SAN DIEGO, Oct 14, 2025 - (ACN Newswire via SeaPRwire.com) - General Atomics Aeronautical Systems, Inc. (GA-ASI) and South Korea industry leader Hanwha Aerospace signed an agreement on October 14 to partner in development of the Gray Eagle® Short Takeoff and Landing (GE STOL) unmanned aircraft system (UAS). This landmark agreement marks the beginning of a new phase in U.S.-Korea defense cooperation, extending beyond traditional alliance structures to deliver next-generation, runway-independent UAS solutions that maximize commanders' options in the face of evolving mission demands.The deal marks the beginning of a co-development and co-production program between GA-ASI and Hanwha, with work set to begin immediately. The GE STOL will be offered to a worldwide customer base, including South Korea Ministry of Defense and the United States War Department.Under the agreement, the two companies will design and build a production representative GE STOL. The maiden flight is scheduled for 2027 and first delivery to customers in 2028. With a GA-ASI-funded prototype already flying, the program has demonstrated its ability to accelerate from development to delivery. By leveraging the trusted Gray Eagle foundation and forward-leaning investments, the partnership offers the fastest path with lowest risk to operational capability. GA-ASI and Hanwha Aerospace will work closely throughout the design phase and establish a production facility in South Korea for final assembly and manufacturing of the GE STOL, with GA-ASI handling the final integration. GA-ASI will continue to produce its other Gray Eagle models in San Diego."GA-ASI and Hanwha are committed to investing in this project and building development and production capabilities in South Korea," said GA-ASI President David R. Alexander. "We'll be leveraging the expertise of both companies to quickly bring the Gray Eagle STOL to global customers."Gray Eagle STOL is the only medium-altitude, long-endurance UAS in its class to offer true runway independence by operating from semi-improved surfaces, including dirt roads, open fields, beaches, and parking lots. This exponentially increases its operational employment by providing multi-mission capability for Reconnaissance, Surveillance, and Target Acquisition (RSTA), counter UAS, and other missions including Manned-Unmanned Teaming (MUM-T) while leveraging GE STOL's modular open systems approach.Using the GE STOL demonstrator, called Mojave, GA-ASI recorded several first-of-their-kind aviation milestones, including a 2024 demonstration when GA-ASI and Hanwha flew Mojave from the South Korean Navy's amphibious landing ship ROKS Dokdo (LPH-6111) as it was underway at sea off the coast of Pohang, South Korea. It has also been launched and recovered aboard the British aircraft carrier HMS Prince of Wales (2023), performed live-fire testing at Yuma Proving Ground, Arizona (2024), and performed dirt strip operations (2023) underscoring GA-ASI's advances in runway independence and operational flexibility.The initiative is part of Hanwha's strategic investment plan in its UAS business. This commitment, together with GA-ASI's continued focus on UAS, demonstrates both companies' strategy to invest ahead of customer demand, reducing risk and lowering lifecycle costs through international cost-sharing, and ensuring timely delivery of next-generation UAS solutions in Korea and abroad."Jointly producing GE STOL in South Korea and the U.S. will create jobs and help Hanwha secure talent in related fields as well as foster our domestic (Korean) UAS industry ecosystem. Hanwha is poised to become a comprehensive UAS company capable of executing everything from design to production and maintenance based on our capabilities, which span from fighter jet engines to radar and avionics equipment," said Mr. Jae-il Son, President and CEO of Hanwha Aerospace.Together, GA-ASI and Hanwha are delivering a low-risk, investment-backed, and innovation-driven UAS solution that provides commanders unmatched flexibility faster and at lower cost.About GA-ASIGeneral Atomics Aeronautical Systems, Inc., is the world's foremost builder of Unmanned Aircraft Systems (UAS). Logging more than 9 million flight hours, the Predator® line of UAS has flown for over 30 years and includes MQ-9A Reaper®, MQ-1C Gray Eagle®, MQ-20 Avenger®, and MQ-9B SkyGuardian®/SeaGuardian®. The company is dedicated to providing long-endurance, multi-mission solutions that deliver persistent situational awareness and rapid strike.For more information, visit www.ga-asi.com.Avenger, EagleEye, Gray Eagle, Lynx, Predator, Reaper, SeaGuardian, and SkyGuardian are trademarks of General Atomics Aeronautical Systems, Inc., registered in the United States and/or other countries.Contact InformationGA-ASI Media Relationsasi-mediarelations@ga-asi.com(858) 524-8101SOURCE: General Atomics Aeronautical Systems, Inc. Copyright 2025 ACN Newswire via SeaPRwire.com. All rights reserved. www.acnnewswire.com

Sole funded activities commenced at the wholly owned Cobar Basin precious-base metals Condobolin projectAirborne geophysical survey mobilised across the historic Condobolin Mineral Field Preparations for diamond drilling at the Meritilga target testing extensions to the existing gold-silver-base metals systemReview commenced assessing the potential for alluvial gold based on prior drillingFurther consolidation of the wider district increasing the foothold of the Condobolin project by a thirdMelbourne, Australia--(ACN Newswire via SeaPRwire.com - October 14, 2025) - Gold-copper explorer and hybrid project generator Kincora Copper Limited (ASX: KCC) (TSXV: KCC) (Kincora or the Company) is pleased to announce that an airborne electro-magnetic (AEM) geophysical survey covering approximately 155km2 has been mobilized at the Condobolin project, located in the southern end of the Cobar Basin. Ahead of this survey, Kincora has pegged the adjacent open ground to expand the total project size by 90km2.The AEM survey is expected to generate new near surface targets and refine existing mineralized systems located under shallow post mineral cover, as well as refine potential deeper source feeder zones. These include the Meritilga target where preparations have commenced for a high impact drilling program to test the down dip and on strike extensions of the existing system which hosts broad near surface gold-silver-base metal mineralisation with ore grade intervals (including 4m @ 20g/t gold and 30.2g/t silver from 75m 1).In light of near record Australian gold and silver prices, Kincora has commenced a review of prior encouraging drilling results within a paleochannel at the Meritilga target, which has including up to 28.4g/t gold in gravels (from 4m) and 3.99g/t gold in basement (from 28m) 2.John Holliday, Technical Committee chair, and Peter Leaman, VP of Exploration, commented,"We are pleased to commence exploration at our wholly owned Condobolin project at a time of significant exploration, development and corporate success in the southern and lesser explored section of the Cobar Basin. Kincora has a well-planned strategy to explore the extensions of the Condobolin Mineral Field, which has a substantial mining history for high grade gold, silver and base metals. The project is well located to existing infrastructure, is easy to explore and has very limited effective exploration below the shallow weathering profile. The extent of historical mining, and geochemical and geophysical anomalies, indicate excellent potential for multiple new discoveries. We are looking to systematically use exploration techniques that have already yielded the Meritilga discovery and many new recent discoveries in the north of the district at similar and earlier stage profile projects. The designed multi-phase campaign is a capital efficient value add strategy at a project that has the potential to excite in the current very strong precious metals environment."Figure 1: Kincora has seven major project groups located in Central West NSW, six porphyry and one Cobar style mineral system, all located in world-class geological terrains which host Tier-1 mines The Condobolin project is in the southern and lesser explored section of the Cobar BasinTo view an enhanced version of this graphic, please visit:https://images.newsfilecorp.com/files/2305/270304_18516798242cc817_001full.jpgCOBAR DISTRICTThe Cobar Basin has a 150-year history of high-grade, long-life mining and is an important supplier of critical and precious metals. The region benefits from established infrastructure and favourable ESG considerations with significant scope for processing and mining efficiencies, supporting potential consolidation.The district has recently seen several significant new discoveries utilising modern exploration techniques in lesser explored regions (eg Federation, Achilles, Mallee Bull, Southern Nights and Wagga Tank) and emerging corporate activity (eg Harmony's A$1.6 billion takeover for MAC Copper (MAC.ASX) and Kingston Resources (KSN.ASX) recently receiving A$50 million cash for the first tranche of its divestment of its PNG Misima project).CONDOBOLIN PROJECTThe project and regional profiles' support the Condobolin project being an asset that a junior explorer such as Kincora can add significant value to. A multi-phase exploration campaign of regional scale exploration and target specific drilling has commenced and is fully funded following the Company's July 2025 non-brokered private placement (C$4m raising with a 12-month hold period).The Condobolin project was historically the focus of up to 25 informal open pit operations (peak late 1800's-early 1900's), with mining impacted by the water table and exploration by the weathering profile. The mineral field has not been effectively explored below the weathered zone (~30m).Very limited modern exploration has taken with initial activities by Clancy Exploration (Clancy, now RareX Limited) yielding encouraging results at all five prospects drilled (2011-13), including a virgin high-grade gold discovery at the Meritilga Prospect.More recently within the immediate district, Kingston Resources (ASX: KSN) has significantly expanded the resources and restarted hard rock mining at the Mineral Hill mine, Talisman Mining (ASX: TLM) has recent new success at its Rip N Tear and Durnings targets (to both the immediate north and south of Mineral Hill), while Australian Gold and Copper (ASX: AGC) has excited the market with its new potential district scale discovery at its Achilles target located within the south western extension of the Cobar Basin.The Condobolin project is located approximately 40km south from the mill at Mineral Hill and north of the Condobolin town (which is the primary source of employees to Mineral Hill operation who drive through the Condobolin project to work) - see Figure 2.Kincora has consolidated a 100% project ownership and continued to expand our foothold across the near surface potential of the historical Condobolin Mineral Field. The total project size is 297km2 across two adjacent licenses with a new license application (latter 90km2) - see Figure 3.To advance the potential of the wider project and historical mining field, Kincora has mobilised an AEM survey covering over 800 line-kilometres utilising Expert Geophysics Pty Ltd's (Expert Geophysics) TargetEM26 system. Approximately 20% of the wider project is out-sub cropping with the average depth of cover in non-outcropping areas less than 5 metres supporting very easy exploration with surface geology and sampling being an effective, quick and cheap methods - see Figures 3 & 4.AEM surveys have proven to be a highly effective discovery technique in this region significantly contribution in several recent discoveries in the Cobar Basin. The survey is a quick low impact method to provide subsurface structure across the full historic Condobolin Mineral Field with an infill survey across multiple targets, including Meritilga, many of which have significant base metal and gold-silver anomalies - see Figures 3 & 4 overlaying lead anomalism from soil sampling.Figure 2: Regional brownfield and greenfield exploration projects are generating new discoveries and drill targets in a lesser explored but historic mining districtThe Condobolin project is located at the southern end of the Cobar Basin, benefits from existing infrastructure and is near the Mineral Hill mill which is seeking organic and inorganic means to fill existing excess mill capacityTo view an enhanced version of this graphic, please visit:https://images.newsfilecorp.com/files/2305/270304_image2.jpgThe Meritilga target was a new discovery made by Clancy in 2012 following up a coincident 2km x 2km arsenic-lead-zinc (+gold) geochemical anomaly and K-channel radiometric anomaly over ridges east of the historic mines at Mascotte and west of Potters. The anomalies coincided with key NE-striking structures identified in detailed 3D induced polarization (IP) surveys 1.The gold, silver and base metals system is situated within a lode with high grade lens (ore grade, eg 4m @ 20g/t gold, 30.2 g/t silver from 75m, including 1m @ 62g/t gold, 60g/t silver in hole CORC029) and a lower grade halo. The lode is a consistent body, open up and down dip 1, 3.Land access agreements are in place and the permitting process commenced for an up to 15 diamond drill hole program for 4100 metres testing down dip (up to 350m depth) and strike extensions and the potential for repeat high grade lens and/or a stacked series of lenses.This setting is supported by the last phase of Reverse Circulation (RC) drilling by Clancy, the one diamond hole drilled by Kincora in 2023, coupled with a favourable structural setting where the main Meritilga Fault has been cross-cut by N-S trending faults 4.The current working geological model, underpinned by pathfinder zonation and coincident geophysical anomalies, supports the potential for a larger mineralised intrusive source at depth - see Figure 6. The AEM survey is expected to also better advance and refine these concepts.Given shifting in commodity prices, Kincora has commenced a review of prior encouraging very shallow gold drilling results of Clancy. In 2011, twenty Air-Core (AC) holes tested the Tilga paleochannel with several significant hits returned. The best intercept was 1m @ 28.4g/t Au (from 4m, hole COAC012 in the gravels) and 3.99g/t Au (from 28m, hole COAC005 in basement) 2.The average depth of the paleochannel gravels was 7.9m with a potential target area of 2km by 0.5km - see Figure 4. The last review of the alluvial gold potential was undertaken by Clancy when the Australian gold price was approximately A$1500/ounce (versus current spot of almost A$6000/oz). The review by Kincora will explore the potential alternatives, budgets and partnering opportunities available to advance the alluvial (placer) gold potential either concurrent with the wider Condobolin project or as a standalone project.Figure 3: Kincora has increased the size of the total Condobolin project by a third and commenced an airborne geophysical survey across the historic Condobolin Mineral Field The extent of historical mining, existing near surface geochemical and geophysical anomalies provides excellent potential for multiple new discoveries as Kincora implements modern systematic exploration approaches that have already yielded the Meritilga discovery plus many recent discoveries in the north of the district at similar and earlier stage profile projectsTo view an enhanced version of this graphic, please visit:https://images.newsfilecorp.com/files/2305/270304_image3_550.jpgFigure 4: The extent of historical mining, existing near surface geochemical and geophysical anomalies, coupled with limited modern exploration or exploration below the weathered zone provides excellent potential for multiple new discoveriesSouth-western portion of the Condobolin Project, including the Tilga Paleochannel where prior Clancy drilling supported the potential for alluvial (placer) goldTo view an enhanced version of this graphic, please visit:https://images.newsfilecorp.com/files/2305/270304_image4.jpgFigure 5: Limited prior modern exploration by Clancy resulted in the Meritilga discovery with follow up drilling planned to test down dip, on strike and the potential for repeat high grade lens and/or a stacked series of lenses. Many other similar mineral systems in the Cobar Basin are vertically extensive with repeat lodes 4.Meritilga is open with a currently defined high (ore) grade lens and a lower grade haloTo view an enhanced version of this graphic, please visit:https://images.newsfilecorp.com/files/2305/270304_kincora.jpgFigure 6: The Condobolin project hosts various polymetallic mineral system styles and deposit targets Target models included high-grade near surface repeat systems similar to other deposits in the southern end of the Cobar Basin as well as intrusion related gold (IRGS) or porphyry systems at depthTo view an enhanced version of this graphic, please visit:https://images.newsfilecorp.com/files/2305/270304_18516798242cc817_006full.jpgAbout Kincora: Kincora Copper Limited (ASX: KCC) (TSXV: KCC) is an emerging Australia-focused gold-copper explorer with a hybrid project generator strategy.The Company is successfully proving up the prospectivity of its extensive project portfolio, which includes multiple district-scale landholdings and scalable drill ready targets. These assets are located in Australia's Lachlan Fold Belt and Mongolia's Southern Gobi, two of the globe's leading porphyry belts, and the historical Condobolin mining field within the Cobar basin in NSW.The Company has already unlocked over $100 million of potential partner funding for multiple earlier stage and/or non-core porphyry projects. These initial deals have supported over 13,500 metres of drilling and over A$6.5m of partner funded exploration since late 2024, with management fees and exploration ramping up.Partner discussions are ongoing for its remaining 100% owned flagship projects that are all situated within existing porphyry camps containing over 20-million-ounce gold equivalent resource inventory.By having a significant portfolio of partner funded large porphyry projects, and a very focused program on a 100% owned Condobolin project, the Company is seeking to position Kincora as a leading institutional grade explorer in the public Australian and Canadian markets, and the leading project generator on the ASX.To find out more please refer to our 2-page July 2025 corporate strategy: https://kincoracopper.com/corporate-strategy/ The Company's website is: www.kincoracopper.comThis announcement has been authorised for release by the Board of Kincora Copper Limited (ARBN 645 457 763)For further information, please contact:Sam Spring, President and Chief Executive Officersam.spring@kincoracopper.com or +61431 329 345Laurie Thomas, Strategic Advisorlaurie.thomas@kincoracopper.com or +1306 341 3826Executive office400 - 837 West Hastings StreetVancouver, BC V6C 3N6, CanadaTel: 1.604.283.1722Subsidiary office AustraliaC/- JM Corporate ServicesLevel 6, 350 Collins Street Melbourne, VIC, Australia 3000References:1 ASX release of Clancy Exploration Limited (now RareX Limited), titled "New Gold-Silver-Copper Discovery at Meritilga Prospect - Condobolin Project" dated March 20th, 2012, which can be obtained via the ASX website (www.asx.com.au). The Clancy results were reported in accordance with the version of the JORC Code existing prior to JORC 2012. Mining Associates has completed an review of sampling techniques and procedures dated January 31st, 2021, as outlined in the Independent Technical Report included in the ASX listing prospectus, which is available at: https://www.kincoracopper.com/investors/asx-prospectus. While the Company has no reason to believe the assay results are not reliable, the Company has not independently verified these results. The Company intends to conduct its own exploration programme as described in this release.2 ASX release of Clancy Exploration Limited (now RareX Limited), titled "Condobolin Project Yields Visible Gold and Potential Alluvial Gold" dated January 20th, 2012, which can be obtained via the ASX website (www.asx.com.au). The Clancy results were reported in accordance with the version of the JORC Code existing prior to JORC 2012. Mining Associates has completed an review of sampling techniques and procedures dated January 31st, 2021, as outlined in the Independent Technical Report included in the ASX listing prospectus, which is available at: https://www.kincoracopper.com/investors/asx-prospectus. While the Company has no reason to believe the assay results are not reliable, the Company has not independently verified these results. The Company intends to conduct its own exploration programme as described in this release.3 ASX release of Clancy Exploration Limited (now RareX Limited), titled "Gold and Silver Hits Extend Meritilga Lode" dated Jube 17th, 2013, which can be obtained via the ASX website (www.asx.com.au). The Clancy results were reported in accordance with the version of the JORC Code existing prior to JORC 2012. Mining Associates has completed an review of sampling techniques and procedures dated January 31st, 2021, as outlined in the Independent Technical Report included in the ASX listing prospectus, which is available at: https://www.kincoracopper.com/investors/asx-prospectus. While the Company has no reason to believe the assay results are not reliable, the Company has not independently verified these results. The Company intends to conduct its own exploration programme as described in this release.4 AGC: "Mkt Cap": market capitalisation as @ COB Oct 9th, 2025. MAC: takeover from Binding Scheme Implementation Deed with Harmony for MAC Copper Limited, May 27, 2025 Cross sections adapted by Kincora and internals noted from public disclosures from MAC Copper (MAC.ASX) relating to its CSA mine + Australian Gold & Copper (AGC.ASX) relating to its Achilles discovery. Strike & depths reported on the same scale.Qualified PersonThe scientific and technical information in this announcement was prepared in accordance with the standards of the Canadian Institute of Mining, Metallurgy and Petroleum and National Instrument 43-101 - Standards of Disclosure for Mineral Projects ("NI 43-101") and was reviewed, verified and compiled by Kincora's staff under the supervision of Peter Leaman (M.Sc. Mineral Exploration, FAusIMM), Senior Vice-President of Exploration of Kincora, and John Holliday (BSc Hons, BEc, member of the Australian Institute of Geoscientists), Non-Executive Director and Chairman of Kincora's Technical Committee, who are Qualified Persons for the purpose of NI 43-101JORC Competent Person StatementInformation in this announcement that relates to Exploration Results, Mineral Resources or Ore Reserves are those that have been previously reported (with the original release referred to in this announcement), in the case of Mineral Resources or Ore Reserves the material assumptions and technical parameters underpinning the estimates have not materially changed, and have been reviewed and approved by John Holliday and Peter Leaman, who are Competent Persons under the definition established by JORC and has sufficient experience which is relevant to the style of mineralisation and type of deposit under consideration and to the activity being undertaking to qualify as a Competent Person as defined in the 2012 Edition of the 'Australasian Code for Reporting of Exploration Results, Mineral Resources and Ore Reserves'. John Holliday and Peter Leaman consents to the inclusion in this report of the matters based on his information in the form and context in which it appears. The review and verification process for the information disclosed herein for the Nyngan Projects have included the receipt of all material exploration data, results and sampling procedures of previous operators and review of such information by Kincora's geological staff using standard verification procedures.Forward-Looking StatementsCertain information regarding Kincora contained herein may constitute forward-looking statements within the meaning of applicable securities laws. Forward-looking statements may include estimates, plans, expectations, opinions, forecasts, projections, guidance or other statements that are not statements of fact. Although Kincora believes that the expectations reflected in such forward-looking statements are reasonable, it can give no assurance that such expectations will prove to have been correct. Kincora cautions that actual performance will be affected by a number of factors, most of which are beyond its control, and that future events and results may vary substantially from what Kincora currently foresees. Factors that could cause actual results to differ materially from those in forward-looking statements include market prices, exploitation and exploration results, continued availability of capital and financing and general economic, market or business conditions. The forward-looking statements are expressly qualified in their entirety by this cautionary statement. The information contained herein is stated as of the current date and is subject to change after that date. Kincora does not assume the obligation to revise or update these forward-looking statements, except as may be required under applicable securities laws.Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) or the Australian Securities Exchange accepts responsibility for the adequacy or accuracy of this release.To view the source version of this press release, please visit https://www.newsfilecorp.com/release/270304 Copyright 2025 ACN Newswire via SeaPRwire.com. All rights reserved. www.acnnewswire.com

HONG KONG, Oct 14, 2025 - (ACN Newswire via SeaPRwire.com) – Everest Medicines today announced that the first patient has been enrolled in a global multi-center Phase I clinical trial of its Tumor-Associated Antigen Cancer Vaccine EVM14 at NEXT Oncology Virginia in the United States. Previously, the Investigational New Drug (IND) application for EVM14 has been approved by the National Medical Products Administration (NMPA) in China. EVM14 becomes Everest Medicines’ first internally developed therapeutic mRNA cancer vaccine to receive IND approvals from both China’s NMPA and the U.S. Food and Drug Administration (FDA).EVM14, an off-the-shelf therapeutic mRNA cancer vaccine, is developed based on Everest Medicines' proprietary mRNA platform. It is formulated with mRNA encoding 5 tumor-associated antigens (TAAs) and is designed to treat various squamous cell carcinomas, including squamous non-small cell lung cancer (sq-NSCLC) and head and neck squamous cell carcinoma (HNSCC). In the targeted cancer types, 96% of patients with sq-NSCLC and 97% of patients with HNSCC expressed at least one of the five target genes[1]. TTA vaccines offer distinct advantages, including elimination of HLA screening requirements, off-the-shelf availability, lower production costs versus personalized neoantigen vaccines, and applicability across multiple tumor types.“The cancer burden in China remains substantial. Neither immunotherapy nor targeted therapy can offer long term benefits to cancer patients. EVM14 is designed to treat various squamous cell carcinomas, EVM14’s unique mechanism offers the potential to complement current treatments by enhancing the efficacy via combination therapies and helping delay disease recurrence, aligning with current trends in oncology drug development.” said Professor Lu Shun, the Lead Principal Investigator in China and Director of the Oncology Department at Shanghai Chest Hospital.“The enrollment of the first patient with EVM14 in the United States marks an important achievement in advancing the global clinical development of our in-house mRNA platform.” said Rogers Yongging Luo, Chief Executive Officer of Everest Medicines. “This progress demonstrates Everest's continued efforts to translate technological innovation into clinical practice and our first move advantage in developing next-generation immuno-oncology therapies, including therapeutic mRNA cancer vaccines. EVM14 is Everest's first therapeutic mRNA cancer vaccine to achieve IND approvals in both China and the U.S. The large patient population faces limited options with existing standard-of-care therapies, highlighting an unmet medical need. As a TAA cancer vaccine, EVM14's unique mechanism offers the potential to complement current treatments by enhancing the efficacy via combination therapies and helping delay disease recurrence, offering hope for long-term cancer-free survival. With EVM14 receiving IND approval from China's NMPA, we look forward to this innovative therapy demonstrating promising therapeutic potential in global multicenter clinical trials, bringing more treatment options to patients worldwide and enhance their quality of life.”Everest Medicines' Jiashan manufacturing site released the first GMP clinical trial batch in June 2025. This batch will support the clinical trials of EVM14 in both China and the United States. The clinical centers involved include NEXT Oncology Virginia, The University of Texas MD Anderson Cancer Center, Memorial Sloan Kettering Cancer Center in the U.S., and Shanghai Chest Hospital in China.Leveraging the company's industry-leading mRNA therapeutic cancer vaccine platform and mRNA in vivo CAR-T platform, it is building a globally competitive R&D pipeline. EVM18, the in vivo CAR-T program, has completed multiple non-human primates (NHPs) trials and achieved preclinical proof-of-concept, with first-in-human data expected to initiate by the end of 2025. EVM16, the personalized therapeutic mRNA cancer vaccine, has initiated its first-in-human trial in China, with patient dosing completed. In the investigator-initiated trial (IIT), dose escalation in the low- and mid-dose cohorts has been completed, with encouraging preliminary data observed. EVM15, the immune-modulatory cancer vaccine, has completed preclinical proof of concept and identified its clinical candidate.Looking ahead, Everest Medicines will continue to deepen its “dual-engine” strategy, maintaining a strong focus on advancing innovative drug discovery and development to drive sustainable growth and global expansion. The Company remains committed to delivering innovative therapies to patients, creating long-term value for shareholders, and driving forward with the vision of becoming a leading global biopharmaceutical company.[1] The Cancer Genome Atlas (TCGA) data Copyright 2025 ACN Newswire via SeaPRwire.com. All rights reserved. www.acnnewswire.com

香港, 2025年10月14日 - (亚太商訊) - 云顶新耀宣布，其通用现货型肿瘤治疗性疫苗EVM14注射液的全球多中心I期临床试验在美国临床研究机构NEXT Oncology Virginia成功入组首例患者。此前，EVM14的新药临床试验申请也已获得中国国家药品监督管理局批准，EVM14成为公司首个实现中国国家药品监督管理局（NMPA）和美国食品药品监督管理局（FDA）IND"双获批"的mRNA肿瘤治疗性疫苗。EVM14基于云顶新耀自主知识产权的mRNA技术平台研发，是一款靶向5个肿瘤相关抗原（TAA）的通用现货型肿瘤治疗性疫苗，拟用于治疗多种鳞状细胞癌包括非小细胞肺鳞癌（sq-NSCLC）和头颈部鳞状细胞癌（HNSCC）。在EVM14 I期临床试验探索的瘤种中，大多数患者会表达5个TAA之一。其中，约96%的sq-NSCLC患者和97%的HNSCC患者检测到至少一个TAA基因的表达[1]。作为肿瘤相关抗原疫苗，EVM14具有无需进行HLA筛选、现货、对比个性化肿瘤新抗原疫苗生产成本更低，并可适用于多瘤种等优势。中国牵头主要研究者、上海市胸科医院肿瘤科主任陆舜教授表示："当前我国肿瘤仍处于高发态势，而现有免疫疗法和靶向疗法往往难以形成持久免疫记忆。肿瘤相关抗原疫苗不仅能够作为现有疗法的有力补充，发挥协同增效作用，还可能减少复发，契合全球肿瘤药物研发趋势。"云顶新耀首席执行官罗永庆表示："EVM14首例患者在美国的成功入组，体现了云顶新耀mRNA平台从技术创新到全球化临床开发的重要进展，也展现出公司在肿瘤治疗性疫苗等新一代肿瘤免疫药物研发方面的先行优势。EVM14是公司首个实现中美IND‘双获批’的mRNA肿瘤治疗性疫苗，这不仅彰显了云顶新耀在mRNA肿瘤治疗领域的技术实力，也体现了监管机构对EVM14科学性与前期研究质量的高度认可。鳞癌患者群体庞大，现有标准治疗难以形成持久免疫记忆，仍未实现令人满意的治疗效果，存在巨大的未满足医疗需求。EVM14作为一款肿瘤相关抗原疫苗，不仅可成为现有疗法的有力补充，还可能减少复发，有望帮助患者实现‘长期无癌生存’的获益。随着EVM14的IND获中国NMPA批准，我们期待该创新疗法将在全球多中心临床上展现积极的治疗潜力，为全球患者带来更多治疗选择，提高患者生活质量。"云顶新耀嘉善工厂已于2025年6月顺利放行首批GMP临床试验样品，该批样品将用于支持云顶新耀在中美两地开展EVM14的临床试验。参与的临床中心包括中国的上海胸科医院和美国的NEXT Oncology Virginia、德州大学安德森癌症中心、纪念斯隆-凯特琳癌症中心等。不仅如此，云顶新耀依托于业内领先的自研mRNA肿瘤治疗性疫苗平台及自体生成CAR-T平台，构建起具备全球竞争力的研发管线。其中，自体生成CAR-T项目EVM18已完成多项非人灵长类动物（猴）研究，并确定临床候选分子，预计于2025年底前启动临床试验。个性化肿瘤治疗性疫苗EVM16已在中国启动首次人体临床试验并完成患者给药；IIT临床试验已完成低、中剂量组爬坡，初步数据积极。现货型免疫调节疫苗EVM15已完成临床前概念验证，并确定候选分子。未来，云顶新耀将持续深化"双轮驱动"战略布局，坚持推动创新药物研发，为持续创新和国际化发展注入强劲动力，持续为患者提供创新疗法，为股东创造长期价值，力争成为全球领先的Biopharma。[1] The Cancer Genome Atlas (TCGA) data Copyright 2025 亚太商讯 via SeaPRwire.com. All rights reserved. www.acnnewswire.com