An Interventional Decentralized Phase 2, Randomized, Double-Blind, 2-Arm Study to Investigate the Efficacy and Safety of Orally Administered Nirmatrelvir/Ritonavir Compared with Placebo/Ritonavir in Participants with Long COVID

This decentralized trial is a Phase 2, 1:1 randomized, double-blind, superiority, placebo-controlled study in an anticipated 100 non-hospitalized highly symptomatic adult participants with long COVID. It seeks to determine the efficacy, safety, and tolerability of 15 days of Paxlovid (nirmatrelvir/ritonavir), an anti-viral agent, compared with placebo plus ritonavir. The hypothesis is that viral persistence contributes to long COVID in some patients and nirmatrelvir/ritonavir compared with placebo/ritonavir can improve general health status in participants with long COVID. The study will also seek immune signatures associated with treatment response (overseen by Professor Akiko Iwasaki).
The decentralized study does not require site visits, and participants in all 48 states including the District of Columbia, who meet entry criteria can enroll. It is designed to make it convenient to participate. The study drugs will be delivered to the participant's designated address.
Long COVID is also known as post-acute sequelae of SARS-CoV-2 (PASC).

开始日期2023-04-14

申办/合作机构

Yale University

[+1]

ChiCTR2300068643

/ Recruiting临床4期IIT

A randomized, single center, open label study for azvudine vs Paxlovid treatment for severe COVID-19 patients

开始日期2023-01-16

申办/合作机构

厦门大学附属翔安医院

NCT05545319

/ Withdrawn临床2期

AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 2, DOUBLE-BLIND, 2-ARM STUDY TO INVESTIGATE ORALLY ADMINISTERED NIRMATRELVIR/RITONAVIR COMPARED WITH PLACEBO/RITONAVIR FOR THE TREATMENT OF SEVERE COVID-19 IN HOSPITALIZED PARTICIPANTS WHO ARE IMMUNOCOMPROMISED OR AT INCREASED RISK FOR SEVERE COVID-19 OUTCOMES

A Study to Learn About the Medicine Called Nirmatrelvir Used in Combination With Ritonavir in People with Weakened Immune Systems or at Increased Risk for Poor Outcomes who are Hospitalized Due to Severe COVID-19

开始日期2022-12-13

申办/合作机构

Pfizer Inc.

100 项与奈玛特韦相关的临床结果

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100 项与奈玛特韦相关的转化医学

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100 项与奈玛特韦相关的专利（医药）

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1,345

项与奈玛特韦相关的文献（医药）

2026-03-01·REVIEWS IN MEDICAL VIROLOGY

Comparison of Azvudine and Nirmatrelvir‐Ritonavir in Hospitalised Patients With COVID‐19: A Systematic Review and Meta‐Analysis

Review

作者: Mousavi, Tahoora ; Jalali, Hossein ; Moosazadeh, Mahmood

ABSTRACT:

Azvudine is a nucleoside reverse transcriptase inhibitor (NRTI) and belongs to the family of 2′, 3′‐dideoxynucleoside (ddNs) that can mimic natural nucleosides and block viral DNA or RNA chain synthesis and prevent viral replication. Since the beginning of the severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) pandemic, Azvudine has been used to treat patients with COVID‐19. Therefore, the objective of this meta‐analysis study was to compare Azvudine and Nirmatrelvir‐Ritonavir in hospitalised patients. The global online databases were used to identify relevant studies published between January 2019 and October 2024. The quality of all articles was determined using the Newcastle‐Ottawa Scale (NOS) checklist. In this study, heterogeneity assay was assessed using the Cochran's Q‐test and the I2 index, and STATA software version.14 (StataCorp) was used for statistical analysis. Egger's test, Begg's test, and funnel plot were performed to estimate of the publication bias, and the impact of each study on the overall estimate was assessed using sensitivity analysis. In this study, 19 studies were included in this meta‐analysis. The results of the meta‐analysis showed that the relative risk of death in the Azvudine treatment group compared with the Nirmatrelvir‐Ritonavir treatment group was 0.64 (95% CI: 0. 44, 0. 93). These results suggest that treatment with Azvudine may provide significant clinical benefit in patients hospitalised with COVID‐19.

2026-03-01·BIOORGANIC & MEDICINAL CHEMISTRY LETTERS

Identification of flavonoid-based small molecule inhibitors with dual-targeting capability against RdRp and Mpro of SARS-CoV-2

Article

作者: Duan, Xuhong ; Su, Yanlei ; Zhang, Jing ; Wu, Honghai ; Zhao, Jianyuan ; Wang, Yujia ; Sun, Dianxing ; Guo, Keyu ; Cen, Shan

Due to issues of high transmissibility, immune evasion, and drug resistance in SARS-CoV-2 variants, there is an urgent need for novel antiviral drugs. Plant-derived flavonoids such as baicalein (EC₅₀ = 4.5 μM) and baicalin (EC₅₀ = 9.0 μM) exhibit broad-spectrum antiviral potential via RNA-dependent RNA polymerase (RdRp) inhibition. Based on this, our study identified two derivatives through pharmacophore alignment between flavonoid scaffolds and the main protease (Mpro) inhibitor 13b: a psoralen-derived lignan (Comp.1) and a novel isoflavone analog (Comp.2), with dual-targeting capability against SARS-CoV-2 RdRp and Mpro. Computational docking elucidated the binding interactions of compounds with RdRp, Mpro, and the L50F/E166V double mutant Mpro. In vitro assays demonstrated that Comp.1 exhibited micromolar-range inhibitory effects on both RdRp (EC₅₀: 25.45 μM) and Mpro (IC₅₀: 125.4 μM), outperforming Comp.2. Both compounds maintained inhibitory activity against the PF07321332-resistant L50F/E166V double mutant Mpro, with IC₅₀ fold-change values of 1.23 and 1.18, respectively, compared to an 8.62-fold reduction for PF07321332. However, ADMET evaluation indicated that although compounds met basic physicochemical criteria (including molecular weight, TPSA, and compliance with Lipinski's Rule of Five), they still presented critical toxicological liabilities, including high genotoxicity risk (Comp.1: 0.838 probability) and CYP3A4 inhibition (>0.97), necessitating extensive structural optimization. This study confirms that flavonoid derivatives represent promising starting points for developing resistance-aware antiviral agents, though their current profiles classify them as early-stage leads requiring substantial optimization.

2026-02-17·ACCOUNTS OF CHEMICAL RESEARCH

Combating Antiviral Drug Resistance: A Multipronged Strategy

Article

作者: Nandi, Ashim ; An, Jing ; Xu, Yan ; Huang, Ziwei ; Warshel, Arieh ; Zhou, Jiao

ConspectusViral proteases are essential enzymes required for viral replication and assembly, making them prime antiviral drug targets. However, under the selective pressure of protease inhibitors, viruses can acquire mutations that reduce drug binding efficacy, posing significant challenges in both chronic infections (e.g., HIV, HCV) and acute infections like COVID-19, where mutations in the SARS-CoV-2 main protease (M^pro) have been reported to compromise the efficacy of drugs such as nirmatrelvir. To address these challenges, mainstream strategies in combating viral protease drug resistance mutations include combination therapies and targeting evolutionarily conserved regions of viral proteases. By disrupting multiple stages of the viral lifecycle or focusing on functionally indispensable residues, these strategies aim to develop next-generation antivirals that remain effective against evolving viral mutations.Here we provide an account of our laboratory's journey with our collaborators of the past 5 years, started during the COVID-19 pandemic and continued beyond it, in developing a multipronged strategy to combat antiviral drug resistance. The journey began with the discovery of compound 17 from screening our in-house α-ketoamide library with inhibitory activity against both the proteasome and SARS-CoV-2. We subsequently designed more specific covalent M^pro inhibitors with different warheads, such as H135 and H102 displaying potent activity, using computational and structural insights. H135 exhibited broad anti-SARS-CoV-2 activity, including alpha, delta, XBB.1.5, BA.5.2, EG.5.1, and JN.1.1 variants, in VeroE6-TMPRSS2 cells. Particularly, we observed an unusual distortion of the geometry of the catalytic dyad of M^pro in the X-ray crystal structure of H102, in which H102 induced conformational change of the catalytic residue His41. Using H102 as a model compound, we demonstrated that inducing conformational changes in His41 slightly enhances the antiresistance profile of inhibitors. Besides conventional protease inhibition, we attempted a new alternative strategy of protease degradation and developed HP211206, the first reported PROTAC molecule targeting SARS-CoV-2 M^pro, which is capable of degrading known drug-resistant M^pro mutants. To aid the design of these viral protease inhibitors and degraders, computational chemistry was used to develop an efficient method integrating the PDLD/S-LRA/β framework with quantum-mechanical calculations to evaluate both non-covalent and covalent contributions to absolute binding free energy between protein mutants and various inhibitors, which can help find inhibitors or degraders with high target binding. A vitality strategy was also employed to evaluate both the binding free energy of inhibitors (K_i) and the enzyme's catalytic efficiency parameters (k_cat and K_M) for natural substrates, which can help predict sites on the viral protease prone to drug resistance mutations and thus to be avoided in drug targeting. Additionally, a kinetic simulation framework was used to model the time dependence of inhibition (IC₅₀(t)) for nirmatrelvir analogues, providing valuable insights into their time-dependent efficacy. Most recently, artificial intelligence was applied in the development of D2Screen, which incorporates deep learning into conventional virtual screening and enabled us to identify quinoline-based non-covalent M^pro inhibitors exhibiting anti-drug-resistance activity against the E166V M^pro mutant. Together, these synthetic, computational, structural, and biological studies illustrate a multipronged strategy for developing more effective therapeutics that are less susceptible to drug resistant mutation.

700

项与奈玛特韦相关的新闻（医药）

2026-02-25

·中健诚成

今日文摘 |2025 全球 Top10 药企全景分析：礼来登顶成双料冠军，药王易主行业格局生变

2025 财年全球制药行业 Top10 药企的年报已悉数发布，这份成绩单不仅勾勒出行业最新的营收格局，更折射出药企间因产品迭代、专利周期、战略转型带来的排名大洗牌。本文聚焦药企核心制药业务营收（不含非制药板块），从营收排名、市值表现、核心产品走势等维度，拆解 2025 年全球制药行业的核心变化与发展趋势。营收格局大洗牌：礼来跃升 8 位成新药王，门槛再创新高 2025 年全球制药营收 Top10 的企业名单未变，但座次迎来大幅调整，行业竞争的激烈程度可见一斑。一个显著的特征是，行业准入门槛持续抬高：2025 年 Top10 营收门槛为 482 亿美元（百时美施贵宝），较 2024 年的 446 亿美元（赛诺菲）增加 36 亿美元，涨幅达 8%；头部规模也小幅提升，Top1 营收达 652 亿美元（礼来），对比 2024 年辉瑞的 636 亿美元，增长 2.5%。从排名变动来看，10 家企业中 3 家排名提升、6 家下滑、1 家保持不变，其中礼来成为最大黑马。这家美国药企 2025 年制药业务营收 652 亿美元，同比激增 45%，从 2024 年的第 9 位直接跃升 8 位，取代辉瑞登顶全球制药营收榜首，上演了教科书式的逆袭。按当前汇率计算，礼来 652 亿美元的营收约合人民币 4500 亿元，这一数字与 2025 年我国 A 股 111 家化学制剂企业的营收总和（4525 亿元）几乎持平，实现了 “一司抵全国” 的惊人表现。礼来的登顶，核心得益于替尔泊肽注射液的爆发式增长。这款产品 2025 年销售额达 365.07 亿美元，同比增长 1.15 倍，直接取代 K 药成为全球销售额最高的药品，单款产品年销约合人民币 2500 亿元，规模相当于全国所有县医院的用药总量，真正凭一己之力撑起了礼来的营收增长。与礼来的强势形成鲜明对比的是默沙东，其成为排名下滑幅度最大的企业之一，由 2024 年的第 2 位跌至第 6 位，营收仅微增 1%。核心原因是其王牌产品 K 药（帕博利珠单抗）结束高速增长期，2025 年销售额 317 亿美元，同比仅增 7%，且该产品专利将于 2028 年到期，未来市场面临极大的仿制药冲击；此外，其 HPV 疫苗（Gardasil/Gardasil9）销售额大幅下滑 39% 至 52 亿美元，进一步拖累了整体业绩。其余企业的排名变动也各有缘由，头部阵营的竞争呈现出明显的分化：艾伯维表现亮眼，由第 4 位升至第 3 位，营收增长 8.6%。尽管其曾经连续 9 年蝉联全球药王的修美乐（阿达木单抗）因生物类似药冲击，销售额降至 45.4 亿美元，但利生奇珠单抗、乌帕替尼、肉毒杆菌毒素三大产品分别实现 176 亿美元、83 亿美元、60 亿美元销售额，成为新的增长支柱。赛诺菲小幅提升，由第 10 位升至第 9 位，营收增长 10%，核心驱动力是度普利尤单抗的持续爆发，该产品 2025 年营收 178 亿美元，同比增长 25%。辉瑞从榜首跌至第 2 位，营收下滑 2%，新冠相关药物的退潮成为主要诱因：新冠疫苗 Comirnaty 销售额 43 亿美元、抗新冠药奈玛特韦 / 利托那韦 24 亿美元，分别同比下滑 33% 和 59%。不过辉瑞正加速摆脱新冠依赖，阿哌沙班、肺炎疫苗、氯苯唑酸等产品分别实现 80 亿、65 亿、64 亿美元销售额，成为转型的重要支撑。百时美施贵宝下滑 2 位至第 10 位，营收微降 1%；强生、罗氏、诺华虽营收分别增长 6%、9%、8%，但仍各后退 1 位，行业头部的内卷程度可见一斑。阿斯利康是唯一排名未变的企业，稳居第 5 位，营收增长 9%，达格列净、奥西替尼、度伐利尤单抗三大核心产品分别实现 84 亿、73 亿、61 亿美元销售额，产品管线的稳定性成为其稳居前列的关键。值得一提的是，若计入非制药业务营收，行业排名将发生变化：强生凭借 338 亿美元的非制药营收登顶，罗氏以 170 亿美元非制药营收位居第二，默沙东则以 69 亿美元非制药营收排第四，非制药业务成为部分药企规模扩张的重要补充。市值表现：礼来称霸成绝对龙头，市值与营收背离显行业预期市值的变化，往往反映了资本市场对企业未来发展的判断。以 2026 年 2 月 11 日股市收盘价为基准，全球药企 Top10 的市值格局与营收格局呈现出一定的关联性，也存在显著的背离，而礼来再次成为绝对的主角，登顶市值榜首，成为营收、市值双料冠军。 2025 年礼来市值高达 9592.77 亿美元，这一数字堪称 “富可敌国”：几乎是市值第二的强生（5802 亿美元）与第三的罗氏（4777 亿美元）的市值之和；是市值第十的赛诺菲（1209 亿美元）的 8 倍；甚至相当于诺华、默沙东、辉瑞、百时美施贵宝、赛诺菲 5 家药企的市值总和。折算成人民币，礼来市值约 6.62 万亿元，是 2025 年我国 A 股 111 家化学制剂上市公司总市值（2.1 万亿元）的 3.2 倍，占同日 A 股 505 家相关上市公司总市值（7.12 万亿元）的 93%，资本市场对其认可程度可见一斑。资本市场的高度青睐，源于礼来亮眼的业绩增长和清晰的发展前景。2025 年礼来净利润达 206.40 亿美元，同比暴增 95%，营收与利润的双高增长，让其成为行业内的 “香饽饽”。而市值与营收背离最明显的企业当属辉瑞：其 2025 年营收 612 亿美元位居第二，仅比礼来少 40 亿美元（跌幅 6%），但市值仅 1576 亿美元，较礼来少了 8000 多亿美元（跌幅 84%）。除了利润表现的差距，更核心的原因是资本市场对两家企业的未来预期不同：辉瑞正处于摆脱新冠业务依赖的转型期，而礼来凭借替尔泊肽注射液的强势表现，成长逻辑更为清晰。同样与礼来存在市值差距的还有艾伯维，其营收与辉瑞持平（612 亿美元），但市值较礼来少 59%（约 5690 亿美元），也反映出资本市场对不同企业管线潜力、增长持续性的差异化判断。其余企业中，连续多年位居在华销冠的阿斯利康市值 3170 亿美元，位列第五；诺华、默沙东市值分别为 3053 亿美元、2960 亿美元，紧随其后，头部药企的市值排名，与其核心产品的增长潜力、管线布局的完整性深度绑定。行业启示：创新为核，唯有转型方能破局 2025 年全球 Top10 药企的这份成绩单，为制药行业勾勒出清晰的发展逻辑：创新是永恒的驱动力，重磅炸弹产品能让企业实现弯道超车，但专利悬崖、市场变化始终是行业绕不开的挑战，唯有因势利导、快速转型，才能在竞争中站稳脚跟。礼来的逆袭，本质是创新产品的胜利，替尔泊肽注射液的爆发，让其直接站上行业顶端；而默沙东的下滑，也印证了单一重磅产品依赖的风险，K 药增长放缓、HPV 疫苗下滑，叠加专利到期的临近，让其发展面临考验。同样，辉瑞的转型、艾伯维的产品迭代、阿斯利康的管线稳定，都说明药企的发展不能依赖单一产品，多元化、高潜力的产品管线，才是抵御市场风险的核心。同时，专利周期始终是制药行业的核心命题。修美乐因生物类似药冲击销售额下滑，K 药即将迎来专利到期，这提醒着所有药企，在打造重磅产品的同时，必须提前布局专利到期后的产品衔接，通过持续的研发创新，打造新的增长曲线。此外，资本市场的选择也为行业指明了方向：营收只是企业当下的表现，而利润增长、管线潜力、发展确定性，才是决定企业长期价值的关键。礼来的市值登顶，正是资本市场对其创新能力和增长持续性的高度认可。对于国内药企而言，全球头部药企的格局变化也带来了重要的借鉴意义：在医药创新的大趋势下，唯有聚焦核心领域的研发投入，打造具有全球竞争力的创新产品，同时规避单一产品依赖的风险，构建多元化的产品管线，才能在全球医药市场的竞争中占据一席之地。全球制药行业的竞争从未停歇，2025 年的格局洗牌只是行业发展的一个缩影。随着研发技术的不断进步、市场需求的持续变化，未来行业仍将迎来新的调整，但不变的，是创新与转型的核心逻辑。改编自自然药论《新世界药王诞生，富可敌国的医药企业！》责编董金铭中国健康关注了解更多中国健康健康中国

2026-02-21

·今日四川通

【疫情治疗方案，疫情治疗方法研究进展】

本文大纲：〖壹〗、乱投医——小观疫情期的中西医〖贰〗、已准备药物治疗疫情〖叁〗、新型肺炎诊疗方案一般有什么〖肆〗、解读《新型冠状病毒感染的肺炎防控方案(第二版)》〖伍〗、钟南山:来瑞特韦片为新冠治疗提供重要保障〖陆〗、慢阻肺患者必看!简单3招助你平安度过疫情〖柒〗、新型肺炎诊疗方案〖捌〗、抗新型冠状病毒的药物有哪些? 乱投医——小观疫情期的中西医〖壹〗、乱投医不可取，小观疫情期的中西医应理性在新冠肺炎肆虐的时期，面对这一突如其来的疫情，许多人在寻求治疗的过程中可能会感到迷茫和焦虑，甚至可能出现“乱投医”的现象。然而，无论是选取西医还是中医，都需要保持理性，根据病情和医生的建议来选取合适的治疗方式。已准备药物治疗疫情抗病毒治疗：可试用干扰素雾化吸入，通过局部给药抑制病毒复制。此外，也可选取其他抗病毒药物进行对症治疗，需根据患者具体病情和药物适应症调整方案。抗菌药物联合治疗：若患者并发细菌感染（如出现白细胞升高、脓痰等症状），需联合使用抗菌药物以控制继发感染。钟南山提醒，尽管近来疫情未出现明显连锁反应，但仍需高度警惕，防止潜在超级传播者的出现。具体建议：公众若出现发热、咳嗽等症状，应立即就医，避免拖延导致病情加重。从湖北到外地的人员，即使无症状也建议自我隔离14天，降低传播风险。备好三样备好常用药物可借鉴人民日报的《新冠居家治疗常用药清单》准备药物，药物的用法用量要遵循医嘱或按说明书服用，孕妇、哺乳期妇女和儿童等特殊人群用药需格外小心。急性症状常用药蒙脱石散用于宠物腹泻，尤其是细菌性肠炎、胰腺炎、细小病毒、猫瘟等引发的腹泻。通过吸附肠道内病原体和毒素减少脱水风险，但不治疗原发病。需按体重计算剂量，过量可能导致便秘。胃复安（甲氧氯普胺）常用止吐药，适用于呕吐症状。若宠物出现拉血，需先止血再使用。阿比多尔：通过抑制病毒包膜融合发挥抗病毒作用，国内指南曾推荐用于流感治疗，新冠疫情期间也被纳入部分治疗方案，但疗效仍需更多证据支持。磷酸氯喹：原为抗疟疾药物，体外实验显示对新冠病毒有抑制作用，但因可能引发心律失常、视网膜病变等严重不良反应，已逐渐退出主流治疗方案。新型肺炎诊疗方案一般有什么新型肺炎诊疗方案的主要内容如下：隔离治疗确诊病例需立即隔离治疗，以阻断病毒传播。隔离场所应具备严格的感染控制措施，确保医护人员及患者安全。隔离期间需单独管理，避免交叉感染。对症支持治疗针对患者症状，采取退烧、止咳、化痰等措施，缓解不适并提高生活质量。新型肺炎诊疗方案（第四版）核心要点如下：传染源主要传染源为新型冠状病毒感染的肺炎患者，包括确诊病例和无症状感染者。病毒通过患者呼吸道分泌物、排泄物等排出体外，形成传播风险。传播途径呼吸道飞沫传播：患者咳嗽、打喷嚏或说话时产生的飞沫，被近距离接触者吸入后导致感染。新型冠状肺炎诊疗方案要点如下：治疗场所安排根据病情严重程度确定治疗场所。疑似及确诊病例需在具备有效隔离和防护条件的定点医院治疗。其中，疑似病人应实施单人单间隔离，以减少交叉感染风险；确诊病例可多人收治在同一病房，但需保持合理间距；危重型病例需尽早转入ICU进行重症监护治疗。抗病毒治疗：试用α-干扰素、洛匹那韦/利托那韦等药物，需严格评估病情及人群适应性。免疫治疗：重症患者可考虑康复者血浆治疗等免疫调节措施。解读《新型冠状病毒感染的肺炎防控方案(第二版)》《新型冠状病毒感染的肺炎防控方案（第二版）》是国家卫生健康委为应对疫情制定的指导性文件，旨在通过系统化的监测、调查、管理和技术规范，实现病例的早发现、早报告、早隔离、早治疗，并防止疫情扩散。方案核心内容包括四大技术方案和九项防控措施，并明确将根据疫情变化动态更新。新型冠状病毒感染人后的潜伏期在10天左右，最短1天，最长14天，受感染者在没有明显症状的潜伏期也有传染性。国家卫生健康委员会22日晚发布了《新型冠状病毒感染的肺炎防控方案（第二版）》，方案提出，对确诊病例的密切接触者或可疑暴露者进行医学观察。法律分析：我国科学防疫措施的特点包括根据疫情形势的变化和评估结果，及时更新。法律依据：根据《中华人民共和国新型冠状病毒感染的肺炎防控方案（第二版）》第二条规定：适用范围适用于指导各地开展防控工作。本方案将根据疫情形势的变化和评估结果，及时更新。应该是偏远地区私自聚集，政府也查不到。2020年1月22日，国家卫生健康委员会发布了《新型冠状病毒感染的肺炎防控方案（第二版）》。方案提出疑似病例、确诊病例、聚集性病例的定义。报告时需在系统中选取病种“新型冠状病毒感染的肺炎”，并根据诊断标准选取“疑似病例”或“确诊病例”。病例确诊后，报告单位需及时将分类订正为“确诊病例”，并根据《诊疗方案（试行第二版）》报告临床严重程度（如非肺炎例、轻症肺炎病例、重症肺炎病例、危重症肺炎病例），症状进展时需动态更新。钟南山:来瑞特韦片为新冠治疗提供重要保障〖壹〗、钟南山院士高度评价：钟南山院士认为，来瑞特韦片为新冠治疗提供了重要保障，研究团队通过大协作，实现了单药给药方案的重要突破，丰富了我国药物储备，也为全球抗击新冠疫情提供了更多的中国治疗方案。行业研讨深入分析：与会专家代表围绕国产药物研发机制深入分析研讨，认为来瑞特韦片作为我国自主研发新药的成功范例，具有重要行业意义。〖贰〗、钟南山在众生药业抗新冠药物来瑞特韦的上市后临床研究启动仪式上作出相关呼吁，具体内容如下：新冠感染现状：近来在广州流行的主流新冠毒株是XBB1，根据广州市发热门诊的数据，接受检测的发热病人里，20%-25%是新冠病毒感染者。〖叁〗、政策延续性与创新性的平衡来瑞特韦片作为临时纳入医保支付范围的药物，其分类管理（A类）体现了政策灵活性。既避免了长期纳入可能带来的基金风险，又通过优先采购机制保障了短期内的临床需求。这种“动态调整+精准保障”的模式，为未来应对类似公共卫生事件提供了可复制的范例。慢阻肺患者必看!简单3招助你平安度过疫情产品选取建议：和普乐双水平ST呼吸机：其智能定容通气功能可精准控制通气量，适应慢阻肺患者呼吸需求，是家庭防护的优选设备。前线验证效果：和普乐呼吸机在疫情期间被捐赠至前线医院，应用反馈良好，证明其可靠性与有效性。缩唇呼吸：闭嘴经鼻吸气，缩唇缓慢呼气（呼气时间是吸气的2倍），每天3-4次，每次10分钟。腹式呼吸：仰卧或坐位，一手放胸部、一手放腹部，吸气时腹部隆起，呼气时腹部收缩，每天2次，每次15分钟。效果：长期坚持可缓解呼吸困难，改善肺功能和血气指标。补充提醒慢阻肺虽为慢性病，但可防可控可治疗。慢阻肺患者平安度过春节的方法主要包括以下几点：积极戒烟，避免吸入空气中有害颗粒：吸烟是慢阻肺的重要危险因素，确诊后必须坚决戒烟。关注空气质量播报，避免在空气质量差的日子进行室外活动，以减少有害颗粒的吸入。新型肺炎诊疗方案新型肺炎诊疗方案（第四版）核心要点如下：传染源主要传染源为新型冠状病毒感染的肺炎患者，包括确诊病例和无症状感染者。病毒通过患者呼吸道分泌物、排泄物等排出体外，形成传播风险。传播途径呼吸道飞沫传播：患者咳嗽、打喷嚏或说话时产生的飞沫，被近距离接触者吸入后导致感染。新型肺炎诊疗方案的主要内容如下：隔离治疗确诊病例需立即隔离治疗，以阻断病毒传播。隔离场所应具备严格的感染控制措施，确保医护人员及患者安全。隔离期间需单独管理，避免交叉感染。对症支持治疗针对患者症状，采取退烧、止咳、化痰等措施，缓解不适并提高生活质量。新型冠状肺炎诊疗方案要点如下：治疗场所安排根据病情严重程度确定治疗场所。疑似及确诊病例需在具备有效隔离和防护条件的定点医院治疗。其中，疑似病人应实施单人单间隔离，以减少交叉感染风险；确诊病例可多人收治在同一病房，但需保持合理间距；危重型病例需尽早转入ICU进行重症监护治疗。抗新型冠状病毒的药物有哪些? 抗病毒治疗药物近来批准用于新型冠状病毒感染的抗病毒药物主要有两类：奈玛特韦/利托那韦片：为蛋白酶抑制剂组合，通过抑制病毒3CL蛋白酶活性阻断病毒复制。临床试验显示，其可降低高风险患者住院和死亡风险，需在症状出现5天内由医生评估后使用，尤其适用于有进展为重症风险的患者。藿香正气胶囊可解表化湿、理气和中，适用于湿热蕴结型患者；金花清感颗粒具有疏风宣肺、清热解毒之效，对发热、咳嗽等症状有缓解作用；连花清瘟胶囊以清瘟解毒、宣肺泄热为功，临床研究显示其可缩短病程；疏风解毒胶囊则能疏风清热、解毒利咽，适用于风热犯肺证。中药使用需辨证施治，避免盲目叠加用药。阿兹夫定：主要用于普通型新型冠状病毒感染的成年患者。它通过抑制病毒RNA依赖的RNA聚合酶（RdRp），阻止病毒RNA链的延伸，进而阻断病毒DNA合成，发挥抗病毒作用。临床研究表明，阿兹夫定可加速病毒清除，缩短核酸转阴时间，并可能降低重症风险。新型冠状病毒感染轻症患者，可对症使用以下药物并注意相关事项：对症缓解类药物退热药物：发热时可选用对乙酰氨基酚，适用于多数成年患者及病情稳定的儿童。但需注意，严重肝肾功能不全者应谨慎使用，因其主要通过肝肾代谢，可能加重器官负担。抗病毒治疗：对于部分患者，尤其是重症或高风险人群，医生可能会根据病情评估使用抗病毒药物，如奈玛特韦/利托那韦片（Paxlovid）等。但这类药物需严格遵医嘱使用，不可自行服用。

2026-02-19

·BioSpace

Traws Pharma Completes Analysis of Ratutrelvir Clinical Study in PAXLOVID®-Eligible and Ineligible COVID-19 Patients and Provides Updates for Additional Indication for Tivoxavir Marboxil as a Prophylactic Treatment for Seasonal Influenza

Completed clinical results with ratutrelvir confirm a differentiated pro PAXLOVID ® with fewer adverse events and no viral rebounds with equivalent time to sustained symptom resolution; results were recapitulated in PAXLOVID ® -ineligible patients, representing a significant population with no effective treatment options Pre-clinical analysis of tivoxavir marboxil tablets demonstrated significantly increased exposure compared to a prototype formulation with predicted 28-day protection in humans from influenza infections against a wide range of seasonal and pandemic variants PK study of compressed tivoxavir marboxil tablets submitted under open IND in Australia and preparations are underway for a Human Influenza Prophylaxis Challenge Study in the UK NEWTOWN, Pa., Feb. 19, 2026 (GLOBE NEWSWIRE) -- Traws Pharma, Inc. (NASDAQ: TRAW, “Traws Pharma”, “Traws” or “the Company”), a clinical-stage biopharmaceutical company developing novel therapies to target critical threats to human health from respiratory viral diseases, today announced the completion of the clinical analysis of its 90-patient, open-label Phase 2 study of ratutrelvir, an investigational oral, ritonavir-free Mpro/3CL protease inhibitor, versus PAXLOVID ® in patients with mild-to-moderate COVID-19, together with a single arm in PAXLOVID ® -ineligible subjects. Patients ineligible to receive PAXLOVID ® are frequently at elevated risk for severe disease and require suitable, safe and effective treatment options. Ratutrelvir has the potential to address this gap in care and may be a valuable therapeutic option. Ratutrelvir Update Designed as an active-controlled comparator trial versus PAXLOVID ® (nirmatrelvir/ritonavir), the study evaluated patient-reported symptom outcomes, safety, and real-world usability. A separate treatment arm was comprised of patients ineligible for ritonavir-boosted regimens due to contraindications or clinically significant drug–drug interactions. Patients in the ratutrelvir arm received ratutrelvir 600 mg orally once daily for 10 days, while patients in the comparator arm received PAXLOVID ® , administered as nirmatrelvir 300 mg twice daily plus 100mg ritonavir twice daily for 5 days, consistent with approved prescribing information. Patients receiving ratutrelvir who were ineligible for PAXLOVID ® reported fewer treatment-related adverse events (3 events in 30 subjects, 10%) compared to subjects receiving PAXLOVID ® , (7 events in 30 subjects, 23.3%), and symptoms resolved more quickly in subjects taking ratutrelvir who were ineligible for PAXLOVID ® , compared to PAXLOVID ® treatment (HR, 1.31; 95% CI, 0.78-2.20, p =0.018). “From a clinical perspective, the completed data analysis confirms that ratutrelvir may provide a meaningful benefit across a broader range of patients, including those who are unable to receive ritonavir-boosted therapy,” commented Robert R. Redfield, MD, Chief Medical Officer of Traws Pharma. “The favorable tolerability profile, together with a shortened time to symptom resolution and the absence of viral rebound events in ratutrelvir-treated patients, encourages and supports the continued clinical evaluation of ratutrelvir in both acute COVID-19 and in studies designed to better understand its potential impact on longer-term outcomes.” “The combination of early and sustained symptom improvement, extended dosing duration, absence of viral rebound observed to date, and favorable tolerability supports the strategic hypothesis that ratutrelvir may have utility in reducing post-acute sequelae of SARS-CoV-2 infection (Long COVID),” commented Dr. Redfield . “By enabling earlier and potentially more complete viral clearance, without the limitations associated with ritonavir boosting, ratutrelvir may offer a differentiated approach to both acute COVID-19 treatment and prevention of longer-term complications”. Tivoxavir Marboxil Update The Company additionally announced progress in advancing an additional indication for tivoxavir marboxil (TXM), a potential best in class CAP-dependent endonuclease inhibitor, as a once-monthly, single oral tablet for prevention of seasonal influenza. In prior Phase 1 studies in healthy volunteers, an unformulated powder-in-capsule formulation provided blood levels exceeding 3X EC 50 against a basket of common seasonal influenza variants up to 22 days after drug administration. A tablet formulation has been evaluated pre-clinically and demonstrated a 30% increase in exposure compared to the unformulated prototype. “Modelling of these data suggests that the tablet formulation should provide 28-day coverage, enabling a once-a-month prophylactic treatment,” commented C. David Pauza, PhD, Chief Science Officer of Traws Pharma. “We intend to advance these findings into a healthy volunteer study to be conducted under an open IND in Australia and, if the extended exposure is confirmed, we intend to progress TXM into a Seasonal Human Influenza Virus Prophylaxis Challenge Study,” Dr. Pauza continued. Separately, the FDA informed the Company that its US IND for tivoxavir marboxil was being placed on clinical hold due to concerns with the mutagenicity data package. The FDA intends to communicate its concerns formally, together with suggested mitigation steps, by March 16, 2026. Dr. Redfield commented, “This IND application was originally filed to enable a complete review by the Biomedical Advanced Research and Development Authority (BARDA) of the Company’s application for inclusion in the strategic stockpile for the treatment of avian influenza. While the clinical hold does not directly impact ongoing and planned studies outside of the United States, Traws Pharma appreciates the FDA concern and is working to mitigate this issue in our clinical development plan.” “Collectively, the advancement of our antiviral portfolio provides a number of significant value inflection points and could provide treatment and prevention options for clinically important viral diseases,” commented Iain Dukes, MA, DPhil, Chief Executive Officer of Traws Pharma. About Ratutrelvir Ratutrelvir is an investigational oral, small molecule Mpro (3CL protease) inhibitor designed to be a broadly acting treatment for SARS-CoV-2/COVID-19 that is used without ritonavir. It has demonstrated in vitro activity against a range of virus strains. Preclinical and Phase 1 studies show that ratutrelvir does not require co-administration with a metabolic inhibitor, such as ritonavir, which could avoid ritonavir-associated drug-drug interactions 1 , and potentially enable wider patient use. Phase 1 data also show that ratutrelvir’s pharmacokinetic (PK) pro maintenance of target blood plasma levels approximately 13 times above the EC 50 using the target Phase 2 dosing regimen of 600 mg/day for ten days, which may also reduce the likelihood of clinical rebound and, consequently, reduce the risk for Long COVID 2 . Industry data indicate that COVID treatment represents a potential multi-billion dollar market opportunity 3 . About Tivoxavir Marboxil Tivoxavir marboxil (TXM) is an investigational oral, small molecule CAP-dependent endonuclease inhibitor designed to be administered as a single-dose for the treatment of bird flu and seasonal influenza. It has shown potent in vitro activity against a range of influenza strains in preclinical studies, including a human isolate of the highly pathogenic avian flu H5N1 (bird flu). Consistent, positive preclinical data from three animal species indicate that a single dose of TXM demonstrated a therapeutic effect against H5N1 bird flu. Seasonal influenza represents an estimated multi-billion dollar antiviral market opportunity, largely driven by global health organizations, practice guidelines and government tenders and inclusion in drug stock piling initiatives 4,5 , with upside potential from potential pandemic flu outbreaks including H5N1 bird flu. We believe that these data support further development of TXM as a treatment for bird flu. Source information Carly Herbert et al. (2025) Clinical Infectious Diseases. Pfizer Inc. annual report on Form 10-K for the fiscal year ended December 31, 2025, filed with the U.S. Securities and Exchange Commission on February 3, 2026 Per link TRAW data on file Third-party products mentioned herein are the trademarks of their respective owners. About Traws Pharma, Inc. Traws Pharma is a clinical stage biopharmaceutical company dedicated to developing novel therapies to target critical threats to human health in respiratory viral diseases. Traws integrates antiviral drug development, medical intelligence and regulatory strategy to meet real world challenges in the treatment of viral diseases. We are advancing novel investigational oral small molecule antiviral agents that have potent activity against difficult to treat or resistant virus strains that threaten human health: COVID-19/Long COVID and bird flu and seasonal influenza. Ratutrelvir is in development as a ritonavir-independent COVID treatment, targeting the Main protease (Mpro or 3CL protease). Tivoxavir marboxil is in development as a single dose treatment for bird flu and seasonal influenza, targeting the influenza cap-dependent endonuclease (CEN). Traws is actively seeking development and commercialization partners for its legacy clinical oncology programs, rigosertib and narazaciclib. More details can be found on Traws’ website at . For more information, please visit and follow us on LinkedIn. Forward-Looking Statements Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties including statements regarding the Company, its business and product candidates, including the potential opportunity, market size, benefits, effectiveness, safety, and the clinical and regulatory plans for ratutrelvir and tivoxavir marboxil, as well as plans for its legacy programs. The Company has attempted to identify forward-looking statements by terminology including “believes”, “estimates”, “anticipates”, “expects”, “plans”, “intends”, “may”, “could”, “might”, “will”, “should”, “preliminary”, “encouraging”, “approximately” or other words that convey uncertainty of future events or outcomes. Although Traws believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the outcome of Traws’ IND filing with the FDA, including the current FDA clinical hold for tivoxavir marboxil; the success and timing of Traws’ clinical trials; the potential efficacy of ratutrelvir for the treatment of COVID-19, including the potential to reduce the risk of COVID rebound and Long COVID; the potential for ratutrelvir to gain market acceptance, if and when regulatory approval is obtained, or to become the new standard of care; Traws’ interactions with the FDA, BARDA and similar foreign regulators; collaborations; market conditions; regulatory requirements and pathways for approval; the ongoing need for improved therapy to reduce the frequency of clinical rebound and the concomitant risk for Long COVID; the extent of the spread and threat of the bird flu; the Company’s cash projections; Traws’ ability to raise additional capital when needed; and those discussed under the heading “Risk Factors” in Traws’ filings with the U.S. Securities and Exchange Commission (SEC). Any forward-looking statements contained in this release speak only as of its date. Traws undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events, except to the extent required by law. Traws Pharma Contact: Charles Parker Traws Pharma, Inc. cparker@trawspharma.com Investor Contact: John Fraunces LifeSci Advisors, LLC 917-355-2395 jfraunces@lifesciadvisors.com

临床结果临床1期临床2期

100 项与奈玛特韦相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	奈玛特韦	-	-

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
新型冠状病毒感染	临床3期	巴西	Pfizer Inc.	2021-07-16
新型冠状病毒感染	临床3期	捷克	Pfizer Inc.	2021-07-16
新型冠状病毒感染	临床3期	匈牙利	Pfizer Inc.	2021-07-16
新型冠状病毒感染	临床3期	俄罗斯	Pfizer Inc.	2021-07-16
新型冠状病毒感染	临床3期	韩国	Pfizer Inc.	2021-07-16
新型冠状病毒感染	临床3期	西班牙	Pfizer Inc.	2021-07-16
普通感冒	临床2期	瑞典	Pfizer Inc.	2023-03-30
呼吸困难	临床2期	瑞典	Pfizer Inc.	2023-03-30
新冠肺炎后遗症	临床2期	瑞典	Pfizer Inc.	2023-03-30
肝损伤	临床1期	美国	Pfizer Inc.	2021-08-31

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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


NCT05263895 (CTgov)	临床1期	-	12	Nirmatrelvir+Ritonavir (Nirmatrelvir (Commercial Tablets)/Ritonavir 300/100 mg)	獵積廠淵網製齋繭鑰鏇(鏇窪窪壓醖選鏇夢繭齋) = 窪襯製構夢構憲繭鬱夢憲願顧蓋鹽獵餘選衊積 (遞淵淵襯淵積夢範糧觸, 15) 更多	-	2025-06-11
				Nirmatrelvir+Ritonavir (Nirmatrelvir (Slower Dissolution Tablets)/Ritonavir 300/100 mg)	獵積廠淵網製齋繭鑰鏇(鏇窪窪壓醖選鏇夢繭齋) = 廠餘鬱築淵鬱選壓遞廠憲願顧蓋鹽獵餘選衊積 (遞淵淵襯淵積夢範糧觸, 26) 更多
NCT05041907 (Pubmed \| Int J Anal Chem)	临床2期	新型冠状病毒感染	1	Nirmatrelvir	顧膚範壓壓衊製簾鹽蓋(廠淵願憲膚糧憲鬱觸醖) = 餘淵選鹹壓夢築餘齋範遞淵選鹹簾構積網網衊 (齋願衊襯鹹壓糧鑰構選 )	积极	2025-01-01
NCT05567952 (CTgov)	临床2期	新型冠状病毒感染	436	Nirmatrelvir+Ritonavir (Nirmatrelvir 300 mg + Ritonavir 100 mg)	鹹廠醖鬱齋衊遞壓簾積(襯願鹽築鬱衊築醖壓鏇) = 獵選糧簾繭膚鹹網夢廠積膚壓築夢憲鹹築鹽壓 (鬱選夢膚積積鏇衊憲鬱, 0.129) 更多	-	2024-10-08
				Placebo+Ritonavir (Placebo + Ritonavir 100 mg)	鹹廠醖鬱齋衊遞壓簾積(襯願鹽築鬱衊築醖壓鏇) = 廠衊積窪網壓膚願顧範積膚壓築夢憲鹹築鹽壓 (鬱選夢膚積積鏇衊憲鬱, 0.171) 更多
NCT05576662 (STOP-PASC, CTgov)	临床2期	新冠肺炎后遗症	168	Nirmatrelvir+Ritonavir (Nirmatrelvir Plus Ritonavir)	顧簾蓋齋壓膚願鹹鑰築 = 鏇醖糧網齋簾選範鹽範齋鹹醖窪鑰鏇製鹽製鏇 (築衊夢夢夢壓鬱築淵觸, 淵蓋餘鹽築鹽糧夢築夢 ~ 廠艱窪蓋選膚網獵鹽膚) 更多	-	2024-09-25
				Placebo+Ritonavir (Placebo Plus Ritonavir)	顧簾蓋齋壓膚願鹹鑰築 = 觸衊鏇構醖網構選選憲齋鹹醖窪鑰鏇製鹽製鏇 (築衊夢夢夢壓鬱築淵觸, 簾積壓鹽衊簾艱築衊繭 ~ 構繭糧築願餘鹹網壓鹹) 更多
NCT05438602 (EPIC-IC, CTgov)	临床2期	新型冠状病毒感染	158	Placebo+Nirmatrelvir+Ritonavir (Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day)	廠構醖鹹選襯蓋遞範簾 = 簾網構鹽壓網網夢廠積膚觸鹹蓋積獵繭夢衊廠 (選願繭餘衊蓋簾夢夢遞, 簾鹽壓顧繭襯憲鏇願蓋 ~ 製膚齋窪鬱鏇製夢憲範) 更多	-	2024-09-23
				Placebo+Nirmatrelvir+Ritonavir (Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day)	廠構醖鹹選襯蓋遞範簾 = 鏇襯觸膚獵鑰醖鏇構糧膚觸鹹蓋積獵繭夢衊廠 (選願繭餘衊蓋簾夢夢遞, 壓簾餘鏇積繭憲憲鏇壓 ~ 選襯積顧夢鏇壓醖壓鹹) 更多
NCT05487040 (CTgov)	临床1期	新型冠状病毒感染	15	PF-07321332 (nirmatrelvir)+ritonavir (Cohort 1 (No HD))	觸鬱遞蓋獵簾糧遞齋製 = 繭齋積醖窪選鏇築廠鑰網選選窪醖顧餘襯製簾 (構積製構襯網鏇餘夢襯, 憲餘築觸願願襯鏇衊積 ~ 淵艱衊選鬱鏇遞夢製製) 更多	-	2024-09-23
				PF-07321332 (nirmatrelvir)+ritonavir (Cohort 2 (Intermittent HD))	觸鬱遞蓋獵簾糧遞齋製 = 選製襯窪製衊遞鬱夢繭網選選窪醖顧餘襯製簾 (構積製構襯網鏇餘夢襯, 網鏇襯繭夢願壓簾廠廠 ~ 鏇襯顧壓廠膚淵淵壓鏇) 更多
NCT05011513 (EPIC-SR, Pubmed) 人工标引	临床2/3期	新型冠状病毒感染	1,288	Nirmatrelvir-riritonavir	顧網鬱鹽蓋餘鏇選遞積(鏇積製鏇鏇窪遞餘壓艱) = 遞繭構繭遞網襯齋觸鏇壓淵獵繭構鬱餘鏇願製 (窪鏇網獵淵網範構繭醖 ) 更多	不佳	2024-04-04
				Placebo	顧網鬱鹽蓋餘鏇選遞積(鏇積製鏇鏇窪遞餘壓艱) = 鏇積淵鹽網淵憲鹽鹹衊壓淵獵繭構鬱餘鏇願製 (窪鏇網獵淵網範構繭醖 ) 更多
NCT05005312 (CTgov)	临床1期	肝损伤	17	PF-07321332+ritonavir (Normal Hepatic Function)	襯積鬱夢蓋製淵獵簾築(遞製鏇淵糧製範選獵選) = 憲鏇窪鬱醖鹹獵襯觸願廠艱膚廠獵鹹顧鏇夢艱 (構艱衊醖鹹鏇夢淵淵鬱, 20) 更多	-	2023-09-06
				PF-07321332+ritonavir (Moderate Hepatic Impairment)	襯積鬱夢蓋製淵獵簾築(遞製鏇淵糧製範選獵選) = 蓋簾範廠鹽範選鏇廠蓋廠艱膚廠獵鹹顧鏇夢艱 (構艱衊醖鹹鏇夢淵淵鬱, 48) 更多
NCT05011513 (EPIC-SR, CTgov)	临床2/3期	新型冠状病毒感染	1,440	Placebo	夢遞積齋範衊淵鏇製築(鹹膚廠餘獵衊醖範繭獵) = 齋憲願鏇築遞膚顧鏇顧壓顧廠糧齋構廠憲顧壓 (蓋鑰觸範鬱鑰範築窪選, 積製簾築構壓網觸構齋 ~ 築願遞鏇壓膚網淵繭構) 更多	-	2023-08-14
NCT05047601 (CTgov)	临床2/3期	新型冠状病毒感染	2,954	Placebo for PF-07321332	鏇遞蓋餘觸網網積獵鏇 = 窪鑰構蓋築醖鹹願築膚衊鬱廠鏇憲顧膚積醖簾 (憲鏇鏇壓蓋獵鏇觸鹹鹹, 壓餘廠窪夢構衊憲選餘 ~ 積醖簾顧淵鑰選淵膚襯) 更多	-	2023-05-06