Arteritis

AbbVie’s Rinvoq (upadacitinib) has been approved by the US Food and Drug Administration (FDA) to treat adults with giant cell arteritis (GCA), or temporal arteritis, an autoimmune disease of medium and large arteries. The US regulator’s decision, which comes just three weeks after the European Commission approved Rinvoq for the same indication, was supported by results from the phase 3 SELECT-GCA trial. In the study, 46.4% of patients receiving Rinvoq 15mg in combination with a 26-week steroid taper regimen achieved sustained remission at week 52, compared to 29% of patients randomised to receive placebo alongside a 52-week steroid taper regimen. Additionally, data showed that 34.3% of patients being treated with the Rinvoq combination experienced at least one disease flare through week 52 versus 55.6% of patients in the placebo arm, and AbbVie’s drug was also associated with lower cumulative steroid exposure and sustained complete remission. Occurring most frequently in women aged over 50 years, GCA can cause headaches, jaw pain and visual disturbances such as vision loss, as well as large artery complications and cardiovascular disease. The current mainstay of treatment for the disease, glucocorticoids, can result in drug-associated toxicities, and relapse remains common. AbbVie’s Rinvoq is now the first and only oral Janus kinase (JAK) inhibitor to be approved in the US for adults with GCA, and could allow patients to taper off steroids. “This FDA approval will now provide an alternative treatment option that can offer patients with GCA the possibility of tapering off steroids and achieving sustained remission,” said Roopal Thakkar, executive vice president, research and development, chief scientific officer, AbbVie. SELECT-GCA trial investigator, Peter Merkel, University of Pennsylvania, added: “We now have a new option to treat GCA. The results of this clinical trial show that [Rinvoq] offers patients the chance to reach sustained remission.” Beyond GCA, Rinvoq is approved in the US to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, ulcerative colitis and Crohn’s disease. The drug is also in phase 3 clinical development for alopecia areata, hidradenitis suppurativa, Takayasu arteritis, systemic lupus erythematosus and vitiligo.

当K药与司美格鲁肽在“药王之争”中杀得难解难分时，曾霸榜全球药王11年的艾伯维，正以一场堪称“教科书”式的战略转型，悄然完成从“修美乐依赖”到“多引擎驱动”的蜕变。财报背后的“教科书式破局”4月25日披露的2025年艾伯维Q1财报显示：⦁  公司净收入133.43亿美元，同比增长8.4%，超预期4.4亿美元；⦁  免疫、神经科学、肿瘤、美学四大板块全面开花，收入分别达62.64亿、22.82亿、16.33亿、11.02亿美元，其中免疫板块以16.6%的双位数增速成为核心增长极。从财报看，免疫板块仍然是艾伯维的营收主要支柱，在修美乐业绩放缓的情况下，近年来艾伯维免疫业务的增长都在个位数徘徊，而Q1财报的增长曲线却陡然拔升，首次狂飙到了16.6%的双位数增长高度。这场增长背后，是艾伯维用“创新+布局”书写的“专利悬崖穿越指南”。免疫“双子星”：教科书级的“接力模型”在修美乐因生物类似药冲击收入同比下滑50.6%（仅11.21亿美元）时，喜开悦(利生奇珠单抗)与瑞福（乌帕替尼）组成的免疫“双子星”强势崛起，正以教科书级的姿态上演王者逆袭。靶向IL-23的利生奇珠单抗一季度销售额飙升至34.25亿美元，同比劲增70.5%；JAK1抑制剂乌帕替尼亦不甘示弱，斩获17.18亿美元营收，同比增长57.2%。这对“黄金搭档”的强势崛起，绝非偶然，而是艾伯维前瞻性战略布局的必然结果。早在2016年，当修美乐仍稳居全球药王宝座时，艾伯维便以科研企业特有的敏锐嗅觉，提前布局利生奇珠单抗作为接棒者之一，并于2019年成功推出自研的乌帕替尼，完成新旧产品的战略接力。凭借深厚的研发底蕴与精准的市场预判，“双子星”上市后便势如破竹。去年二者合计营收达176.89亿美元，而从当前的增长态势来看，2025年它们不仅极有可能突破200亿美元营收大关，更有望超越修美乐巅峰时期的210亿美元年营收，以一场完美的“逆袭战”，彻底改写行业对专利悬崖的认知，为全球药企提供破局增长的经典范本。产品力“教科书”：疗效、依从性、适应证的三维制胜法则在竞争白热化的免疫赛道，艾伯维凭借对疾病机制的深刻理解与临床需求的精准把控，以“双子星”构建起难以复制的竞争壁垒。其核心优势，集中体现在疗效、依从性、适应证三大维度的全方位突破。1.疗效为王：头对头较量定义治疗新标准利生奇珠单抗与乌帕替尼以“硬实力”征服市场：前者在克罗恩病3期临床中直接击败强生乌司奴单抗，在银屑病领域又完胜诺华司库奇尤单抗；后者则在与赛诺菲/再生元度普利尤单抗的正面交锋中脱颖而出，以显著的疗效优势重新划定免疫治疗的黄金标准。这种“敢于直面竞品”的临床策略，验证了产品硬实力。2.依从性革新：从“治疗负担”到“便捷体验”的跨越艾伯维深谙“患者体验即竞争力”，通过剂型与给药方式的创新大幅提升治疗便捷性：⦁  利生奇珠单抗以“一年4针”的方案，将传统频繁注射的负担压缩至最低，搭配国内首创的随身给药器，让患者居家即可完成治疗；⦁  乌帕替尼则实现了JAK1抑制剂从注射到口服的迭代升级，并于2024年在美国推出口服溶液剂型，进一步解决吞咽困难患者的用药痛点，真正将“便捷治疗”落到实处。3.适应证拓展：构建全领域覆盖的“护城河”“双子星”以“闪电战”式的适应证布局抢占市场高地：⦁  乌帕替尼上市5年迅速覆盖9大适应证，不仅承接修美乐核心治疗领域，更于2025年4月斩获欧盟巨细胞动脉炎（GCA）适应证，成为全球首个且唯一获批该适应证的口服JAK抑制剂；⦁  利生奇珠单抗则聚焦克罗恩病、银屑病等领域，形成“多病种突破”的双线攻势，为患者提供个性化治疗选择。在中国市场，二者更是火力全开：乌帕替尼7项适应证全部纳入医保，另有4-5项新适应证申报在即；利生奇珠单抗作为全球首个IL-23抑制剂，已获批克罗恩病适应证，溃疡性结肠炎适应证申请也进入冲刺阶段。随着更多临床研究结果将于年内揭晓，这对“黄金组合”有望持续领跑自免赛道，为中国免疫疾病患者带来更高效、更便捷的治疗方案，书写未来十年的行业新篇。下一个十年：从免疫王者到跨界破局者减重赛道：差异化破局的教科书级示范2025年3月，艾伯维以22亿美元重金押注丹麦Gubra公司的长效胰淀素类似物GUB014295全球权益，强势切入万亿减重市场。这一决策，精准踩中行业痛点：在GLP-1靶点竞争近乎白热化的当下，艾伯维另辟蹊径，直击现有药物“肌肉流失”的短板——胰淀素不仅能减少脂肪堆积，还可保留肌肉量，搭配长效设计提升患者依从性，直击减重药物停药率高的核心难题。高盛预测，2030年全球减肥药市场规模将达1300亿美元，而艾伯维凭借“靶点创新+技术差异化”的组合拳，已提前锁定赛道前排席位。全领域BD：构建永不落幕的创新引擎减重领域的突破，只是艾伯维多元化战略的冰山一角。2025年Q1，公司在免疫学、肿瘤学、神经科学等赛道同步加码BD布局：通过前瞻性的管线投资与技术合作，艾伯维打造出一套“新旧药物无缝接力”的增长模型——每一款明星产品步入成熟期前，新一代创新药已蓄势待发。这种“未雨绸缪”的战略定力，让艾伯维得以在医药行业的周期性浪潮中，始终保持稳健增长的主动权，成为全球药企跨越周期、持续创新的鲜活教科书。结语：从修美乐的“单药依赖”到免疫“双子星”的“双引擎驱动”，艾伯维用“提前布局、头对头临床验证、适应证快速拓展”的组合策略，完成了从“专利悬崖穿越者”到“行业规则制定者”的身份跃迁。其方法论——在核心赛道建立技术壁垒，用BD填补管线断层，以适应证拓展延长产品生命周期——正在成为全球药企的“破局教科书”。当免疫“双子星”的光芒照亮增长曲线，艾伯维证明：真正的行业标杆，从不止于守住王座，更在于定义下一代增长规则。撰稿｜方涛之编辑｜江芸 贾亭运营｜廿十三康方生物回应！依沃西到底打没打败K药？受集采冲击，罗氏诊断中国区营收大幅下降新事 | 知名医院副院长任上被查

Plus, news about the Novo Nordisk Foundation and Tonix: AbbVie’s Rinvoq gets label expansion: The blockbuster JAK inhibitor won approval in the US to treat adults with giant cell arteritis, an autoimmune disease that causes inflammation of the arteries, often in the scalp and head. Rinvoq was approved in Europe for the same condition earlier this month. — Nicole DeFeudis #AUA2025: Relmada Therapeutics’ interim Phase 2 data in bladder cancer: The company said NDV-01, a reformulation of two chemo drugs, achieved an 85% overall response rate in 20 patients with non-muscle invasive bladder cancer. Two patients with carcinoma in situ achieved a complete response. Already below $1.00, Relmada’s stock price $RLMD was down 18% on Tuesday morning. — Max Gelman Novo Nordisk Foundation expands certain grants beyond Denmark: The grants, which are awarded through the foundation’s annual Challenge Programme, will now be available to researchers in most of Europe. The new area includes Europe’s Schengen area — this accounts for most EU member countries plus a handful of non-member countries — Ireland and the UK. The overall budget for grants this year is DKK 600 million (€80 million). — Max Gelman Tonix discontinues cocaine intoxication trial: The biotech discontinued the Phase 2 study for TNX-1300 due to slower-than-projected enrollment, it said in an SEC filing last week. — Max Gelman Hello, Mark Smith You’re an essential part of the biopharma world. Share your voice on this important question to help shape our understanding of the industry. Can you help us out? Hello, Mark Smith You’re an essential part of the biopharma world. Share your voice on this important question to help shape our understanding of the industry. Can you help us out?