A Phase 3, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Switching to Long-acting Antiretroviral Therapy of Broadly Neutralizing Antibodies Teropavimab and Zinlirvimab in Combination With the Capsid Inhibitor Lenacapavir Twice-Yearly Versus Cabotegravir and Rilpivirine Every 8 Weeks in Virologically Suppressed Adults With HIV-1 on Oral Daily Antiretroviral Therapy

The goal of this clinical study is to compare how effective a long-acting injectable treatment of lenacapavir (LEN), teropavimab (TAB), and zinlirvimab (ZAB) versus (CAB) and rilpivirine (RPV) injections given every 8 weeks in adults with HIV-1 whose virus is well controlled on daily oral treatment, after 1 year (52 weeks) of the treatment.
The primary objective of this study are to evaluate the efficacy of switching to the regimen of LEN, TAB, and ZAB versus switching to CAB and RPV in virologically suppressed people with HIV-1 (PWH) as determined by the proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 52.

开始日期2026-07-14

申办/合作机构

Gilead Sciences, Inc.

NCT07683000

/ Recruiting临床3期

A Phase 3, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Switching to a Regimen of Broadly Neutralizing Antibodies Teropavimab and Zinlirvimab in Combination With Capsid Inhibitor Lenacapavir Twice-Yearly in Virologically Suppressed Adults With HIV-1 on Stable Oral Treatment Regimens

The goal of this clinical study is to compare how effective a long-acting treatment of injectable combination of lenacapavir (LEN), teropavimab (TAB), and zinlirvimab (ZAB) is versus continuing a daily oral HIV treatment in adults with HIV-1 whose virus is already well controlled, after 1 year (52 weeks) of treatment.
The primary objective of this study is to evaluate the efficacy of switching to the regimen of LEN, TAB, and ZAB versus continuing an oral stable baseline regimen (SBR) in virologically suppressed people with HIV-1 (PWH) as determined by the proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 52.

开始日期2026-07-14

申办/合作机构

Gilead Sciences, Inc.

NCT07708727

/ Not yet recruiting临床2/3期

An Operationally Seamless Phase 2/3 Randomized, Open-label, Active-Controlled Study Evaluating the Safety and Efficacy of an Injectable Regimen of GS-3242 in Combination With Lenacapavir Versus Biktarvy (Bictegravir/Emtricitabine/Tenofovir Alafenamide) in Treatment-Naive People With HIV-1

The study will have two portions: Phase 2 and Phase 3. Phase 2 will further have 2 parts: Part A and Part B.
The goal of Phase 2, Part A is to assess the effectiveness of study drugs GS-3242 plus Lenacapavir (LEN) versus Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF)), in people with HIV-1 (PWH) who are new to treatment. This will be done in Treatment Groups 1, 2 and 3 at Week 35.
The goal of Phase 2, Part B is to compare the effectiveness of study drugs, GS-3242 and LEN versus B/F/TAF in Groups 4 and 3 at Week 26.
The goal of Phase 3 is to assess the long-term effectiveness of study drug GS-3242 and LEN versus B/F/TAF, at Week 52.
The primary objectives of this study are:
Phase 2, Part A: To evaluate the efficacy of intramuscular (IM) GS-3242 plus IM LEN versus B/F/TAF in treatment-naive people with HIV-1 (PWH) in Treatment Groups 1, 2, and 3 at Week 35. Phase 2, Part B: To evaluate the efficacy of IM GS-3242 plus IM LEN versus B/F/TAF in treatment-naive PWH in Treatment Groups 4 and 3 at Week 26.
Phase 3: To evaluate the efficacy of IM GS-3242 plus IM LEN versus B/F/TAF in treatment-naive PWH at Week 52.

开始日期2026-07-01

申办/合作机构

Gilead Sciences, Inc.

100 项与来那帕韦钠相关的临床结果

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100 项与来那帕韦钠相关的转化医学

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100 项与来那帕韦钠相关的专利（医药）

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项与来那帕韦钠相关的文献（医药）

2026-12-31·Emerging Microbes & Infections

Challenges facing long-acting PrEP implementation in large populations

Article

作者: Liao, Yu ; Sun, Caijun

The introduction of long-acting antiviral prophylaxis drugs, exemplified by the twice-yearly injectable capsid inhibitor lenacapavir [1,2], marks a remarkable advance in HIV prevention, which address the adherence issue that has limited the real-world use of daily oral pre-exposure prophylaxis (PrEP) [3,4]. The long-acting formulations of lenacapavir offer a potent prevention tool, particularly well-suited for countries where the HIV transmission mainly occurred in certain populations with high incidence.

2026-08-01·AIDS

Baseline and week 48 resistance analysis in participants receiving bictegravir + lenacapavir in the phase 2 ARTISTRY-1 study

Article

作者: Naik, Vidula ; Montezuma-Rusca, Jairo Mauricio ; Margot, Nicolas A. ; Sklar, Peter ; Callebaut, Christian ; Pennetzdorfer, Nina

Background::

ARTISTRY-1 is an operationally seamless Phase 2/3 study evaluating the safety and efficacy of once-daily oral lenacapavir (LEN) + bictegravir (BIC) in virologically suppressed participants without known integrase strand-transfer inhibitor (INSTI) resistance, compared to a complex multi-tablet regimen.

Methods::

Baseline HIV-1 resistance-associated mutations (RAMs) were assessed via historical genotypic reports (HGR) and proviral DNA genotyping (GenoSure Archive, Monogram Biosciences). The impact of baseline RAMs on Week 48 efficacy in the Phase 2 part of the study was evaluated. Post-baseline genotypic and phenotypic resistance was assessed in participants with confirmed virologic rebound (HIV-1 RNA ≥50 copies/ml; analyzed if ≥200 copies/ml).

Results::

Baseline HIV-1 genotypic data from HGR and/or proviral DNA analyses were available for 98% (125/128) of participants. RAMs for nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), and protease inhibitors (PIs) were found in 81%, 65%, and 46% of participants, respectively; 11% had primary INSTI RAMs by proviral DNA genotyping. Baseline RAMs had no impact on Week 48 efficacy. One participant with baseline resistance to NRTIs, NNRTIs, and PIs, and detectable baseline viral load met the criteria for resistance testing. A novel capsid polymorphism (N74T) emerged in this individual, with no impact on LEN susceptibility.

Conclusions::

Despite high frequencies of baseline resistance, substantial rates of viral suppression were maintained through Week 48 and no on-treatment resistance to study drugs was detected. These findings support the development of once-daily BIC+LEN STR to improve and optimize treatment options in individuals on complex ART.

2026-07-01·ANTIMICROBIAL AGENTS AND CHEMOTHERAPY

A French national observatory of people with HIV initiating lenacapavir-based treatment after regulatory approval

Article

作者: Ghosn, Jade ; Fofana, Djeneba ; Calvez, Vincent ; Cazanave, Charles ; Esnault, Violaine ; Bouvier-Alias, Magali ; Mchantaf, Gilbert ; Avettand-Fenoel, Véronique ; Bachelard, Antoine ; Jacomet, Christine ; Gantner, Pierre ; Allavena, Clotilde ; Phung, Bao ; Makinson, Alain ; Alidjinou, Enagnon Kazali ; Moal, Gwenael Le ; Alexandre, Kevin ; Beby-Defaux, Agnès ; Boever, Corinne Merle de ; Montrouge, Thomas ; Bellecave, Pantxika ; Bonnet, Fabrice ; Moisan, Alice ; Marcelin, Anne-Geneviève ; Chaix, Marie-Laure ; Delaugerre, Constance ; Tumiotto, Camille ; Wirden, Marc ; Rodallec, Audrey ; Coulon, Pauline ; Lambert-Niclot, Sidonie ; Molina, Jean-Michel ; Robineau, Olivier ; Pourcher, Valérie ; Hocqueloux, Laurent ; Rahi, Mayda ; Montès, Brigitte ; Descamps, Diane ; Le Hingrat, Quentin ; Proux, Carolien ; Alessandri-Gradt, Elodie ; Charpentier, Charlotte ; Lazaro, Estibalitz ; Charre, Caroline ; Lacombe, Karine ; Rioux, Christophe ; Ursenbach, Axel ; Peytavin, Gilles ; Gallien, Sébastien ; Garnier, Elisabeth ; Lê, Minh

ABSTRACT:

There is limited data on lenacapavir (LEN) use, the newest capsid inhibitor, in observational settings. We describe population characteristics and pharmaco-virological outcomes of people with HIV-1 (PWH) who initiated LEN-based treatment. We conducted a national retrospective observational study of PWH initiating LEN-based treatment in France after its approval (December 2022). Virological failure (VF) was defined as two consecutive viral loads (VLs) ≥50 c/mL, and a non-virological response as a VL decrease of <1 log 10 c/mL or still >50 c/mL at W24. Ninety-six PWH were included; 49 were virologically suppressed at initiation. Median follow-up on LEN was 12 months (IQR = 8–17). Genotypic susceptibility score was <1 in 59 cases (61%). Twelve participants (12.5%) discontinued LEN-based treatment. Among the virologically suppressed and viremic PWH at initiation, 94% and 64% had VL <50 c/mL at the last follow-up visit, respectively. VF occurred in 8 PWH (3 in virological success and 5 viremic at baseline), and a non-virological response was observed in 12 PWH. Capsid sequence at VF was available for eight subjects, showing the emergence of N74D mutation in one. LEN plasma concentrations were available for 13 of the 20 PWH presenting with VF or non-response with adequate concentrations in 90% of cases. Twenty-four participants received cabotegravir + LEN, 18 having VL <50 c/mL at the last follow-up visit. Our observational findings confirm that LEN-based regimens are effective among heavily treatment-experienced individuals with advanced resistance. In this population, LEN-based treatments were associated with high rates of sustained virological suppression and a low incidence of capsid emergent resistance.

1,071

项与来那帕韦钠相关的新闻（医药）

2026-08-05

·FiercePharma

Gilead’s HIV PrEP franchise hits $1B quarterly sales, but analysts question Yeztugo durability

Gilead Sciences’ HIV prevention business reached a milestone, exceeding $1 billion in quarterly sales for the first time. But despite the record revenue, as highlighted Tuesday by CEO Daniel O’Day, one group of analysts is raising doubts about the long-term growth of Yeztugo, the company’s much-touted long-acting PrEP option. Gilead’s PrEP sales more than doubled year over year to $1.03 billion in the second quarter of 2026, far outpacing the U.S. PrEP market’s overall growth of 14%, commercial chief Johanna Mercier said on Tuesday’s call. The strong growth was led by Gilead’s daily pill Descovy, whose PrEP sales jumped 60% year over year to $801 million. Yeztugo’s $232 million also topped analysts’ consensus by $17 million (8%). Despite the beat, Gilead has kept its Yeztugo full-year forecast unchanged at about $1 billion, which, to the Leerink team, spells “measured confidence.” Yeztugo’s launch momentum looks strong so far. Merely four full quarters into its debut, the twice-yearly injection is now the leader across the entire PrEP switch market, Mercier said. More than 70% of users have returned for their reinjection at six months, a persistence rate that Mercier said tracks “well above available PrEP options.” In a recent U.S. real-world study of nearly 1,700 individuals, the persistence rate for GSK’s bimonthly Apretude was reported at 57% over time. With about 40% of PrEP takers still on first-generation generic Truvada or any meds offered for free under a federal mandate, Leerink analysts “see meaningful headroom for Gilead’s branded portfolio,” including Yeztugo. Despite the positive sign, Leerink also spotted several uncertain signals related to Yeztugo’s long-term growth. Even with enthusiasm around twice-yearly Yeztugo injections, Gilead has developed a weekly oral formulation based on the same lenacapavir ingredient, which is now under FDA review for PrEP with a decision expected by Feb. 2, 2027. Explaining the rationale, Mercier said about 80% to 85% of the PrEP market consists of daily oral medications, calling that a “huge opportunity” for a weekly oral option. To Leerink’s analysts, this comment equates to Gilead “tacitly admitting that a sizable portion of the market prefers the convenience and on-off optionality of orals.” The analysts also questioned whether the 70%-plus return rate will be maintained over time and in later adopters. Gilead is leveraging existing healthcare systems, such as electronic health records, to implement several programs that set up reminders for reinjection, “to make sure that they’re part and parcel of your logistics,” Mercier said on the call. “I think they're all going to be very positive to continue to support our persistency rates,” she said. Whether the overall PrEP market will keep growing at a fast pace remains to be seen, even though Gilead management confirmed to Leerink that the company sees double-digit category expansion into the next decade. “We believe Gilead['s] efforts to expand into communities with high HIV incidence but low PrEP use—Black, Latino, cisgender women—may have diminishing returns, as these populations may have shorter persistence compared to groups with high PrEP awareness and usage,” the Leerink team said, citing a recent survey. Not all analysts see a problem down the road. In their Tuesday note, Jefferies’ analysts put their Yeztugo peak sales estimate at $9.5 billion, even higher than their previous projection of $8.9 billion back in March. In contrast, Wall Street’s consensus prediction dropped from $7.7 billion to $6.7 billion during the period. Thanks to better-than-expected performance from the entire HIV franchise, Gilead’s overall second-quarter sales, at $7.6 billion, came 3% above consensus.

2026-08-05

·摩熵医药

抗病毒巨头Q2营收78亿美元，明星药Veklury暴跌81%！

注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需要得到授权。 8月4日，吉利德公布2026年第二季度财报。总营收78亿美元，同比增长10%，超出市场预期的74亿美元。产品销售额（剔除Veklury）76亿美元，同增10%。但归母净利润为 -105亿美元，GAAP每股亏损8.45美元。截图来源：吉利德企业官网赚钱的业务在涨，花钱的步子更大。这是吉利德转型期的典型财务画像。 01 HIV依然是“现金牛”：PrEP季度首破10亿美元 HIV依然是吉利德最稳固的压舱石。二季度HIV产品销售额56.9亿美元，同比增长12%。核心产品Biktarvy贡献38亿美元，同增7%。一款已上市多年的单片复方方案，这个体量还在涨，说明市场拉力足够强。截图来源：吉利德2026年Q2财报 Descovy的PrEP适应症销售额约9.67亿美元，同增48%。加上Yeztugo的2.23亿美元，吉利德PrEP业务整体季度销售额首次突破10亿美元，同比翻倍。一个细分赛道，单季10亿美元——这个数字超过多数药企全部产品线一个季度的总收入。吉利德在这个赛道上的护城河已经不只是“先发优势”，而是药物发现、长效制剂、患者依从性管理的多维壁垒。管线还在加码： FDA已受理Yeztugo（lenacapavir）300mg片剂的补充新药申请，作为每周一次口服PrEP方案，PDUFA日期2027年2月2日；与默沙东合作的每周一次口服islatravir+lenacapavir方案，两项III期（ISLEND-1和ISLEND-2）均取得积极结果。全年HIV销售增长预期已上调至9%-10%。一个判断：HIV业务正在从“靠Biktarvy吃存量”转向“靠PrEP吃增量”的双引擎结构。 02 肿瘤业务：Trodelvy升级，CAR-T承压，ADC接棒肿瘤是吉利德过去几年最用力砸钱的方向。二季度表现喜忧参半。好消息是Trodelvy。这款TROP2 ADC二季度销售4.57亿美元，同增26%。6月，FDA批准其用于一线治疗mTNBC，不再限定PD-L1状态——适应症扩容直接打开了更大的患者池。目前Trodelvy已在全球60多个国家获批二线及以上mTNBC，50多个国家获批经治HR+/HER2-转移性乳腺癌。Trodelvy正在从一个“后线挽救药”变成“前线标准方案”。坏消息是细胞疗法。 Yescarta销售3.46亿美元（-12%），Tecartus为0.7亿美元（-24%），合计4.17亿美元，同比下降14%。截图来源：吉利德2026年Q2财报全球多款CAR-T疗法已获批上市，赛道正从蓝海急速转向红海。价格竞争加剧、适应症高度重叠。据摩熵医药数据库统计，全球获批上市的CAR-T药物已超过15款。从临床研发进度看，吉利德的KITE-772目前处于全球申请上市阶段，另有5款在研产品推进至Ⅰ期临床，1款进入Ⅲ期临床。截图来源：摩熵医药全球药物研发数据库（查数据.找摩熵）真正的战略看点不在已上市产品，而在管线端的两次重仓： 4月完成对Arcellx的收购，收获anito-cel——一种基于D-domain binder技术的CAR-T疗法，用于四线及以上复发/难治性多发性骨髓瘤，PDUFA日期定在12月23日。这可能是吉利德在细胞疗法赛道上的翻身仗。 5月完成对Tubulis的收购（前期31.5亿美元），补充下一代ADC资产。GS-8824（原TUB-040）是一款NaPi2b靶向拓扑异构酶I抑制剂ADC，在铂耐药卵巢癌I期临床中，选定剂量组确认ORR达61%，mPFS为11个月，血液学毒性较低。这套组合拳的逻辑很清晰：CAR-T守阵地，ADC拓疆土。但EVOKE-3的失败（Trodelvy+Keytruda一线NSCLC折戟）提醒一件事——ADC+IO联合的边界仍然存在，并非所有组合都能跑通。 03 肝病接棒新冠：Veklury退场，Livdelzi翻倍肝病业务二季度销售8.77亿美元，同比增长10%。增长核心是Livdelzi（seladelpar）——一款用于原发性胆汁性胆管炎（PBC）的药物，2024年获批，2026年Q2销售额1.67亿美元，同比翻倍以上。截图来源：吉利德2026年Q2财报另一亮点是Hepcludex，5月获FDA加速批准，成为美国首个且唯一获批治疗慢性丁型肝炎（HDV）的药物。HDV影响全球约1200万人，长期以来几乎没有有效治疗选择——这是典型的“小众但刚需”市场。另一边，Veklury（瑞德西韦）正在加速退场。二季度销售仅2300万美元，同比暴跌81%。新冠住院率持续下降，这款曾经的“明星药物”正走向终点。吉利德已将其全年销售预测从约6亿美元下调至约3亿美元。截图来源：吉利德2026年Q2财报一个时代的落幕，另一个时代的开启——从抗新冠到抗丁肝，吉利德在抗病毒领域完成了业务接力。结语吉利德正处在一个微妙的转折点。 HIV是现金牛，但它已不再是“一家HIV公司”。通过密集收购和管线推进，它正在把自己重新定义为一家横跨抗病毒、肿瘤和自免的多元化生物制药企业。这个转型的代价是账面上一百多亿美元的收购支出和单季105亿美元的巨额亏损。但如果anito-cel顺利上市、GS-8824推进到注册临床、Livdelzi和Trodelvy持续放量，这笔投资在未来三到五年内有可能转化为可观的收入增量。两重悬疑仍待解开：第一重：细胞疗法的竞争格局。 Yescarta和Tecartus连续下滑，CAR-T赛道正在从“蓝海”变成“红海”。anito-cel能否帮吉利德守住阵地，是2026年12月23日之前最大的问号。第二重：EVOKE-3的失败。 Trodelvy+Keytruda在一线NSCLC的折戟是一个清醒剂——ADC的边界仍然存在，并非所有联合都能跑通。从有管线到有产品、从有产品到有销售，每一步都伴随着淘汰率。 END 本文为原创文章，转载请留言获取授权点击阅读原文，申请摩熵医药企业版免费试用！

2026-08-05

·GBIHealth

默沙东、辉瑞、渤健等多家MNC发布财报

默沙东2026Q2财报：销售额增长4%至166亿美元 2026年8月5日，默沙东（MSD，NYSE：MRK）公布2026年第二季度（Q2）财务业绩。集团Q2全球总销售额达到166亿美元，同比增长4%（按固定汇率计算，下同）。销售增长反映了肿瘤业务的持续强劲表现，包括Keytruda QLEX的初期上市放量，以及Winrevair等新产品的贡献。PD-1抑制剂可瑞达（帕博利珠单抗）及其皮下注射剂型Keytruda QLEX合计贡献84亿美元，同比增长4%；其中Keytruda QLEX销售额为4.63亿美元。用于治疗肺动脉高压的欣瑞来（索特西普）销售额增长75%，达到5.88亿美元。报告期内，默沙东管线取得多项进展。Lipfendra（enlicitide）获得美国FDA批准，这是首个且目前唯一的每日一次口服PCSK9抑制剂，用于降低高胆固醇血症成人患者的LDL-C。此外，默沙东与科伦博泰联合开发的TROP2 ADC芦康沙妥珠单抗（sac-TMT，商品名：佳泰莱）在针对特定晚期或复发性子宫内膜癌患者的TroFuse-005试验中取得了积极结果。默沙东还与吉利德合作，公布了每周一次口服HIV治疗组合islatravir和lenacapavir的积极III期数据。默沙东同时上调并收窄全年销售预期范围，目前预计2026年全年销售额在663亿至673亿美元之间。辉瑞2026Q2：营收达到150亿美元，上调全年指引 2026年8月4日，辉瑞（NYSE：PFE）公布2026年第二季度（Q2）财务业绩。公司Q2营收达150亿美元，按运营口径计算（下同）同比增长1%，其中上市及收购产品增长18%。剔除新冠疫苗复必泰和口服抗病毒药物Paxlovid后，Q2营收同比增长5%。辉瑞已上调其2026年全年营收指引，以中值计算提高5亿美元，调整后全年营收区间为605亿至625亿美元。报告期内，辉瑞全球生物制药业务营收达到146.61亿美元，同比增长1%，主要得益于艾乐妥、备思复、维达全家族、博瑞纳等多个品类产品的推动，但部分被新冠产品及其他品类产品的收入下滑所抵消。产品销售额艾乐妥（阿哌沙班）：这款与百时美施贵宝联合推广的抗凝药物在Q2贡献了24.25亿美元收入，同比增长19%，主要得益于美国市场定价动态带来的净价格上升；备思复（维恩妥尤单抗）：这款由Seagen研发的ADC在Q2录得6.67亿美元，同比增长23%，主要得益于其在一线局部晚期或转移性尿路上皮癌（la/mUC）市场份额的提升，以及不适合顺铂肌层浸润性膀胱癌（MIBC）适应证的上市推广；罕见病药物维达全家族（Vyndaqel、Vyndamax、Vynmac）营收达17.62亿美元，同比增长8%，主要得益于国际市场强劲的需求增长和可及性改善；博瑞纳（洛拉替尼）营收增长37%至3.54亿美元，主要得益于一线ALK阳性转移性非小细胞肺癌（ALK+ mNSCLC）患者份额的增加。渤健2026Q2财报：收入增长3% 2026年7月29日，渤健（Nasdaq：BIIB）发布2026年第二季度财务业绩。报告期内，公司收入27.36亿美元，同比增长3%（按固定汇率计算，下同）。增长型产品组合收入10.6亿美元，同比增长24%。增长型产品组合包括7款产品：①SPINRAZA（诺西那生钠）销售额4.02亿美元（+2%），主要由高剂量方案的需求推动。各上市地区的方案转换速度均超公司预期；②LEQEMBI（仑卡奈单抗）全球市场销售额为1.84亿美元（+15%），其中美国市场销售额为9700万美元，保持连续增长。首创的抗淀粉样蛋白居家起始给药制剂LEQEMBI IQLIK已获美国FDA 批准；③SKYCLARY销售额1.68亿美元（+29%），主要得益于欧洲及其他国际市场的持续上市推动的全球需求增长；④ZURZUVAE销售额7100万美元（同比增长 53%）；现已在德国上市，这是其在欧美以外的首次商业化上市；⑤SYFOVRE销售额1.62亿美元（+8%），创上市以来最强单季需求，渤健自2026年5月14日完成对Apellis的收购后，确认了其中的9700万美元收入；⑥EMPAVELI销售额4600万美元（+123%），渤健自收购完成后确认了其中的3000万美元收入；⑦VUMERITY销售额1.97亿美元（-7%），主要受库存动态影响（上半年该药销售额同比增长7%）。拜耳2026Q2：销售额增长2.2%至108.72亿欧元 2026年8月4日，拜耳（德国证券交易所代码：BAYN）公布2026年第二季度（Q2）财报。集团2026Q2销售额为108.72亿欧元（约合125.51亿美元，GBI计算，下同），同比增长2.2%（经汇率与资产组合调整，下同）。处方药事业部销售额为44.58亿欧元（51.46亿美元），与去年基本持平（+0.8%）。其中癌症治疗药物诺倍戈（达罗他胺）以及用于治疗慢性肾病和心力衰竭的可申达（非奈利酮）再次实现显著增长。诺倍戈期内销售额增长63.9%至8.8亿欧元（10.16亿美元），主要得益于美国和欧洲市场销量提升；可申达销售额增长82.9%至3.29亿欧元（3.80亿美元），主要得益于美国和中国市场销量增加。曼月乐系列产品同样表现强劲，在美国市场推动下，全球销售额增长9.0%，达到3.43亿欧元（3.96亿美元）。在影像诊断领域，优维显（碘普罗胺）和CT高压注射系统产品线销售额分别增长26.8%和8.1%。受专利到期影响，口服抗凝药拜瑞妥（利伐沙班）销售额下降42.4%至3.74亿欧元（4.32亿美元）；眼科药物艾力雅（阿柏西普）销售额下降32.8%至5.73亿欧元（6.61亿美元），整体与预期相符。健康消费品事业部销售额增长1.5%至14.45亿欧元（16.68亿美元）。几乎所有品类和地区均实现增长，其中消化道健康品类表现最为突出，销售额增长9.4%至2.44亿欧元（2.82亿美元）。而由于季节性需求疲软，抗过敏与感冒品类销售额下降8.0%至2.42亿欧元（2.79亿美元）。从区域来看，该事业部在美国市场仍面临疲软市场环境带来的压力，欧洲/中东/非洲、拉丁美洲以及亚太地区则实现同比增长。武田发布2026财年第一季度财报：收入77亿美元 2026年7月30日，武田（TSE：4502/NYSE：TAK）发布2026财年第一季度财务业绩。报告期内公司收入12199亿日元（约77.4亿美元），同比下滑0.5%（按固定汇率计算，下同）。公司核心营业利润3589亿日元（约22.77亿美元），同比下滑0.5%。公司预计2026财年全年收入为46400亿日元，呈现低个位数下滑；核心利润11600亿日元，预计下滑5%~8%。武田的下一步增长将由三款产品驱动。近期在中国获批上市的ORZEYFUL（奥普雷顿）是一款具有同类首创作用机制的食欲素（Orexin）受体激动剂，旨在解决导致1型发作性睡病（NT1）的食欲素缺乏问题。其新药上市申请正在美国和日本接受审批。Rusfertide，一款用于治疗血液肿瘤真性红细胞增多症（PV）成人的潜在同类首创铁调素（Hepcidin）类似物，已获得美国FDA优先审评资格，预计下半年在美国商业化上市。Zasocitinib，一款下一代、高选择性且强效用于治疗银屑病的TYK2抑制剂，已证实可通过每日一次、无禁食限制的便捷口服给药，实现快速且持久的皮损清除效果，公司计划于2026年提交监管申请，并预计于2027年上半年实现商业化上市。安进2026Q2财报：收入101亿美元 2026年8月4日，安进（Nasdaq：AMGN）公布了公司2026年第二季度财务业绩。报告期内（第二季度），公司收入100.54亿美元，同比增长10%，经审计的营业利润增至35亿美元。六大核心增长驱动产品同比增长26%，占第二季度产品销售额的近70%。2026年上半年，公司收入186.72亿美元，报告期内，公司产品总销售额达95.37亿美元，同比增长9%。其中销售额最高的产品为地舒单抗（Prolia销售额7.59亿美元，Xgeva销售额3.52亿美元），共11.11亿美元，同比下滑超30%；Repatha（依洛尤单抗）销售额9.53亿美元，同比增长37%；Evenity（罗莫索珠单抗）销售额7.14亿美元，同比增长38%；Enbrel（依那西普）销售额5.8亿美元，同比下滑4%。公司决定终止一款减肥药AMG 513的开发，该药目前处于Ⅰ期临床研究。公司在该领域的管线仅剩Maridebart cafraglutide (MariTide，研发代号AMG 133)，目前正在进行针对肥胖、2型糖尿病和慢性体重管理等适应证的Ⅲ期研究。全球医疗情报领导者解锁隐藏在数据中的商业潜力关于 G B I ” 自从2002年成立以来，GBI始终以技术为驱动，为药企、器械及行业相关服务商提供贯穿生命周期的全球药品市场竞争数据、全球行业资讯、HCPs洞察、全国医疗器械数据等商业信息与洞察，助力企业在进行战略布局和决策时，脱颖而出。历经20余年的深耕细作GBI已成为95%以上跨国药企、国内头部药企、咨询与投资机构等医疗圈灯塔用户值得信赖的长期合作伙伴。联系我们投稿 | 发稿 | 媒体合作 ▶ olivia.xu@generalbiologic.com 数据库 | 咨询服务 | 资讯追踪 ▶ 点击左下“阅读原文”完成表单填写点击阅读原文，解锁完整双语新闻

财报抗体药物偶联物疫苗并购

100 项与来那帕韦钠相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB15673

研发状态

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
HIV感染	欧盟	Gilead Biopharmaceutics Ireland UC	2022-08-17
HIV感染	冰岛	Gilead Biopharmaceutics Ireland UC	2022-08-17
HIV感染	列支敦士登	Gilead Biopharmaceutics Ireland UC	2022-08-17
HIV感染	挪威	Gilead Biopharmaceutics Ireland UC	2022-08-17

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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


NCT05729568 (Pubmed \| Lancet Microbe)	临床2期	HIV感染	80	Lenacapavir+Teropavimab+Zinlirvimab	繭鬱窪遞選壓簾淵艱觸(襯廠顧糧壓窪夢膚夢獵) = 簾鹽繭網鹽鑰廠願窪鑰壓積範齋齋築選觸製齋 (憲鹹積齋觸衊鹹壓蓋觸 )	积极	2026-03-01
				SBR	選範鑰襯齋築窪衊齋艱(壓鬱齋糧構餘蓋壓膚簾) = 網齋繭獵築築憲範蓋艱選廠範顧壓膚壓壓淵齋 (願夢壓製顧鏇獵繭願鬱, 0.0 ~ 12.8) 更多
NCT05052996 (Pubmed \| Ann Intern Med)	临床2期	HIV感染	104	Islatravir + Lenacapavir	繭遞遞膚夢鹹選鹽顧鏇(願鹽網衊簾蓋網構鹹鏇) = 鏇觸顧夢糧獵壓製窪網餘衊顧製糧廠遞顧窪築 (齋獵網鬱膚鬱遞觸選壓 ) 更多	积极	2025-12-23
				Bictegravir, Emtricitabine, Tenofovir Alafenamide	艱淵餘膚鏇醖顧襯蓋廠(壓獵選醖夢廠廠築蓋鏇) = 壓鬱糧壓製鹽齋糧襯蓋壓醖衊膚鏇餘鬱齋淵衊 (鏇獵糧淵積簾網糧獵範 ) 更多
NCT04994509 \| NCT04925752 (PURPOSE 2, NEWS) 人工标引	临床3期	HIV感染	-	lenacapavir (每年两次)	窪襯廠鹽簾積範製壓憲(選繭衊選獵遞鏇襯餘製) = 孕妇与非孕妇安全性相似，按妊娠期或产后状态预测的Yeztugo 暴露无临床显著差异，母乳喂养婴儿暴露量也极小。鑰構膚簾壓觸膚獵繭製 (範壓鹽衊觸鹹鏇鹽夢鏇 ) 更多	积极	2025-07-16
NCT05729568 (CTgov)	临床2期	HIV感染	83	Antiretroviral Therapy	積遞鏇鬱鹽鏇遞窪廠積 = 製選製艱築膚製築艱網艱選廠窪鏇鹹築觸構繭 (繭鑰淵範憲衊顧鏇獵願, 齋觸製遞觸製觸艱鹹顧 ~ 選壓衊醖廠糧壓壓製構) 更多	-	2025-07-15
NCT04994509 \| NCT04925752 (PURPOSE 2, FDA_CDER) 人工标引	临床3期	HIV感染	-	YEZTUGO (PURPOSE 1)	壓夢範憲膚築獵獵齋選(獵齋構膚淵網壓憲醖窪) = 鬱遞夢構醖襯廠範鑰獵願糧遞廠膚顧簾簾觸願 (願觸淵艱淵鬱願餘襯構 )	积极	2025-06-18
				TRUVADA (PURPOSE 1)	壓夢範憲膚築獵獵齋選(獵齋構膚淵網壓憲醖窪) = 觸鑰鹽構簾鬱憲糧遞糧願糧遞廠膚顧簾簾觸願 (願觸淵艱淵鬱願餘襯構 )
NCT04150068 (Phase 2/3 Trial, Pubmed \| Clin Infect Dis)	临床2/3期	HIV感染 multidrug-resistant HIV-1	72	Lenacapavir + OBR	顧範窪鹹鑰淵顧築壓選(壓蓋蓋壓衊壓膚選艱蓋) = There were no Grade 4 or serious treatment-related adverse events 壓鏇餘觸繭衊襯鏇鏇齋 (廠壓齋選壓齋糧築壓鑰 ) 更多	积极	2025-03-17
PipelineReview \| Pubmed 人工标引	临床1期	HIV感染	40	ventrogluteal intramuscular injection lenacapavir with 5% w/w ethanollenacapavir with 5% w/w ethanol	淵鏇淵願窪襯遞襯鏇廠(遞簾鹹積鬱簾願簾廠壓) = 膚鬱鑰鬱憲繭鬱餘構醖夢憲餘壓淵製鑰製鹹窪 (艱廠獵製餘壓觸廠顧蓋, 56.1 ~ 112.0) 更多	积极	2025-03-12
				ventrogluteal intramuscular injection lenacapavir with 10% w/w ethanollenacapavir with 10% w/w ethanol	淵鏇淵願窪襯遞襯鏇廠(遞簾鹹積鬱簾願簾廠壓) = 簾範夢蓋選築壓襯淵鹽夢憲餘壓淵製鑰製鹹窪 (艱廠獵製餘壓觸廠顧蓋, 55.3 ~ 105.5) 更多
NCT04811040 (CTgov)	临床1期	HIV感染	32	LEN+Zinlirvimab+Teropavimab (Primary Cohort: LEN+Teropavimab+Zinlirvimab 10 mg/kg)	鹽鏇鏇鑰繭繭構築襯構 = 憲積製襯鏇憲顧簾選簾憲襯鏇鹽齋艱簾製簾鹹 (壓選範壓淵蓋簾製夢夢, 艱鹽簾壓壓製鹹壓衊築 ~ 膚鹽齋顧憲醖壓鏇夢範) 更多	-	2025-01-27
				LEN+Zinlirvimab+Teropavimab (Primary Cohort: LEN+Teropavimab+Zinlirvimab 30 mg/kg)	鹽鏇鏇鑰繭繭構築襯構 = 衊構膚糧獵衊鏇鑰顧艱憲襯鏇鹽齋艱簾製簾鹹 (壓選範壓淵蓋簾製夢夢, 鬱製鏇憲夢觸醖壓觸襯 ~ 憲鬱衊鏇鑰齋獵觸衊顧) 更多
NCT05052996 (CTgov)	临床2期	HIV感染	142	LEN+ISL (Cohort 1- Group 1 (ISL+LEN))	積淵築襯淵壓願蓋構積(網淵繭鏇網鹽網鹽膚繭) = 鑰蓋選顧鹽網遞艱構築鏇願築築廠衊鹹簾範鹹 (淵鏇憲膚鬱願餘衊蓋襯, 265.0) 更多	-	2025-01-14
				LEN+ISL (Cohort 1- Group 2 (B/F/TAF to ISL+LEN))	積淵築襯淵壓願蓋構積(網淵繭鏇網鹽網鹽膚繭) = 餘鑰鏇獵餘襯鹽鹽襯糧鏇願築築廠衊鹹簾範鹹 (淵鏇憲膚鬱願餘衊蓋襯, 304.8) 更多
NCT04925752 (PURPOSE 2, Pubmed \| N Engl J Med) 人工标引	临床3期	HIV感染	3,265	Lenacapavir	獵鹹選餘構憲餘衊簾鏇(鏇鹹願選夢獵鑰鏇膚窪) = 糧鏇鏇構築廠齋醖淵餘簾顧窪構網顧醖蓋顧鹹 (願糧鑰膚衊衊醖蓋願願, 0.01 ~ 0.37) 更多	积极	2024-11-27
				Emtricitabine-tenofovir disoproxil fumarate (F/TDF)	獵鹹選餘構憲餘衊簾鏇(鏇鹹願選夢獵鑰鏇膚窪) = 築顧醖憲憲淵鬱夢願窪簾顧窪構網顧醖蓋顧鹹 (願糧鑰膚衊衊醖蓋願願, 0.43 ~ 1.77) 更多