A PHASE 3, PLACEBO-CONTROLLED, DOUBLE-BLINDED, RANDOMIZED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF DIFFERENT VACCINATION SCHEDULES OF 6-VALENT OSPA-BASED LYME DISEASE VACCINE, VLA15, IN HEALTHY ADULT PARTICIPANTS

The purpose of this study is to learn about the safety and effects of the Lyme disease vaccine (called VLA15) when given at different time points.
This study is seeking participants who:
* are generally healthy and between 18 and 44 years of age,
* have never had a vaccine for Lyme disease before,
* are not currently taking, or haven't recently taken, medicines like chemotherapy, blood products, or blood thinners, and
* are not pregnant or breastfeeding and do not plan to become pregnant while receiving the study vaccine.
All participants in this study will receive a total of 5 doses through a shot in the upper arm. Four doses will be the study vaccine (VLA15), and 1 dose will be saltwater.
The study will compare the experiences of people receiving the study vaccine at different time points. This will help see if the study vaccine is safe and will help understand its effect on the body.
Participants will take part in this study for about 2 years. During this time, the participants will have 11 planned visits - 8 will be at the study clinic and 3 will be done over the phone. The clinic visits may include having a health check, giving a small amount of blood (about 20 mL or 4 teaspoons), and getting the study vaccine or saltwater as a shot.

开始日期2025-11-19

申办/合作机构

Pfizer Inc.

NCT05634811

/ Completed临床3期

A PHASE 3, RANDOMIZED, PLACEBO-CONTROLLED, OBSERVER-BLINDED TRIAL TO EVALUATE THE SAFETY OF A 6-VALENT OspA-BASED LYME DISEASE VACCINE (VLA15) IN HEALTHY CHILDREN 5 THROUGH 17 YEARS OF AGE

This study is to understand if the study vaccine (called VLA15) is safe in healthy children.
We are looking for children who:
* are healthy
* are age 5 through 17
* have not been diagnosed with any form of Lyme disease in the past
* have not received any vaccines for Lyme disease in the past
Lyme disease happens most often in children of this age. The study vaccine may be used potentially to help prevent Lyme disease. The goal of this study is to get more information about the safety of the study vaccine in this age group.
Participants will be in this study for about 2 years. During that time, they will receive VLA15 or placebo (sterile saltwater solution) by a "shot" in the arm. We will compare experience of children receiving VLA15 to those receiving the placebo. Participants will not know whether they get VLA15 or placebo.
Everyone participating in this study will:
* get the shots in a clinic or in a hospital office
* receive a total of 4 shots
* receive the first 3 shots within 6 months
* receive the last shot about 1 year afterwards
* need to come to the trial site for 6 planned visits; 4 of these are vaccination visits and 2 are follow-up visits. We will contact you by phone 1 time every year during the study to monitor your experience. You may have extra visits if you experience a severe reaction after a vaccine dose.

开始日期2022-12-12

申办/合作机构

Pfizer Inc.

NCT05477524

/ Active, not recruiting临床3期

A Phase 3, Multicenter, Placebo-Controlled, Randomized, Observer-Blinded Trial to Evaluate the Efficacy, Safety, Tolerability, Immunogenicity, and Lot Consistency of a 6-Valent OspA-Based Lyme Disease Vaccine in Healthy Participants ≥5 Years of Age

The main purpose of this clinical study is to evaluate a 6-valent OspA-based Lyme disease vaccine (VLA15) for prevention of Lyme disease within North America and Europe. Approximately 9,400 healthy participants (this number excludes participants from 8 sites which were terminated for quality issues) 5 years and older will be recruited from areas with high levels of endemic Lyme disease to receive VLA15 or placebo (an inactive substance consisting of saltwater). Each participant will have about a 50% chance of receiving VLA15 and about a 50% chance of receiving placebo. A subset of participants will receive VLA15 from 3 different lots or placebo (1:1:1:3 ratio) to assess lot equivalence.
Participants will receive a 3-dose primary vaccination series at about 0, 2, and 5 to 9 months and then receive a booster dose about 12 months after end of primary vaccination series. Vaccination of participants will occur at a time of year such that the primary series is completed before the peak Lyme disease season followed by a booster dose just prior to the beginning of the second Lyme disease season. A subset of participants will be followed for a third Lyme disease season.
Comparison will be made between the Lyme disease cases of people receiving the study vaccine to those of the people who are not. This will help us determine if the study vaccine is safe and effective.
If enrolled, participants will need to visit the research site at least 7 times during the study, and for a subset of participants up to 9 times. There will also be at least 5 telephone contacts. It is expected that each participant will take part in this study for up to about 2 and a half years. The subset of participants followed for a third Lyme disease season will take part in this study for up to about to 3 and a half years.

开始日期2022-08-04

申办/合作机构

Pfizer Inc.

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100 项与 VLA15 相关的临床结果

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100 项与 VLA15 相关的转化医学

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100 项与 VLA15 相关的专利（医药）

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项与 VLA15 相关的文献（医药）

2026-03-01·VACCINE

Protective properties of a candidate C-terminal domain OspA vaccine for prevention of Lyme disease

Article

作者: Baranova, Danielle ; Li, Yan ; Embers, Monica E ; Simon, Raphael ; Seidel, Stefan ; Park, Jeong-Jin ; Hochreiter, Romana ; Timofeyeva, Yekaterina ; Anderson, Annaliesa S ; Hasenkampf, Nicole R ; Esadze, Alexandre ; Kanevsky, Isis ; Wellnitz, Sabine ; Gribenko, Alexey ; Gaylord, Michelle ; Tran, Sirena ; Tardo, Amanda C ; Singh, Guy ; Dane, Jill ; Meinke, Andreas ; Sun, Jun ; Giordano-Schmidt, Donna ; Bartuschka, Ursula ; Lundberg, Urban ; Kalina, Warren ; Jost, Sandra ; Fritzer, Andrea

Lyme disease is a growing public health concern that is geographically focused in regions where ticks that carry the causative bacteria, Borrelia burgdorferi sensu lato (s.l.), are endemic. Outer surface protein A (OspA) is expressed by B. burgdorferi s.l. spirochetes during the tick phase and OspA antibodies introduced during tick feeding can block transmission and prevent B. burgdorferi infection. Candidate Lyme disease vaccine VLA15 is comprised of the C-terminal domains of the six B. burgdorferi s.l. OspA serotypes (ST) prevalent in North America and Europe. We report herein that non-human primates immunized with VLA15 were protected against challenge with Ixodes scapularis ticks bearing B. burgdorferi sensu stricto (s.s.) (OspA ST1). Levels of residual B. burgdorferi s.s. tick colonization were reduced in ticks that fed on VLA15-immunized primates compared to those immunized with full length-OspA ST1 (FL-OspA) at a point when OspA-binding IgG levels were similar. Furthermore, monoclonal antibodies targeting the C-terminal half of OspA, elicited by FL-OspA immunization in primates, were more effective at complement-mediated bactericidal killing in vitro and clearance of spirochetes in ticks versus those directed against other parts of the protein.

2025-10-01·Therapeutic advances in vaccines and immunotherapy

Exploring the safety and immunogenicity of the VLA15 vaccine among healthy or high-risk population: a systematic review and meta-analysis of randomized controlled trials

Review

Background::

Lyme disease, the most common vector-borne illness in the Northern Hemisphere, is caused by Borrelia burgdorferi and transmitted via tick bites. With rising global incidence and no approved human vaccine, VLA15, a novel recombinant vaccine targeting six OspA serotypes, shows promise as an effective preventive strategy.

Objective::

This study aims to assess the safety and immunogenicity of the VLA15 vaccine among healthy or high-risk populations.

Design::

We conducted a systematic review and meta-analysis of three randomized controlled trials.

Methods::

This systematic review and meta-analysis, registered in PROSPERO (CRD420251058818), was conducted following PRISMA guidelines. A thorough search of PubMed, EMBASE, Cochrane Library, Scopus, ScienceDirect, and ClinicalTrials.gov was performed up to May 2025. Data extraction and quality assessment (using Cochrane ROB 2) were performed independently by reviewers. Risk ratios (RR) with 95% confidence intervals (CI) were calculated using random-effects models.

Results::

Three RCTs, including 5907 participants (4500 VLA15; 1407 placebo), met inclusion criteria. VLA15 recipients showed a significantly higher risk of adverse events: fever (RR 2.65, 95% CI: 1.77–3.96), headache (RR 1.40, 95% CI: 1.21–1.62), fatigue (RR 1.33, 95% CI: 1.15–1.55), and arthralgia (RR 2.50, 95% CI: 1.67–3.76), all with p < 0.0001. Subgroup analysis revealed a dose-response trend for arthralgia, particularly at 135 μg and 180 μg doses. However, nausea (RR = 1.34, p = 0.10) and severe unsolicited AEs (RR = 1.22, p = 0.42) were not statistically significant, suggesting no meaningful increase in these risks. Immunogenicity outcomes consistently favored VLA15, showing elevated IgG levels, GMTs, and seroconversion rates.

Conclusion::

VLA15 exhibits strong immunogenicity and acceptable safety, despite an increased risk of mild-to-moderate adverse events. Continued research and monitoring are warranted to support its use in Lyme disease prevention.

2024-09-01·LANCET INFECTIOUS DISEASES

Optimisation of dose level and vaccination schedule for the VLA15 Lyme borreliosis vaccine candidate among healthy adults: two randomised, observer-blind, placebo-controlled, multicentre, phase 2 studies

Article

作者: Schneider, Martina ; Klingler, Anton ; Bender, Wolfgang ; Larcher-Senn, Julian ; Hochreiter, Romana ; Bézay, Nicole ; Wressnigg, Nina ; Eder-Lingelbach, Susanne ; Kadlecek, Vera ; Wagner, Laura ; Obersriebnig, Michaela ; Dubischar, Katrin ; Derhaschnig, Ulla

BACKGROUND:

Rising Lyme borreliosis incidence rates, potential for severe outcomes, and limitations in accurate and timely diagnosis for treatment initiation suggest the need for a preventive vaccine; however, no vaccine is currently available for human use. We performed two studies in adults to optimise the dose level and vaccination schedule for VLA15, an investigational Lyme borreliosis vaccine targeting outer surface protein A (OspA) serotypes 1-6, which are associated with the most common pathogenic Borrelia species in Europe and North America.

METHODS:

Both randomised, observer-blind, placebo-controlled, multicentre phase 2 studies included participants aged 18-65 years without recent history of Lyme borreliosis or tick bites. Study one was conducted at nine clinical research and study centre sites in the USA (n=6), Germany (n=2), and Belgium (n=1); study two was conducted at five of the study one US sites. Based on a randomisation list created by an unmasked statistician for each study, participants were randomly assigned via an electronic case report form randomisation module to receive 90 μg (study one only), 135 μg, or 180 μg VLA15 or placebo by intramuscular injection at months 0, 1, and 2 (study one) or 0, 2, and 6 (study two). Study one began with a run-in phase to confirm safety, after which the Data Safety Monitoring Board recommended the removal of the 90 μg group and continuation of the study. In the study one run-in phase, randomisation was stratified by study site, whereas in the study one main phase and in study two, randomisation was stratified by study site, age group, and baseline B burgdorferi (sensu lato) serostatus. All individuals were masked, other than staff involved in randomisation, vaccine preparation or administration, or safety data monitoring. The primary endpoint for both studies was OspA-specific IgG geometric mean titres (GMTs) at 1 month after the third vaccination and was evaluated in the per-protocol population. Safety endpoints were evaluated in the safety population: all participants who received at least one vaccination. Both studies are registered at ClinicalTrials.gov (study one NCT03769194 and study two NCT03970733) and are completed.

FINDINGS:

For study one, 573 participants were screened and randomly assigned to treatment groups between Dec 21, 2018, and Sept, 26, 2019. For study two, 248 participants were screened and randomly assigned between June 26 and Sept 3, 2019. In study one, 29 participants were assigned to receive 90 μg VLA15, 215 to 135 μg, 205 to 180 μg, and 124 to placebo. In study two, 97 participants were assigned to receive 135 μg VLA15, 100 to 180 μg, and 51 to placebo. At 1 month after the third vaccination (ie, month 3), OspA-specific IgG GMTs in study one ranged from 74·3 (serotype 1; 95% CI 46·4-119·0) to 267·4 units per mL (serotype 3; 194·8-367·1) for 90 μg VLA15, 101·9 (serotype 1; 87·1-119·4) to 283·2 units per mL (serotype 3; 248·2-323·1) for 135 μg, and 115·8 (serotype 1; 98·8-135·7) to 308·6 units per mL (serotype 3; 266·8-356·8) for 180 μg. In study two, ranges at 1 month after the third vaccination (ie, month 7) were 278·5 (serotype 1; 214·9-361·0) to 545·2 units per mL (serotype 2; 431·8-688·4) for 135 μg VLA15 and 274·7 (serotype 1; 209·4-360·4) to 596·8 units per mL (serotype 3; 471·9-754·8) for 180 μg. Relative to placebo, the VLA15 groups had more frequent reports of solicited local adverse events (study one: 94%, 95% CI 91-96 vs 26%, 19-34; study two: 96%, 93-98 vs 35%, 24-49 after any vaccination) and solicited systemic adverse events (study one: 69%, 65-73 vs 43%, 34-52; study two: 74%, 67-80 vs 51%, 38-64); most were mild or moderate. In study one, unsolicited adverse events were reported by 52% (48-57) of participants in the VLA15 groups and 52% (43-60) of those in the placebo groups; for study two these were 65% (58-71) and 69% (55-80), respectively. Percentages of participants reporting serious unsolicited adverse events (study one: 2%, 1-4; study two: 4%, 2-7) and adverse events of special interest (study one: 1%, 0-2; study two: 1%, 0-3) were low across all groups. A single severe, possibly related unsolicited adverse event was reported (worsening of pre-existing ventricular extrasystoles, which resolved after change of relevant concomitant medication); no related serious adverse events or deaths were reported.

INTERPRETATION:

VLA15 was safe, well tolerated, and elicited robust antibody responses to all six OspA serotypes. These findings support further clinical development of VLA15 using the 180 μg dose and 0-2-6-month schedule, which was associated with the greatest immune responses.

FUNDING:

Valneva.

121

项与 VLA15 相关的新闻（医药）

2026-02-19

·BioSpace

Valneva Reports Preliminary Unaudited 2025 Revenue and Cash and Provides 2026 Outlook

Total Revenues of €174.7 million in line with guidance, including €157.9 million in product sales Strong year-end cash position of €109.7 million, with enhanced financial flexibility following successful debt refinancing 2026 to be a potentially transformational year with Phase 3 Lyme disease data expected in the first half of the year Chief Executive Officer’s contract renewed for a further three-year term, ensuring continuity in leadership Lyon (France), February 19, 2026 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) a specialty vaccine company, today reported its preliminary unaudited full-year 2025 revenue and cash results 1 and provided a first outlook for 2026. 2025 full-year revenue and cash results (unaudited): Total revenues of €174.7 million in 2025 compared to €169.6 million in 2024 including recognition of variable consideration relating to the research collaboration and licensing agreement for the Lyme disease program Product sales of €157.9 million compared to €163.3 million in 2024, as third-party sales decreased by 42.3% to €19.2 million (€33.2 million in 2024), as expected Product sales increased by 9% at constant exchange rate (CER) 2) and excluding third-party sales Cash and cash equivalents of €109.7 million as of December 31, 2025, compared to €168.3 million as of December 31, 2024 2026 Outlook and Financial Guidance: First Phase 3 data readout for Lyme disease vaccine candidate anticipated in the first half of 2026, with regulatory submissions expected to follow as planned by Pfizer, subject to positive results If successful, VLA15 will be the fourth vaccine developed by Valneva and its successful commercialization by Pfizer would enable Valneva to further expand and accelerate a pipeline of innovative vaccines in line with its strategic vision First Phase 2 data for tetravalent shigella vaccine candidate S4V2 A decision on subsequent development steps is anticipated in the second half of 2026 Progress in enhancing the R&D pipeline with differentiated vaccine candidates addressing areas of high unmet medical need Total revenues for 2026 are expected in the range of €155-170 million, including product sales between €145-160 million Lower product sales guidance in 2026 compared to 2025 reflects continued growth of established commercial brands, offset by the wind-down of third-party sales as previously guided. Disciplined cash management to continue with operating cash burn expected to decline further in 2026 while sustaining strategic R&D investments Peter Bühler, Valneva’s Chief Financial Officer , commented, “2025 challenged our resilience while reaffirming the strength of our team’s disciplined execution. We remained committed to growing our commercial brands and made strong progress across our key R&D programs, despite headwinds around IXCHIQ ® and the broader geopolitical pressures. As we enter 2026, we look forward to the potentially transformative Phase 3 data readout for our Lyme disease vaccine candidate, while remaining focused on prudent capital allocation, to support shaping and growing our business in line with our strategic vision.” Valneva also announced today that its Board of Directors has renewed Thomas Lingelbach’s mandate as Chief Executive Officer for a further three-year term and confirmed his continued role as a Board member, subject to approval at the Company’s 2026 Annual General Meeting. Anne-Marie Graffin, Chairperson of Valneva’s Board of Directors, commented, “As a co-founder of the Company, Thomas has been a driving force behind our growth, culture, and sustained success over the past 13 years. The Board firmly believes that his continued leadership is critical as we enter the next era of the Company’s development, and we have full confidence in his ability to drive the Company’s future and deliver value for all our stakeholders.” Non-IFRS Financial Measures - Product sales (excluding third-party sales) at constant exchange rates: References to changes in net sales at constant exchange rates (CER) indicate that the impact of currency fluctuations has been removed. This is done by recalculating net sales for the period in question using the exchange rates applied in the prior period. € in million Twelve months ended December 31 (unaudited results, consolidated per IFRS) 2025 2024 Year-over-year growth % Product sales 157.9 163.3 - 3.3% Third-party product sales 19.2 33.2 - 42.3% Product sales excluding third-party sales 138.7 130.1 + 6.7% Effect of exchange rates (excluding third-party sales) 3.1 Product sales (excluding third-party sales) at constant exchange rates (CER) 141.8 + 9.0% About Valneva SE We are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. We take a highly specialized and targeted approach, applying our deep expertise across multiple vaccine modalities, focused on providing either first-, best- or only-in-class vaccine solutions. We have a strong track record, having advanced multiple vaccines from early R&D to approvals, and currently market three proprietary travel vaccines. Revenues from our growing commercial business help fuel the continued advancement of our vaccine pipeline. This includes the only Lyme disease vaccine candidate in advanced clinical development, which is partnered with Pfizer, the world’s most clinically advanced Shigella vaccine candidate, as well as vaccine candidates against other global public health threats. More information is available at . Valneva Investor and Media Contacts Laetitia Bachelot-Fontaine VP, Global Communications and European Investor Relations M +33 (0)6 4516 7099 laetitia.bachelot-fontaine@valneva.com Joshua Drumm, Ph.D. VP, Global Investor Relations M +001 917 815 4520 joshua.drumm@valneva.com Forward-Looking Statements This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to the progress, timing, results and completion of research, development and clinical trials for product candidates, to regulatory approval of product candidates and review of existing products, and financial guidance including projected product sales, total revenue and total R&D investments. In addition, even if the actual results or development of Valneva are consistent with the forward-looking statements contained in this press release, those results or developments of Valneva may not be sustained in the future. In some cases, you can identify forward-looking statements by words such as “could,” “should,” “may,” “expects,” “anticipates,” “believes,” “intends,” “estimates,” “aims,” “targets,” or similar words. These forward-looking statements are based largely on the current expectations of Valneva as of the date of this press release and are subject to a number of known and unknown risks and uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievement expressed or implied by these forward-looking statements. In particular, the expectations of Valneva could be affected by, among other things, uncertainties and delays involved in the development and manufacture of vaccines, unexpected clinical trial results, unexpected regulatory actions or delays, competition in general, currency fluctuations, the impact of the global and European credit crisis, and the ability to obtain or maintain patent or other proprietary intellectual property protection. Success in preclinical studies or earlier clinical trials may not be indicative of results in future clinical trials. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements made in this press release will in fact be realized. Valneva is providing this information as of the date of this press release and disclaims any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. 1 The financial figures presented in this release are preliminary and unaudited. The final audited financial results, which remain subject to approval by the Board of Directors, are expected to be published in March. 2 Changes in product sales are presented at constant exchange rate (CER), where indicated. The definition of CER is provided in this press release Attachment 2026_02_19_FY2025_RevCash_PR_EN_Final

财报疫苗高管变更临床3期

2026-02-19

·Pharmaceutical Technology

Valneva’s Lyme disease vaccine offers beacon of hope amid 2025 sales dip

Valneva’s commercial portfolio is made up of three travel vaccines. Credit: mundissima/Shutterstock.com Valneva reported a drop in product sales in 2025 amid market restrictions for chikungunya vaccine Ixchiq, with the travel vaccine specialist betting on upcoming readouts to turn the business’ growth around. As per preliminary results, Valneva’s product sales reached €157.9m ($186.1m) in 2025, a 3.3% drop from €163.3m in 2024. The company’s commercial products include Japanese encephalitis vaccine Ixiaro and cholera vaccine Dukoral, but its lead brand is Ixchiq. Ixchiq has endured a difficult regulatory spell over the past year. In August 2025, the US Food and Drug Administration (FDA) suspended Ixchiq’s license due to “serious safety concerns”. The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) followed suit in February 2026 for the same reasons. The vaccine had been temporarily suspended in people over 65 years of age in the UK in June 2025. While Valneva did not reveal Ixchiq’s sales numbers for 2025, the company said the total product sales downturn was “expected”. The segment that dragged growth was third-party sales, which decreased 42.3% – though this contributed €19.2m to the €157.9m. Despite its products not tracking well, Valneva’s total revenue increased to €174.7m in 2025, up from €169.6m in 2024. The company added that this was buoyed by the ongoing research collaboration and licensing agreement for the Lyme disease programme with Pfizer. In April 2020, Pfizer began working with Valneva to help develop the latter’s Lyme disease vaccine candidate, which was in Phase II trials at the time. Valneva expects the first Phase III (NCT05477524) data readout for the candidate, dubbed VLA15, in the first half of 2026. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence VLA15 could represent an avenue back to more positive financial results for Valneva. There is currently no approved vaccine available for the disease that is caused by a bacterial infection transmitted by infected tick bites. Recent estimates by the US Centers for Disease Control and Prevention (CDC) suggest that approximately 476,000 people may be diagnosed and treated for Lyme disease each year in the US. “VLA15’s successful commercialisation by Pfizer would enable Valneva to further expand and accelerate a pipeline of innovative vaccines in line with its strategic vision,” Valneva said in a statement. Valneva also plans to report the first Phase II data for tetravalent shigella vaccine candidate S4V2 in 2026. In-licensed from LimmaTech Biologics AG, Valneva will make a decision on the next steps of development for the jab in the second half of 2026. While shareholders prepare for pipeline updates this year, they could be set for another financially lukewarm year for Valneva. The company said it expects 2026 total revenues of between €155-170m – the higher end of this forecast would still represent a near $5m drop from 2025’s figure. Peter Bühler, Valneva’s chief financial officer, commented: “2025 challenged our resilience while reaffirming the strength of our team’s disciplined execution. We remained committed to growing our commercial brands and made strong progress across our key R&D programmes, despite headwinds around Ixchiq and the broader geopolitical pressures. As we enter 2026, we look forward to the potentially transformative Phase III data readout for our Lyme disease vaccine candidate, while remaining focused on prudent capital allocation, to support shaping and growing our business in line with our strategic vision.” Valneva is not the only company to struggle with sales growth amid a US vaccine landscape that has undergone volatility in the past year. Moderna also reported declining vaccine sales in its Q3 results, leading to a trim in its 2025 guidance. Health Secretary Robert F Kennedy (RFK) Jr has implemented policies to reduce reliance on vaccines for respiratory diseases, though there has been a knock on effect to the travel vaccine sector.

疫苗临床2期引进/卖出临床3期

2026-02-04

·新湾novaBAY

新湾药点｜辉瑞2025年业绩深度解析

2 月 3 日，制药巨头辉瑞（Pfizer）披露 2025 年第四季度及全年财报。在 COVID-19 相关产品收入大幅回落的背景下，公司凭借核心产品矩阵的稳健表现、管线的突破性进展与精细化运营，实现全年营收 626 亿美元，调整后稀释每股收益 3.22 美元，超额完成全年预期目标。更重要的是，4 项关键审批、8 项 III 期临床数据读出、11 项核心关键研究启动，以及肥胖、肿瘤等领域的管线爆发，正推动辉瑞从疫情后的调整期迈向高质量增长的新周期。财务表现：逆境中彰显运营韧性 2025 年的辉瑞，在营收结构调整中展现出强大的运营韧性。全年总营收 626 亿美元，虽受 COVID-19 产品收入下滑拖累，但剔除该板块后，核心业务实现稳健的运营收入增长。第四季度营收 176 亿美元，同比微降 3%，这一波动主要源于 Comirnaty 等新冠相关产品的收入回落，而非核心业务的基本面变化。盈利端的表现更能体现公司的成本控制与结构优化成效。全年调整后稀释每股收益 3.22 美元，第四季度达 0.66 美元，同比增长 3%，增速跑赢营收，核心盈利能力持续提升。毛利率方面，调整后销售成本占比降至 28.9%，较上年同期下降 3.4 个百分点，这一方面得益于产品结构向高毛利创新药倾斜，另一方面也反映出公司的生产优化与成本调整方案的显著成效。费用管控上，辉瑞展现出精准的资源配置能力。销售、一般及管理费用（SI&A）第四季度同比下降 5% 至 41 亿美元，全年同比微降 1% 至 107.33 亿美元，营销推广与企业职能支出的精细化管理成效显著；研发投入则向核心管线聚焦，全年调整后研发费用同比增长 4%，第四季度达 31 亿美元，重点加码肿瘤与肥胖领域的候选药物开发，为未来增长储备动力。资本配置上，辉瑞坚持 “研发投入 + 股东回报 + 债务优化” 的平衡策略。2025 年累计向股东返还 98 亿美元，同时投入 104 亿美元用于内部研发、88 亿美元用于业务拓展（包括 Metsera 收购与三生制药授权合作），并将整体杠杆率稳定在约 2.7 倍的目标水平。这种兼顾短期回报与长期增长的资本运作，为公司穿越行业周期提供了坚实支撑。管线突破：多领域多点开花，核心资产成增长引擎 2025 年的辉瑞管线，堪称 “多点突破、全面开花”。公司不仅在既有优势领域持续巩固地位，更在肥胖、肿瘤等热门赛道实现关键性进展，为后续增长注入强劲动力。肥胖领域无疑是辉瑞 2025 年的最大惊喜。核心候选药物 PF’3944（MET-097i）作为一款全偏向性、超长效 GLP-1 受体激动剂，凭借独特的白蛋白结合结构实现超长半衰期，为月度给药奠定基础。Phase 2b VESPER-3 试验数据惊艳：从每周给药切换至每月给药后，患者体重仍持续下降，3.2mg 与 4.8mg 月度剂量组在 28 周时较安慰剂分别减重 12.2% 和 12.3%，且未出现体重平台期；模型预测 9.6mg 高剂量组减重效果或可达 15.8%。安全性方面同样表现优异，胃肠道不良事件以轻中度为主，因不良反应导致的停药率仅 4.6%，与每周给药的 GLP-1 类药物相当。基于这一数据，辉瑞计划 2026 年推进 10 项 III 期试验，覆盖无 2 型糖尿病、合并 2 型糖尿病的肥胖 / 超重人群，以及月度、每周给药方案，同时布局并发症干预与联合疗法，剑指千亿美元级肥胖治疗市场。肿瘤领域持续深耕，ADC 与双特异性抗体成核心发力点。通过收购 Seagen 纳入的 PADCEV，与 pembrolizumab 联合用于肌浸润性膀胱癌（MIBC）的两项 III 期试验（EV-303、EV-304）进展顺利，其中 EV-303 已提交监管申请，有望成为顺铂不耐受 MIBC 患者的新选择。同时，公司推进多款新型 ADC 药物，包括 sigvotatug vedotin（SV）、PDL1V 等，覆盖非小细胞肺癌、头颈部鳞状细胞癌等多个适应症，其中 SV 已进入 III 期开发阶段。双特异性抗体领域，PD-1xVEGF 双抗 PF’4404 布局 1 线转移性结直肠癌、非小细胞肺癌等适应症，2026 年预计启动 4 项 III 期试验；ELREXFIO 在双药暴露复发 / 难治性多发性骨髓瘤中的 III 期数据即将读出，有望进一步拓展应用场景。此外，TALZENNA 与 XTANDI 联合疗法在转移性去势敏感性前列腺癌中的 III 期试验（TALAPRO-3）、TUKYSA 在 HER2 + 转移性乳腺癌维持治疗中的研究（HER2CLIMB-05），均为肿瘤业务增添增长确定性。其他治疗领域同样亮点纷呈。偏头痛领域，NURTEC 持续领跑口服 CGRP 类药物市场，2025 年第四季度斩获 83% 的新处方份额，同时推进慢性偏头痛、月经相关性偏头痛等新适应症开发；罕见病领域，HYMPAVZI（marstacimab）用于血友病 A/B 合并抑制剂患者的 III 期试验数据积极，已提交监管申请，有望填补临床空白；疫苗领域，Lyme 病疫苗候选物 PF-07307405 进入 III 期开发，25 价肺炎球菌结合疫苗（PCV25）推进顺利，为疫苗业务注入新活力。战略布局：并购整合 + AI 赋能，构建长期增长护城河辉瑞 2025 年的稳健表现，离不开其清晰的战略布局 —— 通过并购整合补强管线短板，借助技术赋能提升运营效率，同时聚焦核心领域打造差异化竞争优势。在业务发展层面，公司延续 “精准并购 + 授权合作” 的策略。通过收购 Seagen，快速获取 PADCEV、ADCETRIS 等成熟 ADC 产品与多款临床阶段候选药物，强化肿瘤领域布局；收购 Metsera 与 Biohaven，分别补强代谢疾病与神经领域管线；与三生制药达成授权合作，推进 PD-1xVEGF 双抗在华临床试验，加速中国市场拓展。这些交易不仅丰富了公司的产品矩阵，更整合了核心技术平台，为后续创新奠定基础。 AI 赋能成为辉瑞转型的重要抓手。公司将 AI 全面嵌入研发、生产与商业化全流程：研发端通过 AI 加速药物发现与临床设计，提升管线推进效率；生产端借助 “Golden Batch” 等 AI 工具优化制造流程，支撑生产优化落地；商业化端利用 AI 分析用户数据，实现精准营销与个性化推广。这种 “AI + 医药” 的深度融合，不仅降低了运营成本，更让资源向高价值项目集中，为长期增长提供技术支撑。成本优化与资源聚焦同步推进。公司通过成本重组与生产优化计划，预计到 2027 年累计实现 72 亿美元净成本节约，其中 2025 年已超额完成目标，节省的资金将重点再投资于研发与核心业务拓展。同时，公司主动剥离非核心资产，聚焦肿瘤、肥胖、疫苗、罕见病等优势领域，避免资源分散，提升整体运营效率。 2026展望：机遇与挑战并存，管线催化剂成关键面向 2026 年，辉瑞给出了审慎而乐观的财务指引：预计全年营收 595 亿至 625 亿美元，调整后稀释每股收益 2.80 至 3.00 美元，有效税率约 15.0%。这一指引既考虑了部分产品专利到期带来的 generic 与 biosimilar 竞争（预计造成约 15 亿美元收入冲击），也反映了公司对核心管线商业化与新适应症拓展的信心。 2026 年将是辉瑞管线的 “关键催化年”。肥胖领域，PF’3944 的 10 项 III 期试验将全面推进，月度给药方案的临床数据与市场潜力备受关注；肿瘤领域，PADCEV 的 MIBC 适应症监管审批、ELREXFIO 的 III 期数据读出、多款 ADC 与双抗的 III 期试验启动，将持续为业务增长赋能；罕见病与疫苗领域，HYMPAVZI 的获批、Lyme 病疫苗的 III 期进展，有望打开新的市场空间。此外，公司计划启动约 20 项关键研究，进一步充实管线厚度。但挑战同样不容忽视。部分成熟产品面临的竞争压力、创新药研发的不确定性、全球医疗保健成本控制带来的定价压力，都将考验公司的应变能力。不过，从行业趋势来看，辉瑞在肥胖、肿瘤等高速增长赛道的布局，与全球未被满足的医疗需求高度契合；而其通过并购整合与 AI 赋能构建的竞争优势，也为穿越行业周期提供了保障。从更长远视角看，辉瑞正通过 “管线深耕 + 技术赋能 + 全球化布局”，逐步实现从 “疫情受益企业” 向 “多元化创新药企” 的转型。2026 年的管线数据与商业化进展，将是检验这一转型成效的关键。这家制药巨头能否凭借差异化的产品矩阵与高效的运营体系，在激烈的市场竞争中持续领跑，值得行业持续关注。参考资料：Pfizer 4Q 2025 Earnings Teleconference 免责声明：本文基于 Pfizer 官方发布公开文件解读，不构成投资建议。关于我们京卫源孵化产业园位于大兴生物医药产业基地华佗路51号院，在空间规划上精准匹配生物医药产业特性，通过科学优化的面积配置、高适配性层高设计、稳定可靠的电力保障、高标准承重结构及产业化配套空间，构建起覆盖早期研发、中试放大至产业化落地的空间集群，可以充分满足各类生物医药项目不同发展阶段的差异化需求。为加速生物医药创新成果转化落地，园区凭借深耕行业多年积累的临床转化经验与市场前瞻洞察力，聚焦生物医药创新孵化核心赛道，构建了覆盖生物医药全生命周期的一站式全链条服务生态体系，形成三大核心服务能力：一是覆盖药物研发到上市销售等关键环节的技术孵化与转化赋能能力；二是链接和加速国际国内优质资源的双BD合作服务能力，助力项目拓展全球市场网络；三是从项目发展规划到市场价值变现的全流程加速服务能力，全方位降低项目开发风险、提高开发效率，最大化项目临床和市场价值。二期建成后，京卫源以“新湾novaBAY”为品牌引领，持续整合产业链上下游资源，致力于成为生物医药创新项目的“成长沃土”与“加速引擎”，为区域生物医药产业高质量发展注入强劲动能。

财报临床3期并购

100 项与 VLA15 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
莱姆病	临床3期	美国	Valneva Sweden AB	2022-01-30
神经莱姆病	临床1期	美国	Pfizer Inc.	2017-01-31
神经莱姆病	临床1期	美国	VALNEVA Austria GmbH	2017-01-31
神经莱姆病	临床1期	比利时	VALNEVA Austria GmbH	2017-01-31
神经莱姆病	临床1期	比利时	Pfizer Inc.	2017-01-31

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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


NCT04801420 (VLA15-221, GlobeNewswire) 人工标引	临床2期	莱姆病	560	VLA15 (month 0-2-6)	壓廠積築選積衊觸鹽齋(壓壓醖願壓範觸築夢簾) = 繭壓遞憲醖夢顧齋鹹顧壓選製醖願繭淵鹹鑰遞 (醖範壓簾鏇鹹鑰醖壓壓 ) 更多	积极	2025-11-26
				VLA15 (month 0-6)	壓廠積築選積衊觸鹽齋(壓壓醖願壓範觸築夢簾) = 積繭壓鬱淵夢製遞構顧壓選製醖願繭淵鹹鑰遞 (醖範壓簾鏇鹹鑰醖壓壓 ) 更多
NEWS 人工标引	临床2期	莱姆病	560	VLA15	蓋積衊鏇願願選淵衊鬱(艱積醖艱壓鹹衊壓餘構) = Seroconversion rates hit 100% for all outer surface protein A serotypes in all age groups 餘夢廠觸憲鬱顧鏇蓋繭 (齋遞窪廠鹹艱獵廠壓繭 ) 更多	积极	2025-09-03
				placebo
NCT04801420 (VLA15-221, NEWS) 人工标引	临床2期	莱姆病	-	VLA15	膚壓顧齋衊構夢鑰廠觸(襯範膚積簾壓鹹淵顧觸) = New results from the study demonstrated a significant anamnestic antibody response across all six serotypes covered by the vaccine in paediatric, adolescent, adult and older adult participants, measured one month after administration of the second booster dose. 襯鏇選簾構觸廠鑰餘襯 (簾糧願糧鹹築糧糧製鹽 ) 更多	积极	2024-09-06
				Placebo
NCT04801420 (VLA15-221, GlobeNewswire) 人工标引	临床2期	莱姆病	560	VLA15 second booster dose	選糧艱夢壓製窪鏇壓淵(鹽積網鹹夢觸鹽鏇鑰膚) = 構壓製齋襯鬱鑰糧糧衊製構築鹽壓網範網簾鹹 (齋襯遞簾鬱蓋遞獵淵構 )	积极	2024-09-03
				Placebo	-
NCT04801420 (VLA15-221, CTgov)	临床2期	莱姆病	625	VLA15 (Group 1: VLA15)	鏇廠構衊廠憲選鹽壓廠 = 膚築鹽鏇選廠壓餘壓範鏇膚夢襯糧夢鑰夢築醖 (憲獵醖蓋蓋膚鏇構鑰醖, 積願鬱顧齋鏇膚夢鑰襯 ~ 糧糧網願範齋齋鹹積憲) 更多	-	2023-06-07
				Placebo+VLA15 (Group 2: VLA15 + Placebo)	鏇廠構衊廠憲選鹽壓廠 = 觸築積範願壓醖製蓋製鏇膚夢襯糧夢鑰夢築醖 (憲獵醖蓋蓋膚鏇構鑰醖, 餘構繭鬱繭獵糧鬱鑰窪 ~ 壓夢鬱鏇鹽餘夢繭簾窪) 更多
NCT03970733 (CTgov)	临床2期	莱姆病	246	VLA15 (VLA15 With Alum Lower Dose)	餘鑰觸鏇膚餘繭鏇簾鏇(淵壓顧襯鑰憲繭製選窪) = 選鬱積夢衊築築顧鹽醖範鹹築鬱簾齋範窪糧願 (鑰鏇網艱餘繭憲膚顧鬱, 餘觸繭壓衊網繭艱膚艱 ~ 顧製範願廠鬱淵夢築繭) 更多	-	2021-07-08
				VLA15 (VLA15 With Alum Higher Dose)	餘鑰觸鏇膚餘繭鏇簾鏇(淵壓顧襯鑰憲繭製選窪) = 膚襯壓蓋廠窪糧選範淵範鹹築鬱簾齋範窪糧願 (鑰鏇網艱餘繭憲膚顧鬱, 蓋製餘鏇餘築網壓製鬱 ~ 鏇築構築簾壓齋網憲積) 更多
NCT03769194 (CTgov)	临床2期	莱姆病	572	VLA15 (VLA15 Low Dose)	鹹簾襯糧鹽積餘膚襯淵(壓蓋選網鑰鬱憲鏇鏇鬱) = 壓鏇蓋淵範餘積窪廠鬱積醖艱範製觸遞衊鏇齋 (製鬱製獵簾積積鬱築鹹, 膚齋選觸網夢鹽顧鑰鑰 ~ 鑰選艱衊窪鑰構選鹹襯) 更多	-	2021-06-30
				VLA15 (VLA15 Medium Dose)	鹹簾襯糧鹽積餘膚襯淵(壓蓋選網鑰鬱憲鏇鏇鬱) = 鹽簾繭鏇糧範簾積築艱積醖艱範製觸遞衊鏇齋 (製鬱製獵簾積積鬱築鹹, 醖廠餘淵觸網網願襯繭 ~ 糧鏇鬱夢蓋蓋鹽窪築鏇) 更多