A single-center, open-label, fixed-sequence Phase 1 trial to evaluate the effect of multiple doses of pritelivir on the pharmacokinetics of substrates for CYP2C9, CYP2B6, CYP3A4 and OATP2B1 - Pritelivir DDI study with celiprolol, flurbiprofen, bupropion and midazolam

开始日期2021-10-18

申办/合作机构

Aicuris Anti-Infective Cures AG

NL-OMON50254

/ CompletedN/A

A single center, open-label Phase 1 trial to evaluate the mass balance and metabolite profile of a single oral dose of pritelivir. - Mass balance and metabolite profile of pritelivir.

开始日期2021-10-05

申办/合作机构

Aicuris Anti-Infective Cures AG

NCT05513625

/ Completed临床1期

A Single-center, Open-label, 2-period Fixed-sequence Phase I Trial to Evaluate the Effect of Esomeprazole on the Pharmacokinetics of Pritelivir

To investigate the effect of esomeprazole (ESO) on the pharmacokinetics of pritelivir (PTV), and to investigate the safety and tolerability of PTV.

开始日期2020-07-13

申办/合作机构

Aicuris Anti-Infective Cures AG

100 项与普利特利韦相关的临床结果

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100 项与普利特利韦相关的转化医学

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100 项与普利特利韦相关的专利（医药）

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项与普利特利韦相关的文献（医药）

2025-12-01·PHARMACEUTICAL RESEARCH

Next Generation 3D Printed Multipurpose Intravaginal Ring For Sustained Co-Delivery of Antiretroviral Drugs and A Contraceptive Hormone

Article

作者: Chan, Evan ; Maturavongsadit, Panita ; Dahl, Denali K ; Janusziewicz, Rima ; Benhabbour, S Rahima ; Shrivastava, Roopali ; Montgomery, Stephanie A

OBJECTIVE:

Globally, a significant overlap exists between females affected by HIV and HSV-2 infections, and who have an unmet need for contraception. Intravaginal rings (IVRs) have become widely accepted by women worldwide for contraception and hormone replacement therapy and provide a promising platform as a multipurpose prevention technology (MPT).

METHODS:

Using state-of-the-art 3D printing process known as continuous liquid interface production (CLIP™), IVRs with an internal honeycomb (HC 2.53 mm) geometry were fabricated with a silicone-urethane resin. IVRs were loaded with a triple-drug combination of an anti-HIV drug (Dapivirine, DPV, 30 mg), an anti-herpes drug (Pritelivir, PTV, 20 mg) and a contraceptive hormone (Levonorgestrel, LNG, 2.0 mg) using a solvent swelling method in acetone.

RESULTS:

IVRs elicited zero-order release kinetics following an initial burst for all three APIs when formulated individually or in combination. Release rates were above benchmark therapeutic targets for DPV and LNG (200 µg/day DPV, 20 µg/day LNG). A series of accelerated stability studies demonstrated the physical integrity of IVRs after 6 months of storage at 40ºC/75%RH. DPV remained stable over 6 months, whereas PTV and LNG exhibited significant decrease in concentration after 3 months of storage with presence of degradation products detected by HPLC. Mouse size placebo rings (3 mm OD) elicited 100% cell viability in relevant cell lines and were well tolerated in vivo in mice.

CONCLUSIONS:

Collectively, these results demonstrate that this first-in-line 3D printed MPT IVR has potential to expand preventative choices for young women and girls against HIV, HSV, and unplanned pregnancy.

2025-11-07·Science Advances

Structural basis of herpesvirus helicase-primase inhibition by pritelivir and amenamevir

Article

作者: Morstadt, Lucia M. ; He, Qixiang ; Babayeva, Nigar D. ; Tahirov, Tahir H. ; Baranovskiy, Andrey G. ; Suwa, Yoshiaki ; Lim, Ci Ji

Widespread herpesvirus infections are associated with various diseases. DNA replication of human herpes simplex virus type 1 (HSV-1) requires a helicase-primase (HP) complex of three core proteins: UL5, UL52, and UL8. This complex unwinds viral DNA and synthesizes primers for DNA replication, making it an attractive antiviral target. Although HP inhibitors pritelivir and amenamevir were identified through screening, their binding mechanisms remain unclear. Here, we report cryo–electron microscopy structures of HSV-1 HP bound to a forked DNA template alone and in complex with pritelivir or amenamevir. The structures reveal a bilobed architecture highlighting HP coordinated action at the replication fork and providing a structural basis for HP inhibition by illustrating precisely how pritelivir and amenamevir block helicase activity. Data lay a solid foundation for the development of improved antiviral therapies.

2025-11-01·ANTIVIRAL RESEARCH

Structural determinants of nervous system exposure of adibelivir (IM-250) and related herpes helicase-primase inhibitors across animal species

Article

作者: Kleymann, Gerald ; Gege, Christian ; Hoffmann, Thomas

The high incidence and prevalence of herpes infections pose a significant health burden worldwide. Herpes simplex virus infections are the cause of herpes labialis, genital herpes or herpes keratitis and in rare cases life-threatening herpes encephalitis, meningitis or disseminated disease. After primary infection, herpes simplex viruses (HSVes) establish latency in the trigeminal and sacral ganglia and at least 30 % of patients experience clinically manifestant recurrences for life. For effective treatment of these neurotrophic HSVes, adequate drug exposure in the nervous system is essential. Here we report the post administration exposure of structurally different helicase-primase inhibitors (HPIs) in plasma, blood, organs and, in particular, the nervous system of animals by HPLC/MS. In diverse animal species, after single or multiple doses of helicase-primase drugs by oral or intravenous administration, only adibelivir (IM-250) achieved concentrations in the nervous system in the range of plasma or blood levels (ratio 0.5 to 4 nervous system/plasma), while other helicase-primase inhibitors with distinct structures, including amenamevir, pritelivir or ABI-5366, showed a low brain/plasma ratio of less than 0.1. The efficient passage of helicase-primase drugs through the blood-brain and blood-nerve barrier is based on their distinct structure and chemical properties. In preclinical studies published so far, adibelivir was efficacious in the herpes encephalitis and neonatal animal model and reduced the reactivation competence of the neuronal latent herpes viral reservoir. Ongoing clinical trials with HPIs will show whether sufficient drug exposure in brain and ganglia will translate into more effective herpes therapies for patients.

项与普利特利韦相关的新闻（医药）

2026-03-17

·今日头条

国际突破！外用制剂靶向复发͞疱͟͞疹͟管理新时代

【核心发现】 2025年12月，《柳叶刀·传染病学》在线发表了Aboyvir（͞阿͟͞博͟͞维͟͞尔͟）治疗单纯͞疱͟͞疹͟病毒（HSV）感染的跨国III期临床研究成果。这项覆盖12个国家、纳入2400例患者的随机对照试验证实，该非核苷类外用制剂通过靶向病毒包膜融合蛋白实现感染早期阻断，将病灶愈合时间较传统标准治疗缩短36%，且对核苷类耐药株保持完全活性。研究同期配发的评论指出，这是近二十年来HSV外用治疗领域首个具备"改变临床实践潜力"的阳性结果。 Aboyvir（͞阿͟͞博͟͞维͟͞尔͟ 【研究设计：超越传统范式的跨国协作】该研究采用"适应性平台试验"设计，突破了传统III期临床的单一模式。研究在北美、欧洲、亚太、拉美四大区域同步开展，但允许各中心根据本地监管要求调整对照组设置——美国中心采用阿昔洛韦乳膏+口服安慰剂，欧洲中心采用喷昔洛韦乳膏，亚太中心则设置三臂对照（Aboyvir（͞阿͟͞博͟͞维͟͞尔͟、阿昔洛韦、安慰剂）。这种灵活性使研究在18个月内完成入组，较传统模式提速40%，同时保证了结果在全球范围的适用性。主要终点设定为"完全上皮化时间"，即皮损从水疱出现至结痂脱落、新生上皮覆盖的时长。关键次要终点包括：病毒载量下降动力学（PCR定量）、疼痛视觉模拟评分（VAS）变化、患者总体印象变化量表（PGI-C），以及6个月内复发频次。研究特别预设了"耐药亚组分析"，纳入既往阿昔洛韦治疗失败或实验室确认TK缺陷型病毒感染的病例。【数据解读：三个层面的临床意义】第一层面：速度——重新定义急性期管理。意向性治疗分析显示，Aboyvir（͞阿͟͞博͟͞维͟͞尔͟组中位完全上皮化时间为2.7天（95%CI 2.4-3.0），阿昔洛韦组为4.2天（95%CI 3.8-4.6），风险比HR=0.64（p<0.001）。更值得关注的是"早期应答"指标：给药后6小时，Aboyvir组水疱停止进展率已达67%，而阿昔洛韦组仅为31%（p<0.001）。这一差异提示两种机制的本质区别——核苷类药物需等待病毒进入细胞后开始复制才能发挥作用，而Aboyvir的病毒进入阻断机制在感染最前端即产生效应。第二层面：广度——耐药问题的解决路径。研究纳入的127例核苷类耐药患者中，Aboyvir（͞阿͟͞博͟͞维͟͞尔͟组完全上皮化时间与非耐药患者无显著差异（2.9天 vs 2.7天，p=0.42），而阿昔洛韦组耐药患者疗效显著劣于敏感患者（6.1天 vs 4.2天，p<0.001）。这一发现具有重要公共卫生意义：全球HSV耐药监测网络数据显示，免疫抑制人群（HIV感染者、器官移植受者）中核苷类耐药率已达12%-18%，此前该类患者缺乏有效的外用替代方案。第三层面：深度——复发频率的长期影响。探索性分析追踪了完成6个月随访的患者（n=1896），发现Aboyvir（͞阿͟͞博͟͞维͟͞尔͟组在每次发作早期规范使用的情况下，年度复发中位数为1.8次，较阿昔洛韦组的3.4次下降47%（p=0.003）。研究者推测，急性期病毒载量的有效控制可能减少了神经节内病毒储备的补充，但这一机制需进一步病毒学验证。【机制验证：从临床到实验室的回溯】同期发表的机制研究为临床发现提供了分子解释。冷冻电镜结构分析显示，Aboyvir（͞阿͟͞博͟͞维͟͞尔͟活性成分与HSV-1 gB融合蛋白的"融合环"结构域结合，稳定其预融合构象，阻止融合肽插入宿主细胞膜。这一作用模式与已知的gB抑制剂（如BAY 57-1293）不同，后者靶向gB的胞外结构域，而Aboyvir的结合位点更靠近膜融合关键区域，解释了其高抑制活性（IC50=0.08μM）。更重要的是，该结合位点在HSV-1与HSV-2间高度保守（序列同源性94%），在测试的15种临床分离株（包括8种TK缺陷型耐药株）中均未发现自然突变导致的结合亲和力下降。这一"保守性验证"为Aboyvir的广谱有效性提供了结构生物学基础。【监管进展与可及性】基于该研究结果，Aboyvir（͞阿͟͞博͟͞维͟͞尔͟已于2025年下半年在欧盟、英国、加拿大、澳大利亚、新加坡、日本等8个国家/地区获批上市。中国国家药品监督管理局于2025年1月批准进口注册，成为国内首个获批的HSV非核苷类外用制剂。药品审评报告显示，NMPA认可了该研究的多国家数据外推性，未要求补充中国人群临床试验，仅基于药代动力学桥接研究即作出审批决定——这体现了中国监管科学对国际多中心试验证据的接受度提升。【专家评述】《柳叶刀·传染病学》配发评论指出，Aboyvir（͞阿͟͞博͟͞维͟͞尔͟的获批"标志着HSV治疗从'抑制复制'向'阻断进入'的机制转型"。评论作者、美国国立卫生研究院（NIH）病毒学家Dr. Lawrence Corey写道："对于一种影响全球半数人口的慢性感染，任何能够减少复发、简化治疗、规避耐药的新工具都值得欢迎。Aboyvir的临床数据令人信服，但其真正价值将在真实世界长期使用中显现——患者是否愿意在每次前驱症状出现时立即使用？这种'治疗即预防'的模式能否改变HSV的自然史？这些问题需要上市后研究回答。" 【结语】 Aboyvir（͞阿͟͞博͟͞维͟͞尔͟的多国临床验证，为HSV感染的治疗提供了新的循证选择。从病毒包膜蛋白的结构研究，到跨国临床试验的设计创新，再到监管科学的全球协作，这一案例展示了现代药物研发的完整链条。对于全球数十亿HSV携带者而言，"阻断"不仅是一个机制术语，更意味着在病毒激活的"黄金窗口"内重获控制权的可能。

2026-03-15

·生物医药技术与产业

医药投资前沿周报（2026.03.08–03.14）

核心结论速览- 全球首证：博睿康侵入式脑机接口获NMPA三类证，赛道从实验室进入商业化元年- 代谢赛道爆发：先为达偏向型GLP-1获批、翰森双靶点III期成功，国产减重药全球卡位- 监管与交易：生物医学新技术条例落地；雅培210亿美元收购Exact Sciences，IVD早筛整合加速- 风险提示：他泽司他全球撤市，安全性与长期随访成投资核心标尺- 投资主线：脑机接口、GLP-1差异化、ADC双抗、肿瘤早筛、医疗AI三类证一、国内外药企与Biotech重大事件（上市/非上市） 1. 跨国药企- 益普生/和黄医药：3/9 他泽司他全球撤市，因致癌风险；NMPA撤注册、医保撤挂网- 礼来：eloralintide（长效胰淀素）中国获批3项肥胖III期- 诺和诺德：司美格鲁肽MASH伴中重度肝纤维化拟优先审评- 罗氏：与华润医药商业签署中国渠道合作2. 国内Biotech/上市药企- 先为达生物：3/9 埃诺格鲁肽（全球首个cAMP偏向型GLP-1）获批减重适应症- 翰森制药：奥莱泊肽（GLP-1/GIP双靶点）肥胖III期达主要终点，胃肠道安全性优- 春禾医药：VG081821（A2A受体拮抗剂）获CDE批准NASH II期，全球首创靶点路径- 亚虹医药：希维她（CIN2无创光动力）获批，重塑宫颈病变非手术治疗格局- 复宏汉霖：HLX316（实体瘤ADC）、HLX3901（四特异性抗体）获批I期- 华东医药：HDM2024（EGFR/HER3双抗ADC）获FDA I期许可来源：公司公告、NMPA/FDA、药渡、21世纪经济报道二、重点靶点与赛道临床进展（肿瘤/自免/神经/代谢/抗衰老） 1. 肿瘤 - Vertex povetacicept（IgAN，自免+肾病）：III期中期分析36周，蛋白尿显著下降；血尿缓解率85.1% vs 23.4%（Δ61.7%，P<0.0001），计划近期提交BLA- 中国生物制药艾贝格司亭α：III期头对头非劣于培非格司亭，严重中性粒细胞减少发生率更低，数据发表于JCO Oncology Advances- 豪森阿美替尼：ACROSS 2研究登《CA》，EGFR共突变NSCLC显著改善PFS/OS，确立标准方案- 正大天晴 TQB3454（IDH1抑制剂）：晚期胆管癌III期达主要终点，国内首个、全球第二个阳性IDH1抑制剂- JSKN016（TROP2/HER3双抗ADC）：启动三阴乳腺癌III期，II期ORR 80%，安全性优异 2. 代谢/抗衰老 - 翰森奥莱泊肽：每周一次，减重显著；恶心<10%、呕吐<5%，胃肠道耐受性同类最优- 先为达埃诺格鲁肽：全球首个偏向型GLP-1减重药，长期体重管理获批 3. 神经/自免 - 牛津大学 RIO HIV：2期结果，54%受试者停抗逆转录病毒治疗20周无病毒反弹，功能性治愈里程碑- 吉利德 BIC/LEN单片复方：HIV III期维持病毒学抑制，耐受性良好来源：公司公告、CROI 2026、ECR 2026、NEJM、《CA》三、前沿赛道：合成生物学/脑机接口/医疗AI/手术机器人/高端器械 1. 脑机接口（本周最大里程碑） - 博睿康：3/13 全球首个侵入式脑机接口三类证获批，用于颈髓损伤四肢瘫手部功能代偿；硬脑膜外微创、无线供能；36例临床抓握改善率100%- 阶梯医疗：完成5亿元战略融资（阿里/腾讯领投）；256通道高通量侵入式产品进入临床，计划年内多中心注册临床 2. 医疗AI - 浙大二院×达摩院：多模态AI辅助诊断获NMPA三类证，覆盖12大类217种疾病；肺结节准确率98.7%，速度提升8倍- MIT/哈佛：AI脑干解析软件登PNAS，帕金森/AD早诊准确率92%，检出率提升57%- 英矽智能×Liquid AI：共建轻量化制药科学大模型，加速分子设计与临床转化 3. 手术机器人 - 佗道医疗：全球首次活体动物双器械自动化连续胆囊切除，迈向全自动外科- 精锋医疗：12035公里远程手术，延迟199毫秒，世界纪录- 中科院自动化所：眼科手术机器人定位误差11.71μm，眼底注射成功率100%，登Science Robotics 4. 合成生物学 - 深圳先进院：人工光合工程细胞直接利用太阳能合成高值化学品，登Nature Sustainability- 衍微科技：北京经开区启动智能生物制造示范工厂，政策与产能双落地 5. 高端介入 - 微创心脉：可解脱带纤维毛栓塞弹簧圈获NMPA注册证- MIT×解放军总医院：磁控纳米机器人血栓清除登《Lancet》，急性脑梗15分钟再通，无出血并发症来源：NMPA、Science Robotics、Nature Sustainability、公司公告、36氪四、重要获批与III期数据读出 1. 获批- 先为达：埃诺格鲁肽（减重）- 博睿康：植入式脑机接口（全球首证）- 亚虹医药：希维她（CIN2）- 春禾医药：VG081821（NASH II期）2. III期成功- 翰森：奥莱泊肽（肥胖）- 正大天晴：TQB3454（胆管癌）- Vertex：povetacicept（IgAN）- 中国生物制药：艾贝格司亭α（CIN预防）来源：CDE、FDA、公司公告、药明康德五、顶刊（Nature/Science/Cell/NEJM/Lancet）突破 - Nature：IL-2-TGFβ共激动剂诱导免疫耐受，自免/过敏新靶点；华人团队发现角质形成细胞代谢警报素调控全身体液免疫- Science：单次肌注saRNA治疗心梗，长效蛋白表达，心脏功能显著改善- Cell：铁蛋白团簇连接子增强CAR-T，抗原逃逸下100%小鼠生存，剂量降至1/5- Lancet：匹米替尼（和誉医药CSF-1R抑制剂）登刊，腱鞘巨细胞瘤显著缓解；磁控纳米机器人血栓清除临床成功- NEJM：Finerenone用于1型糖尿病合并CKD，降低肾脏终点风险来源：Nature、Science、Cell、Lancet、NEJM官网六、大额融资、并购、BD（≥5亿元人民币/≥7000万美元） 1. 并购- 雅培：发行200亿美元债券，推进210亿美元收购Exact Sciences，强化结直肠癌早筛与多癌检测2. License in/out- 中国生物制药→赛诺菲：罗伐昔替尼（JAK/ROCK）全球授权，总对价15.3亿美元- 德琪医药→优时比：ATG-201（CD19/CD3双抗）全球授权，总对价11.8亿美元（首付0.6亿）3. 融资- 阶梯医疗：5亿元战略融资（阿里/腾讯领投）- Candid Therapeutics：合并+私募融资5.05亿美元，聚焦TCE管线- 艾凯生物：A3轮超亿元，AI+iPSC细胞治疗来源：公司公告、SEC、36氪、药渡七、重点赛道竞争格局简评 1. GLP-1：偏向型、双靶点、口服成差异化；先为达、翰森、恒瑞卡位全球，礼来/诺和诺德仍主导，国产性价比与安全性突围2. ADC：双抗ADC、双靶点ADC成主流；JSKN016、HLX316等进入III期，同质化转向靶点与载荷创新3. CGT：iPSC与体内编辑提速；士泽生物、艾凯生物临床推进，支付与规模化是瓶颈4. 小核酸：siRNA高血压、乙肝推进；圣因、瑞博出海，长效与递送成壁垒5. AI制药：从发现走向验证；英矽智能、深势科技与药企绑定，三类证产品放量6. 合成生物学：AI+菌种+产能闭环；凯赛、华恒、衍微科技产业化落地7. 脑机接口：商业化元年开启；博睿康首证领跑，阶梯医疗、Neuralink临床竞速，脊髓损伤、神经康复率先变现8. 医疗AI：三类证成门槛；多模态、影像+病历+基因融合成趋势来源：行业白皮书、券商研报、公司管线八、政策面（NMPA/FDA/医保/集采） 1. 中国- 国务院令818号：《生物医学新技术临床研究和转化应用管理条例》5/1施行，备案制+安全伦理双审，利好CGT/脑机接口/细胞治疗- 医保：2026至少1批药品+耗材集采；创新药预沟通机制落地；他泽司他撤挂网- 集采：国采1–8批接续3月执行；第六批耗材（球囊/泌尿介入）勾量，5月实施2. 海外- FDA：批准Novocure Optune Pax（胰腺癌电场疗法）；Pritelivir突破性疗法认定- MHRA：4月实施临床试验新规，I期14天快速通道来源：国家医保局、NMPA、FDA、MHRA、新华网九、风险与机会信号（一级/二级投资）风险信号 1. 安全性黑天鹅：他泽司他撤市，提示长期随访与真实世界数据必要性2. 集采压力：耗材与化药接续采购，利润承压3. 临床失败风险：后期临床数据不及预期、靶点证伪4. 监管趋严：新技术伦理与安全审查加强机会信号 1. 脑机接口：全球首证落地，2026商业化元年，一级早期/二级器械龙头优先2. 代谢差异化：偏向型GLP-1、双靶点、口服，国产全球卡位3. 肿瘤早筛：雅培收购Exact Sciences，赛道整合加速，IVD与分子诊断受益4. 医疗AI三类证：从试点到商业化，业绩兑现5. 创新药出海：大额License-out持续，估值与现金流双升潜在投资标的（一级/二级） - 一级：阶梯医疗、艾凯生物、春禾医药、Candid Therapeutics- 二级：博睿康、先为达生物、翰森制药、中国生物制药、微创心脉、亚虹医药来源：分析师整理、公开信息数据截止：2026.03.14 18:00信息来源：NMPA、FDA、医保局、公司公告、Nature/Science/Cell/NEJM/Lancet、药渡、36氪、21世纪经济报道、券商研报需要我把这份周报精简为3页路演版PPT提纲，并标注一级/二级重点标的与仓位建议吗？

2026-03-03

·allsci.com

Asahi Kasei acquires Aicuris for anti-infective cures in EUR 780m deal

Asahi Kasei has agreed to acquire Germany-based Aicuris Anti-infective Cures AG for approximately EUR 780 million (USD 919 million), strengthening the Japanese group’s infectious disease portfolio focused on immunocompromised patients. The transaction will see Asahi Kasei purchase all issued shares of Aicuris and is expected to close by June 2026, subject to customary conditions. The acquisition adds a pipeline of antiviral therapies targeting infections common in transplant recipients and other immunocompromised populations, complementing Asahi Kasei’s existing presence in transplantation and nephrology. Aicuris pipeline and technologies Aicuris brings three key antiviral assets to Asahi Kasei. Prevymis (letermovir), a cytomegalovirus (CMV) terminase inhibitor discovered by Aicuris, is marketed globally by Merck under license. The drug is approved for CMV prophylaxis in transplant patients, and Aicuris receives royalties as the originator. These royalty revenues will transfer to Asahi Kasei after the acquisition closes. Pritelivir is a helicase-primase inhibitor targeting herpes simplex virus (HSV) infections in immunocompromised patients. The mechanism differs from nucleoside analog antivirals such as acyclovir, enabling activity against drug-resistant HSV strains. Pritelivir has received FDA Fast Track and Breakthrough Therapy designations, and Phase III studies have been completed, with a regulatory submission anticipated in 2026. The company’s earlier-stage program, AIC468, is an antisense oligonucleotide designed to inhibit replication of BK virus (BKV) in kidney transplant recipients. The therapy has completed Phase I development. No antiviral therapies are currently approved in the United States for BK virus infection. Strategic expansion in transplant and nephrology The acquisition continues Asahi Kasei’s strategy of building a specialty pharmaceutical platform focused on diseases affecting transplant recipients and kidney patients. The company acquired Veloxis Pharmaceuticals in 2020 for USD 1.3 billion, gaining the transplant immunosuppressant Envarsus XR, and Calliditas Therapeutics in 2024 for approximately USD 1.1 billion, adding Tarpeyo for IgA nephropathy. With Aicuris, Asahi Kasei expands into antiviral treatments for infections that frequently complicate transplantation, including CMV reactivation, HSV disease, and BK virus nephropathy. These infections remain significant clinical risks in transplant recipients despite advances in immunosuppressive therapy. Market and competitive landscape The antiviral pipeline targeting transplant-associated infections has drawn increasing industry interest in recent years. Programs in development include BK virus therapies such as MAU868, a monoclonal antibody currently in clinical trials, and next-generation HSV antivirals being developed by companies including Assembly Biosciences. Against this backdrop, the Aicuris acquisition provides Asahi Kasei with a combination of near-term commercial potential through pritelivir, existing royalty revenue from letermovir, and earlier-stage pipeline assets, strengthening its position in transplant medicine. The company expects the acquisition to contribute to operating income beginning in fiscal 2028, as it builds a broader pharmaceutical portfolio spanning transplantation, nephrology, and infectious diseases.

上市批准临床1期并购快速通道突破性疗法

100 项与普利特利韦相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	普利特利韦	-	DB11844

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
单纯疱疹	临床3期	美国	Aicuris Anti-Infective Cures AG	2017-05-08
单纯疱疹	临床3期	阿根廷	Aicuris Anti-Infective Cures AG	2017-05-08
单纯疱疹	临床3期	澳大利亚	Aicuris Anti-Infective Cures AG	2017-05-08
单纯疱疹	临床3期	比利时	Aicuris Anti-Infective Cures AG	2017-05-08
单纯疱疹	临床3期	加拿大	Aicuris Anti-Infective Cures AG	2017-05-08
单纯疱疹	临床3期	法国	Aicuris Anti-Infective Cures AG	2017-05-08
单纯疱疹	临床3期	德国	Aicuris Anti-Infective Cures AG	2017-05-08
单纯疱疹	临床3期	希腊	Aicuris Anti-Infective Cures AG	2017-05-08
单纯疱疹	临床3期	以色列	Aicuris Anti-Infective Cures AG	2017-05-08
单纯疱疹	临床3期	意大利	Aicuris Anti-Infective Cures AG	2017-05-08

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03073967 (PRIOH-1, GlobeNewswire) 人工标引	临床3期	单纯疱疹	-	Pritelivir	淵淵鹽艱廠遞鹹製蓋鹽(糧夢積醖淵鬱網膚鏇廠) = met its primary endpoint of complete lesion healing in immunocompromised patients infected with refractory herpes simplex virus (HSV) 製鬱鹽遞蓋積艱壓糧窪 (積鬱選積廠積淵艱築鬱 ) 达到	积极	2026-01-29
				Investigator’s choice treatment
NCT03073967 (PRIOH-1, GlobeNewswire) 人工标引	临床3期	单纯疱疹	-	Pritelivir	淵鑰積憲膚窪淵壓觸鏇(衊窪製簾簾獵糧廠艱願): P-Value = 0.0047 更多	积极	2025-10-16
				Standard-of-care (SoC) treatments
NCT05513625 (CTgov)	临床1期	单纯疱疹	16	Pritelivir (100 mg Pritelivir)	膚簾願壓構觸窪衊簾顧(壓獵積製繭簾醖餘構範) = 夢鹽壓獵糧鹹壓糧醖蓋鬱顧積鹽鬱廠鹹顧顧糧 (衊顧蓋餘艱積壓淵觸獵, 421) 更多	-	2023-09-15
				pritelivir+ESO (40 mg qd ESO and 100 mg Pritelivir)	膚簾願壓構觸窪衊簾顧(壓獵積製繭簾醖餘構範) = 築餘餘鹽壓齋鹹鹽衊蓋鬱顧積鹽鬱廠鹹顧顧糧 (衊顧蓋餘艱積壓淵觸獵, 141) 更多
NCT01658826 (CTgov)	临床2期	生殖器疱疹	91	AIC316 (AIC316)	築膚網鑰夢窪鏇製夢築(鏇積範憲網簾構衊壓簾) = 繭鹽衊顧齋壓齋憲鹹糧鏇齋願廠窪獵襯顧壓窪 (齋範鬱蓋膚構鹽憲範築, 5.2) 更多	-	2023-04-21
				Valacyclovir (Valacyclovir)	築膚網鑰夢窪鏇製夢築(鏇積範憲網簾構衊壓簾) = 廠廠餘構醖夢襯壓膚齋鏇齋願廠窪獵襯顧壓窪 (齋範鬱蓋膚構鹽憲範築, 10.8) 更多
NCT01047540 (CTgov)	临床2期	生殖器疱疹	156	AIC316 (Dose Regimen 1)	網醖廠鏇願鹽壓鹽憲糧(願衊壓鹹鹽鹹窪憲夢選) = 膚觸範鏇糧壓鹹醖鹹築蓋齋蓋膚壓獵夢餘獵壓 (壓淵襯醖鬱構窪鑰艱憲, 23.79) 更多	-	2022-02-04
				AIC316 (Dose Regimen 2)	網醖廠鏇願鹽壓鹽憲糧(願衊壓鹹鹽鹹窪憲夢選) = 鬱遞鏇選廠繭憲窪簾繭蓋齋蓋膚壓獵夢餘獵壓 (壓淵襯醖鬱構窪鑰艱憲, 12.61) 更多
NCT02871492 (LipP1, CTgov)	临床2期	唇疱疹	362	Pritelivir (Pritelivir 5% w/w Ointment)	衊築鬱鹹壓餘願壓艱廠 = 襯淵製襯積獵鑰觸積築艱衊餘簾醖簾窪製願齋 (艱築壓簾繭襯廠餘淵餘, 獵築糧簾餘製簾築衊鏇 ~ 衊壓壓獵淵選繭積鹹鏇) 更多	-	2021-07-13
				Pritelivir ointment matching placebo (Pritelivir Ointment Matching Placebo)	衊築鬱鹹壓餘願壓艱廠 = 鏇餘網襯積築構選憲憲艱衊餘簾醖簾窪製願齋 (艱築壓簾繭襯廠餘淵餘, 觸蓋艱壓築構簾遞鏇壓 ~ 壓齋鹽餘鹽壓蓋糧鹽窪) 更多
NCT01658826 (Pubmed \| J Coll Physicians Surg Pak \| JAMA) 人工标引	临床2期	单纯疱疹	91	Pritelivir	壓遞範艱觸鹹願積顧廠(襯醖膚製齋範簾淵鬱糧) = 壓製積鹹繭鏇製鏇襯蓋願淵選醖鏇襯蓋遞顧鹽 (鏇獵憲襯膚網窪簾鏇憲 ) 更多	积极	2016-12-20
				valacyclovir	壓遞範艱觸鹹願積顧廠(襯醖膚製齋範簾淵鬱糧) = 衊糧淵醖襯膚淵範膚觸願淵選醖鏇襯蓋遞顧鹽 (鏇獵憲襯膚網窪簾鏇憲 ) 更多
NCT01047540 (Pubmed 1 \| Pubmed 2 \| N Engl J Med)	临床2期	单纯疱疹	156	Pritelivir 5 mg daily	膚鹹構範簾製膚願憲遞(鏇鏇構醖齋鹹餘構壓膚) = 鹽鏇簾築齋積鏇窪糧蓋網選鑰願襯願膚網鹽壓 (蓋積範築遞醖選衊遞鹹 )	-	2014-01-16
				Pritelivir 25 mg daily	膚鹹構範簾製膚願憲遞(鏇鏇構醖齋鹹餘構壓膚) = 蓋鏇艱選繭鑰淵衊觸積網選鑰願襯願膚網鹽壓 (蓋積範築遞醖選衊遞鹹 )