Teclistamab

4月16日，强生公布2024Q1财报，总营收213.83亿美元，同比增长2.3%。研发投入35.42亿美元，同比增长2.5%。2023年，在完成消费者保健业务剥离后，强生整合制药（原杨森后更名为“强生创新制药”）、医疗科技两大业务。强生创新制药专注于肿瘤、免疫、神经、心血管、肺动脉高压和视网膜等领域；医疗科技则致力于外科、骨科、眼科和介入解决方案领域。财报显示，强生创新药业务第一季度收入135.62亿美元（+1.1%），医疗科技业务收入78.21亿美元。其中，创新药业务主要收入来源肿瘤学营收48.14（+17.1%）和免疫学营收42.47亿美元（+3.3%）。抗肿瘤业务的增长，主要得益于Carvykti（西达基奥仑赛）、Darzalex（达雷妥尤单抗）、Erleada（阿帕他胺）以及Tecvayli（特立妥单抗）的销售额拉动。其中，与传奇生物合作的BCMA CAR-T疗法Carvykti上市第二年，即2023年销售额便达5亿美元。加上该药本月初刚成功提至二线，今年冲击10亿美元销售额也未尝不可。还有BCMA×CD3双抗Tecvayli，今年二月份成功拓展新适应症，用于已达到并维持完全缓解（CR）至少六个月的R/R 多发性骨髓瘤（MM）患者，快速放量也将持续。在MM这一适应症上，强生布局有抗CD38单抗、CAR-T、BCMA×CD3双抗、CD3×GPRC5D双抗各类产品，旨在重新定义其治疗模式。值得注意的是，对比强生2023年12月时的管线，在刚更新的管线中，两个肿瘤的I期项目JNJ-8114 (PSMA/CD3)、JNJ-4916溶瘤病毒已不再见。自免业务倒未出现明显增长，主要原因在于旗下明星产品Stelara（乌司奴单抗）在美专利已于2023年9月到期，正在面临众多生物类似药围剿。据Pharma ONE数据库统计，全球共有78家公司参与Stelara生物生物类似药的研究，其中8款获批上市，3款处在上市申请阶段，24款已进入临床三期。此外，旗下修美乐同靶点TNF-α抑制剂，Remicade（英夫利昔单抗）销售额出现双位数下滑，这款首批于1998年的老药，表现也算坚挺。使强生自免业务未出现整体下滑的是旗下新势力Tremfya（古塞奇尤单抗）的业绩增长。这款IL-23单抗首批于2017年，用于治疗成人中重度斑块状银屑病，后又相继在美国、日本等地区拓展了包括掌跖脓疱病、银屑病关节炎等多项适应症。Tremfya2023年全球销售额达31.46亿美元，能否完全接住Stelara百亿美元颠覆销售额的接力棒，值得期待。再者，便是2024年第一季度强生的BD动向。1月8日，强生宣布以20亿美元的交易总价收购Ambrx，获得旗下用于转移性去势耐受性癌症前列腺癌治疗的ARX517（PSMA ADC）等多款ADC候选药物。此举不仅是在补Zytiga（阿比特龙）业绩下滑的窟窿，也帮助强生为后续乳腺癌等其他实体瘤的开发做好铺垫。如果说收购Ambrx是对强生创新药业务的增强，那么131亿美元收购Shockwave便是对其医疗科技业务进行增强。Shockwave拥有目前唯一商用的血管内碎石术（IVL）技术，用于治疗钙化外周动脉疾病和钙化冠状动脉疾病。这是继2023年11月强生以4亿美元的预付款收购研发用于治疗房颤的左心耳封堵器的Laminar，以及于2022年11月以166亿美元收购心脏泵巨头Abiomed之后，在心血管领域的又一轮巨额收购。至此，强生将在房颤、心力衰竭、血管钙化、心绞痛等多个心血管领域疾病中夺得主导地位。最后，强生将2024全年预期增长提升至“5.5%-6%”（887-891亿美元），此前预期为5%-6%（882-890亿美元）。以下为强生创新药管线2024年关键事件。封面图来源：123rf版权声明/免责声明本文为原创文章。本文仅作信息交流之目的，不提供任何商用、医用、投资用建议。文中图片、视频、字体、音乐等素材或为药时代购买的授权正版作品，或来自微信公共图片库，或取自公司官网/网络，部分素材根据CC0协议使用，版权归拥有者，药时代尽力注明来源。如有任何问题，请与我们联系。衷心感谢!药时代官方网站:www.drugtimes.cn联系方式:电话:13651980212微信:27674131邮箱:contact@drugtimes.cnODAC全票通过！MRD有望成为多发性骨髓瘤加速批准的试验终点AACR之后，又会有多少BD交易产生？夹在“见死不救”与“画饼充饥”之间的肿瘤学药物加速批准点击阅读原文，了解更多！

Johnson & Johnson is advancing in multiple myeloma with new drugs Tecvayli and Carvykti and mainstay Darzalex all achieving major sales increases in the first quarter. For the first time, Johnson & Johnson has reported sales numbers for its novel multiple myeloma treatment Tecvayli and they indicate that the bispecific, which was approved in October 2022, is off to a solid launch. In the first quarter, Tecvayli generated $133 million in revenue, compared to $63 million in sales in the first quarter of last year. Also of note was that $101 million of Tecvayli’s first-quarter sales came in the United States, where the B-cell maturation antigen (BCMA) targeting agent can be used after four previous treatments. In Europe, it's allowed after three other therapies. Tecvayli’s sales were up sequentially from $112 million in the third quarter of 2023 and $126 million in the fourth quarter. “We’re seeing very strong uptake and rapid adoption whether we’re in the U.S., Germany, Austria, France—the major markets that have launched to date,” Jennifer Taubert, J&J innovative medicines chief, said during a conference call. “As the first and we believe best-in-class, off-the-shelf BCMA bispecific, we really believe that therapy is offering deep and durable responses.” Virtually all the news J&J reported from its multiple myeloma franchise was positive, with Taubert calling it a “true stronghold for us.” Mainstay Darzalex, which is approaching a decade on the market, continued its strong growth trajectory with a 21% increase year over year to $2.7 billion for the quarter. Its sales also were up 5.5% sequentially. Most of the growth came in the front-line setting, Taubert added.   J&J also reported positive momentum for multiple myeloma cell therapy Carvykti, which posted sales of $157 million, which was up from $72 million year over year. “There’s always questions on how we are doing on expanding our capacity,” Taubert said. “We have doubled our manufacturing capacity since the beginning of 2023 for cell processing. We are continuing to work on our Ghent (Belgium) facility to have that as a secondary source of supply. We’ve brought on some contract manufacturers and we have completely transformed and expanded lentivirus production so that is not a rate-limiting step.” As for Carvykti failing to top the previous quarter sales of $159 million, Taubert chalked it up to “phasing and timing of orders,” adding that “there was nothing to see there.” Additionally, J&J said that the launch of another multiple myeloma bispecific, Talvey, which was approved in August of last year, is progressing well. For the quarter overall, J&J’s sales reached $21.4 billion, which were up 2.3% year over year and 7.6% when eliminating the impact of COVID vaccine sales. The company’s medical devices sector did some heavy lifting in the quarter, with sales up 6.3% compared to a 1% increase in sales in the pharma sector. J&J also narrowed its 2024 guidance to a range of $88 billion to $88.4 billion versus a prior window of $87.8 billion to $88.6 billion.