Fam-trastuzumab deruxtecan-NXKI

iStock, jesadaphorn Clinical trial setbacks have limited the near-term opportunities for some of Daiichi Sankyo’s ADCs but the drug developer is betting near-term readouts will catapult it into the top tier of oncology companies in the coming years. Daiichi Sankyo was flying high in October 2023. The clinical and commercial success of the antibody-drug conjugate Enhertu had established the Japanese pharma as a major player in a red-hot modality, persuading Merck to pay a nearly unprecedented $4 billion upfront for the rights to three drug candidates. Thirty months later, the Japanese drugmaker is reeling from a recent demand reassessment. Daiichi reported that forecast demand for its antibody-drug conjugates (ADCs) is below the minimum purchase requirements of deals with contract manufacturing organizations (CMOs), triggering about $850 million in charges linked to outsourcing activities and a retreat from a planned facility expansion. Daiichi agreed to the CMO deals as Enhertu was resetting expectations for its ADC business. The HER2-directed ADC that Daiichi developed with AstraZeneca remains a powerhouse product, with sales rising 26% to 561.1 billion Japanese yen ($4.4 billion) last year and forecast to jump again in 2026. But the company’s pipeline of next-generation candidates stuttered, hurting efforts to add new growth drivers. A series of setbacks The honeymoon period for the Merck deal was short-lived. In June 2024, the FDA rejected Merck and Daiichi’s HER3-directed ADC patritumab deruxtecan on manufacturing grounds. The temporary setback preceded a permanent problem, with the partners withdrawing a filing for approval in May 2025 after the drug candidate failed to significantly improve overall survival in a Phase 3 lung cancer trial. Pipeline Pharma Pipeline Stalls for First Time in Decades: Citeline Some disease areas bucked the trend of shrinking pipelines, however, with immune and cardiovascular indications seeing an upward trend in investigational assets. April 6, 2026 · 2 min read · Tristan Manalac Read more Daiichi “pushed the boundaries” with the HER3-directed ADC, John Tsai, the company’s global head of R&D, said on an earnings call in May. However, the asset “did not demonstrate positive results in the EGFR-mutated lung cancer area,” he said, delaying the treatment’s anticipated launch. Merck started a Phase 3 study of the ADC in breast cancer last year, setting an anticipated completion date in 2033. Daiichi recently left patritumab deruxtecan off its five-year plan for growing oncology sales to 2.3 trillion Japanese yen ($14.6 billion) by 2030. The company took a write-down on inventories of the drug candidate for the 2025 financial year. The patritumab deruxtecan saga played out in parallel to setbacks to Daiichi and AstraZeneca’s TROP2-directed ADC. The companies withdrew a filing for approval of datopotamab deruxtecan in November 2024 and refiled in another indication. The switch followed the failure of the drug candidate to improve overall survival in Phase 3 breast and lung cancer trials. The FDA approved the ADC, now sold as Datroway, for breast cancer i n January 2025 and expanded the label to include lung cancer five months later. However, the lung cancer approval, the big opportunity for Datroway, covers a smaller population than AstraZeneca and Daiichi originally targeted. Daiichi took two write-downs on inventories of the ADC in the 2025 financial year. Data from a Phase 3 first-line lung cancer study were due last year but have slipped to the back half of 2026. The trial is part of a push to move Datroway into earlier lines of therapy in breast and lung cancer while expanding into other tumor types. Success could fuel growth of a product that generated sales of 47.6 billion Japanese yen ($300 million) in Daiichi’s 2025 financial year. Becoming a top 5 cancer player With Daiichi forecasting 111.4 billion Japanese yen ($710 million) in Datroway sales for this financial year, the TROP2 ADC could start to lessen the company’s reliance on Enhertu. But the path to the 2030 sales target also relies on contributions from two other ADCs: Merck-partnered candidates against B7-H3 and CDH6. Insights HER2’s Digital Rebirth Is Unlocking the Full Potential of ADCs As next-generation antibody-drug conjugates reshape cancer care, digital pathology and artificial intelligence are transforming how HER2 is measured. The advances aim to help clinicians identify low and ultra-low expressors, match patients to the right therapies and make more precise treatment decisions. February 10, 2026 · 3 min read · Jennifer C. Smith-Parker Read more The FDA is reviewing the B7-H3-targeted ADC, ifinatamab deruxtecan, in small cell lung cancer and could approve the treatment this year. In December 2025, the regulator put a Phase 3 trial of the drug candidate on partial hold in response to deaths from interstitial lung disease (ILD)—a known adverse event associated with ADCs—but the agency lifted the restrictions the following month. Daiichi has reported ILD cases in recipients of the CDH6-directed ADC, raludotatug deruxtecan, but most events as of the October 2025 readout were low grade. The 50.5% response rate in people with platinum-resistant ovarian cancer suggests the ADC is more effective than standard-of-care chemotherapy, offering Daiichi and Merck encouragement as they advance toward Phase 3 data in this patient population. The study is one of five pivotal trials of Daiichi ADCs that are scheduled to deliver data in the company’s 2027 financial year. Daiichi forecasts the drugs to be worth $2 billion to $6 billion in peak sales. With Daiichi making the same forecast for drugs with readouts in each of the next five years, the company has multiple shots on goal to regain momentum by establishing its ADCs in more populations. Daiichi has other candidates in development, with patritumab deruxtecan and the early-phase programs DS-3939 and DS3790 contributing to the company’s belief that it can become a top-five player in cancer by 2035. But the near-term recovery rests on Enhertu, Datroway and the B7-H3 and CDH6 ADCs, assets that fueled Daiichi’s emergence as an ADC leader and later its struggles to capitalize on that position. .responsive-container { display: flex; flex-wrap: wrap; border: 1px solid #ededed; font-family: Helvetica, Arial, Sans-Serif; padding: 20px 20px 10px 20px; } .column-left { flex: 1; max-width: 45%; padding: 20px 20px 10px 20px; } .column-right { flex: 2; padding: 20px 20px 10px 20px; } @media (max-width: 768px) { .column-left, .column-right { max-width: 100%; flex: 100%; padding: 10px 0; } } Subscribe to ClinicaSpace! Clinical trial results, research news, the latest in cancer, cell and gene therapy hbspt.forms.create({ region: "na1", portalId: "4413123", formId: "674f4dc0-7371-4190-86cc-e1afd00b08ea", onFormSubmitted: function($form, data) { window.dataLayer = window.dataLayer || []; window.dataLayer.push({ 'event': 'GTMevent', 'event_name': 'newsletter_sign_up' }); } });

当2023年H1财报陆续落地，全球制药版图再次洗牌。 强生、默沙东、诺华三强依旧稳居第一梯队，而 辉瑞、艾伯维、罗氏则因不同变量陷入调整。以下为七家巨头核心数据速览： 强生：制药业务收入271.44亿美元，同比+3.7%，Q2收入137.31亿美元，同比+3.1%。 辉瑞：上半年总收入310亿美元，同比-42%；Q2收入127亿美元，同比-54%；剔除新冠产品后同比+5%。 默沙东：总营收295.22亿美元，同比-3%；Q2收入150.35亿美元，同比+3%。 诺华：净销售收入265.75亿美元，同比+8%；Q2净销售收入136.22亿美元，同比+9%。 艾伯维：总营收260.9亿美元，同比-7.2%，研发投入40.25亿美元，同比+29.6%。 罗氏：制药业务收入226.81亿瑞士法郎（约250.15亿美元），同比+8%；研发投入64.49亿瑞士法郎，同比+8%。 赛诺菲：净收入同比增长4.4%，达201.87亿欧元（约218.06亿美元）。 若把新冠疫苗剔除在外， 修美乐长达20年的独占期正式结束，专利悬崖让出“药王”宝座；业内普遍预测， 默沙东K药（Keytruda）将在今年拿下全球销售额冠军。 2.1 △ K药：冲刺200亿美元 K药在华继续保持+20%增速，半年销售额达120.65亿美元。下半年若US/EU新辅助/辅助NSCLC、一线HER2阴性胃癌、辅助NSCLC等适应症获批， 全年有望突破200亿美元大关，稳稳锁定“药王”头衔。 2.2 △ 修美乐：专利悬崖后的守城战 上半年修美乐收入75.53亿美元，同比下滑25.2%。不过艾伯维手握两款接力产品：Skyrizi（瑞莎珠单抗）销售额32.43亿美元，同比+48%；口服JAK1抑制剂Rinvoq（乌帕替尼）销售额16.04亿美元，同比+51.7%。 双箭齐发试图弥补“王者”失速。 2.3 △ 伊布替尼与Venclexta：老兵新传 自Pharmacyclics收购以来，BTK抑制剂伊布替尼已为艾伯维贡献逾230亿美元。Venclexta（维奈克拉）上半年收入11.09亿美元，同比+13.4%，随着多发性骨髓瘤（MM）和骨髓增生异常综合征（MDS）拓展，增长潜力仍足。 2.4 △ Dupixent：超级重磅炸弹雏形 赛诺菲明星产品Dupixent半年创收48.78亿欧元（约52.69亿美元），增速36.7%， 年底突破100亿美元几乎无悬念。此外，庞贝氏症新药Nexviazyme同比增长153.4%，多发性骨髓瘤新药Sarclisa增长43.4%，双线发力托举业绩。 3.1 △ 默沙东：HPV疫苗一骑绝尘 K药与HPV疫苗贡献中国区收入超一半。HPV疫苗三个月销售额猛增47%，九价扩龄至9-45岁女性后需求持续释放；年初智飞生物续签1000亿元采购协议， 主要含约980亿元HPV疫苗，为默沙东注入长期确定性。 3.2 △ 阿斯利康：8大十亿品种齐飞 剔除新冠业务后，阿斯利宁其他板块均实现两位数增长。Ultomiris、Imfinzi、Farxiga等8款产品销售额超10亿美元；其中Ultomiris半年飙升64%，Imfinzi增长57%， 为阿斯利康提供稳定现金流。 3.3 △ 诺华：Kesimpta增速惊人 CD20全人源单抗Kesimpta（奥法妥木单抗）上半年销售额8.73亿美元，同比+103%，成为诺华增长最快的单品；多发性硬化症新适应症获批后销量一路狂飙。 辉瑞罕见心肌病三剑客Vyndaqel/Vyndamax/Vynmac上半年合计销售14.68亿美元，同比+29%，成为罕见病赛道亮点；然而新冠口服药Paxlovid已悄然淡出畅销榜。BMS来那度胺销售额从52.98亿美元骤降至32.18亿美元，CAR-T产品Abecma与Breyanzi虽分别仅贡献约3亿美元，却 展现出免疫细胞疗法的新希望。罗氏“老三架马车”Avastin、Herceptin、MabThera继续受生物类似药冲击，中国区收入占比下降。 BCG报告指出， 自2021年起创新疗法已占据全球生物制药收入的一半以上；单抗、双抗、ADC、CAR-T、RNAi五大领域价值年复合增长率均超两位数，其中双抗最高达30%。TCR-T、微生物疗法、PROTAC等新兴技术进入临床阶段的项目逐年递增，TCR-T更是高达144%的惊人增速。辉瑞以428亿美元收购ADC龙头Seagen后，etrasimod、elranatamab、MenABCWY等十余款候选药物即将登陆市场；阿斯利康Enhertu与第一三共分摊销售已达11.69亿美元， 有望冲击百亿美元俱乐部；诺华PCSK9 siRNA新药Leqvio半年销量增长近三倍，国内上市预期渐近。 当修美乐的独占期正式结束，“药王”头衔进入群雄逐鹿时代。K药、Dupixent、Skyrizi、Rinvoq等接力产品能否延续爆发式增长？传统小分子与生物药如何在新兴细胞与基因疗法夹击下守住阵地？全球医药市场风云莫测，MNC们的下一轮增长曲线将在政策、支付、研发效率与患者价值的多重考题中见分晓。