A Phase II Randomized, Double-blind Study to Evaluate the Safety, Neutralizing Activity and Efficacy of AZD3152 for Pre-exposure Prophylaxis of COVID-19 in Participants Having an Increased Risk for Inadequate Response to Active Immunization (NOVELLA)

AZD3152, a single mAb, is being developed to have broad neutralizing activity across known SARS-CoV-2 variants of concern for pre-exposure prophylaxis of COVID-19.
The aim of the Phase II study is to evaluate the safety, neutralizing activity and efficacy of AZD3152 for pre exposure prophylaxis of COVID-19

开始日期2023-09-29

申办/合作机构

AstraZeneca PLC

NCT05932641

/ Completed临床1期

A Phase I Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD3152 in Healthy Japanese Adults

AZD3152 is being evaluated for administration to prevent COVID-19. This Phase I study will gather important information on the safety and tolerability of AZD3152 as well as relevant data on the PK, PD (as the neutralising responses against SARS-CoV-2) profile and the generation of ADA to AZD3152.

开始日期2023-07-31

申办/合作机构

AstraZeneca PLC

NCT05872958

/ Completed临床1期

A Phase I, Randomized, Safety and Pharmacokinetics Study of AZD3152 in Healthy Adults (Little DIPPER)

This is a dose exploration study to evaluate the safety and pharmacokinetics (PK) of AZD3152 in healthy adult male and female participants, across different dose levels and routes of administration (ie, Intramuscular [IM] injection and Intravenous [IV] infusion).

开始日期2023-05-19

申办/合作机构

AstraZeneca PLC

100 项与 Sipavibart 相关的临床结果

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100 项与 Sipavibart 相关的转化医学

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100 项与 Sipavibart 相关的专利（医药）

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项与 Sipavibart 相关的文献（医药）

2026-11-01·Infectious Diseases and Therapy

Safety, Pharmacokinetics, and Predicted Neutralizing Activity of the SARS-CoV-2 Monoclonal Antibody Sipavibart: Results from Little DIPPER and the SUPERNOVA Substudy

Article

作者: Ramesh, Mayur ; Gibbs, Michael ; Soboleva, Karina ; Clegg, Lindsay ; Aksyuk, Anastasia A ; Francisco, Dave ; Cohen, Taylor S ; Chang, Lee-Jah ; Chang, Yue ; Ghosh, Sambuddha ; Puri, Aashima ; Zhang, Huixia ; Matthews, Sam

INTRODUCTION:

The rapid evolution of SARS-CoV-2 has necessitated efforts to accelerate the clinical evaluation of neutralizing monoclonal antibodies. Little DIPPER and the SUPERNOVA substudy explored the feasibility of immunobridging efficacy from tixagevimab-cilgavimab to sipavibart using predicted neutralizing antibody (nAb) titers.

METHODS:

The randomized, phase 1, Little DIPPER study evaluated the safety and pharmacokinetics of intramuscular (300 mg or 600 mg) and intravenous (300 mg, 600 mg, or 1200 mg) sipavibart in healthy participants. The randomized, phase 2, SUPERNOVA substudy evaluated the safety, predicted nAb activity, and pharmacokinetics of intravenous sipavibart 1200 mg and intramuscular tixagevimab-cilgavimab 300 mg in immunocompetent and immunocompromised individuals. Predicted nAb titers at day 29 for sipavibart against SARS-CoV-2 BA.2.86 and for tixagevimab-cilgavimab against SARS-CoV-2 Alpha were compared in a noninferiority analysis.

RESULTS:

In Little DIPPER, 96 participants received sipavibart (n = 80) or placebo (n = 16). Through day 91, adverse events (AEs) occurred in 23 participants (28.8%) who were administered sipavibart and one (6.3%) who was administered placebo. Sipavibart exhibited dose-proportional increases in serum exposure following intramuscular or intravenous administration. In the SUPERNOVA substudy, 468 participants received sipavibart (n = 310) or tixagevimab-cilgavimab (n = 158). Through day 29, AEs occurred in 81 participants (26.1%) who were administered sipavibart and 33 (20.9%) who were administered tixagevimab-cilgavimab. No serious hypersensitivity reactions occurred. The ratio of predicted nAb titers for sipavibart against BA.2.86 to tixagevimab-cilgavimab against Alpha (4.07) met noninferiority (90% confidence interval 3.71-4.46 [lower limit > 0.8]) and superiority (95% confidence interval 3.65-4.53 [lower limit > 1.0]) criteria. Serum sipavibart exposures were similar between immunocompetent and immunocompromised participants.

CONCLUSION:

These results demonstrate the feasibility and appropriateness of conducting phase 1 and 2 studies to support rapid immunobridging analyses, and accelerate the delivery of new SARS-CoV-2-neutralizing monoclonal antibodies to immunocompromised individuals.

TRIAL REGISTRATION:

ClinicalTrials.gov identifiers: NCT05872958, NCT05648110.

2026-11-01·JOURNAL OF INFECTION AND CHEMOTHERAPY

A phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of sipavibart in healthy Japanese adults

Article

作者: Eto, Takashi ; Kim, Hyosung ; Okada, Hiroshi ; Shinbo, Takumi ; Noda, Yoshinori

BACKGROUND:

Sipavibart, a recombinant human immunoglobulin G1-based monoclonal antibody against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein, is approved in Japan for prevention of COVID-19 in immunocompromised individuals. This phase 1 study evaluated the safety and pharmacokinetics (PK) of sipavibart in Japanese individuals.

METHODS:

Healthy Japanese adults (18-55 years) were enrolled into one of three cohorts, and randomized to sipavibart 300 mg intramuscularly (IM) or placebo (Cohort 1), sipavibart 600 mg IM or placebo (Cohort 2), or sipavibart 1200 mg intravenously (IV) or placebo (Cohort 3). Participants were followed for approximately 1 year post-administration. Safety/tolerability (occurrence of adverse events [AEs]), PK, pharmacodynamics (PD; neutralizing response against SARS-CoV-2 variants), and immunogenicity (development of anti-drug antibodies [ADAs]) were assessed.

RESULTS:

Twenty-four individuals (56% male) were randomized, with eight participants (sipavibart, n = 6; placebo, n = 2) in each cohort. Through Day 91 (primary safety endpoint), AEs were reported in five participants (27.8%) in the total sipavibart group and one (16.7%) in the pooled placebo group. There were no deaths, serious or treatment-related AEs, or AEs leading to discontinuation. PK parameters indicated consistent exposure across sipavibart administration routes and doses. Neutralizing antibody titers against all tested SARS-CoV-2 variants increased over time. A linear PK/PD relationship was observed across serum sipavibart concentrations for the SARS-CoV-2 variants tested. No participants developed treatment-emergent ADAs.

CONCLUSIONS:

Single IM and IV doses of sipavibart were well tolerated in healthy Japanese adults, with a linear PK/PD relationship across tested SARS-CoV-2 variants.

2026-09-01·INTERNATIONAL JOURNAL OF INFECTIOUS DISEASES

Cross-neutralization of SARS-CoV-2 BA.3.2.2 lineage by JN.1 mRNA vaccine-induced immunity

Article

作者: Mizukami, Takuo ; Yoshihara, Yasuo ; Sato, Ryoichi ; Hasegawa, Hideki ; Sano, Kaori ; Miyakawa, Kei ; Seki, Yohei

OBJECTIVES:

The SARS-CoV-2 BA.3.2.2 sublineage has emerged globally as the dominant branch of BA.3.2 by late 2025, yet its antigenic relationship with JN.1 vaccine-induced immunity remains unclear.

METHODS:

We evaluated neutralizing antibody responses in 25 JN.1 mRNA vaccinees against eight variants, stratified by anti-nucleocapsid antibody serostatus.

RESULTS:

Postvaccination titers increased significantly against all variants in both N antibody-negative and -positive groups. Cross-neutralization against BA.3.2.2 was detected in both groups despite lower titers compared to JN.1. Antigenic cartography revealed that BA.3.2.2 was antigenically isolated from all JN.1-descendant variants. AZD3152/sipavibart retained potent neutralization against BA.3.2.2 but completely lost activity against all F456L-harboring JN.1-descendant variants, while VYD222/pemivibart and SA55 maintained broad activity.

CONCLUSIONS:

Retention of wild-type F456 in BA.3.2.2 preserves class 1/2 antibody epitopes, providing a mechanistic basis for cross-neutralization and suggesting a potential therapeutic window for sipavibart should BA.3.2.2 expand globally, pending clinical confirmation.

项与 Sipavibart 相关的新闻（医药）

2026-01-29

·PRNewswire

LifeArc Ventures 2025: New geographies and investments, a growing team and continued portfolio progress

LONDON, Jan. 29, 2026 /PRNewswire/ -- LifeArc Ventures, the venture capital arm of the medical research organisation, LifeArc, had its most active year to date in 2025, announcing investments in four new innovative life sciences portfolio companies and further funding and supporting its portfolio, which stood at 20 companies at year end. Since its inception in 2020, the portfolio has grown through Seed and Series A investments, expanding its investments into Series B in 2025. LifeArc Ventures participated in two new Series B rounds in transformative companies as part of top tier global syndicates, as well as supporting existing portfolio companies with their Series A and B raises. LifeArc Ventures anticipates another year of substantial progress in 2026, with multiple clinical starts expected alongside further new investments. Clare Terlouw, Managing Partner of LifeArc Ventures, said: "This year we've announced four new investments, including our first in German, Swiss and Scandinavian companies. This geographic expansion is part of our long-term strategy to diversify the portfolio, entering new territories and therapeutic areas while sustaining our UK focus. We're encouraged by the way our investments are maturing across the portfolio, and by our ability to attract talented individuals with the experience and expertise to support our growing footprint and ambitions. 2026 promises to be a transformative year for our portfolio companies and for our fund." LifeArc Ventures invests broadly across therapeutics and tech-enabled biotechnology companies across all modalities and therapeutic areas as part of its direct investment strategy. LifeArc Ventures also runs a fund of funds strategy and has invested in ten leading global life sciences venture funds to date. The goal is to return capital to LifeArc's balance sheet as part of the organisation's long term financial sustainability, whilst supporting the translation of bold scientific ideas into transformative solutions for patients. A growing specialist team The appointments of Olivia Cavlan, MD, as Partner, and Diana Röttger as Investment Principal, in 2025 further strengthened LifeArc Ventures' commercial, operational and scientific expertise, reinforcing its ability to source and manage promising additional investments as well as actively supporting the growth and governance of our existing portfolio. Expanding the portfolio with high-impact investments complemented by targeted follow-ons LifeArc Ventures deployed capital across a diverse array of therapeutic modalities and technologies, in particular areas with significant unmet needs such as autoimmune diseases, fibrosis and CNS disorders. GlycoEra AG's $130 million Series B: LifeArc Ventures joined Novo Holdings, Catalio Capital Management, QIA, Sofinnova Partners, 5AM Ventures, Roche Ventures, Bristol Myers Squibb, Agent Capital, MP Healthcare Venture Management, and Sixty Degree Capital. The funding will be used to transform GlycoEra into a clinical stage company with its lead program targeting IgG4 applicable to multiple autoimmune conditions. GlycoEra is based in Switzerland and the U.S. Hillstar Bio's $67 million Series A: Co-investing with Droia Ventures, Frazier Life Sciences and Novo Holdings, LifeArc Ventures supported the U.S.-based company's launch focused on precision immunotherapies. Exciva's €51 million Series B: LifeArc Ventures joined GIMV, EQT, Fountain Healthcare Partners and Andera to support the German company's Phase 2 study evaluating Deraphan for treatment of agitation associated with Alzheimer's disease (ADA). ADA represents a significant unmet need, affecting more than 30-50% of patients at any point in time. A phase 1 trial with Deraphan has been successfully completed and showed that the combination is safe and well-tolerated. Tribune Therapeutics' €23 million Series A: LifeArc Ventures led the Series A, partnering with Scandinavian investors Novo Holdings, HealthCap, Innovestor's Life Science Fund, Inven2, Industrifonden, and Investinor to help drive the Swedish/Norwegian company's development of TRX-44, a first-in-class CCN5-mimicking therapy. This investment targets idiopathic pulmonary fibrosis, advancing the program toward pivotal clinical trials. In addition, two of our companies announced substantial further funding: Maxion Therapeutics' $72 million oversubscribed Series A: Alongside the other existing investors Monograph Capital and BGF, and joined by new investors General Catalyst, British Patient Capital, Solasta Ventures, and Eli Lilly and Company, LifeArc Ventures supported Maxion's plans to transform into a clinical-stage company, taking the lead KnotBody® program candidate MAX001 to clinical proof-of-concept for inflammatory diseases, unlocking new therapeutic possibilities. Affect Therapeutics' $26 million Series B: LifeArc Ventures participated alongside Allumia Ventures, Artis Ventures, City Light Capital, and Limitless Ventures to help scale up Affect's AI-powered virtual clinic. Already operating in more than 20 U.S. states, the platform integrates behavioral therapy, biological monitoring, and incentives to address substance use disorders and co-occurring mental health challenges, expanding partnerships with health plans and employers. Substantive portfolio progress: from patents to partnerships Several of LifeArc Ventures' portfolio delivered substantial achievements in 2025, expanding IP, strengthening leadership, receiving clinical authorisations and forming strategic alliances including: AviadoBio and UgeneX Therapeutics' exclusive option and license agreement: AviadoBio secured an option to worldwide rights (ex-Greater China) to UGX-202, an advanced optogenetics gene therapy for retinitis pigmentosa and retinal diseases, currently in Phase 1. The deal includes up to $413 million in milestones and royalties. Fluid Biomed appoints senior medtech executive John Kilcoyne as Independent Board Chair: The appointment brings decades of experience in leading high-growth medical device companies to Canada-based Fluid Biomed as it accelerates development of its unique polymer–based stent technology to treat brain aneurysms and stroke. Ikarovec substantive regulatory and clinical progress: positive FDA feedback on development plan for IKAR-001, first-in-class dual pathway gene therapy for geographic atrophy, and promising data presented on therapeutic potential in geographic atrophy and wet AMD. Maxion Therapeutics' leadership and Board strengthened: Joel Edwards (formerly VP of Corporate Strategy and Operations at Ionis Pharmaceuticals) joined as Chief Business Officer to drive partnerships for the KnotBody® pipeline, while Dr. Santiago Arroyo (formerly CMO of Momenta Pharmaceuticals until its sale to J&J for $6.5bn) was appointed Non-Executive Director to guide clinical advancement post-Series A. RQ Bio accelerates seasonal influenza programme: After the success of developing Kavigale for COVID-19, RQ Bio has successfully turned its attention to generating potent and resilient long-acting antibodies for seasonal influenza A for vulnerable individuals. Contacts: About LifeArc LifeArc is a not-for-profit medical research organisation with one clear purpose – transforming the lives of people living with rare diseases and drug-resistant infections. We aim to deliver this by conducting and funding pioneering research, and working with partners to accelerate the translation of scientific breakthroughs into new tests and treatments. Through our LifeArc Ventures team, we invest in innovative life sciences companies with significant follow-on investment reserved for successful portfolio companies. Our ventures approach focuses on investing in novel translational science and technology across a broad range of indications and the full spectrum of therapeutics, healthtech and medical devices - with the dual goal to generate financial returns to LifeArc and to deliver life-changing patient impact. Find out more on / or follow us on LinkedIn or Twitter (@LifeArcVentures). SOURCE LifeArc 21% more press release views with Request a Demo

临床1期临床2期高管变更引进/卖出

2025-08-05

·EndPoints

AstraZeneca culls plans for Evusheld successor in the US following Covid evolution

AstraZeneca is no longer seeking FDA approval for its Covid-19 prevention antibody known as sipavibart, a company spokesperson confirmed to Endpoints News . The monoclonal antibody was meant to be a successor to AstraZeneca’s former blockbuster Evusheld, which was authorized in the US, EU and other countries to help prevent Covid in immunocompromised individuals. The FDA pulled Evusheld’s emergency authorization in January 2023 due to ineffectiveness against most circulating variants. As for sipavibart, it’s approved in other regions. Japan and the EU greenlit the antibody after it passed muster in a Phase 3 trial that read out in May 2024. It is known as Kavigale in those markets. In the 3,330-person trial, AstraZeneca said sipavibart helped curtail symptomatic Covid in immunocompromised individuals as compared to Evusheld or placebo. At the time, the drugmaker thought the antibody could potentially work in an “ evolving variant landscape .” The company attributed its decision to sideline sipavibart in the US to currently circulating variants. “Due to the high prevalence of SARS-CoV-2 variants that are resistant to sipavibart, we are not currently pursuing a BLA in the US in Covid-19 prophylaxis,” the AstraZeneca spokesperson said in an email. Chemical & Engineering News first reported the news on Tuesday. It marks another Covid-related setback for AstraZeneca. The company developed a vaccine with the University of Oxford, eventually delivering Vaxzevria to more than 180 countries. The pharmaceutical company later withdrew the shot globally last year. At the time, a spokesperson said “no future commercial demand for the vaccine is expected.” AstraZeneca is not completely out of Covid R&D. The pharma is working on an mRNA-VLP vaccine that’s in Phase 1 , according to its most recent quarterly results. Immunocompromised individuals have said they are looking for other prevention tools after the FDA revoked the authorizations of Evusheld and antibodies from other biotech and pharma companies . The antibodies had offered an alternative , or additional, method of protection alongside vaccines. Invivyd’s Pemgarda is authorized for emergency use for Covid prevention in the US. Meanwhile, other efforts have also stalled over the years. A startup called Aerium Therapeutics shuttered last year after Covid variants threw a wrench in its R&D plans.

临床3期疫苗紧急使用授权上市批准信使RNA

2025-06-04

·贝壳社

FDA失速？生物药审批“欧洲优先”背后的监管困局

作者：布布在全球新药审批格局中，美国长久以来被视为全球创新药物的“首发地”。然而，根据Pink Sheet对2024–2025年药品审批数据的深度分析揭示出一种值得关注的新趋势：在22款先获欧盟（EU）批准的新产品中，绝大多数为生物制剂，而非传统的小分子药物。这一现象或许并非偶然，而是源自美国在合同生产和质量审评上的系统性挑战。01FDA仍然领先，但欧盟“抢跑”增多Pink Sheet的最新分析指出，截至2025年5月20日，FDA已批准17款新药和生物制剂，欧盟和美国监管机构总计批准了37款产品。其中美国仍在整体数量上保持首批优势。然而，这一优势在生物制剂领域出现了“局部滑坡”。2024–2025年间，在欧盟率先获批的22款产品中，绝大多数为疫苗、抗体、细胞疗法和基因疗法等生物制品（表1）。表 1. 2024年至2025年5月20日欧盟领先美国上市新药一览表如果我们回顾2024年全年批准的新药构成，可以看出美国FDA在小分子药物领域仍保持强势地位。2024年FDA共批准了61款创新药物，而欧盟为37款，其中大部分欧盟获批产品最终也在美国获得上市许可。然而，在某些结构复杂、制造要求高的生物制剂领域，这一优势正在减弱。以典型案例来看，Novavax的COVID-19疫苗Nuvaxovid早在2021年底就已获得欧盟批准，美国直到2025年5月才完成正式批准，时间滞后超过40个月；medac/Medexus的Grafapex（treosulfan）在欧盟于2019年获批，美国则在2025年初才通过，滞后长达67个月。类似的还有Atara的Ebvallo（tabelecleucel），其在2022年即获欧盟上市许可，至2025年仍未获得FDA批准，反而收到CRL，主要因制造流程未满足FDA对一致性和GMP的高标准要求。在2025年欧盟先批的新药中，有3款用于新冠防治，包括Arcturus的Kostaive（首个自扩增 mRNA疫苗）、阿斯利康的Kavigale（长效抗体），以及InflaRx的Gohibic（ARDS治疗用抗体）。虽然这些产品在欧盟获得上市，但在美国则未能获得常规BLA批准，甚至部分尚未递交上市申请，反映出制药企业对美国监管节奏及市场预期的重新权衡。进一步观察数据还发现：除了极端的时间滞后案例，诸如PTC的Kebilidi（延迟28.9个月）、Orchard的Lenmeldy（延迟39个月）、Akebia的Vafseo（延迟11.1个月）等产品，也呈现出“欧先美后”的审批路径。这种时间差的背后，除了临床数据与适应症设定外，核心在于FDA对制造数据、生产体系一致性和第三方代工厂的深度审查，这些都大幅拉长了美国市场的准入周期。总体而言，美国FDA在新分子实体方面仍占据审批数量和速度的双重优势。但欧盟在生物制剂审批方面的“抢先”现象愈发频繁，且集中于制造复杂、CMC挑战高的产品类别。这种结构性变化表明，美国的全球首发地位虽未动摇，但已开始面临来自欧盟在特定技术领域上的有效挑战。02生物制剂审批的软肋：制造质量与第三方生产FDA对生物制剂的质量审评严苛，尤其在生产可比性（comparability）、验证数据完整性以及第三方合同生产（CDMO）设施的合规性方面，要求尤为苛刻。据统计，2024–2025年欧盟先批的22款药品中，有8款在FDA因制造相关问题收到完整回应信（CRL），其中5例直接关联第三方生产设施的质量问题。来自礼来（Lilly）的lebrikizumab（Ebglyss）便是典型案例：FDA要求其聘请第三方重新评估生产数据的可靠性，而欧洲则在早于FDA近一年时间内给予上市许可。又如Atara的复发或难治性EB病毒阳性移植后淋巴增殖性疾病细胞疗法Ebvallo（tabelecleucel）在欧洲通过“特殊情况”通道获批后迅速上市，而FDA因GMP问题和第三方厂商不合规发出CRL，并一度对临床试验实施临床暂停。此外，FDA对于海外生产数据的采信门槛亦显著提高。例如，PTC的基因疗法Kebilidi因临床研究样品与商业化产品工艺不一致被要求补充新的临床数据，导致美国上市时间晚于欧盟两年有余。03FDA对毒性与安全性数据关注严格除了生产环节，美国FDA在药物的安全性评估与数据完整性方面也保持着高度谨慎的态度，常常比其他监管机构设置更高的准入门槛。这种审慎策略虽然有助于保障患者利益，但在全球同步申报的背景下，也往往造成美方审批节奏的明显滞后。某些药物即便在日本或欧盟等海外市场已有多年上市经验和临床安全记录，仍可能因潜在的器官毒性问题而遭遇FDA的严格质疑。例如，Akebia Therapeutics 开发的口服HIF-PHI药物 Vafseo（vadadustat）早在2020年即在日本获批用于肾性贫血治疗，并在2023年获得欧盟上市许可。然而，FDA在审评过程中高度关注其早期临床试验中出现的肝脏不良反应，认为现有数据尚不足以排除肝毒性风险。在经历一次完整回应信（CRL）后，企业不得不收窄适应症范围，仅限于透析依赖型患者，并配套长期肝功能监测方案，最终才于2024年在美获批。这一过程反映出，即便拥有海外上市经验，美国监管方依旧对潜在毒性保留更高警惕性，特别是在作用机制新颖或靶点复杂的药物中更为常见。对于依赖复杂检测指标作为关键终点的产品，FDA尤其强调原始数据的可追溯性与逻辑一致性。以treosulfan（商品名为Grafapex）为例，该药在欧盟早于2019年便已获批用于造血干细胞移植前的预处理，但其美国新药申请于2020年提交后，连续两次遭遇FDA完整回应信（CRL）。FDA指出，该药关键终点为“无事件生存期（EFS）”，但企业最初提交的数据包中缺少全部患者的骨髓和血细胞检查原始记录，无法支撑终点判定。这一问题使得监管机构在2021年CRL中明确表示“无法确认EFS结果的可信度”，并在随后的补充回复中继续批评数据缺失与逻辑混乱。最终，企业在2024年提交了系统化的溯源审计材料，覆盖所有受试者的骨髓报告与原始数据后才获得FDA认可。这一审批过程充分说明，FDA在面对此类数据驱动型药物时，其标准不仅仅是“有效”或“安全”，而是“数据是否完整”、“分析是否透明”、“原始记录是否经得起溯源”。这些标准常常远超其他地区的监管机构，从而导致明显的审批周期延长。这也凸显出FDA在面对临床关键指标时，极度重视数据基础是否扎实、可重复。04制度因素也在“带节奏”FDA加速批准机制本意是为了让严重疾病领域的潜力药物更快上市，早期释放治疗价值。但自2022年《食品药品综合改革法案》（FDORA）生效后，该机制增加了一项关键性新要求：药品在获得加速批准时就开始进行验证性研究。这项变革虽有助于提升加速批准的可信度，却也在客观上延缓了部分创新疗法的上市节奏，尤其影响了那些尚未启动确证性试验或临床路径复杂的产品。再生元开发的CD20×CD3双特异性抗体odronextamab（商品名：Ordspono）便面临这一制度掣肘。该药在欧盟已于2024年8月获得批准，用于治疗两种B细胞非霍奇金淋巴瘤：复发或难治性的滤泡性淋巴瘤（FL）和弥漫性大B细胞淋巴瘤（DLBCL）。而在美国，尽管再生元也同步递交了BLA申请，但FDA于2024年3月向其发出完整回应信（CRL），指出公司所提交的III期OLYMPIA临床试验尚处于剂量探索阶段，未能满足FDORA法规下“确证性试验正在进行”的要求。因此，再生元不得不分拆提交，将BLA缩减为只覆盖FL适应症，而DLBCL部分则延后处理。这类制度性的门槛，不仅延迟了多发适应症同步推进的可能，也对企业的申报策略、临床节奏与商业部署带来更高的不确定性。05新药首发地的多极化趋势已成现实值得注意的是，在FDA持续应对制造质量、毒性控制、制度改革等多重挑战的同时，全球“首批上市地”的格局本身也在悄然发生变化。2024年FDA新批准药物中，越来越多的全球首次批准地已不在美国，而是来自亚洲、欧洲或加拿大（表2）。表 2. 非美国首次上市的FDA 2024年批准新药例如，2024年FDA批准的新药中，包括百济神州的Tevimbra、Akebia的Vafseo、阿斯利康的Voydeya、安斯泰来的Vyloy等多个产品，均早在中国、日本或欧盟市场获批。其中一些药品在FDA批准时，已在海外市场销售多年，甚至首次上市时间可追溯至十多年前。这不仅反映出这些国家监管机构能力的提升，也显示出全球药企对不同市场审批效率和路径确定性的重新评估与布局。对FDA而言，这种趋势可能进一步加剧其在生物制剂领域的“时间劣势”感知。从全球新药审批格局来看，“美国首批”已不再是唯一常态，首发地的多极化趋势正在成为行业新现实。06结语回顾2024–2025年欧盟“抢先”批准的生物制剂清单，人们看到的不只是个别产品命运的转折，更是一种全球监管格局的悄然重塑。在FDA仍牢牢掌握大多数全球首批审批主导权的同时，那些复杂度高、路径前沿、生产挑战大的创新疗法，越来越倾向于先在欧盟完成上市首发。这并非意味着FDA正在“放慢脚步”，而是反映出其对制造一致性、毒性控制、数据可追溯性和制度规范的多重叠加标准，正成为全球最严的准入门槛之一。随着FDORA等法规的强化实施，“快速上市”的定义在美国变得更为谨慎和多条件绑定。与此同时，EMA的策略则体现出更大程度的灵活性：在制造问题尚可控、数据充分支持疗效的基础上，以有条件批准、例外路径等方式为高需求治疗选项开通通道。这种对风险与应急之间的动态平衡，正成为欧盟在新药首发竞争中频频“超车”的关键变量。对全球药企而言，未来的新药首发路径不再只是技术成熟度与市场潜力的博弈，更是对不同监管体系中“可控性”与“可预测性”的评估。在这一新格局下，制造体系的稳健程度、注册策略的全球统筹能力，以及企业自身的临床开发节奏掌控，将共同决定创新药物能否在全球多个市场高效落地。首发之争的焦点，已从审批速度的简单比较，转向了对监管适应能力的全链条挑战。往期推荐1医健企业前沿动态2医健行业BD/出海/投融资洞察___*声明：本文仅为作者观点，不构成任何投资建议，且非治疗方案推荐Ref.Silverman, B. EU Authorization Before US? Biologics Manufacturing Is Likely To Blame. Pink Sheet. 26. 05. 2025.关于贝壳社贝壳社是国内领先的医健创新创业服务平台，构建了"产业空间+创业教育+投资孵化+资本运作"四位一体服务体系，为医健领域创业企业提供全周期赋能。通过深度挖掘高成长项目、精准匹配产业资源及全球化生态网络，覆盖企业从孵化培育到加速发展的全链路，重点提供包括空间落地、创业培训、资本运作及跨境资源链接服务。贝壳社以加速科学技术成果转化与产业升级为目标，致力于成为医健领域的孵化器、加速器、连接器。

疫苗信使RNA细胞疗法优先审批上市批准

100 项与 Sipavibart 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D12974	-	J06BD09	-

研发状态

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适应症	国家/地区	公司	日期
新型冠状病毒感染	日本	AstraZeneca KK	2024-12-27

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适应症

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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


NCT05648110 \| NCT05872958 (Little DIPPER, Pubmed \| Infect Dis Ther)	临床1/2期	-	564	Sipavibart	襯積願鹹獵襯窪製鑰糧(膚鬱醖積遞網鏇積觸網) = 窪窪夢齋淵襯範繭齋窪窪範選餘構製築遞廠製 (觸糧壓繭膚範憲鬱築積 )	积极	2026-09-07
				Placebo	襯積願鹹獵襯窪製鑰糧(膚鬱醖積遞網鏇積觸網) = 淵顧憲鹽鬱鹹繭顧顧壓窪範選餘構製築遞廠製 (觸糧壓繭膚範憲鬱築積 )
NCT06057064 (NOVELLA, CTgov)	临床2期	新型冠状病毒感染	116	Biological: AZD3152 (AZD3152)	鹹製窪壓鏇壓構蓋選餘 = 顧鬱範鏇觸獵簾鏇夢窪鏇齋選壓鹹夢鏇鹽醖積 (夢廠鑰鏇夢醖蓋憲糧遞, 膚選網襯鑰淵糧鬱壓簾 ~ 醖鹹獵鏇獵鏇鏇衊積顧) 更多	-	2025-08-15
				Biological: Placebo (Placebo)	鹹製窪壓鏇壓構蓋選餘 = 構淵糧齋獵窪艱製醖遞鏇齋選壓鹹夢鏇鹽醖積 (夢廠鑰鏇夢醖蓋憲糧遞, 壓願淵廠遞憲醖齋鬱範 ~ 鏇鹹膚積積鬱蓋範衊壓) 更多
NCT05648110 (SUPERNOVA, NEWS) 人工标引	临床3期	新型冠状病毒感染	3,335	Sipavibart	淵壓窪築膚餘觸窪餘鹽(膚繭壓網築製醖壓壓餘) = reducing the risk of symptomatic disease from any SARS-CoV-2 variant and the risk of infections from variants not harbouring the F456L mutation, relative to the comparator. 製願夢齋壓網觸選廠繭 (簾衊鏇膚廠選夢築餘淵 ) 达到更多	积极	2024-05-16