Efimosfermin alfa

近日，CDE最新公示，葛兰素史克（GSK）1类生物新药注射用Efimosferminalfa（受理号：CXSL2600372）在华临床试验申请获受理。这款以20亿美元总价收购的长效FGF21类似物，凭借每月1次注射、逆转肝纤维化的亮眼数据，成为MASH（代谢功能障碍相关脂肪性肝炎，原NASH）赛道的重磅玩家，正式开启中国临床征程。 一、CDE公示：GSKEfimosferminalfa登陆中国，20亿管线再落一子 4月2日，国家药监局药品审评中心（CDE）受理品种目录更新，葛兰素史克（中国）投资有限公司提交的注射用Efimosferminalfa临床试验申请正式获批受理，药品类型为治疗用生物制品，注册分类1类新药，承办日期为2026年4月2日。 这是Efimosferminalfa首次进入中国临床开发阶段，也是GSK在代谢性肝病领域的关键落子。回溯这款药物的前世今生，其最初由BostonPharmaceuticals研发，2025年5月，GSK以总金额20亿美元（含3.5亿美元首付款、16.5亿美元里程碑）完成收购，将其纳入自身肝病管线，彼时该药已推进至III期临床阶段，被GSK定位为“潜在同类最佳”的MASH治疗药物。 Efimosferminalfa（曾用研发代号BOS-580、GSK364735）是一款长效FGF21（成纤维细胞生长因子21）类似物，通过对天然FGF21进行氨基酸改造，大幅提升了药物稳定性和半衰期，实现每月1次皮下注射的便捷给药，完美解决了天然FGF21体内易降解、半衰期短的临床痛点。二、II期数据炸裂：50%肝脂肪减少，38.5%患者肝脏脂肪正常化 Efimosferminalfa的核心竞争力，来自其在MASH患者中展现的突破性临床数据。 在针对活检确诊F2/F3期MASH患者的II期临床试验中，24周治疗数据显示： 肝脏脂肪显著逆转：患者肝脏脂肪含量（MRI-PDFF）平均相对减少约50%，38.5%的患者实现肝脏脂肪正常化（≤5%）； 肝损伤快速改善：ALT（谷丙转氨酶）平均降低31.1U/L，肝脏炎症得到显著缓解； 纤维化逆转明确：PRO-C3降低20.1%、ELF评分降低0.7，从分子水平证实肝纤维化逆转，且获益独立于GLP-1类药物的减重作用； 安全性可控：整体耐受性良好，未出现严重安全性事件，为长期用药奠定基础。 基于这一数据，GSK在2025年10月正式启动两项全球III期临床试验（ZENITH-1、ZENITH-2），计划分别招募1200名、1250名F2/F3期MASH患者，进一步验证其长期疗效与安全性，目标直指全球MASH适应症获批。三、FGF21赛道白热化：Efimosferminalfa的差异化优势在哪？ MASH（原NASH）是全球肝病领域的未满足刚需，全球患者超3亿，中国患者约1.5亿，却长期缺乏有效治疗药物。FGF21类似物因同时作用于肝脏、脂肪、肌肉等多个代谢器官，成为MASH、肥胖、2型糖尿病等代谢疾病的热门研发方向，赛道玩家云集。 更关键的是，Efimosferminalfa的作用机制不依赖GLP-1通路，可与GLP-1类药物联用，为MASH合并肥胖、糖尿病患者提供联合治疗方案，进一步拓展了临床应用场景。四、GSK押注中国：MASH市场的本土化布局 此次Efimosferminalfa在华申报临床，是GSK深耕中国肝病市场的重要一步。 作为全球肝病领域的老牌药企，GSK在乙肝、脂肪肝等领域布局深厚，此次以20亿美元收购Efimosferminalfa，正是瞄准了中国庞大的MASH患者群体。随着中国代谢性疾病患病率持续攀升，MASH已成为继病毒性肝炎后，中国慢性肝病的首要病因，临床需求迫切。 此次Efimosferminalfa在华申报，意味着GSK将同步推进全球III期与中国临床研究，有望加速该药物在中国的获批进程，让中国患者尽早用上这款每月1次的长效治疗药物。同时，也将搅动国内MASH赛道的竞争格局，倒逼本土药企加速FGF21、GLP-1等靶点的研发进度。五、赛道展望：FGF21能否成为MASH治疗的下一个爆款？ 目前，全球MASH治疗领域，GLP-1类药物、FGF21类似物、PPAR激动剂等多靶点并行，而FGF21类似物因“同时改善肝脂、炎症、纤维化”的三重获益，被行业视为最具潜力的方向之一。 Efimosferminalfa的全球III期数据，将直接决定其能否成为首个获批的长效FGF21类MASH药物。而此次中国申报，也让国内患者看到了新的治疗希望。对于GSK而言，Efimosferminalfa不仅是20亿美元收购的管线资产，更是其在代谢肝病领域翻盘的核心筹码。💬 互动时间 全球 III 期临床同步推进，Efimosfermin alfa 有望多久在中国获批上市？欢迎在评论区留下你的观点，我们一起讨论！ 识别微信二维码，添加抗体圈小编，符合条件者即可加入 抗体微信群！ 请注明：姓名+研究方向！ 版 权 声 明 本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观不本站。

iStock, vectorslab Overall, the top 16 largest pharmaceutical companies spent $159 billion on research and development in 2025, compared to $165 billion the year prior. Here’s where all that cash went at companies like Johnson & Johnson, Amgen and Pfizer. R&D spending at the top 16 pharmaceutical companies declined by 3.6% overall in 2025, as many aggressively cut spending and refocused pipelines. AbbVie had the steepest decline, meaning the company spent 29% less on research. Overall, the top 16 heavyweights spent $159.1 billion on R&D in 2025, compared to $165 billion the previous year. Johnson & Johnson’s research expenses fell by nearly 15% to $14.7 billion. Much of that decline can be attributed to changes made in 2023, when the healthcare giant completed a prioritization of its R&D investment within the Innovative Medicines segment. J&J exited a number of programs at the time, including infectious diseases and vaccines, such as a respiratory syncytial virus (RSV) adult vaccine program, hepatitis and HIV development. While that program wrapped up in 2024, J&J’s 2025 spend reflects a slimmer organization. Earnings J&J Reigns as Top Pharma by Revenue While Lilly Leapfrogs on Strong Obesity Sales While Johnson & Johnson retains the top revenue rank across the major pharma companies, Eli Lilly last year established itself as the clear leader in the obesity market, in the process capturing investors’ attention and enthusiasm. March 18, 2026 · 8 min read · Tristan Manalac Read more Similarly, Bristol Myers Squibb dropped R&D spending by 11% in 2025 to $9.95 billion. The company attributed this to lower impairment charges for the period, which can result from writing down failed programs, and the ongoing strategic productivity initiative. BMS originally announced that program in April 2024, pledging to achieve $1.5 billion in cost savings through eliminating jobs and prioritizing development programs. The company cut several legacy programs from its 2019 Celgene acquisition in the process. Merck is also doing a little restructuring. The company cut R&D expenses by 12% for 2025 thanks to lower charges for business development activity. But those savings were offset by higher clinical activity and restructuring costs. Pfizer, too, flagged restructuring across the company as impacting its R&D spend, which fell 4% to $10.21 billion. AbbVie, meanwhile, took on $4.48 billion in impairment charges to its line item on R&D expenses. Absent that charge, the company’s adjusted R&D spend actually rose by $1 billion, CEO Robert Michael explained during a February earnings call. After the adjustment, AbbVie spent $8.99 billion on R&D, according to the company’s earnings report. On the other side of the coin, pharmas including GSK and Amgen pumped money into research. Amgen had the biggest increase, with 22% more going toward programs like the weight loss asset MariTide. The company spent $7.27 billion overall on R&D, representing 20% of its revenue. Earnings GSK Says No to GLP-1s, Prioritizes ‘Downstream Effects’ of Obesity Instead of joining the increasingly crowded GLP-1 arena, GSK will focus its efforts downstream of obesity—a push currently anchored by its Phase III-ready FGF21 analog efimosfermin alfa for liver fibrosis. February 4, 2026 · 2 min read · Tristan Manalac Read more Regeneron had a 14% boost, spending $5.85 billion on research. Among the larger pharmas, the company spends by far the greatest share of its revenue on R&D, with 41% of its income going toward clinical development and related expenses. Across the pond, GSK bumped up R&D spending by 18%, particularly increasing its spend in oncology and vaccines. The company expects to continue this trend as it invests more and adopts operational efficiencies to lower costs. One drag on GSK’s R&D expenses was the termination of the anti-TIGIT program belrestotug , which meant an impairment charge of £471 million ($631 million). The therapy produced disappointing results in the Phase II GALAXIES Lung-201 study in non-small cell lung cancer (NSCLC). Meanwhile, GSK funneled energy—and cash—into its antibody drug conjugate (ADC) programs, the MASH drug efimosfermin , hepatitis B treatment bepirovirsen and more. Finally, AstraZeneca added 5% to its funding for R&D, for a total of $14.23 billion. This went toward work on immuno-oncology bispecifics, cell therapy and ADCs. Key readouts throughout the year also unlocked Phase 3 development, which accelerated expenses. .responsive-container { display: flex; flex-wrap: wrap; border: 1px solid #ededed; font-family: Helvetica, Arial, Sans-Serif; padding: 20px 20px 10px 20px; } .column-left { flex: 1; max-width: 45%; padding: 20px 20px 10px 20px; } .column-right { flex: 2; padding: 20px 20px 10px 20px; } @media (max-width: 768px) { .column-left, .column-right { max-width: 100%; flex: 100%; padding: 10px 0; } } Subscribe to BioPharm Executive! Market insights, trending business and policy stories for biopharma leaders hbspt.forms.create({ region: "na1", portalId: "4413123", formId: "7c139b3c-ff0b-44e0-bffe-f449801dca59", onFormSubmitted: function($form, data) { window.dataLayer = window.dataLayer || []; window.dataLayer.push({ 'event': 'GTMevent', 'event_name': 'newsletter_sign_up' }); } });