A Placebo-Controlled, Double-Blind, Randomized, Phase 3 Study to Evaluate the Effect of Obicetrapib 10 mg and Ezetimibe 10 mg Fixed-Dose Combination or Obicetrapib 10 mg Daily on Top of Guideline-Recommended Lipid-Lowering Therapy in Participants With Type 2 Diabetes and/or Metabolic Syndrome (RUBENS Trial)

This study will be a placebo-controlled, double-blind, randomized, Phase 3 study to evaluate the efficacy, safety, and tolerability of obicetrapib 10 mg, both as a fixed-dose combination (FDC) with ezetimibe 10 mg and as monotherapy, on top of guideline-recommended lipid-lowering therapy in patients with metabolic syndrome and/or Type 2 Diabetes Mellitus.

开始日期2025-12-11

申办/合作机构

NewAmsterdam Pharma Corp.

NCT06982508

/ Recruiting临床2期

A Randomized, Double-Blind, Placebo-Controlled Parallel Trial to Assess the Effects of Obicetrapib on Levels of Antioxidants in Plasma and HDL Particles in Healthy Volunteers: The VERMEER Study

The goal of this clinical trial is to learn if Obicetrapib works to change antioxidant levels in HDL and plasma, as well as retinal tissue. The main questions it aims to answer are:
Do Obicetrapib effect absorption of antioxidants in a person's blood or their eye tissue? Researchers will compare Obicetrapib to a placebo (a look-alike substance that contains no drug) to see if Obicetrapib helps improve a person's ability to absorb antioxidants.
Participants will:
Take Obicetrapib or a placebo every day for 4 months Visit the clinic once every 8 weeks for checkups and tests Have their blood taken and their eyes checked to measure antioxidant levels

开始日期2025-09-09

申办/合作机构

MB Clinical Research & Consulting LLC

NCT06496243

/ Recruiting临床2期

A Phase 2 Study to Evaluate the Effect of Obicetrapib Alone and in Combination With Evolocumab (Repatha®) on Lipoprotein (a) in Patients With Mild Dyslipidemia: The VINCENT Study

The goal of this open label 16 week trial is to evaluate Lp(a) levels for patients with elevated Lp(a) being treated with obicetrapib and obiceptrapib/evolocumab
Patients will:
Have baseline Lp(a) tested at randomization Take 10mg/dL obiceptrapib daily for 8 weeks and have Lp(a) tested at Week 8 Take 10 mg/dL obicetrapib daily/evolocumab 140 every other week for 8 weeks and have Lp(a) retested at Week 16

开始日期2024-12-02

申办/合作机构

NewAmsterdam Pharma Co. NV

100 项与 Obicetrapib 相关的临床结果

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100 项与 Obicetrapib 相关的转化医学

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100 项与 Obicetrapib 相关的专利（医药）

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项与 Obicetrapib 相关的文献（医药）

2026-06-01·CARDIOVASCULAR DRUGS AND THERAPY

Lipoprotein(a) in Cardiovascular Diseases and Emerging Therapeutic Strategies

Review

作者: Smith, Emily Lauren Schenk ; Selico-Dunn, Alexandra C ; Al-Horani, Rami A

Abstract:

Purpose:

Lipoprotein(a) [Lp(a)] is increasingly recognized as a genetically determined, independent risk factor for atherosclerotic cardiovascular disease (ASCVD). This review examines the structure, pathophysiology, and epidemiology of Lp(a), with a focus on its contribution to ASCVD and related conditions such as aortic valve stenosis and peripheral artery disease. The main research question addresses how Lp(a) influences cardiovascular risk and how emerging therapies may modify this risk.

Methods:

This review synthesizes published evidence describing the biological characteristics of Lp(a), its mechanistic roles in disease, and its epidemiologic associations with cardiovascular outcomes. It also evaluates current and investigational therapeutic approaches by examining clinical trial data for agents targeting Lp(a).

Results:

Lp(a) contributes to residual cardiovascular risk through proatherogenic, proinflammatory, and prothrombotic mechanisms. Current evidence highlights its involvement in ASCVD, aortic valve stenosis, and peripheral artery disease. Clinical studies of antisense oligonucleotides, small interfering RNAs, oral small molecules, and CRISPR-based gene editing, including pelacarsen, olpasiran, zerlasiran, lepodisiran, muvalaplin, and obicetrapib, demonstrate promising efficacy and safety. These agents show potential to significantly reduce Lp(a) levels and influence future cardiovascular prevention strategies.

Conclusion:

As novel therapies advance and clinical guidelines evolve, Lp(a) is emerging as a central determinant in personalized cardiovascular care. The increasing emphasis on Lp(a) testing underscores its importance in risk stratification and future therapeutic decisionmaking.

2026-06-01·Vascular diseases (Paris, France)

Lipid-modifying efficacy and safety of obicetrapib in high-risk cardiovascular patients: A systematic review and meta-analysis

Review

作者: Kayani, Abdul Mueez Alam ; Lemus-Zamora, Ricky E ; Garcia, Alan ; Umar, Muhammad Faiq ; Navarro-Martinez, Daniel ; Rashid, Muhammad Affan

INTRODUCTION:

Atherosclerotic cardiovascular disease (ASCVD) remains a leading cause of morbidity and mortality, particularly among high-risk patients. Despite the availability of multiple lipid lowering therapies, many patients fail to achieve the guideline recommended low-density lipoprotein cholesterol (LDL-C) targets. Obicetrapib, a cholesteryl ester transfer protein (CETP) inhibitor optimizes lipid profile by blocking the exchange of cholesterol esters from high-density lipoprotein cholesterol (HDL-C) to Apolipoprotein B (ApoB) containing lipoproteins. This study evaluates the efficacy and safety of obicetrapib as an adjunctive therapy in high-risk ASCVD patients.

METHODS:

Online databases were searched. Outcomes included percentage changes in LDL-C, HDL-C, non-HDL-C, total cholesterol, triglyceride, ApoB, lipoprotein (a) [Lp(a)] and risk of any adverse events (AE), AE leading to discontinuation, acute kidney injury (AKI), transaminase or creatine kinase (CK) elevation and hypertension. Risk ratio (RR) for categorical outcomes and mean difference (MD) for continuous outcomes were reported using 95% confidence intervals (CI).

RESULTS:

Three studies with 3088 patients (mean age 64 ± 11, 37% female) were selected. Obicetrapib significantly reduced LDL-C (-31.75%), non-HDL-C (-29.35%), triglyceride (-5.61%), Lp(a) (-35.67%), ApoB (-19.37%), and increased HDL-C (+125.94%) with no difference in total cholesterol levels. Obicetrapib was not associated with increased risk for any AE, AE leading to discontinuation, AKI, transaminase or CK elevation, and hypertension.

CONCLUSION:

Obicetrapib substantially improved lipid profiles in high-risk ASCVD patients on maximally tolerated lipid lowering therapy, without increased short-term adverse events. However, further long-term randomized studies are needed to confirm sustained efficacy, long-term safety, and potential impacts on clinical cardiovascular outcomes.

2026-06-01·American journal of preventive cardiology

Obicetrapib and renal function: A welcome signal, but not yet a kidney story

作者: Ray, Kausik K ; Barkas, Fotios

226

项与 Obicetrapib 相关的新闻（医药）

2026-07-31

·贝美研发

药研行业周报（2026.07.25-2026.07.31）

📌 本周要闻速览本周（7.25-7.30）药研行业呈现「政策交易双活跃、研发审评双提速」的格局。政策端，原料药登记主体变更管理规定征求意见持续发酵，A状态原料药跨法人转让合规通道正式开辟，将重塑原料药分拆、授权与并购交易架构。交易端，中药产业首笔海外BD交易落地。研发端，多款首仿药获批上市，但同时多品种首仿与改良新药申请受挫，审评标准系统性升级信号明确。【交易·重磅】原料药登记主体变更新规征求意见，首次允许A状态原料药批文独立交易，告别单纯文号倒卖模式【交易·首单】梦阳药业与TCMG达成中药产业首笔海外BD交易，生白口服液获美国独家商业化权益（最高7000万美元）【研发·首仿】艾迪药业达芦那韦片国内首仿获批，填补成人及儿童多重耐药HIV挽救治疗国产空白【研发·首仿】山东朗诺艾托格列净片首仿获批，打破默沙东进口原研独占格局（SGLT2抑制剂，年销超4亿）【研发·受挫】48款药品同日遭拒，蔗糖羟基氧化铁咀嚼片、哌拉西林钠他唑巴坦钠注射液、褪黑素颗粒等首仿全折戟【研发·创新】科伦博泰首个双载荷ADC药物SKB565获批临床，ADC技术从单载荷向双载荷演进一、项目交易动态1.1 原料药登记主体变更新规——开辟批文独立交易通道【政策背景】2026年7月23日，国家药监局发布《化学原料药登记主体变更管理规定（征求意见稿）》，首次设立化学原料药登记主体变更行政许可路径。本周该政策持续发酵，成为行业最受关注的制度性变革。【核心要点】 •允许A状态原料药在保留原登记号及关联审评关系的前提下进行主体变更，打破近十年「原料药登记主体=生产主体、禁止过户流转」的监管规则 •差异化审批：无场地变更20个工作日，有场地变更另行规定 •增设创新原料药特殊保护条款，转让需取得权益方同意 •覆盖跨境转让、反垄断审查等特殊场景【行业影响】将重构原料药企业商业模式，推动产业链垂直整合，盘活存量审评资源，加速行业洗牌。意见反馈截止8月22日。【重要性】★高 | 来源：国家药监局、医药经济报等1.2 中药BD首单落地——生白口服液授权美国市场【交易概况】2026年7月21日，梦阳药业与美国TCMG签署中药产业史上首笔商业化权益交易。TCMG获得生白口服液在美国市场20年独家商业化权益。【交易条款】 •首付款：22.5万美元 •潜在商业化权益对价：最高7000万美元 •潜在总金额：最高达300万美元（注：原文披露口径存在差异，以正式公告为准） •梦阳药业保留资产所有权并独家供货【意义】探索了中药以膳食补充剂类别切入美国医院体系的新路径，填补中药产业在全球BD版图上的空白，为后续中药出海提供可借鉴模式。【重要性】★高 | 日期：2026-07-28 | 来源：E药经理人1.3 批文与牌照转让市场活跃 •药品批发公司牌照转让：北京、湖北、浙江等地项目挂牌，含《药品经营许可证》、冷链设备及GSP体系，转让周期45-120个工作日（新规下强监管周期延长） •药厂批文转让及OEM代工：山东国科药业等企业提供批文转让与贴牌生产服务，需遵循「先审后转」机制，受让方需具备生产许可证并通过GMP检查 •僵尸批文激活：连续5年未生产批文可完成工艺验证恢复生产后转让【重要性】中 | 来源：11467企业黄页等二、研发进展2.1 创新药进展【上半年11款国产首创1类新药获批】 2026年上半年，国家药监局批准38个1类创新药，其中11个新靶点、新机制药物全部为国产。6月22日单日即有4款全球首创国产1类新药获批： •百利天恒——EGFR/HER3双抗ADC •科济药业——舒瑞基奥仑赛 •智翔金泰——斯乐韦米单抗 •普莱医药——培来加南喷雾剂此外，恒瑞、先为达等企业多款全球首创药物也相继获批。标志中国创新药研发向「全球首创」加速迈进。【重要性】★高 | 日期：2026-07-29 | 分类：一类创新【EMA推荐批准12款新药含首款银屑病口服药】欧洲药品管理局（EMA）人用医药产品委员会推荐批准12款新药，亮点品种： •Icotyde——首款口服IL-23受体蛋白药物（中重度银屑病） •Susvimo——首款可补充的眼科植入物（湿性黄斑变性） •Lyrokaul、Evlarco、Ubeslo——三款降脂新药 •Lynavoy——胆汁淤积性瘙痒 •Nezglyal——罕见病用药【重要性】★高 | 日期：2026-07-27 | 分类：一类创新【石药创新密集兑现期】 •恩维曲妥珠单抗（HER2 ADC，1类新药）：7月16日上市申请获受理 •乌司奴单抗：2026年5月获批，国内第三家，切入15亿自免赛道（原研全球年销超百亿美元） •恩舒幸、恩益坦等生物药已商业化落地 •ADC药物SYS6010等多项III期临床同步推进【重要性】中 | 日期：2026-07-29 【科伦博泰双载荷ADC SKB565获批临床】科伦博泰新型双载荷ADC药物SKB565获CDE批准开展临床试验，用于晚期实体瘤。这是该公司首个进入临床的「双弹头」ADC，代表ADC技术从单载荷向双载荷演进。【重要性】中 | 日期：2026-07-28 | 分类：一类创新【福元医药3款创新药步入临床】福元医药稳步推进「仿创结合」策略，3款创新药步入Ⅰ期临床及以上阶段： •FY101注射液（1类新药） •FY103注射液（1类新药） •奥美沙坦酯左氨氯地平片（2.3类改良型，已步入Ⅲ期临床）公司2019年至今已斩获79个重磅品种、94个产品过评，瞄准心脑血管及代谢疾病市场。【重要性】中 | 日期：2026-07-242.2 首仿与仿制药进展【首仿获批汇总】 2.3 研发受挫——审评标准系统性升级 7月27日国家药监局密集发布通知件，多款药品申请被拒，凸显审评红线全面收紧：【趋势判断】复杂制剂、改良新药、中药同名同方药的审评门槛系统性抬升，技术要求和临床价值导向更加严格。仿制药企业需在立项阶段更审慎评估技术壁垒与成功率。【PS】有感兴趣的品种可以底部留言，看大家最想了解哪个产品，专门抽时间进行解读。三、行业法规与政策3.1 化学原料药登记主体变更管理规定（征求意见稿）【发布单位】国家药品监督管理局【发布日期】2026年7月23日【意见反馈截止】2026年8月22日【核心内容】 •首次设立化学原料药登记主体变更行政许可路径 •A状态原料药可保留原登记号及A状态进行主体变更 •关联审评关系保持不变，无需重新开展关联审评 •无场地变更审批时限20个工作日，有场地变更另行规定 •创新化学原料药增设研发权益保护条款 •覆盖跨境转让、反垄断审查等特殊场景【影响评估】彻底改变过去必须通过股权收购实现批文流转的模式，原料药批文成为可独立交易的资产。将加速行业整合、盘活存量批文、重塑交易架构，但需防范批文炒作及技术衔接风险。3.2 药品批发企业转让进入强监管阶段本周多地药品批发公司牌照转让项目显示，新规下转让流程从单点交接转向全链闭环，强调穿透式核查与质量管理体系承接实效，转让周期从45-75天延长至90-120个工作日，合规审查标准提升。3.3关于第12批集采进展第12批国家组织药品集中带量采购于7月31日在上海开标，是国家集采启动以来规模最大的一批：纳入品种：65个（数量创历史新高）投标企业：495家企业，859个产品报量机构：4.5万家医药机构采购周期：中选结果执行之日起至2029年12月31日，共3年拟中选结果：预计今日晚间产生四、关注重点 •《化学原料药登记主体变更管理规定》正式稿发布预期及首批A状态原料药主体变更交易落地情况 •8月22日意见反馈截止前行业各方反馈动向及可能的细则调整 •艾迪药业达芦那韦片、山东朗诺艾托格列净片上市后的医院准入与销售放量进度 •科伦博泰双载荷ADC SKB565、石药创新HER2 ADC等创新药临床推进节点 •下半年创新药BD出海交易趋势及跨国药企合作动态 •蔗糖羟基氧化铁咀嚼片、褪黑素颗粒等受挫品种后续重新申报动态免责声明：本报告由AI基于公开信息自动整理生成，仅供参考，不构成任何投资或决策建议。信息来源包括药融圈、医药魔方、药事纵横、E药经理人、国家药监局等公开渠道，如有偏差请以官方信息为准。

2026-07-30

·管线研发速递

新药速递｜7.23-7.30：全球扎堆获批、重磅临床接连出炉，中国创新药驶入出海快车道

医药研发圈本周热度拉满！欧美药监集中放行多款First-in-class新药，国内NMPA接连落地全球首创品种；CLDN18.2 ADC、双抗联合疗法交出里程碑III期数据；百亿级药企并购轮番上演，叠加工信部发布上半年创新药全景成绩单，全球生物医药产业迎来密集兑现期。本文将从全球新药获批、重磅临床突破、药企资本交易、国内创新产业盘点四大维度，完整梳理本周核心行业动态。一、全球三地药监密集放行，多款全球首创新药落地（一）美国FDA：本月多款新分子实体获批，慢病、肿瘤、神经领域全面开花获批日期药物通用名（商品名）研发企业核心适应症 7.24 Bevacizumab-vikg（Lytenava） Outlook Therapeutics Inc 用于治疗新生血管（湿性）年龄相关性黄斑变性患者 7.24 Centanafadine（Simtriyo）大冢制药用于治疗注意力缺陷多动障碍 7.22 Zidesamtinib（Jideytro） Nuvalent Inc 用于治疗接受过ROS1激酶抑制剂治疗后，局部晚期或转移性ROS1阳性非小细胞肺癌的成人患者 7.15 Enlicitide（Lipfendra）默沙东降低低密度脂蛋白胆固醇，全球首款口服PCSK9抑制剂，每日口服片剂强效降低LDL-C，打破PCSK9靶点只能皮下注射的局限 7.14 Gedatolisib（Revtorpyk）惠氏联合氟维司群，用于治疗激素受体阳性、人表皮生长因子受体2阴性、局部晚期或转移性乳腺癌，且在转移性阶段接受至少一线内分泌治疗进展后未检测到PIK3CA突变 7.7 Atacicept（Trutakna） Vera Therapeutics 旨在减少有疾病进展风险的原发性免疫球蛋白A肾病成人患者的蛋白尿数据来源：FDA Novel Drug Approvals 2026 （二）中国NMPA：国产原研持续突围，多项疗法实现全球率先上市本周国内创新药审批迎来爆发，多款First-in-class、国产首创品种集中获批，抗感染、自身免疫、糖尿病、肿瘤、嗜睡症赛道多点突破：获批日期药品名称申报企业核心价值解读 7.29 盐酸伊司特韦片西湖制药用于治疗成人轻型、中型新型冠状病毒感染（COVID-19） 7.29 瑞西奇拜单抗注射液（商品名：华亦净）上海华奥泰治疗成人(体重≥40kg)泛发性脓疱型银屑病发作 7.29 舒地胰岛素注射液恒瑞医药中国首个自主研发长效胰岛素类似物，，打破海外药企长效胰岛素长期垄断格局 7.23 琥珀酸思普可泮片海思科全球首款每日1次口服补体B因子抑制剂，用于阵发性睡眠性血红蛋白尿症（PNH）；III期临床血红蛋白达标率59.5%，远高于经典注射药物依库珠单抗8.3%，口服剂型彻底改写罕见血液病治疗范式 7.23 苹果酸法米替尼胶囊恒瑞医药新增适应症联合注射用卡瑞利珠单抗（艾瑞卡 ®）用于复发或转移性宫颈癌成人患者的一线治疗。这是国内首个获批用于宫颈癌一线治疗的国产PD-1联合抗血管靶向去化疗方案，标志晚期宫颈癌正式迎来不含化疗的一线靶免新选择 7.21 奥博雷通片（奥泽悦）武田用于16岁及以上青少年和成人1型发作性睡病患者。全球首个口服OX2R食欲素受体激动剂，中国为全球首个上市国家，用于1型发作性睡病；超85%患者日间嗜睡症状恢复至正常水平，告别中枢兴奋剂依赖数据来源：NMPA、CDE、行业医药资讯平台（三）欧盟EMA：CHMP月度会议释放12项积极意见，降脂赛道迎来多款新品 7月下旬欧洲人用医药产品委员会（CHMP）月度评审收官，共计推荐12款新药获批，降脂领域成果最为突出：Obicetrapib（Ubeslo/Evlarco）：新一代CETP胆固醇通路抑制剂，单药LDL-C降幅40%，联合依折麦布降脂可达50%，专为他汀不耐受高血脂人群打造；Lyrokaul（lerodalcibep）：每月1次皮下注射降脂药，可居家自行给药。二、重磅III期临床数据集中公布，多个靶点迎来历史性突破本周全球各大药企密集披露关键注册临床顶线结果，ADC、双抗、肺癌、代谢四大赛道改写治疗格局，国产创新药临床实力备受全球瞩目： 1.全球首个CLDN18.2 ADC III期总生存期获益敲定：阿斯利康Sone-Ve登顶胃癌靶向治疗 7月27日，阿斯利康宣布Sonesitatug vedotin（Sone-Ve，AZD0901/CMG901）治疗胃癌的III期CLARITY-Gastric01研究取得了积极结果。这是Sone-Ve披露的第一个III期研究结果。该药物最早由康诺亚+乐普生物研发，2023年以6300万美元首付款+最高11.6亿美元里程碑授权给阿斯利康，是中国ADC出海里程碑项目；虽无进展生存期统计学获益，但总生存期作为注册核心终点完全达标，即将递交全球多国上市申请。 2.强生双抗组合疗效比肩CAR-T，多发性骨髓瘤后线治疗再添优选方案 Tecvayli联合Talvey两款双特异性抗体III期MonumenTAL-6数据出炉：疾病进展或死亡风险分别降低了73%（HR=0.27）和89%（HR=0.11）。此外，Tal-Tec方案组的死亡风险较PVd方案组降低了62%（HR=0.38）。 3.国产三项肺癌III期数据出炉，重塑非小细胞肺癌一线治疗体系国内药企集中交出肺癌重磅临床成果，三条主流赛道全线突破：①依沃西单抗（PD-1/VEGF双抗）+化疗一线肺鳞癌：头对头优于替雷利珠单抗联合化疗，康方生物自主研发的First-in-Class的双特异性抗体依沃西单抗（Ivonescimab）联合化疗将患者的死亡风险降低 34%（中位总生存期分别为27.9个月vs 23.7个月），依沃西单抗也因此成为全球首个在头对头III期临床试验中正面击败抗PD-1单抗并实现总生存期和无进展生存期双显著阳性的PD-1×VEGF双特异性抗体。刊发于《柳叶刀》；②国产TROP2 ADC +帕博利珠单抗一线PD-L1阳性NSCLC：PFS显著延长，全球首个证实ADC+IO优于免疫+化疗的III期证据；③奥希替尼联合化疗一线EGFR突变肺癌：PFS大幅延长，疾病进展风险降56%。 4.恒瑞GLP-1/GIP双靶减重降糖III期登顶，国产多肽追赶海外第一梯队恒瑞瑞普泊肽（HRS9531）III期顶线数据积极：36周治疗后，4mg剂量组糖化血红蛋白降幅高达2.67%，血糖达标率94.5%；减重适应症国内上市申请已于2025年递交，降糖适应症近期即将申报，国产长效GLP-1赛道竞争进入白热化阶段。三、百亿级并购频繁落地，全球药企管线洗牌加速本周医药资本市场交易活跃度居高不下，迷幻药、肿瘤、CDMO、AI基因组学赛道大额并购接连落地：收购事件交易总金额战略布局意义礼来收购AtaiBeckley 最高38亿美元拿下迷幻类抗抑郁新药BPL-003，布局难治性抑郁症赛道，精神神经疾病成为巨头必争领域 GSK收购Nuvalent 106亿美元 2026年度全球第二大医药并购，全盘吸纳ROS1/TRK肺癌靶向管线，夯实肿瘤核心板块阿斯利康×正大天晴 2亿美元 COPD呼吸管线项目海外授权，深化国内药企与跨国巨头双向合作阿斯利康×迪哲医药 15亿美元肺癌靶向药物全球权益授权，国产小分子靶向药持续出海变现 Samsung Biologics收购PolyPeptide 18.1亿美元扩充多肽原料药与CDMO产能，抢占全球多肽药物生产供应链 Tempus AI收购 Personalis 15亿美元 AI+基因组技术深度整合，精准医疗数字化进程提速 Incyte收购Vega Therapeutics 约20亿美元布局罕见血液病资产，补齐自身炎症血液管线短板数据来源：BioSpace、EMJ Reviews 行业综述四、工信部发布上半年创新药成绩单：国产创新驶入黄金发展期 7月20日工信部官方发布2026上半年中国生物医药产业核心数据，全方位展现国内创新药硬核实力：①新药获批数量：上半年共计38款创新药获批上市，其中国产创新药31款，占比超过80%。且据国家药监局披露，这31款国产创新药中有11个属于全新靶点、全新机制的药物，且全部为自主研发的国产创新药；②创新出海成果：81笔国产新药对外授权（License-out）交易落地，交易总额约1100亿美元，已达到2025年全年总额的80%，合作覆盖全球20余个国家；③产业业绩向好：超38家创新药企预告上半年净利润实现正向增长；④里程碑成果密集兑现：全球首个双特异性ADC、实体瘤CAR-T疗法、乙肝/丁肝靶向单抗、国产首创放射性新药均于上半年陆续获批上市。从跟随仿制到源头创新、从国内临床走向全球商业化，中国生物医药产业已经完成阶段性跨越。结语全球药监审批、关键临床、大额资本交易轮番落地，肿瘤、代谢、罕见病、神经精神领域创新持续迭代；一边是跨国药企重金并购补齐管线，另一边是中国创新药以First-in-class产品、大额海外授权站稳全球舞台。后续随着多款III期数据持续读出、新药商业化铺开，生物医药行业创新红利还将持续释放。

2026-07-29

·BioSpace

NewAmsterdam Pharma to Host Investor Day on August 5, 2026

NAARDEN, The Netherlands and MIAMI, July 29, 2026 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam” or the “Company”), a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease (“CVD”) with elevated low-density lipoprotein cholesterol (“LDL-C”), for whom existing therapies are not sufficiently effective or well-tolerated, today announced that it will host an Investor Day event for analysts and investors on August 5, 2026 beginning at 9:00 a.m. ET in New York City. Please join members of our management team, including: Michael Davidson, M.D., Chief Executive Officer; John Kastelein, M.D., Ph.D., FESC , Founder and Chief Scientific Officer; BJ Jones , Chief Commercial Officer; Ian Somaiya , Chief Financial Officer; and Matthew Philippe , Executive Vice President and Head of Investor Relations. A live webcast of the Investor Day event will be available, and those who intend to join virtually can pre-register for the webcast through the link here. The live webcast and supporting presentation materials will be available on the Events section of the Investor Relations page of the NewAmsterdam website at ir.newamsterdampharma.com at the time of the live event. An archived replay will be available on the NewAmsterdam website. Please note advanced registration is required for in-person attendance. About Obicetrapib Obicetrapib is a novel, oral, low-dose CETP inhibitor that NewAmsterdam is developing to overcome the limitations of current LDL-lowering treatments. In each of the Company’s Phase 2 trials, ROSE2, TULIP, ROSE, and OCEAN, as well as the Company’s Phase 3 BROOKLYN, BROADWAY and TANDEM trials, evaluating obicetrapib as monotherapy or combination therapy, the Company observed statistically significant LDL-lowering combined with a side effect pro to that of placebo. The Company commenced the Phase 3 PREVAIL cardiovascular outcomes trial in March 2022, which is designed to assess the potential of obicetrapib to reduce occurrences of MACE. The Company completed enrollment of PREVAIL in April 2024 and randomized over 9,500 patients. Commercialization rights of obicetrapib in Europe, either as a monotherapy or as part of a fixed-dose combination with ezetimibe, have been exclusively granted to the Menarini Group, an Italy-based, leading international pharmaceutical and diagnostics company. ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); About NewAmsterdam NewAmsterdam Pharma (Nasdaq: NAMS) is a late-stage biopharmaceutical company whose mission is to improve patient care in populations with metabolic diseases where currently approved therapies have not been adequate or well tolerated. We seek to fill a significant unmet need for a safe, well-tolerated and convenient therapy that lowers LDL-C while advancing innovation beyond a single marker to better address cardiovascular risk. In multiple phase 3 trials, NewAmsterdam is investigating obicetrapib, an oral, low-dose and once-daily CETP inhibitor, alone or as a fixed-dose combination with ezetimibe, as LDL-C lowering therapies to be used as an adjunct to statin therapy for patients at risk of CVD with elevated LDL-C, for whom existing therapies are not sufficiently effective or well tolerated. Company Contact Matthew Philippe P: 1-917-882-7512 matthew.philippe@newamsterdampharma.com Media Contact Real Chemistry on behalf of NewAmsterdam Christian Edgington P: 1-513-310-6410 cedgington@realchemistry.com Investor Contact Precision AQ on behalf of NewAmsterdam Austin Murtagh P: 1-212-698-8696 austin.murtagh@precisionaq.com

100 项与 Obicetrapib 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB14890

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
复杂性血脂异常	申请上市	欧盟	Menarini International Operations Luxembourg SA	2026-07-23
原发性高胆固醇血症	申请上市	欧盟	NewAmsterdam Pharma Co. NV	2025-08-18
2型糖尿病	临床3期	美国	NewAmsterdam Pharma Corp.	2025-12-11
高脂血症	临床3期	美国	NewAmsterdam Pharma Corp.	2025-12-11
代谢综合征	临床3期	美国	NewAmsterdam Pharma Corp.	2025-12-11
高脂蛋白血症	临床3期	美国	NewAmsterdam Pharma Holding BV	2022-07-25
高脂蛋白血症	临床3期	加拿大	NewAmsterdam Pharma Holding BV	2022-07-25
高脂蛋白血症	临床3期	捷克	NewAmsterdam Pharma Holding BV	2022-07-25
高脂蛋白血症	临床3期	荷兰	NewAmsterdam Pharma Holding BV	2022-07-25
高脂蛋白血症	临床3期	挪威	NewAmsterdam Pharma Holding BV	2022-07-25

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临床结果

适应症

分期

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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


NCT05425745 (BROOKLYN, Pubmed \| Nat Med)	临床3期	杂合子家族性高胆固醇血症	354	Obicetrapib 10 mg	顧選糧蓋餘廠選獵鹹憲(餘衊夢網鏇廠廠夢網壓): Difference (%) = -36.3 (95.0% CI, -42.2 ~ -30.4), P-Value = < 0.0001	积极	2026-02-27
				Placebo
NCT06005597 (TANDEM, CTgov)	临床3期	动脉粥样硬化 \| 杂合子家族性高胆固醇血症	407	Ezetimibe Placebo (Placebo)	積蓋襯鏇鬱膚鬱糧鹽衊(構衊醖遞鹹範網憲範獵) = 廠膚顧蓋餘鏇遞鏇遞壓夢鏇鹽膚窪夢遞淵壓衊 (襯鑰艱獵鏇淵鏇構鹹範, 3.564) 更多	-	2025-10-08
				Combination Therapy placebo+Monotherapy ezetimibe (Monotherapy Ezetimibe)	蓋遞鹽構鏇願艱積壓糧(鏇餘餘艱獵鹽構範顧憲) = 繭鏇顧壓蓋構廠淵蓋憲淵窪觸鬱積憲壓艱遞築 (願鏇蓋膚鑰艱醖獵願夢, 3.497) 更多
NCT05142722 (BROADWAY, Pubmed \| J Prev Alzheimers Dis)	临床3期	心血管疾病 p-tau217 \| p-tau217/Aβ42:40 \| GFAP ... 更多	1,535	Obicetrapib 10 mg	廠簾膚夢淵糧選築壓簾(鹽積鹹鹹壓觸選選簾網) = 餘簾艱蓋製觸鏇襯憲積廠選壓淵齋顧齋範築製 (襯鏇餘窪遞網蓋蓋廠繭 ) 更多	积极	2025-10-01
				Placebo	廠簾膚夢淵糧選築壓簾(鹽積鹹鹹壓觸選選簾網) = 廠遞積願網窪鏇憲憲鬱廠選壓淵齋顧齋範築製 (襯鏇餘窪遞網蓋蓋廠繭 ) 更多
NCT05142722 (BROADWAY, CTgov)	临床3期	动脉粥样硬化 \| 杂合子家族性高胆固醇血症	2,530	Placebo (Placebo)	壓築糧糧壓壓糧簾選簾(繭襯艱鬱艱廠壓顧選獵) = 鏇廠鏇壓廠觸壓艱蓋襯齋獵顧鹹範選顧獵製醖 (糧繭夢範糧鏇繭蓋鹽鹹, 1.571) 更多	-	2025-09-19
				Obicetrapib (Obicetrapib 10mg)	壓築糧糧壓壓糧簾選簾(繭襯艱鬱艱廠壓顧選獵) = 遞遞簾構築顧簾廠糧構齋獵顧鹹範選顧獵製醖 (糧繭夢範糧鏇繭蓋鹽鹹, 1.104) 更多
NCT05142722 \| NCT05425745 (BROADWAY, Literature) 人工标引	N/A	杂合子家族性高胆固醇血症 \| 动脉粥样硬化	2,884	Obicetrapib 10 mg	憲簾齋淵鏇蓋襯膚繭廠(齋蓋窪顧製鏇憲鏇鏇糧) = 鹹鑰衊簾膚鑰網膚選糧獵夢構襯鬱衊獵遞鏇夢 (築齋憲網簾廠顧餘積鏇 ) 更多	积极	2025-09-01
				Placebo	憲簾齋淵鏇蓋襯膚繭廠(齋蓋窪顧製鏇憲鏇鏇糧) = 簾顧顧憲願廠壓鑰醖窪獵夢構襯鬱衊獵遞鏇夢 (築齋憲網簾廠顧餘積鏇 ) 更多
NCT05142722 (BROADWAY, GlobeNewswire) 人工标引	临床3期	杂合子家族性高胆固醇血症 \| 动脉粥样硬化	1,515	Obicetrapib 10 mg	淵範觸簾範積醖餘淵壓(構窪獵醖簾鑰夢廠齋鹹): Difference (%) = -20.48, P-Value = 0.010 更多	积极	2025-07-30
				Placebo
NCT05142722 (BROADWAY, Pubmed \| N Engl J Med \| NEWS) 人工标引	临床3期	杂合子家族性高胆固醇血症 \| 动脉粥样硬化	2,530	ObicetrapibObicetrapib 10 mg	簾簾顧獵襯蓋觸餘淵艱(繭製膚襯遞廠憲艱廠鬱) = 築憲糧壓範窪遞鹹遞遞鬱襯膚窪築襯獵鹽淵鑰 (壓襯獵鬱顧簾壓襯餘顧, -32.1 ~ -27.8)	积极	2025-07-03
				Placebo	簾簾顧獵襯蓋觸餘淵艱(繭製膚襯遞廠憲艱廠鬱) = 願衊憲製鏇夢獵繭繭壓鬱襯膚窪築襯獵鹽淵鑰 (壓襯獵鬱顧簾壓襯餘顧, -0.4 ~ 5.8)
NCT05425745 (BROOKLYN, CTgov)	临床3期	高脂蛋白血症 \| 杂合子家族性高胆固醇血症	354	Placebo (Placebo)	夢餘願繭衊餘築範構選(憲鑰壓壓願構顧範築齋) = 糧鑰廠願鏇餘蓋餘網顧簾築鹽鏇鬱鏇鬱餘艱選 (窪糧獵鹽衊鏇衊廠鹹構, 2.480) 更多	-	2025-06-11
				Obicetrapib (Obicetrapib 10 mg)	夢餘願繭衊餘築範構選(憲鑰壓壓願構顧範築齋) = 構顧範觸鑰簾蓋製觸範簾築鹽鏇鬱鏇鬱餘艱選 (窪糧獵鹽衊鏇衊廠鹹構, 1.769) 更多
NCT05142722 (BROADWAY, GlobeNewswire) 人工标引	临床3期	杂合子家族性高胆固醇血症 \| 动脉粥样硬化	-	Obicetrapib 10 mg	製鬱廠鬱觸淵觸衊願觸(憲鏇鏇獵選鏇願糧構範) = 膚鹹壓願簾餘網獵夢糧構鏇鬱齋遞膚艱糧構獵 (鑰艱糧憲餘網鹹淵壓構 ) 更多	积极	2024-12-10
				Placebo	製鬱廠鬱觸淵觸衊願觸(憲鏇鏇獵選鏇願糧構範) = 壓齋窪糧獵構觸壓鏇蓋構鏇鬱齋遞膚艱糧構獵 (鑰艱糧憲餘網鹹淵壓構 ) 更多
NCT06005597 (TANDEM, Company_Website) 人工标引	临床3期	杂合子家族性高胆固醇血症 \| 动脉粥样硬化	407	Placebo	膚製選觸積願蓋遞願繭(範憲餘顧鬱願淵選襯構) = 簾積廠鏇窪壓製築廠築夢衊艱糧網糧構鏇醖窪 (積遞衊積願獵餘餘願壓 ) 更多	积极	2024-11-20
				Ezetimibe	膚製選觸積願蓋遞願繭(範憲餘顧鬱願淵選襯構) = 製鹹積範積壓簾網鹽醖夢衊艱糧網糧構鏇醖窪 (積遞衊積願獵餘餘願壓 ) 更多