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More than four years after its CAR-T star Carvykti’s initial FDA approval, Legend Biotech has reached a major milestone, posting its first profitable quarter. The company recorded $63 million in adjusted net income for the second quarter, bouncing into the black for the first time following a $10.5 million net loss in the first three months of 2026. Driven by strong demand for Carvykti, Legend expects to sustain profitability through the second half of 2026. Legend’s swing to profitability comes amid a surprise leadership transition . Ying Huang, Ph.D., the CEO who shepherded Carvykti’s launch, resigned in late July to lead upstart K2 Therapeutics. On an interim basis, the CEO baton was passed to Alan Bash, who has been president of Carvykti since 2024. “As the interim CEO, my focus is really on maintaining our focus on execution and delivering on our priorities, which are specifically around growing Carvykti and accelerating our pipeline,” Bash said in an interview with Fierce Pharma. In the search for a permanent replacement, Legend’s board is avoiding a deadline to focus on “looking at various qualities that would provide for the best long-term leader given the stage of the growth of the company,” Bash said on Legend’s earnings call Tuesday. Despite the hard-won corporate profitability and strong 50% year-over-year sales growth, Carvykti faces several challenges. The rise of off-the-shelf bispecifics threatens to complicate Legend’s partnership with Johnson & Johnson, while Gilead Sciences’ expected entry with anito-cel poses a fresh autologous rival. Compounding those pressures is a broader industry challenge, namely the laborious expansion of CAR-T into community care settings. J&J’s bispecific antibodies Tecvayli and Talvey have posted some powerful clinical data in earlier-line multiple myeloma. These include MajesTEC-3, which recently got the combination of Tecvayli and J&J’s Darzalex approved by the FDA; MajesTEC-9 for Tecvayli monotherapy in a CD38-experienced population; and most recently, striking efficacy from the duo T-cell engager combo of Tecvayli and Talvey from the MonumenTAL-6 trial. While investors worry these advances could shift J&J’s commercial priorities, Bash maintained that the two companies’ alliance remains robust. “The bispecifics do provide an excellent option for patients, but Legend and J&J are both very committed to the opportunity with Carvykti,” Bash said, pointing to J&J’s stated $5 billion peak sales target for the BCMA-directed CAR-T. Bash argued that market growth for CAR-T and TCEs is not a zero-sum game. With well over 100,000 relapsed or refractory myeloma patients in the U.S. and other major markets and fewer than 10% having utilized a BCMA therapy, “there is significant room for other options as well as Carvykti to grow,” Bash noted. Furthermore, Carvykti’s unique profile as a one-time infusion with durable remissions and extended treatment-free intervals—or the potential for cure—is attractive to many patients, Bash said. And when patients have access to both CAR-T and TCE, doctors may prefer reaching for a CAR-T first, he noted. Treatment sequencing is central to the current clinical conversation in myeloma, Bash explained to Fierce. Real-world evidence increasingly shows a that CAR-T-first strategy yields an optimal efficacy and safety profile when used earlier in the treatment paradigm. In a retrospective study using data from the TriNetX US Collaborative Network between 2021 and 2023, researchers linked BCMA-targeted CAR-T therapy to significantly improved two-year overall survival compared to Tecvayli, even though the latter was associated with lower risks of cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome (ICANS). During a panel discussion at ASCO 2026, Saurabh Chhabra, M.D., a hematologist-oncologist from Mayo Clinic, said his preference is to use CAR-T first before bispecifics. “That’s mainly because with the constant pressure from the bispecific antibody, we worry about development of the BCMA gene mutations […] which can impair the activity of the T cells when we collect them for CAR-T,” he said, adding that more data are needed to answer whether finite duration of TCE treatment could solve that problem. As for upcoming competition from Gilead’s anito-cel, Legend has argued that the newcomer will not pose an immediate threat because it is slated for a later-line indication. Compared with its original fifth-line nod, about 70% of Carvykti uses in the U.S. today are for second- to fourth-line patients, Bash noted on Tuesday’s call. When the two therapies eventually collide in earlier lines, Bash is counting on the experience Carvykti has built among doctors, as well as what he called a “best-in-class” manufacturing network, to retain market leadership. After years of heavy investments, Legend and J&J have built enough production capacity to fully meet global demand near the end of 2025. Today, the partners have reduced Carvykti’s product turnaround time to within four weeks, a window that Bash said is “fully meeting” a patient’s clinical need given the bridging therapy they receive between cell collection and final product infusion. The Legend exec also touted a 99% manufacturing success rate and a 97% reliability rate in terms of delivering the product on the date it commits to. “I think we’ve really taken manufacturing out of the equation for the patient experience, and we are continuing to expand that capacity, reduce the turnaround time and deliver to patients,” he said. External competition aside, Legend and J&J face the systemic challenge of bringing Carvykti closer to patients on the community level, as setting up appropriate infrastructure at new treatment centers takes time. Currently, up to 40% of Carvykti’s treatment network consists of regional and community hospitals, Bash noted. To promote penetration, the companies are pushing for Carvykti administration in the outpatient setting, made feasible by its delayed onset of cytokine release syndrome (CRS). Patients may later require inpatient admission to manage the immune side effect, but infusion in outpatient offices frees up bed capacity for treatment centers. Last year, the FDA removed the Risk Evaluation and Mitigation Strategies requirements for existing CAR-T therapies, allowing patients to be monitored closer to home and get back to their lives more quickly. To tackle the bottleneck around apheresis, meanwhile, Legend and J&J are currently trying to identify third parties who can provide this service to centers. Ultimately, the two companies are not navigating the logistical challenge alone; the whole cell therapy field is striving to establish meaningful CAR-T infrastructure across community oncology settings.

作者 | 草履虫  编辑 | 郑瑶 随着2026年上半年跨国药企（MNC）财报季基本落幕，全球制药企业TOP20榜单也随之出炉。 从排名来看，礼来以427.73亿美元的制药业务营收位居榜首，同时以49%的同比增速领跑TOP20，展现出强劲的增长势头。 艾伯维、强生、阿斯利康、罗氏、默沙东和辉瑞等传统制药巨头仍稳居第一梯队。与此同时，拜耳则基本与去年同期持平，同比增长0.2%（表1）。 值得关注的是，头部药企之间的增长分化正进一步加剧。 礼来、诺和诺德分别实现49%和18%的同比增长，以GLP-1药物为代表的代谢疾病赛道继续成为全球制药行业最重要的增长引擎之一；诺华和德国默克则成为TOP20中仅有的两家制药业务收入同比下滑的企业，降幅分别为2.0%和0.3%，整体业绩承压明显。 从高速增长到逆势下滑，不同药企在产品周期和核心品种表现上的差异，正在越来越直接地反映到半年报成绩上。 表1.2026上半年全球TOP20制药企业营收排名 数据来源：各公司财报整理 01礼来营收增速双领先 前三格局初现 礼来2026上半年总营收427.73亿美元，同比增长49%。制药业务收入和增速均位列头部MNC第一，与第二名艾伯维拉开108亿美元差距。其中，中国市场收入16.35亿美元，同比激增73%，增速同样位居已披露企业之首（表2）。 上半年，礼来旗下八款核心产品合计收入290.77亿美元，占总营收68%。其中替尔泊肽（Mounjaro和Zepbound）收入276.93亿美元（+88%），与竞争对手司美格鲁肽（175亿美元）拉开102亿美元差距，坐稳全球药王宝座。 此外，其口服小分子GLP-1药物奥氟格列隆（Orforglipron，Foundayo）上市首个季度即实现9800万美元销售额。 后续第三款GLP-1产品Retatrutide也已完成5项Ⅲ期临床，预计明年一季度递交上市申请，有望进一步巩固其在代谢领域的竞争优势。基于上半年的强劲表现，礼来再次上调全年营收预期至850亿—870亿美元。 艾伯维上半年总营收319.92亿美元，同比增长11.2%，位居制药业务营收榜第二名。其中免疫学业务收入160.76亿美元，同比增长15.7%，占公司总营收比例达到45.7%。 艾伯维在免疫学领域拥有三款重磅产品，分别是阿达木单抗（Humira）、利生奇珠单抗（Skyrizi）和乌帕替尼（Rinvoq）。 其中，作为曾经全球“药王”的Humira，受2023年专利到期及生物类似药竞争影响，销售额持续承压（图1）。今年上半年收入进一步下滑至14.44亿美元，同比下降37.2%。 图1.艾伯维3款自免产品销售额变化情况 图片来源：艾伯维官网数据整理 Skyrizi和Rinvoq正成为Humira之后艾伯维新的增长支柱。Skyrizi凭借多项适应症的快速拓展实现持续放量，2025年销售额高达175.62亿美元，同比增长49.87%（图1）；2026年上半年Skyrizi进一步实现99.88亿美元营收，同比增长27.3%，与Rinvoq合计销售额达到146.32亿美元，占免疫业务收入91%，占公司总营收46%。 在Skyrizi和Rinvoq的强力驱动下，艾伯维成功完成“后修美乐时代”的战略切换（图1），实现了由单一超级产品向多元化免疫平台的平稳过渡。 强生上半年总营收493.72亿美元（+8.2%）。其中，创新制药收入318.10亿美元（+9.4%），位居全球制药业务营收榜第三名。 强生的创新制药业务主要聚焦肿瘤、自免、神经、肺动脉高压、感染、心血管及代谢等六大板块，肿瘤业务的增长主要由达雷妥尤单抗（Darzalex）、阿帕他胺（Erleada）和西达基奥仑赛（Carvykti）等产品强劲驱动。 其中，达雷妥尤单抗（Darzalex）收入81.71亿美元（+20.6%），西达基奥仑赛（Carvykti）收入也强劲增长55.1%至12.54亿美元（2025H1为8.08亿美元）。 值得注意的是，强生的3款双抗产品开始发力，特立妥单抗（Tecvayli）、塔奎妥单抗（Talvey）、埃万妥单抗（Rybrevant）合计收入13.34亿美元（2025H1为8.29亿美元），其中后两款产品增速高达70%。 自免业务，古塞奇尤单抗（Tremfya）保持涨势，上半年收入36.54亿美元（+70.6%）。神经科学领域，抑郁症药物艾司氯胺酮鼻喷雾剂（Spravato）表现亮眼，上半年销售额达到10.52亿美元（+43.2%）。 从半年报成绩来看，强生正在稳步接近年初定下的千亿美元营收预期目标。并且，强生也基于上半年收入进一步上调了全年营收预期，由1003亿—1013亿美元调整至1008亿—1014亿美元。 02赛诺菲、BI、再生元 跑出“加速度” 今年上半年，勃林格殷格翰（BI）、再生元和赛诺菲的制药业务均保持较快增长，增幅分别达到20.1%、17.8%和15.7%，明显高于行业整体水平。 赛诺菲2026年上半年实现总营收257.42亿美元，同比增长15.7%。其中，度普利尤单抗（Dupixent）仍是公司最核心的增长引擎。 作为全球最畅销的自免药物，度普利尤单抗上半年销售额约108.83亿美元，同比增长34.4%，成为继替尔泊肽、司美格鲁肽和K药之后，全球又一款半年度销售额迈入“百亿美元俱乐部”的超级大单品。 随着其在特应性皮炎、哮喘、慢阻肺等2型炎症疾病中的持续渗透，赛诺菲预计，到2030年度普利尤单抗销售额有望达到约250亿欧元（约290亿美元），进一步向平台型超级单品迈进。 BI上半年总营收达到183.49亿美元，同比增长16.2%；其中，人用药品业务收入153.1亿美元，同比增长20.1%。 恩格列净（Jardiance）一款产品便贡献了66亿美元收入，是公司当前最主要的增长动力。 不过，BI并非只依赖一款成熟产品。2025年获批的肺纤维化药物那米司特（Jascayd）和HER2突变非小细胞肺癌药物宗艾替尼（Hernexeos）已经进入商业化阶段。 与此同时，GLP-1R/GCGR双激动剂Survodutide已进入Ⅲ期并取得积极数据，公司还启动了三项肿瘤Ⅲ期研究。 从半年报表现来看，BI今年总营收有望突破300亿欧元（约346亿美元），恩格列净销售额也有望超过100亿欧元（约115亿美元，不包括礼来收入）。 再生元上半年同样保持较快增长，实现营收78.96亿美元，同比增长17.8%。其中，与赛诺菲合作相关收入（主要来自Dupixent共同商业化）达到43.55亿美元，同比增长28%，成为业绩增长的重要驱动力。 产品端，眼科业务正加速向高剂量产品切换，阿柏西普（EYLEA HD）上半年全球销售额达到17.64亿美元，同比增长62%，其中美国市场销售额为10.65亿美元。 与此同时，传统阿柏西普眼内注射溶液（EYLEA）销售快速下滑，使EYLEA系列合计销售额降至33.45亿美元，同比下降17%。 肿瘤产品西米普利单抗（Libtayo）上半年销售额达到9.28亿美元，同比增长40%，已成为继度普利尤单抗和阿柏西普之后，再生元最重要的增长品种之一。 整体来看，再生元的增长结构正在发生变化，商业化动力逐步从传统眼科单一支柱转向免疫、眼科和肿瘤业务共同驱动。 03诺华、德国默克逆势承压 上半年TOP20企业制药业务合计营收达4385.26亿美元，其中18家实现同比增长，行业整体延续稳健扩张态势（表1）。 相比之下，诺华和德国默克成为TOP20中仅有的两家制药业务收入同比下滑的企业，降幅分别为2.0%和0.3%。 这两家公司均处于产品更替阶段，部分成熟品种受到专利到期和市场竞争加剧影响。与同期依靠重磅创新药快速放量实现增长的MNC相比，其医药板块整体表现偏弱，短期业绩压力较为明显。 7月21日，诺华发布2026年上半年财报，总营收达275.21亿美元，同比下降2%；核心营业收入为108.37亿美元，同比下降7%。其中，第二季度净销售额为144.08亿美元，同比增长1%，净利润为32.57亿美元，同比下降19%，整体业绩仍明显承压。 专利悬崖是拖累诺华业绩的重要因素。上半年，沙库巴曲缬沙坦（Entresto）、艾曲泊帕（Promacta）和Tasigna三款成熟产品明显失速，销售额合计减少超过30亿美元。 不过，诺华并非缺少接棒产品。 瑞波西利（Kisqali，32.11亿美元，+48%）、奥法妥木单抗（Kesimpta，25.88亿美元，+29%）、阿思尼布（Scemblix，9.95亿美元，+85%）、镥[177Lu]-特昔维匹肽（Pluvicto，12.93亿美元，+55%）、英克司兰（Leqvio，9.32亿美元，+64%）等新产品仍保持高速增长，只是现阶段尚不足以完全填补成熟品种下滑留下的缺口。 表2. 2026年上半年 MNC中国区制药收入排名 数据来源：各公司财报整理 值得注意的是，诺华在中国市场的表现相对突出。上半年，诺华中国区销售额约25亿美元，同比增长7%（表2），是除礼来外中国区业绩唯一保持正增长的头部企业，这一表现主要得益于多款创新产品持续放量。 2026年1月，英克司兰正式进入国家医保；第二季度，该产品全球销售额达到4.80亿美元，同比增长59%。 与此同时，瑞波西利在中国早期乳腺癌新增处方市场的份额达到46%；口服慢性自发性荨麻疹药物瑞米布替尼（Rhapsido）已在中国治疗超过3000名患者；镥[177Lu]-特昔维匹肽（Pluvicto）也在持续推进中国市场准入。随着上述产品逐步放量，新产品正成为支撑诺华中国区后续增长的重要力量。 与诺华类似，德国默克医药业务也处于产品换挡期。2026H1，德国默克实现营收120.39亿美元，同比增长0.3%，但核心医药Healthcare板块明显承压，上半年收入47.88亿美元，同比下降0.3%。 产品销售方面，曾经的增长支柱——多发性硬化症（MS）药物克拉屈滨（Mavenclad）受到美国仿制药竞争冲击，上半年销售额降至6.11亿美元，同比下降10.7%；PD-L1抗体阿维鲁单抗（Bavencio）销售额为3.00亿美元，同比下降17.5%；老牌MS药物重组干扰素β-1α（Rebif）销售额下降15.2%；抗肿瘤西妥昔单抗（Erbitux）则基本持平于6.81亿美元。 相比之下，促排卵重组复方制剂注射用人促卵泡激素α、促黄体激素α（Pergoveris）销售额增长14.8%，收购SpringWorks获得的尼罗司他（Ogsiveo）和米达美替尼（Gomekli）也分别贡献1.59亿美元和0.80亿美元收入，成为德国默克医药板块为数不多的增量来源。 不过，这些产品目前体量仍相对有限，尚不足以完全抵消核心成熟品种下滑带来的影响，德国默克医药业务的产品接续压力仍然存在。 04结语 随着2026年上半年头部MNC财报陆续披露，全球制药行业的增长版图也愈发清晰。 过去由肿瘤药长期占据主导的市场格局，正在被GLP-1、自免等赛道快速改写，替尔泊肽、度普利尤单抗等超级单品对药企业绩的拉动愈发显著。可以预见，未来几年，围绕这些高景气赛道和重磅品种的竞争仍将继续，并成为影响全球药企座次变化的重要变量。 参考资料： 各企业官微、官网等 本期素材组图片来源：https://unsplash.com/s/photos/  END