Chikungunya virus vaccine (Valneva)

Total product sales of €64.0 million In-line with expectations; full-year guidance of €135 -150 million reaffirmed Solid cash position of €121.5 million as of end June 2026 Reflects disciplined cash management and proceeds from the recent reserved offering 1 Restructuring program implemented with positive P&L and cash flow impacts expected in the second half of the year and beyond Regulatory decisions for Lyme disease vaccine candidate expected in the next twelve months 2 Pfizer remains optimistic about obtaining registration for the vaccine candidate 3 Lyon (France), August 13, 2026 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported its condensed consolidated financial results for the first half of the year ended June 30, 2026, provided key corporate updates, and reaffirmed its financial guidance for 2026. The half year financial report, including the condensed consolidated interim financial report and the half year management report, is available on the Company’s website ( Financial Reports – Valneva ). Valneva will provide a live webcast of its half year 2026 results conference call beginning at 3 p.m. CEST / 9 a.m. EDT today. This webcast will also be available on the Company’s website. Please refer to this link: First-half 2026 Financial Update Total revenues were €65.8 million, including €64.0 million in product sales, compared with €97.6 million and €91.0 million, respectively, in the first half of 2025. The year-over-year decrease primarily reflects the planned wind-down of third-party sales (down €10.5 million versus the first half of 2025) and the expected phasing of product sales, including the distribution transition in Germany and timing of IXIARO ® shipments to the U.S. Department of Defense (DoD). Cash position was €121.5 million as of June 30, 2026, compared with €109.7 million as of December 31, 2025. This strong cash position reflects the positive impact of restructuring initiatives, disciplined cash management and €37 million in gross proceeds from the successful reserved offering completed in the second quarter of 2026. Net loss of €63.3 million compared with a net loss of €20.8 million in the first half of 2025, reflecting lower gross margin due to lower sales and manufacturing volumes as well as one-off impacts on cost of goods sold, including IXCHIQ ® -related contract termination costs and inventory write-offs. Financial Outlook Despite the continued adverse impact of the geopolitical environment on travel, Valneva reaffirmed its 2026 guidance with expected product sales of €135 million to €150 million and total revenues of €145 million to €160 million. Product gross margins are expected to improve in the second half of the year following one-off effects in the first half of 2026 Valneva successfully implemented a global restructuring initiative 4 to reduce its cash burn through a significant workforce reduction, the reprioritization and rescheduling of R&D activities and the streamlining of its global operations. As part of this initiative, the Company also agreed to sell its Nantes site in France for €6.2 million. A preliminary sale agreement has been signed with Nantes Métropole, and the transaction is expected to close in September 2026. Peter Bühler, Valneva’s Chief Financial Officer, commented, “Our focus over the past few months, following the Lyme VALOR results has been to restructure and refocus our operations. The successful financing completed in April has enabled us to build and maintain a strong cash position, allowing us to prioritize resources on our core business and key strategic priorities while preserving the flexibility to accelerate growth should the Lyme program progress successfully toward licensure and commercialization.” Financial Information (Unaudited results, consolidated per IFRS) € in million Six months ended June 30, 2026 2025 Total Revenues 65.8 97.6 Product Sales 64.0 91.0 Profit / (loss) for the period (63.3) (20.8) Adjusted EBITDA 5 (40.1) (6.0) Cash and cash equivalents 121.5 161.3 Clinical Stage Programs LYME DISEASE VACCINE CANDIDATE – LB6V (formerly VLA15) Regulatory decisions expected in the next twelve months In March 2026, Valneva and Pfizer announced topline results from the Phase 3 VALOR “Vaccine Against Lyme for Outdoor Recreationists” clinical trial ( NCT05477524 ) evaluating their investigational six valent OspA-based Lyme disease vaccine candidate LB6V 6 . Since then, Pfizer has been engaging with regulatory authorities to align on potential pathways to licensure and has expressed optimism regarding the vaccine candidate's regulatory approval prospects 7 . Regulatory decisions are expected in the next twelve months 8 . LB6V is currently the only Lyme disease vaccine candidate in late-stage clinical development. The program has received PRIME designation from the European Medicines Agency (EMA) and Fast Track designation from the U.S. Food and Drug Administration (FDA). If approved, LB6V has the potential to address a significant unmet medical need, with more than 80 million people in the United States and over 200 million people in Europe estimated to live in areas at elevated risk of Lyme disease. CHIKUNGUNYA VACCINE - IXCHIQ ® / VLA1553 Ongoing post-marketing commitments activities, including Pilot Vaccination Campaign in Brazil Several post-marketing commitments activities for IXCHIQ ® are ongoing. These include the ongoing Pilot Vaccination Strategy (PVS) in Brazil. This is the first large-scale public vaccination campaign using IXCHIQ ® in a real-world setting, conducted by the Brazilian Ministry of Health with support from Valneva and its local partner, Instituto Butantan. To date, approximately 50,000 adults aged 18 to 59 years have already been vaccinated as part of this campaign. The PVS, together with several studies that are ongoing or in preparation 9 , 10 , 11 , 12 , will serve as the basis for current and planned post-marketing Phase 4 studies evaluating the effectiveness and safety of IXCHIQ ® to generate real-world evidence in larger and more specialized populations. SHIGELLA VACCINE CANDIDATE – S4V2 First Phase 2 results expected shortly S4V2 is the world’s most clinically advanced tetravalent vaccine candidate against shigellosis, the second leading cause of fatal diarrhea worldwide. Two clinical trials of S4V2, a Phase 2 infant safety and immunogenicity trial 13 , and a Phase 2b Human Challenge trial (CHIM) 14 , sponsored by LimmaTech Biologics AG, are ongoing. Results from both studies are expected in the third quarter of 2026. Based on the outcome of these studies and the future R&D strategy, Valneva will determine the appropriate next steps, including whether to assume responsibility for the vaccine candidate's late-stage clinical development 15 . No approved multivalent Shigella vaccine is currently available outside of Russia or China, and the development of Shigella vaccines has been identified as a priority by the World Health Organization (WHO) 16 . In October 2024, the U.S. FDA granted Fast Track designation to S4V2, recognizing its potential to address a serious condition and fill an unmet medical need 17 . The global market opportunity for a vaccine against Shigella is estimated to exceed $500 million annually 18 . First-Half 2026 Financial Review (Unaudited, consolidated under IFRS) Revenues Valneva’s total revenues were €65.8 million in the six months ended June 30, 2026, compared to €97.6 million for the same period in 2025. The decrease was primarily attributable to the planned discontinuation of the majority of third-party sales, the expected phasing of product sales, including the timing of IXIARO ® shipments to the U.S. DoD, the distributor transition in Germany as well as non-recurring outbreak-related sales of DUKORAL ® and IXCHIQ ® recorded during the first half of 2025 that did not repeat in 2026. Other revenues, including revenues from collaborations, licensing and services, amounted to €1.8 million in the first half of 2026 compared to €6.5 million for the same period in 2025, which included revenues recognized under the exclusive license agreement with the Serum Institute of India for IXCHIQ ® , which was terminated in 2025. Product Sales Total product sales amounted to €64.0 million in the first half of 2026, compared to €91.0 million in the first half of 2025. In line with Valneva’s strategy and prior communications, third-party distribution activities have significantly decreased following the expiration of the Company’s main distribution agreement in 2025. Consequently, third-party product sales decreased by €10.5 million, or 91.6%, to €1.0 million in the first half of 2026 and are expected to represent less than 5% of product sales by the end of the year. Valneva’s commercial portfolio comprises three vaccines: IXIARO ® /JESPECT ® , DUKORAL ® and IXCHIQ ® . Japanese Encephalitis Vaccine IXIARO ® /JESPECT ® Sales of IXIARO ® /JESPECT ® were €44.0 million in the first half of 2026, compared with €54.7 million in the first half of 2025. The year-over-year comparison primarily reflects the transition to a new distributor in Germany in January 2026 as well as the product sales phasing, notably the timing of deliveries to the U.S. DoD. Deliveries under the contract signed in January 2025 continued during the period, and Valneva expects to make additional IXIARO ® deliveries to the DoD during the remainder of 2026, including under a new contract expected in the third quarter. Foreign currency fluctuations had an adverse impact of €1.5 million on IXIARO ® /JESPECT ® sales during the first half of 2026. Cholera / ETEC 19 -Diarrhea Vaccine DUKORAL ® DUKORAL ® sales were €14.7 million in the first half of 2026, compared with €17.4 million in the first half of 2025. The prior-year period benefited from one-time sales associated with the supply of vaccine doses to Mayotte in response to a cholera outbreak. Sales in the first half of 2026 were also affected by the transition to a new distributor in Germany in January 2026. Existing inventory held by the previous distributor remained sufficient to meet market demand during the period, temporarily reducing product shipments, while the geopolitical situation continued to adversely affect travel. Deliveries under the new distribution arrangement are gradually resuming. Foreign currency fluctuations had an adverse impact of €0.4 million on DUKORAL ® sales during the first half of 2026. Chikungunya Vaccine IXCHIQ ® IXCHIQ ® sales were €4.4 million in the first half of 2026 including initial shipments of the vaccine’s drug substance to Instituto Butantan, compared with €7.5 million in the first half of 2025. The prior-year period benefited from sales in the U.S. and from 40,000 doses provided to the French island of La Réunion in response to a chikungunya outbreak. In light of the product uptake in travel, the Company is currently evaluating its future commercial strategy for IXCHIQ ® including a potential focus on endemic markets. Operating Result and adjusted EBITDA Costs of goods and services sold were €59.5 million in the first half of 2026, compared to €47.2 million in the first half of 2025. As a result, gross profit decreased to €6.3 million. The decrease in gross profit was primarily attributable to lower sales and manufacturing volumes across the portfolio, adverse cost impacts related to IXCHIQ ® inventory provisions and third-party manufacturing, supply contract termination costs, and higher idle manufacturing costs that were neither capitalized nor allocated to products. As a result, product-level gross margin before unallocated costs decreased to €14.7 million in the first half of 2026 from €54.4 million in the first half of 2025. Gross profit was further reduced by €9.4 million in unallocated manufacturing costs, including idle capacity and other costs not allocated to products, compared to €6.0 million in the first half of 2025. € in million Six months ended June 30, 2026 (unaudited results, consolidated per IFRS) IXIARO DUKORAL IXCHIQ 3PP Total Products Other / Unallocated / Services Total Product Sales 44.0 14.7 4.4 1.0 64.0 64.0 Cost of Goods Sold (19.2) (11.1) (18.3) (0.8) (49.3) (9.4) (58.7) Gross Profit 24.8 3.6 (13.9) 0.2 14.7 Gross Profit / Product sales 56.4% 24.7% (315.1%) 16.8% 23.0% Other Revenues 0.1 0.1 1.7 1.8 Cost of Services (0.8) (0.8) Total Cost of Goods, Services (10.2) (59.5) Gross Profit (8.5) 6.3 Gross Profit / Total revenues 9.6%* * as % of total revenues € in million Six months ended June 30, 2025 (unaudited results, consolidated per IFRS) IXIARO DUKORAL IXCHIQ 3PP Total Products Other / Unallocated / Services Total Product Sales 54.7 17.4 7.5 11.4 91.0 91.0 Cost of Goods Sold (18.9) (8.2) (2.5) (7.0) (36.6) (6.0) (42.5) Gross Profit 35.8 9.2 5.0 4.5 54.4 Gross Profit / Product sales 65.5% 52.9% 66.2% 39.1% 59.8% Other Revenues 4.4 4.4 2.1 6.5 Cost of Services (0.4) (0.4) (4.3) (4.6) Total Cost of Goods, Services (10.2) (47.2) Gross Profit (8.1) 50.4 Gross Profit / Product sales 51.7% * * as % of total revenues IXIARO ® gross margin was 56.4% in the first half of 2026, compared to 65.5% in the first half of 2025. The decrease mainly reflects lower volumes and adverse changes in manufacturing costs, partly offset by a favorable average selling price and product/country mix effect. The prior year gross margin had benefited from a particularly high manufacturing volume and related cost absorption. DUKORAL ® gross margin was 24.7% in the first half of 2026, compared to 52.9% in the first half of 2025 and 33.3% for the full year 2025. Gross profit decreased to €3.6 million in the first half of 2026 from €9.2 million in the first half of 2025, mainly due to lower volumes. In the first half of 2025, production timing and the prior-year manufacturing shutdown resulted in favorable absorption and inventory valuation effects. By contrast, the first half of 2026 was adversely impacted by inventory valuation and revaluation effects, as well as higher failed batch costs. Gross margin for IXCHIQ ® was negative, mostly impacted by one-time cancellation fees related to external manufacturing commitments of €9.7 million and a €4.5 million non-cash impairment of excess inventory, both resulting from lower than anticipated sales. The financial impact reflects the company’s decision to shift its commercial focus for chikungunya to endemic territories where the risk of chikungunya virus infection is highest. Third-party product gross profit was €0.2 million in the first half of 2026, compared to €4.5 million in the first half of 2025. The decrease reflects the planned wind-down of third-party distribution activities. Cost of services amounted to €0.8 million in the first half of 2026 compared to €4.6 million in the first half of 2025, which included revenue recognition from the IXCHIQ license agreement with Serum Institute of India, terminated in December 2025. Research and development expenses declined to €30.2 million in the first half of 2026, compared to €32.4 million for the same period in 2025. The decrease was largely attributable to the reprioritization and rescheduling of R&D activities. Marketing and distribution expenses totaled €13.5 million in the first half year of 2026, down significantly from €20.3 million in the first half year of 2025. The decrease primarily reflects lower advertising and promotional expenses related to IXCHIQ ® as well as reduced personnel, warehousing and distribution costs. General and administrative expenses decreased to €15.4 million in the first half of 2026, from €19.0 million in the same period of 2025. The reduction was primarily driven by lower personnel costs and savings in advisory and professional services. In the first half of 2026, €3.2 million of expenses were recognized across the affected functions in connection with the workforce reduction and restructuring program initiated in the second quarter of 2026. Other income, net of other expenses, decreased to €2.9 million in the first half of 2026 from €4.6 million in the same period of 2025. The decrease was primarily attributable to lower R&D tax credits, partially offset by higher grant income. Valneva recorded an operating loss of €49.9 million in the first half of 2026 compared with an operating loss of €16.8 million in the same period of 2025. The increase in operating loss was mainly driven by lower product sales and one-time charges related to IXCHIQ ® recorded in the first half of 2026, which were not incurred in the prior-year period. Adjusted EBITDA loss (as defined below) was €40.1 million in the first half of 2026, compared with an adjusted EBITDA loss of €6.0 million in the corresponding period of 2025. Operating Loss and Net Result Operating loss was €49.9 million in the first half of 2026 compared to €16.8 million in the first half of 2025. In the first half of 2026, about 50% of the operating loss was generated by IXCHIQ ® . Net loss was €63.3 million in the first half of 2026 compared to a net loss of €20.8 million in the first half of 2025. The increase was primarily driven by lower gross profit, reflecting lower product sales and higher COGS, including IXCHIQ ® -related manufacturing contract cancellation fees, inventory charges and idle capacity costs. The loss was partly offset by lower R&D, marketing and distribution, and G&A expenses. Finance expense and currency effects resulted in a net finance expense of €13.1 million in the first half year of 2026, compared with a net finance expense of €2.7 million in the first half year of 2025. The increased expenses were mainly attributable to unfavorable movements in the USD/EUR exchange rate, resulting in a foreign currency loss of €3.9 million in the first half of 2026 compared with a foreign currency gain of €7.8 million in the first half year of 2025. Cash Flow and Liquidity Net cash used in operating activities amounted to €13.7 million in the first half of 2026 compared to €10.9 million in the same period of 2025. The increase in the first half of 2026 was primarily driven by increased losses during the period, partially offset by lower net working capital requirements. Cash inflows from investing activities amounted to €0.6 million in the first half of 2026 compared to cash outflows of €1.6 million in the same period of 2025. Cash inflows in the first half of 2026 were largely attributable to proceeds from investments in money market funds. By contrast, cash outflows in the first half year of 2025 were mainly related to the purchase of equipment, partially offset by interest income. Net cash generated by financing activities amounted to €24.5 million in the first half of 2026 compared to a net cash inflow of €9.3 million in the same period in 2025. Cash generated during the first half of 2026 included net proceeds of €34.3 million from a capital raise completed in the second quarter of 2026. By comparison, cash inflows in the same period of 2025 included net proceeds from capital raises of €20.1 million. Both quarters included interest payments, amounting to €8.9 million in the first six months of 2026 and €9.5 million in the same period of the prior year. Cash and cash equivalents were €121.5 million as at June 30, 2026, compared to €109.7 million at December 31, 2025. Non-IFRS Financial Measures Management uses and presents IFRS results as well as the non-IFRS measure of Adjusted EBITDA to evaluate and communicate its performance. While non-IFRS measures should not be construed as alternatives to IFRS measures, management believes non-IFRS measures are useful to further understand Valneva’s current performance, performance trends, and financial condition. Adjusted EBITDA is a common supplemental measure of performance used by investors and financial analysts. Management believes this measure provides additional analytical tool. Adjusted EBITDA is defined as earnings / (loss) for the period before income tax, finance (income)/expense, foreign exchange (gain)/loss, amortization, depreciation, and impairment. A reconciliation of Adjusted EBITDA to net loss for the period, which is the most directly comparable IFRS measure, is set forth below: € in million Six months ended June 30, (unaudited results, consolidated per IFRS) 2026 2025 Loss for the period (63.3) (20.8) Add: Income tax expense 0.3 1.3 Total Finance income (1.1) (1.1) Total Finance expense 10.3 11.6 Foreign currency (gain)/loss – net 3.9 (7.8) Amortization 2.4 2.4 Depreciation 7.7 8.4 Impairment (0.3) - ADJUSTED EBITDA (40.1) (6.0) Product sales (excluding third-party sales) at constant exchange rate: References to changes in net sales at constant exchange rate (CER) indicate that currency fluctuation effects have been removed. Net sales for the period in question are recalculated using the exchange rates applied in the prior period, as detailed below: € in million Six months ended June 30, (unaudited results, consolidated per IFRS) 2026 2025 Product sales 64.0 91.0 Third-party product sales 1.0 11.4 Product sales excluding third-party sales 63.1 79.6 Effect of exchange rates (excluding third-party sales) 1.9 Product sales (excluding third-party sales) at constant exchange rates (CER) 65.0 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.bachelotfontaine@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 “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and securities laws in France. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. All statements other than statements of historical facts contained in this press release are forward-looking statements, including, but not limited to, statements with respect to: future financial performance and financial guidance including projected product sales, total revenue and total R&D investments; Valneva’s plans for investment in future growth; the timing of orders for commercial products; plans and expectations regarding the development, commercialization and commercial prospects of Valneva’s product candidates and commercial products, including the prospects and timing of actions relating to clinical studies and trials and product approvals, such as study initiations, study advancements, data readouts, submissions, filings, approvals, and label expansions; the expected benefits and availability of Valneva’s commercial products and product candidates; and potential growth opportunities and trends, including the assumptions and expectations regarding total market opportunity targeted by Valneva’s product candidates and commercial products. These forward-looking statements are based on Valneva’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties that could cause Valneva’s business, strategy, future results or performance to differ materially from those expressed or implied by the forward-looking statements. Many factors may cause differences between current expectations and actual results, including: Valneva’s success in the commercialization of its commercial products; uncertainties and delays involved in the development and manufacture of vaccines; the potential that success in preclinical testing and earlier clinical trials does not ensure that later clinical trials will generate the same results or otherwise provide adequate data to demonstrate the efficacy and safety of a product candidate; the impacts of macroeconomic conditions, including tariffs and other trade policies, the conflict in Ukraine and the conflict in the Middle East, fluctuations in inflation and uncertain credit and financial markets, on Valneva’s business, clinical trials and financial position; unexpected safety or efficacy data observed during preclinical studies or clinical trials; clinical trial site activation or enrollment rates that are lower than expected; Valneva’s ability to realize the benefits of its collaboration and license agreements; changes in expected or existing competition; changes in the regulatory environment; the uncertainties and timing of the regulatory approval process; the impact of the global and European credit crisis; the ability to obtain or maintain patent or other proprietary intellectual property protection and unexpected litigation or other disputes. Other factors that may cause the Company’s actual results to differ from those expressed or implied in the forward-looking statements in this press release are identified in the section titled “Risk Factors” in Valneva’s Annual Report on Form 20-F for the year ended December 31, 2025 filed with the U.S. Securities and Exchange Commission (“SEC”) and the Autorité des marchés financiers (“AMF”) on March 18, 2026, and in other filings made with the SEC and AMF from time to time. Valneva is providing this information as of the date of this press release and expressly 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, except as required by law. 1 Valneva Announces the Successful Completion of an €84 million Reserved Offering - Valneva 2 3 4 Valneva Reports First Quarter 2026 Financial Results and Provides Corporate Updates - Valneva 5 For additional information on Adjusted EBITDA, please refer to the “Non-IFRS Financial Measures” section at the end of the PR 6 2026_03_23_Lyme-Phase-3-Data-Read-out_PR_EN_FINAL.pdf 7 8 9 Study Details | NCT07347002 | Observational Study to Assess the Effectiveness of VLA1553 Vaccine in Preventing Chikungunya During a Pilot Vaccination Strategy in Brazil | ClinicalTrials.gov 10 Study Details | NCT07414524 | VLA1553-403 Pregnancy Surveillance Study | ClinicalTrials.gov 11 Study Details | NCT07254702 | Prospective Safety Cohort Study After VLA1553 Vaccination in Municipalities Selected for Participation in the VLA1553 Pilot Vaccination Strategy in Brazil | ClinicalTrials.gov 12 CEPI, Chikungunya 13 Valneva and LimmaTech Announce First Vaccination in Phase 2 Infant Study of Tetravalent Shigella Vaccine Candidate S4V2 - Valneva 14 Valneva and LimmaTech Announce First Vaccination in Phase 2b Human Challenge Study of Tetravalent Shigella Vaccine Candidate S4V2 15 Valneva and LimmaTech Enter into a Strategic Partnership to Accelerate the Development of the World’s Most Clinically Advanced Tetravalent Shigella Vaccine Candidate - Valneva 16 Immunization, Vaccines and Biologicals (who.int) 17 Valneva and LimmaTech Awarded FDA Fast Track Designation for Tetravalent Shigella Vaccine Candidate S4V - Valneva 18 LEK analysis 19 Indications differ by country - Please refer to Product / Prescribing Information (PI) / Medication Guide approved in your respective countries for complete information, incl. dosing, safety and age groups in which this vaccine is licensed; ETEC = Enterotoxigenic Escherichia coli (E. Coli) bacterium. Attachment 2026_08_13_VLA_H1_2026_PR_EN_Final

喜欢我的分享，点击上方 关注我吧！ 2026 年 6 月 22–25 日 人用医药产品委员会（CHMP）会议要点 2026 年 6 月人用医药产品委员会（CHMP）会议议程已发布于欧洲药品管理局（EMA）官网；本次会议纪要将于未来数周内对外公示。 2026 年 6 月统计数据 ——CHMP 审评意见及撤回申请月度、累计数据 新药正面审评意见：6 份 其中普通新药 3 款、罕见病药 1 款、生物类似药 2 款； 2026 年累计：42 份 新药否定审评意见：3 份 2026 年累计：6 份 适应症拓展正面审评意见：13 份 2026 年累计：72 份 新药上市申请撤回：0 份 2026 年累计：5 份 6款新药获上市推荐许可 欧洲药品管理局人用医药产品委员会（CHMP）在 2026 年 6 月会议上，推荐六款药品获批上市。 委员会建议授予Aujemflu（灭活流感病毒表面抗原：血凝素 + 神经氨酸酶）上市许可，该疫苗用于 50 周岁及以上人群流感预防。 CHMP 建议授予Hopledo（左旋多巴 / 卡比多巴）上市许可，用于成人帕金森病，且经口服左旋多巴 - 多巴脱羧酶抑制剂方案治疗后病情控制不佳、伴中重度运动波动（运动功能异常）患者。 Onswik（艾夫西托阿法胰岛素）获 CHMP 正面审评意见，适应症为成人 2 型糖尿病。 委员会对2款生物类似药出具支持意见： Denosumab Ascend（地舒单抗）：用于伴骨转移晚期实体瘤成人患者骨相关并发症预防；以及成人、骨骼发育成熟青少年骨巨细胞瘤治疗。 Nylaspeg（培非格司亭）：用于缩短化疗所致中性粒细胞减少症（中性粒细胞为一类白细胞）持续时间，降低发热性中性粒细胞减少症发生率。 复审结果 经复审后，委员会建议授予Daybu（曲非奈肽）上市许可，用于 5 周岁及以上儿童与成人雷特综合征神经行为相关症状治疗。相关神经行为症状包括手部重复刻板动作、躁动、情绪异常、焦虑、睡眠障碍及沟通障碍。 CHMP 最初曾驳回本品用于雷特综合征的上市申请；本次复审后同意批准上市，但适应症范围受限。 如需了解本次复审详细结论，可查阅下方表格配套问答文件。 三款药品获否定审评意见 委员会对三款药品出具不予批准意见： Tacquell（自体黑色素瘤来源肿瘤浸润淋巴细胞，体外扩增）：用于晚期黑色素瘤（已发生全身转移的皮肤恶性肿瘤）。 Yartemlea（那索普利单抗）：用于 2 周岁及以上造血干细胞移植（HSCT）相关血栓性微血管病成人及儿童患者。血栓性微血管病是造血干细胞移植后可危及生命的严重并发症；造血干细胞移植指替换患者自身骨髓，植入供者干细胞重建可生成健康血细胞的骨髓。 Xervyteg（混合异体粪便微生物制剂）：用于急性移植物抗宿主病（aGvHD）。该病为移植术后高危致命病症，骨髓 / 干细胞移植后供体细胞攻击受者机体。 如需了解上述三款药品不予批准的详细说明，可查阅下方表格配套问答文件。 、 12 款药品获批拓展治疗适应症 CHMP 出具正面意见，建议修订Imvanex上市许可条款。本品为天花、猴痘及痘苗病毒（痘病毒科另一毒株）预防疫苗，本次建议适用人群最低年龄下调至 2 周岁及以上（原 12 周岁及以上）。 委员会同时建议欧盟境内已上市的另外 11 款药品新增适应症，分别为：Datroway、Jaypirca、Leqvio、Menquadfi、Opzelura、Orladeyo、Rezolsta、Rinvoq、Stelara、Symtuza、Tecvayli。 两项适应症拓展申请撤回 两款复方制剂拓展适应症申请已撤回：DuoResp Spiromax、BiResp Spiromax（布地奈德 / 福莫特罗）原申请新增 “仅用于轻度哮喘急救缓解治疗” 的适应症。 启动欧盟法规第 31 条集中审评程序 委员会启动对利福平口服混悬液 / 糖浆（20 毫克 / 毫升） 的专项审评。本品含抗生素利福平，用于结核病及其他重度感染治疗。 启动审评原因是监管方担忧辅料二乙醇胺（DEA）含量存在安全隐患；啮齿动物长期高剂量暴露试验提示二乙醇胺可能具有致癌性。 本次审评由荷兰药品管理局依据《欧盟指令 2001/83/EC》第 31 条提请启动，相关启动通告详见下方表格。 集中审评程序收尾结论 CHMP 完成对Tavneos（阿伐可泮） 的全部审评工作，建议欧盟撤销该药品上市许可，现有证据无法证实其临床获益大于用药风险。本品用于成人重度活动性肉芽肿性多血管炎（GPA）、显微镜下多血管炎（MPA），二者均为罕见血管炎症。本次专项审评启动，是因新出现信息对支撑本品欧盟获批的核心临床试验数据完整性提出重大质疑。 其他更新事项 CHMP 批准Fluenz（鼻喷减毒活流感疫苗）可由非医疗专业人员在医护人员监督下完成接种。本品为鼻喷剂型，用于 2 周岁至 18 周岁以下儿童青少年季节性流感预防。 委员会建议修订Ixchiq（减毒基孔肯雅疫苗）上市许可条款，限定仅适用于 12 周岁及以上、基孔肯雅病毒高感染风险人群。 CHMP 完成Mounjaro（替尔泊肽） 新增适应症申请审评：原申请拓展适应症为合并心血管疾病的成人 2 型糖尿病，用于降低主要不良心血管事件（心、循环系统严重病变）风险。委员会未批准该新增适应症，但同意将申报配套研究数据纳入药品说明书，确保临床医师可查阅替尔泊肽在合并心血管疾病 2 型糖尿病人群中的完整研究数据。 【关键专业术语注解】 marketing authorisation：上市许可 positive/negative opinion：正面审评意见 / 不予批准（否定）意见 biosimilar medicines：生物类似药 re-examination：上市申请复审 restricted indication：受限适应症 referral：欧盟集中专项审评程序 excipient：药用辅料 possible carcinogen：潜在致癌物 product information：药品说明书（欧盟统一称谓） febrile neutropenia：发热性中性粒细胞减少症 autologous /allogeneic：自体 / 异体 graft-versus-host disease (GvHD)：移植物抗宿主病 cardiovascular events：心血管不良事件 reliever-only treatment：仅急救缓解治疗 live nasal influenza vaccine：鼻喷减毒活流感疫苗 Agenda：会议议程 minutes：（官方）会议纪要（药监机构固定专用表述，非普通分钟） 原文延伸： https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-22-25-june-2026 内容来源于EMA,翻译仅供参考学习 希望搭建一个理性交流的平台，与志同道合者共同探讨化工的未来图景。    ——专注化工领域   懂您的需求—— 化工综合服务提供商 企业官网建设|产品国内外推广|撮合交易|行情资讯|供应链金融 业务联系：潘经理    手     机：13958177281(微信同号） 邮     箱：472097288@qq.com 加我微信，获取更多福利 化工潘说——化工一起说  关注我，获取更多信息！