Balinatunfib

Sanofi posted a strong set of first-quarter results Thursday morning, with its recombinant factor drug Altuviiio on track to become a blockbuster drug and its crown jewel Dupixent continuing to draw sales. Sales of the French drugmaker’s hemophilia A treatment Altuviiio doubled in the first quarter to €251 million ($286 million), according to a company earnings report . Almost 90% of that number was driven by the US, where patients continued to switch over from older plasma-derived and recombinant factor medicines. The remaining €33 million came from other markets, boosted by a recent launch in Japan. Altuviiio has been steadily gaining market share since it secured FDA approval in 2023, according to Sanofi. If it can replicate its Q1 sales for the rest of the year, the product should reach blockbuster status in 2025, a company spokesperson told Endpoints News in an email. Altuviiio is administered weekly, giving it a significant convenience edge over older recombinant factor drugs, which can require up to thrice weekly dosing. Sanofi’s older recombinant factor medicine, Eloctate, saw sales drop around 21% to €70 million as patients switched to Altuviiio. But its broader hemophilia A franchise fared positively, with sales rising by 50% to €321 million. That number formed part of Sanofi’s total first-quarter sales of €9.9 billion, which were up almost 10% from the same time last year. The figure came in 3% ahead of Wall Street consensus forecasts and was driven by continued growth of the company’s blockbuster inflammatory disease drug Dupixent, Jefferies analysts said in a Thursday note. Dupixent sales were up around 20% in the quarter to €3.5 billion. The growth was driven by rising use in all established indications, as well as “emerging use” in its latest approval for chronic obstructive pulmonary disorder, Sanofi said. Dupixent is expected to reach peak sales of $3.3 billion in COPD alone, according to Wall Street consensus estimates. Sanofi’s hemophilia offering was further bolstered by an FDA approval for siRNA medicine Qfitlia in hemophilia A and B last month. Qfitlia will be sold in the US at an average cost of $642,000 per year, but comes with a boxed warning for thrombotic events and gallbladder disease. Sanofi also reported a Phase 2 disappointment for its oral TNF inhibitor, balinatunfib, in psoriasis. The drug did not hit statistical significance in the primary endpoint of PASI-75, which measures the proportion of patients with a minimum 75% improvement in their psoriasis area and severity index score. Sanofi said the failure was driven by “the limited nature” of the trial, adding it would share full data at a future medical meeting. For now, the company is considering potential combination approaches for balinatunfib. Elsewhere, Sanofi made several cuts to its cancer pipeline. The drugmaker terminated a Phase 2 trial for NK cell engager SAR443579 in acute myeloid leukemia and a Phase 1 study of monoclonal antibody SAR444881 in solid tumors. The cuts are part of a broader pipeline prioritization that should help the company focus on its goal of becoming a world leader in immunology, the spokesperson said. On a call with the media on Thursday, CFO François Roger said the company is continuing to assess how the looming pharma tariffs would impact its business. Editor’s Note: This article was updated to add information about the balinatunfib trial failure and the company’s comments on potential pharma tariffs.

近日，赛诺菲免疫领域潜在重磅药物amlitelimab遭遇挑战——该药物最高剂量组在二期哮喘研究中未能达到主要终点。Amlitelimab是赛诺菲在2021年以11亿美元的预付款以及3.5亿美元的里程碑付款收购Kymab时获得的资产之一。该药是一款抗OX40L单克隆抗体，在哮喘、特应性皮炎等免疫介导疾病和炎症性疾病中展现出治疗潜力。赛诺菲将其与多发性硬化症药物frexalimab和银屑病药物SAR441566并列为潜在峰值销售额超过50亿欧元的候选药物。不过，近期公布的一项II期TIDE-Asthma研究中，最高剂量组未能达到主要终点，为这款潜在重磅药物的前程增加了几分不确定性。这是一项针对437名中重度哮喘患者的II期研究，患者在前24周每四周接受一次Amlitelimab治疗，在剩余的36周每12周接受一次治疗，直至第60周。主要终点是重度哮喘发作的年发生率。关键次要终点包括肺功能和哮喘控制。初步数据显示，在最高剂量水平下，第48周的年化发作率这一主要终点未达到。但中等剂量组相比安慰剂组显示出“统计学显著且具有临床意义”的哮喘发作次数降低。另外，在60周时，高剂量组哮喘发作次数获得更显著的数值减少。在亚组分析中，赛诺菲特别指出amlitelimab在异质性炎症哮喘患者群体中展现出“令人信服的疗效”。公司声明称，若后续研究能验证这一发现，可能为这一长期缺乏有效疗法的患者群体带来突破性治疗方案。基于该积极结果，赛诺菲表示将按计划推进amlitelimab的Ⅲ期临床试验。除了哮喘，赛诺菲还在推进该药物在特应性皮炎、乳糜泻、斑秃、化脓性汗腺炎、系统性硬化症等适应症的临床研究，在免疫疾病中广泛开花。其中特应性皮炎适应症已进入临床Ⅲ期，有望成为下一个Dupixent。图片来源：药智数据结语OX40是一种I型跨膜糖蛋白，是肿瘤坏死因子受体（TNFR）超家族的成员之一，主要表达在活化的效应T细胞和调节性T细胞（Tregs）表面。OX40L是一种Ⅱ型糖蛋白，是OX40的配体，与其结合后能够形成T细胞共刺激物，促进Th2等辅助性T细胞的活化，从而增加IL-4、IFN-γ等细胞因子的表达。因此，阻断OX40与OX40L之间的相互作用具有治疗自身免疫性疾病的潜力。药智数据显示，全球已有多款OX40/OX40L靶向药物进入临床阶段，其中赛诺菲的amlitelimab和安进的rocatinlimab处于第一梯队，已进入临床Ⅲ期。国内药企中，已有百奥泰、创响生物、信达生物等多家企业布局这一赛道。图片来源：药智数据参考来源：1.https://www.fiercebiotech.com/biotech/sanofis-high-hopes-11b-kymab-anti-inflammatory-drug-dented-after-phase-2-asthma-failure声明：本内容仅用作医药行业信息传播，不代表药智网立场。对本文有异议或投诉，请联系maxuelian@yaozh.com。责任编辑 | 小月石合作、投稿 | 马老师 18323856316（同微信） 阅读原文，是受欢迎的文章哦