新症状。

References

参考文献

Avram S, et al. Novel drug targets in 2021. Nature Reviews Drug Discovery. 2022;21(5):328-328.

Avram S等人。2021年的新药目标。自然评论药物发现。2022年；21（5）：328-328。

Ramanan P, Razonable RR. Cytomegalovirus infections in solid organ transplantation: a review. Infection & Chemotherapy. 2013;45(3):260

Ramanan P，Razoble RR。实体器官移植中的巨细胞病毒感染：综述。感染和化疗。2013年；

Camargo JF, Komanduri KV. Emerging concepts in cytomegalovirus infection following hematopoietic stem cell transplantation. Hematol Oncol Stem Cell Ther. 2017;10(4):233-238. doi:10.1016/j.hemonc.2017.05.001

Camargo JF，Komanduri KV。造血干细胞移植后巨细胞病毒感染的新兴概念。造血干细胞疗法。2017年；10（4）：233-238。doi:10.1016/j.hemonc.2017.05.001

LIVTENCITY Package Insert in Japan.

LIVTENCITY套装插入日本。

Avery R, Alain S, Alexander BD, et al. SOLSTICE Trial Investigators. Maribavir for refractory cytomegalovirus infections with or without resistance post-transplant: results from a phase 3 randomized clinical trial. Clin Infect Dis. 2022;75(4):690–701. doi:10.1093/cid/ciab988

Avery R，Alain S，Alexander BD等。SOLSTICE试验调查员。马里巴韦治疗移植后有或没有耐药性的难治性巨细胞病毒感染：来自3期随机临床试验的结果。临床感染Dis。2022年；75（4）：690-701。

de la Hoz RE, Stephanie G, Sherlock C. Diagnosis and treatment approaches to CMV infections in adult patients. J Clin Virol. 2002;25(Suppl 1):S1-S12. doi:10.1016/s1386-6532(02)00091-4

de la Hoz RE，Stephanie G，Sherlock C.成人患者CMV感染的诊断和治疗方法。J Clin Virol。2002年；25（补充1）：S1-S12。内政部：10.1016/s1386-6532（02）00091-4

Azevedo LS, Pierrotti LC, Abdala E, et al. Cytomegalovirus infection in transplant recipients. Clinics (Sao Paolo). 2015;70(7):515-523. doi:10.6061/clinics/2015(07)09

Azevedo LS，Pierrotti LC，Abdala E等。移植受者巨细胞病毒感染。诊所（圣保罗）。2015年；70（7）：515-523。doi:10.6061/诊所/2015（07）09

Styczynski J. Who is the patient at risk of CMV recurrence: a review of the current scientific evidence with a focus on hematopoietic cell transplantation. Infect Dis Ther. 2018;(7):1-16. doi:10.1007/s40121-017-0180-z

。感染疾病。2018年；（7） ：1-16。doi:10.1007/s40121-017-0180-z