A Phase 3, two-part, double-blind, randomized, placebo-controlled study to investigate the safety and efficacy of efimosfermin alfa injection in adult participants with compensated cirrhosis (stage F4 fibrosis) due to metabolic dysfunction-associated steatohepatitis (NEBULA-2)

开始日期2026-07-27

申办/合作机构

GlaxoSmithKline KK

JPRN-jRCT2041260084

/ Not yet recruiting临床3期

A Phase 3, double-blind, randomized, placebo controlled, 2-arm study to investigate the safety and efficacy of efimosfermin alfa injection in adult participants with compensated cirrhosis due to metabolic dysfunction-associated steatohepatitis (NEBULA-1)

开始日期2026-07-27

申办/合作机构

GlaxoSmithKline KK

NCT07701993

/ Recruiting临床3期

A Phase 3, Double-blind, Randomized, Placebo Controlled, 2-arm Study to Investigate the Safety and Efficacy of Efimosfermin Alfa Injection in Adult Participants With Compensated Cirrhosis Due to Metabolic Dysfunction-associated Steatohepatitis (NEBULA-1)

This study will investigate the safety and efficacy of efimosfermin alfa in participants with compensated cirrhosis due to MASH.

开始日期2026-07-22

申办/合作机构

GSK Plc

100 项与 Efimosfermin alfa 相关的临床结果

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100 项与 Efimosfermin alfa 相关的转化医学

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100 项与 Efimosfermin alfa 相关的专利（医药）

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项与 Efimosfermin alfa 相关的文献（医药）

2026-02-01·LANCET

Efimosfermin alfa (BOS-580) once per month in people with metabolic dysfunction-associated steatohepatitis with F2 or F3 fibrosis: results from a 24-week, randomised, double-blind, placebo-controlled, phase 2 trial

Article

作者: Kowdley, Kris V ; Zhao, Jeff ; Odrljin, Tatjana ; Jeglinski, Brenda ; Bain, Gerard ; Loomba, Rohit ; Noureddin, Mazen ; Koziel, Margaret James

BACKGROUND:

The growing prevalence of metabolic dysfunction-associated steatohepatitis (MASH) underscores the unmet need for effective and safe liver-targeted therapies to prevent fibrosis and disease progression. The aim of this study was to evaluate the efficacy and safety of efimosfermin alfa (henceforth referred to as efimosfermin, formerly BOS-580), an FGF21 analogue taken once per month, in patients with MASH and moderate or advanced fibrosis.

METHODS:

This 24-week, randomised, double-blind, placebo-controlled, phase 2 trial evaluated the safety and efficacy of efimosfermin in participants aged 18-75 years with a BMI of at least 27 kg/m² and MASH and F2 or F3 fibrosis present on a diagnostic liver biopsy done either during screening or within 6 months before the first day of dosing, and total activity Nonalcoholic Fatty Liver Disease Activity Score (NAS) of at least 4 with a minimum score of 1 point for all three NAS components (steatosis, hepatocyte ballooning, and lobular inflammation). The trial was conducted at 34 clinical research study sites in the USA. Participants were randomly assigned 1:1 to efimosfermin 300 mg or placebo administered by subcutaneous injection every 4 weeks (Q4W) over 24 weeks, stratified by MASH fibrosis stage (F2 vs F3 stage). Participants, investigators, and those assessing outcomes were masked to group assignment. The primary endpoint was safety and tolerability (ie, treatment-emergent adverse events, changes from baseline to week 24 in blood pressure and heart rate, and the incidence of grade 3 and grade 4 laboratory abnormalities at week 24), analysed in all participants who received at least one dose. This trial is registered with ClinicalTrials.gov (NCT04880031) and was completed on Sept 18, 2024.

FINDINGS:

Between May 4, 2023, and March 22, 2024, of 1171 participants screened, 84 participants were randomly assigned to efimosfermin 300 mg Q4W (n=43) or placebo (n=41); 44 (52%) were female and 40 (48%) were male. 48 (57%) had F2 fibrosis and 36 (43%) had F3 fibrosis; 65 had evaluable week-24 biopsy results. All 43 in the efimosfermin group and 40 of 41 participants in the placebo group received at least one dose. Adverse events were reported in 29 (67%) of 43 participants receiving efimosfermin and 22 (55%) of 40 receiving placebo. The majority of treatment-emergent adverse events were mild (24 [56%] of 43 in the efimosfermin group vs 15 [38%] of 40 in the placebo group) or moderate (18 [42%] vs 14 [35%]) in severity. Most frequent adverse events were gastrointestinal events, which were transient and occurred within the first few weeks of treatment. There were no clinically meaningful changes in vital signs between treatment and placebo groups, and no clinically significant grade 3 or higher laboratory abnormalities observed for either group. No deaths or adverse events greater than grade 3 were observed during the study.

INTERPRETATION:

In this phase 2 trial, treatment with efimosfermin once per month was generally well tolerated in participants with biopsy-confirmed MASH and F2 or F3 fibrosis. These results support the further development of efimosfermin for treatment of MASH-related fibrosis.

FUNDING:

Boston Pharmaceuticals and GSK.

2025-12-01·Gastroenterology & hepatology

Once-Monthly Efimosfermin Alfa for Up to 48 Weeks in MASH With F2/F3 Fibrosis: Results From a Phase 2, Open-Label Extension Study.

Article

2025-08-01·The Lancet Gastroenterology & Hepatology

Efimosfermin alfa (BOS-580), a long-acting FGF21 analogue, in participants with phenotypic metabolic dysfunction-associated steatohepatitis: a multicentre, randomised, double-blind, placebo-controlled, phase 2a trial

Article

作者: Loomba, Rohit ; Clawson, Alicia ; Morrow, Linda ; Odrljin, Tatjana ; Kowdley, Kris V ; Alvarez, Alina Maria ; Bain, Gerard ; Jeglinski, Brenda ; Chowdhury, Swapan ; Kim, Nomita J ; Rodriguez, Jose

BACKGROUND:

Metabolic dysfunction-associated steatohepatitis (MASH) is a progressive disease characterised by steatosis, inflammation, and liver fibrosis. Efimosfermin alfa (efimosfermin, formerly BOS-580) is a long-acting, engineered variant of FGF21 designed to have a prolonged half-life. We aimed to assess the safety and tolerability of multiple efimosfermin doses and dosing regimens compared with placebo and to evaluate exploratory biomarkers of efficacy in participants with phenotypic MASH.

METHODS:

This multicentre, randomised, double-blind, placebo-controlled, phase 2a trial was conducted at 12 centres in the USA. Individuals with phenotypic MASH, aged 18-75 years and with a BMI of 30-45 kg/m², were eligible for the study. Participants were randomly assigned, using a centralised interactive randomisation system with no stratification factors, to one of five dosing cohorts: efimosfermin 75 mg once every 4 weeks, 75 mg once every 2 weeks, 150 mg once every 4 weeks, 150 mg once every 2 weeks, or 300 mg once every 4 weeks, for a 12-week treatment period. Participants were assigned 1:1:1:1 to all cohorts except efimosfermin 150 mg once every 4 weeks, which was initiated after assignment to the other cohorts was complete. Within each cohort, participants were randomly assigned 4:1 to receive efimosfermin or placebo, via subcutaneous injection, in fixed blocks of size five. Investigators and participants were masked to group assignment and treatment allocation. The primary endpoint was safety and tolerability and was assessed throughout the 12-week treatment period and at the follow-up visit 4 weeks after the final dose in the full analysis set, defined as enrolled participants who received at least one dose of study medication. Part A (reported here) of this phase 2 study is complete, while other parts of the phase 2 study are ongoing. This trial is registered with ClinicalTrials.gov (NCT04880031).

FINDINGS:

Between Aug 27, 2021, and July 22, 2022, 360 individuals were screened, of whom 102 were eligible and were randomly assigned to receive placebo (n=37) or efimosfermin 75 mg every 4 weeks (n=8), 75 mg every 2 weeks (n=14), 150 mg every 4 weeks (n=15), 150 mg every 2 weeks (n=15), or 300 mg every 4 weeks (n=13), for a total of 12 weeks. 45 (44%) of the 102 participants were female and 57 (56%) were male, with a mean age of 53 years (SD 11) and mean BMI of 36·5 kg/m² (SD 4·1). Of 65 participants treated with efimosfermin, 43 (66%) had treatment-emergent adverse events (TEAEs): four (50%) of eight participants receiving 75 mg every 4 weeks, ten (71%) of 14 participants receiving 75 mg every 2 weeks, six (40%) of 15 participants receiving 150 mg every 4 weeks; 12 (80%) of 15 participants receiving 150 mg every 2 weeks, and 11 (85%) of 13 participants receiving 300 mg every 4 weeks; TEAEs were recorded in 18 (49%) of 37 participants receiving placebo. TEAEs were typically mild-to-moderate in severity and resolved spontaneously. The most frequent TEAEs were gastrointestinal in nature, reported by nine (24%) of 37 participants in the placebo group and 26 (40%) of 65 participants who received efimosfermin: two (25%) of eight participants receiving 75 mg every 4 weeks, eight (57%) of 14 participants receiving 75 mg every 2 weeks, two (13%) of 15 participants receiving 150 mg every 4 weeks, eight (53%) of 15 participants receiving 150 mg every 2 weeks, and six (46%) of 13 participants receiving 300 mg every 4 weeks. The most common gastrointestinal events were nausea, vomiting, and diarrhoea. There were no treatment-related deaths. At week 12, 47 (89%) of 53 participants receiving efimosfermin for whom data were available had at least a 30% reduction in hepatic fat fraction: five (63%) of eight participants receiving 75 mg every 4 weeks, 11 (92%) of 12 participants receiving 75 mg every 2 weeks, nine (90%) of ten participants receiving 150 mg every 4 weeks, 11 (92%) of 12 participants receiving 150 mg every 2 weeks, and all 11 (100%) participants receiving 300 mg every 4 weeks, compared with two (7%) of 30 participants receiving placebo.

INTERPRETATION:

In participants with phenotypic MASH, efimosfermin had a favourable safety profile and showed improvements in indicators of hepatic steatosis. These results help to inform future studies of efimosfermin in this important disease state.

FUNDING:

Boston Pharmaceuticals.

项与 Efimosfermin alfa 相关的新闻（医药）

2026-08-14

·氨基观察

全球首款CELMoD疗法落地；7月新冠确诊52.2万例

今天聚焦的医药产业核心事件包括：百图生科与Biogend达成数千万美元NewCo交易；中疾控发布7月疫情月报、新增新冠确诊52.2万例；泽璟制药携首份盈利半年报重递港股IPO；复星医药自研CDK4/6抑制剂复妥宁®III期OS数据将亮相2026 ESMO；GSK在华启动MASH新药III期临床；BMS首个CELMoD疗法Zenbexus获FDA加速批准；Insmed支气管扩张症全球首药Brinsupri获批；韩国Celltrion三款ADC全部获FDA快速通道等。 ◍市场速递政策 · 产业动态 8/14百图生科与Biogend达成数千万美元NewCo交易，首个Treg偏向性IL-2双抗落地 8月14日，百图生科宣布与AI驱动的生物疗法公司Biogend以NewCo形式达成技术合作：Biogend由君联资本孵化成立并领投、淡马锡生命科学加速器跟投，百图生科将获得最高千万美元量级的现金价款及高位双位数NewCo权益。有别于传统的单管线授权，Biogend将引进百图生科AI发现系统（2680亿参数基础大模型xTrimo+BioMap OS干湿闭环），面向自身免疫领域批量化开发创新双多抗管线。首批管线中，全球首款用于自免疾病的Treg偏向性IL-2双特异性抗体已完成临床前关键验证，lead分子将受体亚基亲和力差距拉开至390倍以上，而传统定点突变方法的优化上限仅约10倍。解读：这条新闻的价值在于NewCo模式从“卖单管线”升级为“卖发现系统换股权”——AI公司把研发效率本身资本化。IL-2是免疫药最难工程化的靶点之一（治疗窗窄、半衰期短），AI把受体选择性从10倍拉到390倍，说明AI已从提效工具变成设计引擎。君联加淡马锡押注的，正是这种可批量复制管线的工厂式能力。 8/13中疾控发布7月疫情月报：新增新冠确诊52.2万例、死亡1例，哨点阳性率连续5周升至21.2% 8月13日，中国疾控中心官网发布2026年7月全国新冠病毒感染疫情情况：当月全国报告新增确诊病例52.2万例，其中重症487例、死亡1例（因新冠导致呼吸功能衰竭），报告病例数呈波动上升趋势。哨点医院流感样病例新冠阳性率第27至31周连续5周上升，由8.2%升至21.2%；本土病例均为奥密克戎变异株，主要流行株NB.1.8.1及其亚分支占比超98%。疾控中心表示，此次疫情上升仍属周期性波动、强度与前两年相当，当前处于高峰平台期，以轻症为主，特异性治疗药物有效，未发现重大公共卫生风险的变异株。解读：52.2万例的"确诊"口径下，实际感染规模大概率远超报告数——这是乙类乙管后呼吸道传染病监测的常态。这条数据的产业含义有三：其一，新冠已进入类似流感的周期性流行节奏，"备货逻辑"取代"爆发逻辑"，疫苗、检测、口服药企业需按常态化需求做排产与库存管理；其二，NB.1.8.1变异株占比超98%，毒株迭代仍在继续，疫苗毒株匹配度与检测试剂敏感性需持续验证，这本身就是存量市场里的新增量；其三，重症、死亡未现明显压力，医疗秩序平稳，说明当前毒株致病力未显著增强，政策面短期不会出现额外扰动。 ◍资本信息行情 · 融资 · IPO 8/12泽璟制药重递港股IPO：上半年净利6.4亿元首度半年度盈利，AbbVie 1亿美元首付款撑起扭亏 8月12日，泽璟制药（688266.SH）向港交所主板重新递交上市申请，中金公司独家保荐。招股书显示，2026年上半年公司收入12.04亿元、同比大增220.71%，净利润6.4亿元，为公司成立以来首度实现半年度盈利。扭亏主要来自AbbVie就ZG006（DLL3/DLL3/CD3三抗）支付的1亿美元首付款（贡献许可收入约6.55亿元）。公司拥有四款已上市药物，双抗管线具备全球竞争力。解读：泽璟的“首份盈利半年报”含金量需要打问号：6.4亿净利中约6.55亿来自AbbVie首付款确认，扣除后药品业务仍难覆盖研发销售开支，盈利可持续性是市场分歧焦点。 ◍医药动态国内获批 · 临床进展 8/14GSK在中国启动MASH新药Efimosfermin alfa III期临床，每月一次长效FGF21 8月14日，药物临床试验登记与信息公示平台显示，GSK登记ZENITH-2研究，计划在确诊或疑似F2/F3期代谢相关脂肪性肝炎（MASH）患者中评估Efimosfermin alfa的安全性与耐受性，拟入组1250名受试者、其中中国90名，随机接受225mg/300mg或安慰剂治疗52周。Efimosfermin alfa是Boston开发的潜在同类最佳FGF21长效类似物，每月皮下注射一次；今年5月GSK以总额20亿美元（首付12亿）收购其全球开发与商业化权益。解读：MASH是GLP-1之后代谢领域的下一个必争之地。FGF21直接作用于肝脏减脂、抗炎、抗纤维化，与GLP-1的减重路径互补；Efimosfermin alfa用长效化把给药频率压到每月一次，直击依从性痛点。GSK今年5月刚以20亿美元接盘，次月就在中国登记III期，中国市场在代谢药全球布局中的权重可见一斑。 8/14复星医药自研CDK4/6抑制剂复妥宁®III期OS数据首次亮相2026 ESMO，晚期乳腺癌一线进展风险降45% 8月14日，复星医药宣布其控股子公司奥鸿药业自主研发的创新型小分子CDK4/6抑制剂枸橼酸伏维西利胶囊（复妥宁®）III期研究（FCN-437c-Ⅲ-201）长期随访结果及总生存期（OS）数据，入选2026年10月西班牙ESMO年会壁报展示（摘要编号1859P），针对激素受体阳性、HER2阴性（HR+/HER2-）晚期乳腺癌一线治疗。该研究中分析已于今年5月亮相ASCO并同步发表于《JAMA Oncology》：复妥宁®联合方案可将疾病进展风险降低45%；重度胃肠道不良反应少见，≥3级ALT、AST升高发生率分别仅1.9%、1.4%，不良反应相关永久停药率低至1.4%。复妥宁®系国家"重大新药创制"科技重大专项支持的中国原研1类新药，每日一次口服、给药不受饮食约束。解读：CDK4/6抑制剂是HR+/HER2-晚期乳腺癌一线治疗基石，该市场长期由辉瑞、礼来等外资原研主导。复妥宁®用差异化分子结构（甲基哌嗪-哌啶侧链+噻吩并嘧啶母核）规避CDK9抑制，主打低肝损伤、低胃肠道刺激，把安全窗做成竞争卖点。此次OS长期随访数据首次全球亮相，补齐国产CDK4/6抑制剂从近期疗效到长期生存的完整证据链；从ASCO到ESMO仅隔5个月，中国原研在顶级学术舞台的输出节奏正在加快。 ◍海外药闻全球视野 · 跨境动态 8/13FDA加速批准BMS首个CELMoD疗法Zenbexus，复发骨髓瘤MRD阴性缓解率翻倍 8月13日，美国FDA加速批准百时美施贵宝（BMS）的iberdomide（Zenbexus），联合达雷妥尤单抗+地塞米松（ZDd方案），用于至少接受过一线治疗（含蛋白酶体抑制剂和免疫调节剂）的复发或难治性多发性骨髓瘤成人患者。这是FDA批准的首个CELMoD（cereblon E3连接酶调节剂）。III期EXCALIBER-RRMM显示，ZDd组MRD阴性完全缓解率41%、对照组DVd组21%，深度缓解率翻倍；因不良反应停药率7.8%，带胚胎-胎儿毒性及血栓栓塞黑框警告。解读：IMiD是“调节”、CELMoD是“降解”——同一cereblon靶点的机制代际升级。BMS靠Celgene系产品统治骨髓瘤多年，Zenbexus获批既巩固护城河，也为来那度胺/泊马度胺耐药患者打开新选择。更重要的是“BCMA-sparing”：不消耗BCMA靶点，为后续CAR-T与双抗治疗留足空间。 8/13FDA批准Insmed口服药Brinsupri，支气管扩张症迎来全球首款获批药物 8月13日盘后，美国FDA批准Insmed口服药Brinsupri用于治疗非囊性纤维化支气管扩张症，这是该适应症全球首个获批药物。受消息提振，Insmed盘后股价大涨5.77%，杰富瑞、瑞穗、RBC等多家券商上调目标价。摩根大通预计Brinsupri到2033年销售额有望突破70亿美元。支气管扩张症患者气道黏液清除障碍、反复感染，此前长期无药可用，治疗以抗生素和理疗为主。解读：支气管扩张症是典型的“大病种、小关注、无药可用”赛道——患者基数大却长期被忽视。Brinsupri以first-in-class身份打开空白市场，也验证Insmed从吸入剂向口服剂型延展的能力。70亿美元峰值预期能否兑现，取决于真实世界能否持续改善急性加重率——这是医保与处方意愿的决定变量。 8/13韩国Celltrion三款临床阶段ADC全部获FDA快速通道，CT-P73挑战宫颈癌现有疗法 8月13日，韩国Celltrion宣布其ADC候选药CT-P73获得FDA快速通道资格认定，至此该公司全部三款临床阶段ADC（CT-P70、CT-P71、CT-P73）均获该资格。CT-P73针对复发及转移性宫颈癌，非临床研究显示抗肿瘤效果优于现有治疗药物tisotumab vedotin（维汀妥尤单抗）。三款ADC覆盖不同适应症，生物类似药巨头正加速向创新ADC转型。解读：Celltrion是“生物类似药大王”向创新转型的样本：用生物类似药现金流养ADC管线，三款全拿快速通道说明FDA对其临床价值初步认可。这与国产CXO/仿制药企业的转型路径有相似之处——但ADC赛道已极度拥挤，快速通道只是入场券，真正的考验在II期与III期数据。

2026-08-14

·医药经济报

BMS抗肿瘤新药获批上市，GSK、爱科百发推进新药临床进展

BMS抗肿瘤新药获批上市当地时间8月13日，百时美施贵宝（BMS）宣布，美国FDA已批准其创新药Iberdomide（Zenbexus）上市，联合标准治疗方案（达雷妥尤单抗+地塞米松）用于治疗复发或难治性多发性骨髓瘤（MM）。新闻稿显示，Iberdomide是首款获得FDA批准的cereblon E3泛素连接酶调节剂（CELMoD）疗法。截图来源：BMS官网 Iberdomide是BMS CELMoD管线的首款产品。此前，该药曾获得FDA授予的突破性疗法认定和优先审评资格，用于治疗复发或难治性多发性骨髓瘤。本次获批是基于Ⅲ期研究EXCALIBER-RRMM（NCT04975997）的结果。这是一项Ⅲ期、多中心、两阶段、随机、开放标签研究，旨在评估 Iberdomide 联合达雷妥尤单抗和地塞米松 (ZDd) 方案与达雷妥尤单抗、硼替佐米和地塞米松 (DVd) 方案在复发或难治性MM患者中的疗效和安全性。在中国，Iberdomide 的上市申请已于 2025 年 12 月获得 CDE 受理，并被纳入优先审评，适应症为联合达雷妥尤单抗和地塞米松治疗既往接受过至少 1 线治疗的多发性骨髓瘤成人患者。预计将于今年Q4获批。 GSK在中国启动重磅新药Ⅲ期临床 8月14日，药物临床试验登记与信息公示平台官网显示，葛兰素史克（GSK）登记了一项在确诊或疑似F2或F3期代谢相关脂肪性肝炎（MASH）参与者中评价 Efimosfermin alfa 的安全性和耐受性的Ⅲ期、随机、双盲、安慰剂对照、三臂研究（ZENITH-2）。来源：药物临床试验登记与信息公示平台官网 Efimosfermin alfa是Boston开发的一款潜在同类最佳FGF21（成纤维细胞生长因子21）长效类似物，可每月皮下注射给药一次。该产品旨在调节关键代谢途径，以减少MASH患者的肝脏脂肪、改善肝脏炎症和逆转肝纤维化。今年5月，GSK收购了该产品的全球开发和商业化权益，交易总额高达20亿美元，其中首付款为12亿美元。爱科百发抗流感1类新药获批临床 8月13日，爱科百发宣布，公司自主研发的1类新药AK0406注射液获得中国国家药品监督管理局（NMPA）批准开展临床，拟用于流感预防适应症。根据新闻稿，这是该公司首款抗流感长效药物-Fc偶联物新药（AFC, Antiviral Drug-Fc Conjugate）。据悉，AK0406是爱科百发自主研发的创新型长效抗病毒药物，通过将高活性抗病毒小分子与抗体Fc片段进行精准偶联，实现流感暴露前或暴露后的长效预防与潜在治疗应用，满足流感季高发场景下的临床预防需求。临床前研究显示，该药物具有广谱、高活性和长效的抗病毒特性，在结构设计、抗病毒活性、药代动力学及生产等方面实现全面优化。在国际化临床开发方面，AK0406于今年2月获得澳大利亚人类研究伦理委员会（HREC）批准开展1期临床试验，目前已在澳大利亚成功完成全部队列健康成人受试者的入组给药，进入后续随访阶段。来源：国家药监局、企业官网版式：余远泽审核：马飞真实世界证据跻身医保准入“硬通货”，创新药企如何调整战略？机遇藏在碎片化市场：一文读懂东南亚医药出海逻辑京沪浙闽先行试点，商保托底创新药，药企管线布局迎变 www.yyjjb.com.cn 洞悉行业趋势长按关注医药经济报《中国处方药》学术公众号聚焦药学学术和循证研究长按关注中国处方药《医药经济报》终端公众号记录药品终端产经大事件长按关注21世纪药店

2026-07-26

·天潮科普

一次性 18 款！多款 1 类新药获批临床！

根据CDE官网及公开资料，6月8日~6月13日共有18款1类创新药首次在中国获得临床试验默示许可，涵盖小分子、ADC、双抗、生物制剂等类型。以下逐一梳理：一品红（APH03571片）：FLT3抑制剂与IRAK4降解剂双靶点药物，获批用于携带FLT3突变的复发/难治性急性髓系白血病。联邦制药（TUL321胶囊）：新一代补体B因子抑制剂，获批治疗阵发性睡眠性血红蛋白尿症，未来有望拓展至多种补体介导疾病。德琪生物（ATG-201注射液）：CD19/CD3双特异性T细胞衔接抗体，含空间位阻遮蔽技术，获批治疗系统性红斑狼疮，通过清除B细胞发挥作用。科辉智药（ARD-489AD片）：化药新药，获批用于化疗诱导的周围神经病变。齐鲁制药（注射用QLF4113）：新一代生物制剂，全球尚无同靶点药物获批，拟治晚期前列腺癌，有望突破耐药瓶颈。多禧生物（注射用DXC018）：新型HER2双载荷双特异性ADC，兼具双表位结合与双有效载荷递送，获批治疗晚期实体瘤。若见辉瞳生物（ODV混悬滴眼液）：化药新药，获批用于角膜炎及角膜移植术后诱发的角膜新生血管。英脉德医疗（注射用IMD1828）：生物制品新药，拟治晚期实体瘤（含卵巢癌、子宫内膜癌、非小细胞肺癌等）。恩沐生物（CMG2349注射液）：生物制品新药，获批治疗类风湿关节炎。新时代药业（LNF2401注射液）：生物制品新药，获批治疗急性缺血性脑卒中，剂型含静脉滴注与皮下注射。阿斯利康（AZD8965片）：精氨酸酶抑制剂，获批治疗特发性肺纤维化。临床前显示可降低精氨酸酶活性、减少胶原合成，改善肺纤维化。先纬医药（注射用SIM0689）：PD-1/VEGF双靶点药物，获批治疗局部晚期/转移性实体瘤。鞍石生物（ANS02胶囊）：第四代EGFR TKI，获批用于EGFR突变阳性局部晚期或转移性非小细胞肺癌。领泰生物（LT-010391片）：口服靶向KRAS G12D的蛋白降解剂，获批治疗携带KRAS G12D突变的晚期实体瘤。海思科（HSK46256片）：小分子药物，获批治疗晚期实体瘤，对BRCA突变相关乳腺癌、卵巢癌、前列腺癌及颅内肿瘤有效。长泰药业（PC-0120片）：化药新药，获批用于FLT3突变复发/难治性AML。葛兰素史克（注射用Efimosfermin alfa）：FGF21类似物，每月注射一次，获批治疗MASH合并中度至进展期肝纤维化，GSK于2025年5月以约20亿美元收购该疗法。拜耳（VVD-133214片）：WRN共价变构抑制剂，获批用于MSI和/或dMMR晚期结直肠癌一线治疗，在MSI-H细胞中诱导DNA断裂与细胞死亡。期待这些新药后续临床进展顺利，早日惠及患者。

100 项与 Efimosfermin alfa 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
肝纤维化	临床3期	美国	葛兰素史克（中国）投资有限公司	2026-08-14
肝纤维化	临床3期	中国	葛兰素史克（中国）投资有限公司	2026-08-14
肝纤维化	临床3期	日本	葛兰素史克（中国）投资有限公司	2026-08-14
肝纤维化	临床3期	阿根廷	葛兰素史克（中国）投资有限公司	2026-08-14
肝纤维化	临床3期	澳大利亚	葛兰素史克（中国）投资有限公司	2026-08-14
肝纤维化	临床3期	奥地利	葛兰素史克（中国）投资有限公司	2026-08-14
肝纤维化	临床3期	比利时	葛兰素史克（中国）投资有限公司	2026-08-14
肝纤维化	临床3期	巴西	葛兰素史克（中国）投资有限公司	2026-08-14
肝纤维化	临床3期	保加利亚	葛兰素史克（中国）投资有限公司	2026-08-14
肝纤维化	临床3期	加拿大	葛兰素史克（中国）投资有限公司	2026-08-14

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04880031 (Pubmed \| Lancet)	临床2期	代谢功能障碍相关脂肪性肝炎	84	Efimosfermin 300 mg Q4W	獵餘顧築襯築艱膚廠夢(獵鬱鹹膚簾範簾窪製鬱) = Most frequent adverse events were gastrointestinal events, which were transient and occurred within the first few weeks of treatment. 鏇餘淵鏇艱艱製糧襯艱 (憲淵糧夢蓋艱艱淵獵觸 )	积极	2026-02-01
				Placebo
NCT04880031 (Pubmed \| Lancet Gastroenterol Hepatol) 人工标引	临床2期	代谢功能障碍相关脂肪性肝炎	65	Efimosfermin	衊窪繭膚築觸壓齋積鏇(淵鹹膚製壓範齋鹽鏇鏇) = 齋網餘窪壓構鹽構選夢網蓋餘糧鹽衊艱鹽齋鑰 (築製範蓋齋繭齋選餘繭 ) 更多	积极	2025-08-01
				Efimosfermin (75 mg every 4 weeks)	衊窪繭膚築觸壓齋積鏇(淵鹹膚製壓範齋鹽鏇鏇) = 遞憲顧衊獵範願顧鹽餘網蓋餘糧鹽衊艱鹽齋鑰 (築製範蓋齋繭齋選餘繭 ) 更多
NCT04880031 (DDW2025)	临床2期	代谢功能障碍相关脂肪性肝炎 Fibroscan-AST (FAST) \| Fibrosis-4 Index (FIB-4) \| NAFLD Fibrosis Score (NFS)	84	Efimosfermin 300mg	製壓憲餘鬱觸餘鏇繭蓋(鑰鑰鹹淵鏇積齋願鹽夢) = 膚廠膚遞憲齋餘鹽糧壓積壓選鏇襯壓壓襯簾鹹 (襯膚觸築蓋醖積艱廠願 ) 更多	积极	2025-05-03
				Placebo	製壓憲餘鬱觸餘鏇繭蓋(鑰鑰鹹淵鏇積齋願鹽夢) = 選顧範築鏇選憲淵鹹網積壓選鏇襯壓壓襯簾鹹 (襯膚觸築蓋醖積艱廠願 ) 更多
NCT04880031 (BOS-580-201, Biospace) 人工标引	临床2期	代谢功能障碍相关脂肪性肝炎	84	Efimosfermin alfa 300 mg	鏇鹹淵鹽膚夢蓋顧構選(範製積築築鬱壓餘淵築) = 淵構廠網遞艱鏇糧築製鹽鑰範願顧壓鹽糧夢繭 (築積鑰憲鹹窪餘構構蓋 ) 更多	积极	2024-11-15
				Placebo	鏇鹹淵鹽膚夢蓋顧構選(範製積築築鬱壓餘淵築) = 淵餘鹹遞餘積遞膚夢構鹽鑰範願顧壓鹽糧夢繭 (築積鑰憲鹹窪餘構構蓋 ) 更多
Phase 2a study (NASH_TAG2024)	临床2期	-	102	BOS-580	糧觸鹹鏇顧築構顧蓋齋(鏇鬱壓構餘壓範夢醖積) = 繭齋膚鏇鹹蓋觸蓋積願淵鹽襯鬱獵構蓋衊窪網 (鹽網願齋蓋鹽壓顧繭顧 )	积极	2024-01-04
				Placebo	糧觸鹹鏇顧築構顧蓋齋(鏇鬱壓構餘壓範夢醖積) = 獵築夢糧獵網憲遞齋蓋淵鹽襯鬱獵構蓋衊窪網 (鹽網願齋蓋鹽壓顧繭顧 )
NCT04880031 (Biospace) 人工标引	临床2期	代谢功能障碍相关脂肪性肝炎	102	overall	觸鏇網鬱鹽鑰夢網醖積(製顧餘選壓觸餘願鏇鏇) = No treatment emergent adverse events of hypoglycemia were reported in any patient enrolled in the study. 蓋憲觸鬱構獵壓築鑰膚 (餘顧顧鏇齋壓蓋襯願網 ) 更多	积极	2023-11-10
				BOS-580 (HbA1c≥6.5%)
NCT03466203 (Pubmed \| J Clin Endocrinol Metab)	临床1期	高甘油三酯血症 \| 肥胖	64	LLF580 300 mg	糧襯鹽窪選窪膚製壓衊(醖繭窪顧夢鬱築夢構遞) = higher incidence of generally mild to moderate gastrointestinal adverse effects 顧獵餘製壓構製鏇窪鬱 (艱鹽築衊構鬱襯夢獵艱 )	-	2021-08-25