A Multicenter, Randomized, Open-Label, Phase III Clinical Trial to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of NXT007 Prophylaxis Versus Factor VIII Prophylaxis in People With Hemophilia A Without Inhibitors

The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of NXT007 prophylaxis compared with Factor VIII (FVIII) prophylaxis in participants with severe or moderate congenital hemophilia A without inhibitors. The study will include people aged ≥12 years old with severe or moderate congenital hemophilia A without inhibitors on previous FVIII prophylaxis treatment.

开始日期2026-05-15

申办/合作机构

Roche Holding AG

[+1]

NCT07416604

/ Recruiting临床3期

A Multicenter, Randomized, Open-Label, Phase III Clinical Trial to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of NXT007 Prophylaxis Versus Emicizumab Prophylaxis in People With Hemophilia A

The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of NXT007 prophylaxis compared with emicizumab prophylaxis in people age 12 years and older with severe or moderate congenital hemophilia A without factor VIII (FVIII) inhibitors or with hemophilia A of any severity (severe, moderate, and mild) with FVIII inhibitors.

开始日期2026-04-27

申办/合作机构

Roche Holding AG

[+1]

NCT06189508

/ Completed临床1期

An Open-Label, Parallel-Group Phase I Study to Evaluate the Relative and Absolute Bioavailability of Single Subcutaneous Doses of NXT007 Among Injection Sites Abdomen, Upper Arm, and Thigh in Healthy Male Participants

This is a Phase I, open-label, non-randomized, parallel-group, single-dose study in healthy adult male participants. The aim is to investigate the relative bioavailability (rBA) of NXT007 among subcutaneous (SC) injection sites (abdomen, upper arm, and thigh) and the absolute bioavailability (aBA) of SC NXT007 administration. In addition, the pharmacodynamic, safety, tolerability, and immunogenicity of a single dose of NXT007 following SC or intravenous (IV) administration are assessed.

开始日期2024-02-14

申办/合作机构-

100 项与 Zemocimig 相关的临床结果

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100 项与 Zemocimig 相关的转化医学

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项与 Zemocimig 相关的文献（医药）

2026-05-07·BLOOD

NXTAGE: a phase 1/2 study of NXT007 to assess safety, pharmacokinetics, and efficacy in hemophilia A without inhibitors

Article

作者: Miwa, Takuya ; Iwasaki, Keisuke ; Park, Young-Shil ; Amano, Kagehiro ; Chen, Yeu-Chin ; Shima, Midori ; Chen, Chun-An ; Shen, Ming-Ching ; You, Chur-Woo ; Takeyama, Masahiro ; Kobayashi, Ryota ; Wang, Jiaan-Der ; Nogami, Keiji ; Miyake, Takeshi ; Chou, Sheng-Chieh

Abstract:

NXT007 is a next-generation, activated factor VIII (FVIIIa)–mimetic bispecific antibody under investigation in the phase 1/2 NXTAGE trial. Here, we report the primary analysis of the multiple-ascending-dose Part B study in people with hemophilia A (PwHA). Eligible participants were men with severe HA without FVIII inhibitors. Four dose cohorts (B1-B4) were planned, with NXT007 administered subcutaneously at maintenance doses of 0.072 mg/kg, 0.28 mg/kg, 0.70 mg/kg, and 1.08 mg/kg, respectively, every 4 weeks. Primary end points were safety (adverse events [AEs] and serious AEs [SAEs]), tolerability, pharmacokinetics, pharmacodynamics, and efficacy; secondary end points included incidence of anti-drug antibodies (ADAs). Participants in cohorts B1 (n = 10), B2 (n = 6), B3 (n = 6), and B4 (n = 8) had received NXT007 for a median (minimum to maximum) of 114.1 (29-140), 96.4 (88-112), 58.1 (52-72), and 22.2 (4-28) weeks, respectively. Two participants discontinued treatment: NXT007-unrelated AE (n = 1) and complete loss of NXT007 exposure due to ADAs (n = 1). Participants’ plasma NXT007 concentration showed a dose-dependent increase, and predicted FVIII-equivalent activity reached a nonhemophilic level (≥40 IU/dL) in B2 onward. NXT007 had a favorable safety profile at all doses. Most AEs were mild/moderate and all 3 SAEs were considered unrelated to NXT007. Mean annualized treated bleed rates were 1.48 (B1), 0.28 (B2), 0.00 (B3), and 0.00 (B4). Two participants had pharmacokinetics-affecting NXT007 ADAs, including the B1 participant who discontinued treatment. NXTAGE Part B demonstrates that NXT007 could provide nonhemophilic coagulation activity in PwHA, with a less burdensome dose regimen than currently available therapies. This trial was registered at Japan Registry of Clinical Trials as jRCT2080224835.

2026-03-04·Expert Review of Clinical Pharmacology

Factor-VIII mimetic bispecific antibodies for the treatment of hemophilia A: an update

Review

作者: Camelo, Ricardo Mesquita ; Alvares-Teodoro, Juliana ; Muniz Júnior, Roberto Lúcio ; Lamounier de Almeida, Douglas ; Eduarda Alves de Jesus, Vitória ; Pierce, Glenn F

INTRODUCTION:

Bispecific antibodies are used to treat various conditions, with notable results in hemophilia A, a rare bleeding disorder characterized by reduced or absent activity of the coagulation factor VIII (FVIII). Emicizumab is a bispecific antibody that mimics FVIII activity, reducing bleeds in people with hemophilia A (PwHA). The real-world effectiveness and safety profile of emicizumab stimulated the development of additional FVIII-mimetic antibodies.

AREAS COVERED:

This review covers recent progress in hemophilia A treatment, focusing on FVIII-mimetic bispecific antibodies. Emicizumab, the only currently approved FVIII-mimetic bispecific antibody, has shown effectiveness in reducing bleeding rates in PwHA with and without inhibitors, enabling improved musculoskeletal health and quality of life. Other FVIII-mimetic bispecific antibodies are in clinical trials (Mim8 and NXT007). We discuss mechanisms, preclinical and clinical outcomes, real-world data, safety, and new molecules expanding the therapeutic repertoire under development.

EXPERT OPINION:

The advent of FVIII-mimetic bispecific antibodies marks a shift in hemophilia A prophylaxis away from FVIII replacement therapies. Next-generation agents may offer enhanced activity and safety. Despite advances, challenges remain in monitoring activity, managing breakthrough bleeds, and understanding non-hemostatic FVIII roles. As long-acting, subcutaneous agents mature, they may redefine care, enabling personalized, safer, and more accessible prophylaxis across the lifespan.

2026-02-24·Blood Advances

Next-generation FVIIIa-mimetic bispecific antibody NXT007: evaluation in preclinical models of hemostasis and thrombosis

Article

作者: Receveur, Nicolas ; Frey, Nina ; David, Tovo ; Locke, Matthew ; Wyssenbach, Mariella ; Marbach, Sandra ; Albiez, Jamie ; Girotra, Mukul ; Bektic, Lejla

Abstract:

NXT007 is a next-generation factor VIIIa (FVIIIa)-mimetic bispecific antibody currently in phase 1/2 trials. It was developed by optimizing the framework of emicizumab to achieve hemostatic normalization in people with hemophilia A (PwHA). Here, we provide a direct comparison of NXT007 with emicizumab, using a wide range of in vitro and in vivo preclinical models of hemostasis and thrombosis. Both NXT007 and emicizumab increased tissue factor (TF)-triggered peak height thrombin generation when spiked into HA-like (FVIII-neutralized) plasma, with NXT007 being more potent than emicizumab, achieving peak at lower concentrations and producing a higher maximum effect. NXT007 and emicizumab delayed fibrinolysis in a dose-dependent manner, with NXT007 having ∼20-fold more potent antifibrinolytic effect. Both bispecific antibodies corrected clotting times and kinetics of HA-like blood, measured by rotational thromboelastometry, with NXT007 being ∼23-fold more potent. In collagen/TF-coated flow chambers perfused with HA-like blood at arterial shear rates, NXT007 and emicizumab increased fibrin deposition without increasing platelet adherence; the maximum effect of NXT007 was greater than that of emicizumab and was achieved at lower concentration. Following tail vein transection in HA mice, NXT007 was more potent than emicizumab in controlling bleeding. In a ferric chloride carotid injury model, the administration of NXT007 and emicizumab at plasma concentrations of ∼20 to 200 μg/mL had no effect on maximum blood flow reduction, indicating that they do not present a prothrombotic profile in this model. Overall, our data support the ongoing clinical evaluation of NXT007 and suggest that it can substantially improve therapeutic efficacy for PwHA.

项与 Zemocimig 相关的新闻（医药）

2026-08-13

·戊戌数据

【医药早报】2026年8月13日

上半年创新药BD交易破1100亿美元，第12批集采10款原研药中选，药明康德获美法院初步禁令。今日必看 1. 上半年中国创新药BD交易总额达1100亿美元，全球Top10中国占8席中康科技报告显示，2026年上半年中国创新药对外授权交易潜在总额达1100亿美元，全球前十的BD交易里中国占了8席。医保控费压力叠加靶点同质化，加上全球专利悬崖逼近，倒逼创新药加速出海。近五年医保谈判平均降幅超60%，累计节约基金4400亿元，把管线卖给海外成了必然选择。 BD交易正在成为创新药企最重要的现金流来源。 2. 第12批国家药品集采开标，首次有10款原研药中选第12批国家组织药品集中带量采购开标，首次有10款原研药中选。本批集采强调"稳临床、反内卷"，允许按厂牌报量，设了未入围复活机制，还调整了分量模式，保障临床用药延续性。报价过低的药企可能反而无法入围，价格竞争趋于理性。集采不再一味追低价，给原研药留了位置，也在给过热的内卷踩刹车。 3. 药明康德获美国法院初步禁令，国防部"中国军事企业"列名效力暂停美国哥伦比亚特区联邦地区法院批准了药明康德的初步禁令动议，诉讼期间禁止国防部执行"中国军事企业"清单列名效力。法院指出国防部列名理由存在证据解读偏差。消息一出药明康德股价大涨，H股创历史新高。禁令只是临时救济，国防部仍可补充证据重新列名，但短期内利空出尽。 4. 礼来起诉六起黑市retatrutide减重针销售商，该药仍处III期临床礼来公司在美国提起六起诉讼，针对复方药房、医美机构及线上供应商非法销售在研减重药retatrutide。该药仍处于III期临床，未获任何监管批准，FDA已明确其非法。礼来已向监管机构移交200多名个人及实体线索，举报超14000个网站和帖子，推动平台封堵非法销售渠道。减重药黑市乱象持续发酵，药企维权力度在加大，监管也在收紧。 5. "原研一致"商标引争议，开封制药红霉素眼膏被指误导消费者开封制药生产的红霉素眼膏包装标注"原研一致"字样，被指容易跟"仿制药一致性评价"混淆，涉嫌误导消费者。律师认为该商标违反反不正当竞争法、广告法等。属地市场监管部门已现场检查，并将线索移送至上海金山区市场监管局进一步核查商标注册事宜。 "原研一致"打擦边球蹭一致性评价热度，监管已经介入，商标滥用行不通了。新药 / 研发 FDA受理丁肝口服疗法lonafarnib上市申请，潜在首个口服丁肝药 EIT Pharma宣布FDA受理lonafarnib治疗慢性丁型肝炎的NDA，该药为潜在first-in-class口服疗法，已获突破性疗法认定。关键III期D-LIVR研究纳入400余例患者，达到主要终点。若获批，将成为首个口服丁肝治疗药物，填补未满足医疗需求。 III期入组超400例且达到主要终点，距离首个口服丁肝药只差临门一脚。恒瑞医药SHR-6914注射液获批临床，注射用HRS-9190同步推进恒瑞医药旗下苏州盛迪亚生物的SHR-6914注射液获临床试验默许（CTR20262879），同日注射用HRS-9190也获批临床（CTR20262994）。恒瑞持续在创新管线铺货，多个品种同步推进。恒瑞一日双管线获批临床，创新药管线持续扩容。石药集团收到阿斯利康siRNA合作首付款3000万美元石药集团公告已收到阿斯利康就siRNA药物开发合作、选择权及授权协议项下3000万美元首付款。该合作旨在利用石药在siRNA领域的研发能力共同开发创新药物，首付款到账标志着合作正式启动，后续里程碑付款有望进一步增厚业绩。 3000万美元首付款落袋，siRNA赛道再添一单跨国合作。晶蛋生物与Almirall达成2.545亿欧元合作，共同开发皮肤疾病创新药晶蛋生物与阿尔米拉尔签署合作及许可协议，共同开发皮肤疾病创新候选药物。晶蛋生物负责早期发现至临床概念验证，Almirall支付首付款及里程碑付款，总额高达2.545亿欧元，另加销售分成。该合作体现药企合作模式向联合研发、产能共建等多样化发展。 2.545亿欧元总额锁定皮肤病赛道，Biotech出海再添新案例。利福平口服混悬液、氨酚羟考酮片等多品种获批临床本期临床研发动态共6条，除恒瑞系品种外，华益药业的利福平口服混悬液（CTR20262922）、北京华素制药的氨酚羟考酮片（CTR20262919）、江苏众红生物的ZHB107-108舌下片（CTR20262902）均获批临床。恒瑞医药一家独占多个席位，临床布局力度领先。 6条临床动态里恒瑞占近半，大药企临床推进速度远超同行。政策动态 1. 湖南规范整合心血管等三类医疗服务价格项目，新增311项、废止472项湖南省医保局印发通知，落地国家医疗服务价格项目立项指南，新增心血管系统、消化系统、物理治疗类价格项目共311项，废止472项，修订5项，并制定全省最高指导价。新规自2026年10月8日施行，有效期5年，旨在深化医疗服务价格改革，规范项目收费。废止量远超新增量，医疗服务价格项目在"做减法"中走向规范。 2. 宁夏人工耳蜗医保支付扩至全年龄段，预计每名患者减负2.5万元宁夏医保局调整人工耳蜗植入诊疗项目及耗材医保支付范围，由0-7周岁儿童扩展至全年龄段参保患者，符合医学指征的双侧重度、极重度感音神经性耳聋患者均可报销。政策自9月1日起实施，预计为每名患者平均减负2.5万元。医保从"保基本"向"全周期"升级，人工耳蜗不再是儿童的专属福利。 3. 国产创新药面临专利悬崖，原研企业构筑防线随着首批国产创新药专利到期，仿制药企纷纷申报首仿，如贝达埃克替尼、和记黄埔呋喹替尼等。原研企业通过延长专利壁垒、布局新适应症、授权合作等方式应对。业内指出，真正挑战在于专利到期后的增长来源，需持续创新和国际化。首批国产创新药专利到期潮来了，原研药企靠延长壁垒和出海续命。本期重点品种品种出现次数企业 IBI30328 ×8 信达生物 zenagamtide注射液 ×7 诺和诺德 NNC0487-0111注射液 ×6 诺和诺德 RO7589655注射液 ×6 罗氏 CM512注射液 ×4 康诺亚生物想查更多？药达·isearch 免费体验文末「阅读原文」直达戊戌数据 · 医药早报数据来源：药达isearch（https://isearch.wuxuwang.com）戊戌数据（www.wuxuwang.com）内容仅供参考，不构成投资或用药建议 END ★ 点击下方卡片，发现更多精彩

2026-08-12

·丁香园 Insight 数据库

全球药企研发投入 TOP10 榜单揭晓！

制药巨头的研发投入往往被视为创新药领域的风向标。随着 MNC 2026 上半年财报披露结束，全球药企研发投入 TOP10 榜单也正式揭晓。从金额来看，2026 上半年，全球头部药企创新竞争进一步升级，研发投入超过 50 亿美元的药企已经达到 9 家，包括默沙东、罗氏、阿斯利康、礼来、强生、GSK、BMS、诺华和辉瑞。从研发强度来看，榜单中有六家 MNC 的研发投入占总营收比例突破 20% ，包括默沙东、罗氏、阿斯利康、GSK、BMS、诺华。数据来源：各药企2026年H1财报，Insight 制图默沙东上半年，默沙东凭借 223.33 亿美元的研发投入，断层第一，无论是总金额还是增速都远高于其它公司。研发投入的剧增主要是因为默沙东在上半年完成了 2 笔大额并购：今年 1 月，默沙东以 92 亿美元收购 Cidara 公司，囊获了一款潜在首创长效抗病毒药物 CD388；5 月，默沙东又以 67 亿美元收购 Terns（拓臻生物），获得了一款新型口服变构 BCR-ABL1 酪氨酸激酶抑制剂 TERN-701，该药正在被开放用于治疗慢性粒细胞白血病（CML）。如果剔除两笔大额并购，默沙东的其它研发投入为 64.33 亿美元，与去年同期相比（76.69 亿美元），则下降了 16%。默沙东非常有信心应对 Keytruda 即将到来的专利悬崖危机。该公司正在加速完成产品组合转型，未来到 2030 年代中期，现有和潜在增长产品合计有超过 700 亿美元的年收入潜力。截图来源：企业财报 PPT，下同罗氏罗氏的研发投入长期处于全球药企前列，上半年达到了 92.17 亿美元，同比增长 15%；其中，制药业务研发投入有 80.7 亿美元，同比增长 12%。罗氏继续通过合作和并购推进管线进展。今年 6 月，罗氏与 Nurix 达成一项 23 亿美元的合作，共同开发和商业化 Nurix 公司的 BTK 降解剂 Bexobrutideg（NX-5948）。这项合作不仅扩充了罗氏的肿瘤产品线，也有望拓展至免疫学（慢性自发性荨麻疹）和神经病学（多发性硬化症）领域的适应症。到 2030 年，罗氏预计将有高达 19 个新分子实体（NME）上市，覆盖肿瘤、神经、免疫、眼科、心血管、代谢等多个治疗领域。罗氏预测其中多款产品的销售额峰值均有望超过 30 亿美元，包括afimkibart（TL1A 单抗）、giredestrant（SERD）、zemocimig (FIXa/FX 双抗) 、bexobrutideg（BTK 降解剂）、petrelintide（AMYR/CTR 双激动剂）、pegozafermin（FGF21 类似物）、zilebesiran（siRNA）、trontinemab（Aβ/TfR1 双抗）、prasinezumab（靶向聚集的α-突触核蛋白的单抗）、fenebrutinib（BTK 抑制剂）等。阿斯利康上半年，阿斯利康研发投入 75.45 亿美元（+10%），占总营收的比例为 24.6%。 2026 年上半年，阿斯利康的研发管线继续保持强劲进展。其中，有多个 III 期关键临床项目读出阳性结果，包括 Imfinzi±Imjudo 肝癌和膀胱癌、sonesitatug vedotin 胃癌、tozorakimab 慢性阻塞性肺病（COPD）、efzimfotase alfa 低磷酸酯酶症、Ultomiris IgA 肾病研究。同时，还有多款新药在主要市场迎来首次新适应症批准，涵盖乳腺癌、泌尿生殖系统肿瘤、高血压、哮喘多个领域。阿斯利康正在有策略地投资四类「变革性技术/平台」，目标是支撑 2030 年以后的长期增长。投资的四个重点方向是：体重管理与心血管风险因素领域、ADC 与放射偶联药物、下一代免疫肿瘤双特异性抗体、细胞疗法与 T 细胞接合器。阿斯利康预计，2030 年前公司将有一批新分子实体读出关键/注册性数据，涵盖肿瘤、生物药、罕见病多个领域，其中有 10 款产品的年销售峰值有望突破 50 亿美元，这些后期管线有望推动公司进入下一个十年的增长期。礼来礼来上半年研发投入 73.29 亿美元（+21%），占总营收的比例为 17.1%。 2026 上半年，礼来开起了疯狂的买买买模式。根据 Insight 数据库，礼来上半年共计达成 31 项医药交易，位列 MNC 扫货数量榜单第一名；除了授权合作，礼来还收购了多家公司，包括 Ventyx、Kelonia、Ajax Therapeutics、Orna 等等，覆盖心血管&代谢健康（CMH）、肿瘤、神经科学、免疫学、抗感染多个领域。值得一提的是，此前在细胞疗法领域一直没有布局的礼来，今年通过收购 Orna 、Kelonia 囊获了多款体内 CAR-T 管线，正式切入细胞疗法赛道。此外，礼来还在 5 月 26 日宣布收购三家抗感染公司，拓展疫苗管线。 2026 年上半年，礼来凭借 276.93 亿美元（+88%）的收入位居 MNC 制药收入榜单第一名。展望未来，礼来依然有强大的产品组合保持强劲的增长势头。强生强生上半年研发投入 71.8 亿美元，同比增长 6.5%；其中，制药业务研发投入 56.88 亿美元，占到了强生总研发投入的近 79%。上半年，强生管线迎来诸多重磅进展，其中包括：Tremfya（古塞奇尤单抗）获批用于抑制成人活动性银屑病关节炎的结构性关节损伤进展；Caplyta（卢美哌隆）获批用于预防精神分裂症复发；‌Rybrevant Faspro（皮下注射埃万妥单抗）获批用于晚期头颈癌治疗；Talvey（塔奎妥单抗）联合 Darzalex Faspro（达雷妥尤单抗皮下注射）获批用于早期复发或难治性多发性骨髓瘤治疗等等。展望下半年，强生还有望迎来多项里程碑进展，涉及 Talvey(塔奎妥单抗)+Tecvayli(特立妥单抗)、Pasritamig（CD3/KLK2 双抗）、JNJ-6143（调节诱导邻近靶向嵌合体 RIPTAC）等等多款产品。葛兰素史克（GSK）上半年，GSK 研发投入 69.12 亿美元，同比增速高达 49%，是榜单中继默沙东后研发投入增速第二高的企业；研发投入占总营收的比例也达到了 32.2%。今年以来，GSK 继续加码肿瘤领域布局，收购了两款非小细胞肺癌后期阶段药物：ROS1 抑制剂 Jideytro（已获 FDA 批准上市）和 ALK 抑制剂 neladalkib（PDUFA 日期为 2026 年下半年）。根据财报，GSK 有 62 项处于临床开发阶段的资产。目前，GSK 正在加速推进 7 个管线资产，覆盖 18 个适应症，涉及肿瘤、呼吸、肝病和疫苗领域；并预计 2026 年将启动超过 20 项 III 期试验（此前预计为 10 项）。GSK 还计划在英国剑桥生物医学园区建立新的旗舰研发中心。此外，GSK 还制定了一项为期三年的计划，目标是到 2029 年每年节省 19 亿英镑，总成本为 24 亿英镑（其中现金成本为 21 亿英镑），以为后期产品组合提供资金，并提高经营利润率。GSK 强调公司有能力继续扩大业务，并且预计 2031 年以后增长会加速。百时美施贵宝（BMS） BMS 上半年研发投入 56.08 亿美元，同比增长 15.9%；研发投入占总营收的比例为 22.9%。 BMS 的当家产品纳武利尤单抗（PD-1 单抗）近年来的收入增速已经放缓。今年上半年，纳武利尤单抗创收 50.55 亿美元，同比增速仅 4%。当前，BMS 正在加速推进产品管线进展，培养后继接棒产品。根据财报，2026-2028 年，BMS 预计将迎来多项里程碑进展，包括：公布 12 项新分子实体注册临床试验数据；对于已上市的药物，预计将公布 16 项关键临床数据；此外，还将披露 10 项下一代早期创新管线的临床试验数据。诺华诺华上半年研发投入 55.87 亿美元，同比下滑 6%，是 TOP10 榜单中唯一一家研发投入减少的公司。不过，研发投入占公司的营收比例并不低，依然达到 20.3%。 Q2 期间，诺华研发方面取得的部分重要监管里程碑进展，包括：Rhapsido 获欧盟和日本批准用于治疗慢性脊髓性肌萎缩症；Itvisma 获欧盟批准，成为目前唯一获批用于治疗广泛脊髓性肌萎缩症 (SMA) 患者的基因替代疗法；Del-zota 已向 FDA 提交生物制品许可申请 (BLA)，以寻求加速批准用于治疗杜氏肌营养不良症 (DMD)。目前，诺华拥有 114 个在研产品管线，涵盖肿瘤、免疫、神经科学、心血管&肾脏&代谢等疾病领域。其中，Ⅰ/Ⅱ期项目 72 个，Ⅲ 期项目 39 个，注册阶段项目 3 个。辉瑞辉瑞上半年研发投入 52.99 亿美元，同比增长 13%；研发投入占公司的营收比例为 18%。研发费用增长的主要原因是某些肿瘤和肥胖症候选产品的支出增加。 2026 年，辉瑞的战略重点包括四个方向：最大化关键交易的价值，Q2 有 25% 的收入来自收购资产；完成关键研发里程碑进展；通过投资以最大化 2028 年后的增长；以及在整个业务中规模化应用 AI。截至 8 月 4 日，辉瑞产品组合中有 95 个在研项目。在未来 12 个月，辉瑞有望迎来众多催化剂进展，包括监管获批、数据读出、启动关键的临床研究；其中，多项关键进展已在 2026 年达成。艾伯维艾伯维上半年研发投入 48.16 亿美元，同比增长 14.7%；研发投入占公司的营收比例为 15.1%. 艾伯维目前储备了 84 个产品管线，涵盖免疫学、肿瘤、神经科学、医美、眼科护理等领域。其中，Ⅰ 期阶段项目有 34 个，Ⅱ 期阶段项目有 31 个，Ⅲ 期/注册阶段项目有 14 个，已经递交监管申请的项目有 5 个。 2026 年，艾伯维已取得多项监管进展，包括 Epkinly (艾可瑞妥单抗）获批二线治疗滤泡性淋巴瘤、Pivekimab Sunirine（IL3RA ADC）获批治疗母细胞性浆细胞样树突细胞肿瘤、Qulipta（阿托吉泮）获批治用于治疗急性偏头痛。下半年的预期进展包括 Rinvoq（乌帕替尼）获批治疗白癜风、Tavapadon 获批治疗帕金森病等等。编辑：馨药封面来源：站酷海洛免责声明：本文仅作信息分享，不代表 Insight 立场和观点，也不作治疗方案推荐和介绍。如有需求，请咨询和联系正规医疗机构

2026-07-24

·chugai-pharm.co.jp

Chugai Announces 2026 2nd Quarter Results

Chugai News Releases are issued to provide stakeholders with the most up-to-date information related to our company. In some instances, information on products or drug candidates under development may be included, but this is intended for members of the media, shareholders, and investors. The information is not intended for promotional or advertising purposes, or as medical advice, etc. Jul 24, 2026 Corporate TOKYO, July 24, 2026 -- Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced its financial results for the second quarter of fiscal year 2026. Core revenue of ¥663.3 billion (+14.7%), core operating profit of ¥329.1 billion (+21.0%), and core net income of ¥238.4 billion (+23.2%) were achieved (all changes year-on-year) Strong growth in domestic and overseas sales, combined with a significant increase in other revenue driven by one-time income, and royalty income related to Hemlibra® and NEMLUVIO®, resulted in increased revenue and profit year-on-year Achieved eight regulatory filings in Japan during the first half of the year, progressing steadily toward achieving the highest number of filings ever planned R&D activities progressed steadily across both early- and late-stage development, including Chugai-originated projects For NXT007, which is expected to become a next-generation growth driver, two Phase III studies were initiated For AQUA07, the third macrocyclic peptide project, entry into the clinical stage was achieved, with dosing in a Phase I study in ALK-positive non-small cell lung cancer expected to start shortly For Enspryng®, developed using Chugai’s proprietary antibody engineering technologies, the U.S. FDA accepted the regulatory application for thyroid eye disease (TED) and granted Priority Review designation Regarding products out-licensed to third parties, global market penetration of Chugai-originated new products advanced Export sales and royalty income from NEMLUVIO (nemolizumab), a humanized anti-human IL-31 receptor A monoclonal antibody out-licensed to Galderma, drove revenue growth As for Foundayo™ (orforglipron), an oral GLP-1 receptor agonist out-licensed to Eli Lilly, prescriptions were driven in the U.S. primarily by GLP-1 naïve patients, and the oral anti-obesity drug market is expanding. Chugai commenced recognition of royalty income from the product in the second quarter For NXT007, which is expected to become a next-generation growth driver, two Phase III studies were initiated For AQUA07, the third macrocyclic peptide project, entry into the clinical stage was achieved, with dosing in a Phase I study in ALK-positive non-small cell lung cancer expected to start shortly For Enspryng®, developed using Chugai’s proprietary antibody engineering technologies, the U.S. FDA accepted the regulatory application for thyroid eye disease (TED) and granted Priority Review designation Export sales and royalty income from NEMLUVIO (nemolizumab), a humanized anti-human IL-31 receptor A monoclonal antibody out-licensed to Galderma, drove revenue growth As for Foundayo™ (orforglipron), an oral GLP-1 receptor agonist out-licensed to Eli Lilly, prescriptions were driven in the U.S. primarily by GLP-1 naïve patients, and the oral anti-obesity drug market is expanding. Chugai commenced recognition of royalty income from the product in the second quarter Refer to the information below for details on the financial results: Quarterly Reports / Finance Reports https://www.chugai-pharm.co.jp/english/ir/reports_downloads/tanshin.html Presentation Materials In addition to Chugai’s business and financial performance, these materials provide updates on our research and development pipeline. Videos and transcripts (including Q&A) will be made available at a later date. https://www.chugai-pharm.co.jp/english/media/conference.html [2026 Second Quarter Results] 2026 Jan-Jun 2025 Jan-Jun Revenue 663.3 [PDF 142KB] Contact: For Media Chugai Pharmaceutical Co., Ltd. Media Relations Group, Corporate Communications Dept., Naoki Kouzai Tel: +81-3-3273-0881 E-mail: pr@chugai-pharm.co.jp For Investors Chugai Pharmaceutical Co., Ltd. Investor Relations Group, Corporate Communications Dept., Takayuki Sakurai Tel: +81-3-3273-0554 E-mail: ir@chugai-pharm.co.jp Back

临床1期临床3期财报临床结果优先审批

100 项与 Zemocimig 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
血友病A	临床3期	美国	Roche Holding AG	2026-04-27
血友病A	临床3期	中国	Roche Holding AG	2026-04-27
血友病A	临床3期	日本	Roche Holding AG	2026-04-27
血友病A	临床3期	比利时	Roche Holding AG	2026-04-27
血友病A	临床3期	法国	Roche Holding AG	2026-04-27
血友病A	临床3期	德国	Roche Holding AG	2026-04-27
血友病A	临床3期	匈牙利	Roche Holding AG	2026-04-27
血友病A	临床3期	以色列	Roche Holding AG	2026-04-27
血友病A	临床3期	意大利	Roche Holding AG	2026-04-27
血友病A	临床3期	荷兰	Roche Holding AG	2026-04-27

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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


NCT05987449 (ASH2025)	临床1/2期	血友病A	22	NXT007 0.42mg/kg	衊簾憲範衊糧範製鑰簾(壓築糧壓鑰構廠構願鹹) = 製簾襯繭鹹蓋選鹹廠鹹遞淵壓範範築選廠鑰襯 (廠襯鏇願廠願艱網窪鬱 ) 更多	积极	2025-12-06
NCT05987449 (ASH2025)	临床1/2期	血友病A	22	NXT007 1.05mg/kg	衊簾憲範衊糧範製鑰簾(壓築糧壓鑰構廠構願鹹) = 鏇鑰憲鬱窪選觸簾鹹醖遞淵壓範範築選廠鑰襯 (廠襯鏇願廠願艱網窪鬱 ) 更多	积极	2025-12-06
JPRN-JapicCTI-194919 (NXTAGE, ISTH2023)	临床1/2期	-	-	NXT007	鹹餘顧遞夢選網糧顧鬱(齋網鬱憲餘窪糧構鹹襯) = One SAE of erythema whose causality to NXT007 could not be ruled out was reported in the 0.0054 mg/kg group 餘淵選襯鏇艱鹽廠鑰願 (選製醖構鹽鑰鏇鬱窪夢 ) 更多	-	2023-06-24