Everest Medicines a biopharmaceutical company focused on the discovery, clinical development, manufacturing, and commercialization of innovative therapeutics, today announced the successful release of the first clinical batch of EVM14, a Tumor-Associated Antigen (TAA) vaccine, from its Jiashan manufacturing site, Zhejiang Province in China.

Everest医药公司是一家专注于发现、临床开发、制造和商业化创新疗法的生物制药公司，今天宣布，其位于中国浙江省嘉善的制造基地已成功放行了首个EVM14临床批次，EVM14是一种肿瘤相关抗原（TAA）疫苗。

This batch will support the clinical trials of EVM14 in both China and the United States (US). EVM14 received US FDA clearance for its Investigational New Drug (IND) application in March 2025. This release marks another milestone in advancing Everest’s proprietary mRNA platform with end-to-end capabilities spanning antigen design, lipid nanoparticle (LNP) based delivery, CMC process development and GMP manufacturing, laying a solid foundation for future pipeline progression and commercialization..

该批次将支持EVM14在中国和美国的临床试验。EVM14于2025年3月获得美国FDA对其研究性新药（IND）申请的批准。此次发布标志着Everest自主研发的mRNA平台又一里程碑，该平台具备从抗原设计、基于脂质纳米颗粒（LNP）的递送、CMC工艺开发到GMP生产的端到端能力，为未来管线推进和商业化奠定了坚实基础。

The released batch was manufactured at Everest’s Jiashan manufacturing site using the Company’s proprietary mRNA platform, in compliance with global GMP standards.

该批次产品是在 Everest 的嘉善制造基地使用公司的专有 mRNA 平台生产的，符合全球 GMP 标准。

EVM14 is an off-the-shelf therapeutic mRNA cancer vaccine targeting multiple tumor-associated antigens (TAAs) and is designed to treat various squamous cell carcinomas, including non-small cell lung cancer and head and neck cancer. In preclinical studies, EVM14 induced a dose-dependent antigen-specific immune response in mice and significantly inhibited tumor growth in multiple syngeneic tumor models.

EVM14是一种现成的治疗性mRNA癌症疫苗，靶向多种肿瘤相关抗原（TAAs），旨在治疗各种鳞状细胞癌，包括非小细胞肺癌和头颈部癌症。在临床前研究中，EVM14在小鼠中诱导了剂量依赖性的抗原特异性免疫反应，并在多种同基因肿瘤模型中显著抑制了肿瘤生长。

Notably, EVM14 demonstrated the ability to induce immune memory and prevent tumor recurrence and metastasis, offering hope for long-term cancer-free survival. Furthermore, preclinical data demonstrated that the combination of EVM14 with immune checkpoint inhibitors (ICIs), such as PD-1 or PD-L1 inhibitors, greatly enhanced the anti-tumor activity, reduced recurrence and metastasis, and supports clinical exploration of combination therapies..

值得注意的是，EVM14展示了诱导免疫记忆、预防肿瘤复发和转移的能力，为实现长期无癌生存带来了希望。此外，临床前数据表明，EVM14与免疫检查点抑制剂（ICIs），如PD-1或PD-L1抑制剂联用，显著增强了抗肿瘤活性，减少了复发和转移，并支持组合疗法的临床探索。

In March 2025, Everest received FDA Clearance of IND Application for EVM14, marking the Company’s first internally developed mRNA therapeutic vaccine to enter early-stage global clinical development. The Company also plans to submit the IND application for EVM14 to the China's National Medical Products Administration Center for Drug Evaluation (CDE) in the near future. .

2025年3月，Everest公司收到FDA关于EVM14的IND申请批准，这标志着该公司首个自主研发的mRNA治疗性疫苗进入早期全球临床开发阶段。该公司还计划在不久的将来向中国国家药品监督管理局药品审评中心（CDE）提交EVM14的IND申请。

“The release demonstrates Everest’s end-to-end capabilities across the whole value chain of our mRNA platform,” said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. “Off-the-shelf mRNA therapeutic cancer vaccines such as EVM14 can significantly shorten production cycles, improve scalability, and lower manufacturing costs, ultimately benefiting more patients.

“此次发布展示了Everest在我们mRNA平台整个价值链上的端到端能力，”Everest医药公司的首席执行官罗永庆表示。“像EVM14这样的现成mRNA治疗性癌症疫苗可以显著缩短生产周期，提高可扩展性，并降低制造成本，最终使更多患者受益。”

Through our clinically validated and fully-integrated mRNA platform, we have realized synergies with our ‘AI-powered’ pipeline to significantly enhanced the efficiency of mRNA vaccine development. This not only provides strong support for the development of EVM14 and other pipeline assets, but also establishes differentiated competitive advantages as we deepen our strategic focus on mRNA-based cancer therapies and in vivo CAR-T programs.

通过我们临床验证的、完全集成的mRNA平台，我们已实现了与“AI驱动”管线的协同效应，大幅提升了mRNA疫苗开发的效率。这不仅为EVM14及其他管线资产的开发提供了有力支持，还为我们深化在mRNA癌症疗法和体内CAR-T项目的战略重点建立了差异化的竞争优势。

We are fully committed to advancing EVM14 into clinical trials in both China and the U.S., and we look forward to offering more diverse treatment options to cancer patients around the world.”.

我们全力推进EVM14在中国和美国的临床试验，并期待为全球癌症患者提供更加多元化的治疗选择。"

EVM14 utilizes mRNA encoding multiple TAAs encapsulated in a lipid nanoparticle (LNP) delivery system. Following intramuscular injection, EVM14 is taken up by antigen-presenting cells (APCs), where the mRNA is translated into target antigens. These antigens are then processed and presented by major histocompatibility complex (MHC) molecules to T cells, triggering an antigen-specific immune response.

EVM14利用编码多种肿瘤相关抗原（TAAs）的mRNA，封装在脂质纳米颗粒（LNP）递送系统中。通过肌肉注射后，EVM14被抗原呈递细胞（APCs）摄取，其中mRNA被翻译成目标抗原。这些抗原随后被主要组织相容性复合体（MHC）分子处理并呈递给T细胞，从而触发抗原特异性的免疫反应。

The activated T cells migrate to tumor tissues, recognize and kill the cancer cells expressing the target antigens, while also inducing long-term immune memory..

激活的T细胞迁移到肿瘤组织，识别并杀死表达靶抗原的癌细胞，同时诱导长期免疫记忆。

Everest has successfully localized its clinically validated mRNA platform, establishing a fully integrated end-to-end infrastructure covering antigen design, mRNA sequence optimization, LNP delivery, and industrial-scale manufacturing. This platform enables significant improvements in the efficiency of target selection, sequence design, delivery system optimization, and production..

Everest已成功将其经过临床验证的mRNA平台本地化，建立了涵盖抗原设计、mRNA序列优化、LNP递送以及工业化规模制造的全集成端到端基础设施。该平台能够显著提升靶点选择、序列设计、递送系统优化和生产方面的效率。

The platform has previously been clinically validated. In a global Phase II clinical trial enrolling 374 subjects, Everest’s mRNA COVID-19 vaccine candidate PTX-COVID19-B was directly compared with Comirnaty®, Pfizer/BioNTech’s U.S. FDA-approved mRNA vaccine. PTX-COVID19-B demonstrated non-inferiority compared to Comirnaty®.

该平台之前已通过临床验证。在一项全球 II 期临床试验中，入组了 374 名受试者，Everest 的 mRNA 新冠疫苗候选药物 PTX-COVID19-B 与辉瑞/ BioNTech 获美国 FDA 批准的 mRNA 疫苗 Comirnaty® 进行了直接对比。PTX-COVID19-B 显示出与 Comirnaty® 相当的非劣效性。

Additionally, it was generally well-tolerated, with a safety and tolerability profile similar to Comirnaty®. .

此外，它通常具有良好的耐受性，其安全性和耐受性与Comirnaty®相似。

Everest is currently advancing multiple mRNA therapies targeting cancer and autoimmune diseases through its proprietary mRNA technology platform. These include personalized cancer vaccines (PCVs) EVM16, tumor-associated antigen (TAA) cancer vaccines EVM14, immunomodulatory cancer vaccines, and in vivo CAR-T programs.

Everest公司正在通过其专有的mRNA技术平台推进多种针对癌症和自身免疫疾病的mRNA疗法。这些疗法包括个性化癌症疫苗（PCVs）EVM16、肿瘤相关抗原（TAA）癌症疫苗EVM14、免疫调节癌症疫苗以及体内CAR-T项目。

Additionally, the Company is working on next-generation LNP delivery systems to further boost cell-mediated immune responses..

此外，该公司正在开发下一代LNP递送系统，以进一步增强细胞介导的免疫反应。

Everest’s mRNA manufacturing facility in Jiashan, Zhejiang Province in China, spanning 58,000 square meters and built with an investment of over RMB 900 million, is equipped with advanced production facilities that meet both global and China GMP standards.

中国浙江省嘉善县的 Everest 的 mRNA 制造工厂占地 58,000 平方米，投资超过 9 亿元人民币，配备了符合全球和中国 GMP 标准的先进生产设施。

About EVM14

关于EVM14

EVM14 Injection is a preservative-free, sterile mRNA-lipid nanoparticle (mRNA-LNP) cancer vaccine. It is formulated with mRNA solution encoding multiple tumor-associated antigens (TAAs), encapsulated in a lipid nanoparticle system. After intramuscular injection, EVM14 is taken up by antigen-presenting cells (APCs) and translated into target antigens.

EVM14注射剂是一种不含防腐剂、无菌的mRNA-脂质纳米颗粒（mRNA-LNP）癌症疫苗。它由编码多种肿瘤相关抗原（TAAs）的mRNA溶液配制而成，并被封装在脂质纳米颗粒系统中。通过肌肉注射后，EVM14被抗原呈递细胞（APCs）摄取并翻译为目标抗原。

These antigens are processed, presented to T cells by major histocompatibility complex (MHC) molecules and activated antigen-specific T cells. The activated T cells can migrate to tumor tissues, recognize, and kill the tumor cells expressing the target antigens..

这些抗原被处理后，通过主要组织相容性复合体（MHC）分子呈递给T细胞，并激活抗原特异性T细胞。激活的T细胞可以迁移到肿瘤组织，识别并杀死表达目标抗原的肿瘤细胞。

About Everest Medicines

关于 Everest Medicines

Everest Medicines is a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing transformative pharmaceutical products and vaccines that address critical unmet medical needs for patients in Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record from both leading global pharmaceutical companies and local Chinese pharmaceutical companies in high-quality discovery, clinical development, regulatory affairs, CMC, business development and operations.

Everest Medicines是一家生物制药公司，专注于发现、开发、生产和商业化能够满足亚洲市场患者关键未满足医疗需求的变革性医药产品和疫苗。Everest Medicines的管理团队在高质量的药物发现、临床开发、法规事务、CMC、业务发展及运营方面，拥有来自全球领先制药公司和中国本地制药公司的深厚专业知识与丰富成功经验。

Everest Medicines has built a portfolio of potentially global first-in-class or best-in-class molecules in the company’s core therapeutic areas of renal diseases, infectious diseases and autoimmune disorders. For more information, please visit its website at www.everestmedicines.com..

云顶新耀在其核心治疗领域——肾病、传染病和自身免疫性疾病，建立了一系列潜在的全球首创或最佳同类分子组合。欲了解更多信息，请访问其网站www.everestmedicines.com。

Forward-Looking Statements:

前瞻性声明：

This news release may make statements that constitute forward-looking statements, including descriptions regarding the intent, belief or current expectations of the Company or its officers with respect to the business operations and financial condition of the Company, which can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” “confident” and similar statements.

本新闻稿可能包含构成前瞻性陈述的声明，包括关于公司或其高级管理人员对公司业务运营和财务状况的意图、信念或当前预期的描述，这些可以通过诸如“将”、“预期”、“预计”、“未来”、“打算”、“计划”、“相信”、“估计”、“有信心”等术语及类似陈述加以识别。

Such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, or other factors, some of which are beyond the control of the Company and are unforeseeable. Therefore, the actual results may differ from those in the forward-looking statements as a result of various factors and assumptions, such as future changes and developments in our business, competitive environment, political, economic, legal and social conditions.

此类前瞻性陈述并非对未来业绩的保证，且涉及风险和不确定性，或其他因素，其中一些因素超出公司的控制范围且无法预见。因此，实际结果可能因各种因素和假设而与前瞻性陈述中的结果不同，例如我们业务、竞争环境、政治、经济、法律和社会条件的未来变化和发展。

The Company or any of its affiliates, directors, officers, advisors or representatives has no obligation and does not undertake to revise forward-looking statements to reflect new.

公司或其任何关联公司、董事、高级职员、顾问或代表没有义务也不承诺修订前瞻性声明以反映新的情况。

Source: everestmedicines.com

来源：everestmedicines.com