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TAIPEI, March 10, 2025 /PRNewswire/ -- TCI Biotech (TCI Co., Ltd.) (TWSE: 8436), a leading CDMO+ innovator in health food and skincare biotechnology, has released its consolidated financial results for the fiscal year ending December 31, 2024. The company reported steady revenue performance, strong profitability, and continued investment in innovation to drive future growth. Executive Commentary "Our 2024 financial performance underscores TCI Biotech's resilience and ability to navigate market fluctuations while maintaining strong profitability," said Vincent Lin, CEO of TCI Biotech. "We remain committed to expanding smart manufacturing, fostering strategic partnerships, and driving cutting-edge research. By strengthening our financial position, we aim to deliver sustainable growth and long-term value for our stakeholders." Financial Highlights Revenue: NT$7.24 billion in 2024 Gross Profit: NT$3.18 billion, representing a gross margin of 44% Operating Profit: NT$1.03 billion, maintaining a stable 14% operating margin Net Profit: NT$974 million, with earnings per share (EPS) of NT$7.60 Dividend: NT$10 per share, reflecting solid financial performance Cash and Cash Equivalents: NT$4.77 billion, ensuring strong liquidity Key Business Developments Expansion in International Markets: Sales growth in key regions, including North America, Europe, China and Asia, reinforcing TCI Biotech's global footprint. Innovation & R&D: Advances in liquid supplements and skincare, aligned with market trends. The newly established TCI Medical Consultation Panel enhances research and ensures scientific rigor. Operational Efficiency: Strategic cost management and AI-enhanced production processes have contributed to maintaining profitability despite industry challenges. Sustainable Growth Strategies: Continued commitment to ESG (Environmental, Social and Governance) initiatives to enhance corporate responsibility and long-term value creation. Outlook for 2025 TCI Biotech is optimistic about its growth trajectory for 2025, focusing on balanced regional expansion, optimized production capacity, and strategic partnerships with global enterprises. With a commitment to quality, innovation, and customer-centric solutions, the company anticipates sustained momentum in revenue and profitability, reinforcing its position as a leader in biotechnology and smart manufacturing. For more information, please visit www.tci-bio.com. About TCI Biotech TCI Biotech (TCI Co., Ltd.) is a global leader in CDMO+ services, specializing in the research, development, and manufacturing of health foods and cosmetics. Committed to innovation and scientific excellence, TCI delivers high-quality, clinically backed products that empower customers worldwide. Disclaimer: This press release contains forward-looking statements based on current expectations and assumptions, which involve risks and uncertainties. Actual results may differ due to market conditions, regulatory changes, or other unforeseen factors. TCI Biotech assumes no obligation to update forward-looking statements. Investors are advised to review the full financial report and consult professional advisors before making any investment decisions.
OMLYCLO® (omalizumab-igec) is the first and only omalizumab biosimilar approved by the FDA Regulatory approval for interchangeability was supported by positive phase III data demonstrating comparable efficacy and safety profile with the reference product XOLAIR® (omalizumab)[1] The availability of the first omalizumab biosimilar will help increase access and potentially lower the healthcare cost for people with asthma and allergic diseases JERSEY CITY, N.J., March 10, 2025 /PRNewswire/ -- Celltrion today announced the U.S. Food and Drug Administration (FDA) approved OMLYCLO® (omalizumab-igec) as the first and only biosimilar designated as interchangeable with XOLAIR® (omalizumab) for the treatment of moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), Immunoglobulin E (IgE)-mediated food allergy, and chronic spontaneous urticaria (CSU).[2] "We are proud to achieve the approval of the first biosimilar to omalizumab in the U.S., which will help broaden access to this important medicine for patients with allergic and respiratory conditions, as well as for physicians, payers and providers," said Hetal Patel, Vice President of Medical Affairs at Celltrion USA. "The interchangeability designation of OMLYCLO reinforces confidence among physicians and patients that there is no decrease in effectiveness or increase in safety risk associated with switching between OMLYCLO and the reference product." The FDA approval and designation of interchangeability are based on comprehensive clinical evidence, including results from a global Phase III clinical trial involving 619 adult patients with CSU up to Week 40. Patients were randomized to receive 300 mg or 150 mg of OMLYCLO or reference product every 4 weeks. From Week 12, patients who received OMLYCLO were continued on OMLYCLO, and patients who received 300mg of the reference product were re-randomized in a 1:1 ratio to switch to OMLYCLO or to continue reference product. From Week 24, patients were followed up until Week 40 without dosing. The result demonstrated the comparable efficacy and safety of OMLYCLO to reference product during both treatment and off-dose periods.[1] An interchangeable biosimilar is a biosimilar that meets additional requirements outlined by the law that allows for the FDA to approve biosimilar and interchangeable biosimilar medications.[3] "The approval of OMLYCLO could have a meaningful impact for the medical community and patients, offering a high quality and affordable treatment option, while reducing the burden of healthcare costs," said Thomas Nusbickel, Chief Commercial Officer at Celltrion USA. "With our integrated development, manufacturing, and commercialization platform, Celltrion remains committed to alleviating treatment costs and delivering life-changing medicines to support patients with allergic conditions in the U.S." About OMLYCLO® (omalizumab-igec) OMLYCLO® (omalizumab-igec) is the first U.S. Food and Drug Administration (FDA)-approved anti-IgE antibody biosimilar referencing XOLAIR® (omalizumab). OMLYCLO 75 mg/0.5 mL and 150 mg/mL solution in a single-dose prefilled syringe is approved as interchangeable with reference product for all indications based on comprehensive data and clinical evidence confirming the therapeutic equivalence to XOLAIR.[1],[2] OMLYCLO was also approved by the European Commission (EC) in May 2024. INDICATION OMLYCLO® (omalizumab-igec) injection, is an anti-IgE antibody indicated for: Moderate to severe persistent asthma in adults and pediatric patients ≥6 years of age with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms that are inadequately controlled with inhaled corticosteroids Chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients ≥18 years of age with inadequate response to nasal corticosteroids, as add-on maintenance treatment IgE-mediated food allergy in adult and pediatric patients aged ≥1 year age for the reduction of allergic reactions (Type I), including anaphylaxis, that may occur with accidental exposure to one or more foods. To be used in conjunction with food allergen avoidance Chronic spontaneous urticaria (CSU) in adults and adolescents ≥12 years of age who remain symptomatic despite H1 antihistamine treatment Limitations of Use: Not indicated for: acute bronchospasm or status asthmaticus; emergency treatment of allergic reactions, including anaphylaxis; other forms of urticaria. IMPORTANT SAFETY INFORMATION WARNING: ANAPHYLAXIS Anaphylaxis presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of omalizumab products. Anaphylaxis has occurred as early as after the first dose of omalizumab products, but also has occurred beyond 1 year after beginning regularly administered treatment. Because of the risk of anaphylaxis, initiate OMLYCLO therapy in a healthcare setting and closely observe patients for an appropriate period of time after OMLYCLO administration. Health care providers administering OMLYCLO should be prepared to manage anaphylaxis which can be life-threatening. Inform patients of the signs and symptoms of anaphylaxis and instruct them to seek immediate medical care should symptoms occur. Selection of patients for self-administration of OMLYCLO should be based on criteria to mitigate risk from anaphylaxis. Contraindications: Severe hypersensitivity reaction to OMLYCLO or any ingredient of OMLYCLO. Anaphylaxis. Omalizumab products, including OMLYCLO, have been associated with anaphylaxis, reported in both clinical trials and postmarketing data. Patients with a history of anaphylaxis to foods, medications, or other causes face an increased risk. Initiate OMLYCLO only in a healthcare setting with anaphylaxis management capabilities. Patients should be monitored for an appropriate period post-administration, informed of symptoms, and instructed to seek immediate medical care if they occur. Malignancy. Malignancies have been observed in clinical studies, with various cancer types reported. The long-term risk, especially in high-risk groups, is unknown. Acute Asthma Symptoms and Deteriorating Disease. Omalizumab products have not been shown to alleviate asthma exacerbations acutely. Do not use OMLYCLO to treat acute bronchospasm or status asthmaticus. Corticosteroid Reduction. Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of OMLYCLO therapy for asthma or CRSwNP. Eosinophilic Conditions. Be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy, especially upon reduction of oral corticosteroids. Fever, Arthralgia, and Rash. Stop OMLYCLO if a patient develops this constellation of signs and symptoms, including arthritis/arthralgia, rash, fever, and lymphadenopathy. Parasitic (Helminth) Infection. Monitor patients at high risk of geohelminth infection while on OMLYCLO therapy. Laboratory Tests. Omalizumab increases serum total IgE due to drug:IgE complexes. Do not use serum total IgE levels within one year of discontinuation to reassess dosing regimen, as they may not reflect steady-state free IgE. Potential Medication Error Related to Emergency Treatment of Anaphylaxis. OMLYCLO should not be used for the emergency treatment of allergic reactions, including anaphylaxis. Instruct patients that OMLYCLO is for maintenance use to reduce allergic reactions, including anaphylaxis, while avoiding food allergens. Most Common Adverse Reactions Asthma: In patients ≥12 years, reported in ≥1%: arthralgia, general pain, leg pain, fatigue, dizziness, fracture, arm pain, pruritus, dermatitis, and earache. In pediatric patients (6 to <12 years), reported in ≥3%: nasopharyngitis, headache, pyrexia, upper abdominal pain, streptococcal pharyngitis, otitis media, viral gastroenteritis, arthropod bites, and epistaxis. CRSwNP: In ≥3% of adults: headache, injection site reactions, arthralgia, upper abdominal pain, and dizziness. IgE-Mediated Food Allergy: In ≥3% of patients: injection site reactions and pyrexia. CSU: In ≥2% of patients: nausea, nasopharyngitis, sinusitis, upper respiratory tract infections (viral and non-viral), arthralgia, headache, and cough. For more information, see Full Prescribing Information. About Celltrion Celltrion is a leading biopharmaceutical company that specializes in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. Celltrion is a pioneer in the biosimilar space, having launched the world's first monoclonal antibody biosimilar. Our global pharmaceutical portfolio addresses a range of therapeutic areas including immunology, oncology, hematology, ophthalmology and endocrinology. Beyond biosimilar products, we are committed to advancing our pipeline with novel drugs to push the boundaries of scientific innovation and deliver quality medicines. For more information, please visit our website www.celltrion.com/en-us. and stay updated with our latest news and events on our social media: LinkedIn, Instagram, X, and Facebook. About Celltrion USA Celltrion USA is Celltrion's U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to innovative biologics to improve care for U.S. patients. Celltrion currently has nine biosimilar products approved by the U.S. FDA: INFLECTRA® (infliximab-dyyb), TRUXIMA® (rituximab-abbs), HERZUMA® (trastuzumab-pkrb), VEGZELMA® (bevacizumab-adcd), YUFLYMA®(adalimumab-aaty), AVTOZMA® (tocilizumab-anho), STEQEYMA® (Ustekinumab-stba) STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo) as well as a novel biologic ZYMFENTRA® (infliximab-dyyb). Celltrion USA will continue to leverage Celltrion's unique heritage in biotechnology, supply chain excellence and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. For more information, please visit www.celltrionusa.com, and stay updated with our latest news and events on our social media: LinkedIn. FORWARD-LOOKING STATEMENT Certain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion Inc. and its subsidiaries that may constitute forward-looking statements, under pertinent securities laws. These statements may be also identified by words such as "prepares", "hopes to", "upcoming", "plans to", "aims to", "to be launched", "is preparing", "once gained", "could", "with the aim of", "may", "once identified", "will", "working towards", "is due", "become available", "has potential to", the negative of these words or such other variations thereon or comparable terminology. In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion Inc. and its subsidiaries' management, of which many are beyond its control. Forward-looking statements are provided to allow potential investors the opportunity to understand management's beliefs and opinions in respect to the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them. Such forward-looking statements necessarily involve known and unknown risks and uncertainties associated with the company's business, including the risk factors disclosed in its Annual Report and/or Quarterly Reports, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or results expressed or implied by such statements. Celltrion Inc. and its subsidiaries undertake no obligation to update forward-looking statements if circumstances or management's estimates or opinions should change except as required by applicable securities laws. Trademarks OMLYCLO® is a registered trademark of CELLTRION, Inc.XOLAIR® is a registered trademark of Novartis AG. References [1] Sarbjit Singh Saini et al., CT-P39 Compared With Reference Omalizumab in Chronic Spontaneous Urticaria: Results From a Double-Blind, Randomized, Active-Controlled, Phase 3 Study. Available at: https://onlinelibrary.wiley.com/doi/pdf/10.1111/all.16446?msockid=30d535870b30638b14c920090a18627c [Last accessed March 2025] [2] OMLYCLO U.S. prescribing information (2025) [3] U.S. Food and Drug Administration (FDA). Available at: https://www.fda.gov/drugs/things-know-about/9-things-know-about-biosimilars-and-interchangeable-biosimilars [Last accessed March 2025] US-OML-25-00001 For further information please contact: Andria Arenaaarena@jpa.com+1 516-578-0057
CAMBRIDGE, Mass., March 7, 2025 /PRNewswire/ -- Nona Biosciences, a global biotechnology company providing integrated solutions from "Idea to IND" (I to ITM), today announced to unveil its innovative AI-assisted drug discovery engine, Hu-mAtrIxTM. This new platform, powered by advanced artificial intelligence, integrates seamlessly with the company's proprietary Harbour Mice® technology platform, aiming to accelerate antibody discovery across multiple key therapeutic areas, including neurodegenerative and metabolic diseases, and more. Nona's cutting-edge technology platform enables a fully integrated antibody discovery from protein design and single cell-based antibody screening to next-generation sequencing, antibody modeling and engineering. The Hu-mAtrIxTM platform is designed to significantly shorten discovery timelines, increase efficiency, and improve the overall success rate of antibody drug development by introducing a creative paradigm of antibody discovery empowered by AI and automation technologies. Hu-mAtrIxTM offers integrated solutions to identify the best antibodies with high efficiency. It allows the exploration of large libraries of human antibody sequences to identify the best sequence with the desired target specificity and binding affinity. Furthermore, it can predict the key antibody properties such as stability, manufacturability and immunogenicity, mitigating development risks in the early stages of discovery. In addition, Nona Biosciences is developing a new AI model to expand its core technology platform HCAb PlusTM. The new model leverages the unique capabilities of its HCAb Harbour Mice®, the industry's leading fully human heavy-chain-only transgenic mouse platform, and the proprietary HCAb dataset, to push the boundaries of antibody discovery, enabling the identification of rare, highly specific antibodies with greater precision and efficiency. "We are excited to introduce the Hu-mAtrIxTM platform, an assistant tool to complement and enhance our existing antibody discovery solutions," said Dr. Jingsong Wang, Chairman of Nona Biosciences. "By combining our proprietary Harbour Mice® with the power of AI, we are addressing key challenges in drug discovery—reducing time-to-market, increasing the likelihood of successful candidates, and providing our partners with more targeted therapeutic options." About Nona Biosciences Nona Biosciences is a global biotechnology company committed to cutting edge technology innovation and providing a total solution from "Idea to IND" (I to ITM), ranging from target validation and antibody discovery through preclinical research. The integrated antibody and antibody-related discovery services with multiple modalities range from antigen preparation, animal immunization, single B cell screening, to antibody lead generation and engineering, developability assessment and pharmacological evaluation, leveraging advantages of Harbour Mice® platforms and the experienced therapeutic antibody discovery team. Harbour Mice® generates fully human monoclonal antibodies in classical two light and two heavy chain (H2L2) format, and heavy chain only (HCAb) format. Integrating Harbour Mice® and a single B cell cloning platform, Nona Biosciences is focused on driving global inventions of transformative next-generation drugs. For more information, please visit: www.nonabio.com.
HONG KONG, March 7, 2025 /PRNewswire/ -- The true value of proper valuation comes from independence. Through independent research conducted by professional valuers, startups and venture capital firms gain access to objective analysis performed using appropriate valuation approaches. Valtech has actively helped numerous aspiring startups and fund managers by performing comprehensive business valuations, analysing business models and projected growth prospects, and in-depth benchmarking analysis. This support greatly facilitates and accelerates price discovery and deal negotiation processes. Today, Max Tsang, a director of Valtech Valuation, — a CPA, CFA, FRM, Chartered Valuation Surveyor, and a business appraiser Accredited in Business Valuation (ABV) by AICPA — is pleased to share the firm's insights and experience. The aim is to help more startups understand the true value of professional valuation and rethink how they should prepare for it. Valuing a Business: More Art than Science Valuation is not an exact science. The use of more data, research, and databases does not automatically lead to a more accurate result. Valuation is inherently dependent on the basis of value. Market value and investment value defined by International Valuation Standards (IVS) are possible basis of value for startup valuation. The selection of basis of value will depend on the purpose of valuation and the actual context. In addition, the judgment will also include underlying key assumptions and the details in application of valuation methods. Depending on knowledge and skills in finance and investment banking, valuation specialist can supplement the analysis using a great variety of skills such as monte carlo simulation, regression, waterfall charts etc. All these will affect the influence and impact of the valuation. Valuation Methods Explained There are three general approaches in valuation: Cost ApproachThis method is rarely applied in startup valuations, as most founders believe their innovative ideas are worth far more than the initial costs incurred. Income ApproachThis method can be applied, but it is often challenging for pre-revenue startups. However, a reasonable and well-supported financial projection and capital budgeting analysis can clearly communicate your financial goals and illustrate the expected growth trajectory over the next 3-5 years. With Valtech's guidance, this becomes a logical and systematic process — identifying the value creation potential from each unit of product or service sold. By making reference to relevant sources, Valtech define realistic market size and growth assumptions, ensuring the financial model is logical and persuasive. Market Approach (They call it Comprehensive Benchmarking) This approach uses comparative analysis, collecting valuation metrics from public companies and private transactions. Think of it like valuing your apartment based on recent sales of similar apartments nearby. However, startup founders often fall victim to survivorship bias — they focus only on announced valuations of successful startups, often ignoring adjustment factors like funding round stage, geography, and business model differences. In reality, systematic, logical, and persuasive adjustments are necessary to align benchmark data with the unique circumstances of the subject startup. Valtech ensures these adjustments are applied appropriately. In application, there are further variations of method for better analysis. For example, risk net present value method (a variety of income approach) is considered to be a better method in valuing biotechnology and healthcare startups. Budget Concerns — Finding the Right Balance Valtech fully recognizes that early-stage startups often have tight budgets when appointing valuation specialists. However, the quality of your valuation report directly impacts investors' first impressions of your company. A well-prepared valuation not only demonstrates professionalism, but also shows how well your team can communicate and support your claims with solid evidence and sensible forecasts. Engaging a reputable and professional valuation team gives investors confidence that your valuation is grounded in independent analysis, rather than soley internal projections. Avoid Over-Reliance on Generative AI for Business Plans A lengthy business plan does not guarantee a good business plan. For valuation purposes, the focus should be on: Your team's profiles and experience Your business model and its unique value proposition The innovative and competitive aspects of your products or services Clear and realistic expansion plans A well-defined budget for utilizing the funds raised Generative AI can assist in drafting, but blindly relying on AI-generated content often results in generic, unfocused plans that fail to address the unique qualities of your business. Investors expect tailored narratives with authentic insights — something no AI can fully capture. Your Startup is Unique — Focus on Your Uniqueness As a startup, you have a unique business idea — one that either solves a critical pain point in the market or disrupts existing players through innovation. While AI can assist in brainstorming, your competitive edge lies in your team's creativity, execution capability, and market understanding. Ask yourself: Can AI generate innovative business ideas? Yes — but the real question is: How unique, feasible, and defensible are those ideas? Plenty of Successful Fundraising Stories from Valtech Clients Valuation is not just about calculating numbers — it's about explaining your venture through numbers. Valtech provides multi-dimensional analysis, considering both the founder's perspective and the investor's perspective. This balance helps create valuation reports that are credible and persuasive. At the same time, investors rely on more than just valuation reports. Many uses proprietary scorecards to evaluate: Team quality and experience Product-market fit Competitive advantage and IP Business scalability and operational resilience Exit potential and projected returns Valtech has witnessed countless successful fundraising journeys among its clients — all at reasonable and defensible valuations. These startups come from diverse sectors, but they all share a common trait: they provide solid proof to justify their value. This proof can take various forms: Well-articulated ideas with clear commercial potential Working prototypes A strong, experienced founding team Established strategic partnerships Demonstrated viability in reaching the next growth stage Final Thoughts — Valtech's Value Proposition Startup valuation is not a one-size-fits-all exercise. Every startup has a unique story, growth trajectory, risk profile, and value proposition. At Valtech, they go beyond just crunching numbers. They help startups shape their valuation report, and navigate the challenging price discovery process with confidence. If you want to secure investment at a reasonable and defensible valuation, you need more than just financial modeling skills — you need a trusted valuation partner who understands investor needs, market dynamics, and trends. This is exactly what Valtech Valuation delivers. Simply visit https://valtech-valuation.com Max Tsang / Marvin Wong / Jimmy Wong T: +852 23889262Email: admin@valtech-valuation.comSingapore: Ritika Gupta | +65 84949455 | admin-sg@valtech-valuation.sg
The first patient has been dosed with EVM16 at Peking University Cancer Hospital, marking a major milestone as Everest's proprietary AI-based tumor neoantigen prediction algorithm and clinically validated mRNA platform progress into human trials. In preclinical studies, EVM16 demonstrated significant tumor growth inhibition in syngeneic mouse model, with repeated dosing showing favorable safety and tolerability. Preclinical data also showed a synergistic anti-tumor effect when EVM16 was combined with a PD-1 antibody, supporting its potential use in combination therapies in clinical settings. SHANGHAI, March 6, 2025 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the discovery, clinical development, manufacturing, and commercialization of innovative therapeutics, today announced that the first patient has been dosed with the Company's internally developed personalized mRNA cancer vaccine EVM16 at Peking University Cancer Hospital in the investigator-initiated clinical trial (IIT) EVM16CX01. EVM16CX01 is the first-in-human (FIH) trial for EVM16, conducted jointly at Peking University Cancer Hospital and Fudan University Shanghai Cancer center, to assess the safety, tolerability, immunogenicity, and preliminary efficacy of EVM16 as a monotherapy and in combination with a PD-1 antibody in patients with advanced or recurrent solid tumors. EVM16 is a novel personalized therapeutic mRNA cancer vaccine internally developed by Everest. It contains neoantigens with high immunogenicity potential, predicted based on the unique tumor mutations of each patient using Everest's proprietary AI-based neoantigen prediction algorithm, EVER-NEO-1. The vaccine is designed to encode dozens of tumor neoantigens. The vaccine uses a lipid nanoparticle (LNP) delivery system to efficiently deliver neoantigen-encoded mRNA in vivo, activating neoantigen-specific tumor-killing T cells and inhibiting tumor growth. In preclinical studies, vaccination with EVM16 stimulated a strong neoantigen-specific T cell response in different mouse models and showed significant tumor growth inhibition in the syngeneic B16F10 mouse melanoma model. EVER-NEO-1, the AI-based neoantigen prediction algorithm developed in-house by Everest, can identify the majority of reported tumor neoantigens, as well as several previously unreported neoantigens. Furthermore, the neoantigen prediction capability of EVER-NEO-1 was shown to be either comparable to or superior to leading industry algorithms in multiple independent validation studies. Preclinical data also demonstrated that the combination of EVM16 and a PD-1 antibody has synergistic effects, which supports the combination of EVM16 with checkpoint inhibitors in clinical settings. In preclinical toxicity studies, repeated dosing with EVM16 was well tolerated and safe. Taken together, the preclinical studies show that EVM16 is safe and efficacious and has potential to bring benefits to cancer patients. "The first patient dosed with the personalized mRNA cancer vaccine EVM16 represents a notable milestone in its clinical development. EVM16 is a customized vaccine based on each patient's tumor-specific mutations, and using the cutting-edge mRNA technology, to activate the patient's tumor-specific immune response to recognize and attack tumor cells." said Professor Shen Lin, Director of the Gastrointestinal Oncology Department at Beijing Cancer Hospital and Chair of the Gastric Cancer Expert Committee of the Chinese Society of Clinical Oncology. " In preclinical studies, we are excited to discover that EVM16, when combined with PD-1 antibodies, demonstrated synergistic anti-tumor effects, further highlighting its broader potential for clinical application. We are confident in achieving positive outcomes in the upcoming clinical trials, bringing hope to cancer patients." "In recent years, AI has become a major force in drug development, especially in the area of mRNA vaccines. AI is increasingly seen as a crucial tool for boosting research efficiency and accuracy, attracting substantial attention from both the biopharmaceutical industry and governments worldwide. Everest has demonstrated the clinical validation capabilities of its mRNA platform since 2021, with an emphasis on employing AI to identify tumor neoantigens. By continually optimizing its algorithms, the company has enhanced the precision of neoantigen recognition and validation, giving it a strong foundation and a competitive edge in developing mRNA-based cancer vaccines." said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "EVM16 is the first personalized mRNA cancer vaccine internally developed by Everest. The first patient dosing marks a significant milestone in its clinical development of EVM16, indicating our proprietary tumor neoantigen AI-based algorithm system and mRNA technology platform have advanced to human trials. As a cancer vaccine candidate developed using our proprietary mRNA platform, we look forward to demonstrating EVM16's therapeutic potential in upcoming clinical trials, with the goal of offering innovative treatment options to cancer patients worldwide and expand choices for those facing life-threatening diseases." According to the Globocan's data in 2022, there were 19.976 million new cancer cases globally, with 9.744 million cancer-related deaths1. Immunotherapy including checkpoint inhibitors has become an important part of treating some cancer types. However, they are only effective for some patients, and there is an urgent need to develop new generations of immunotherapies, such as personalized mRNA cancer vaccines, that have demonstrated early promise in clinical setting. Everest Medicines is currently developing a range of mRNA cancer therapeutics, including personalized cancer vaccines (PCVs), tumor-associated antigen (TAA) vaccines, immunomodulatory cancer vaccines, etc. Additionally, the company is working on next-generation lipid nanoparticle (LNP) delivery systems to enhance cell-mediated immune responses. Everest Medicines will submit an investigational new drug application for its TAA vaccines in China and the United States in 2025. About EVM16 EVM16 is a novel personalized mRNA cancer vaccine independently developed by Everest Medicines. EVM16 contains neoantigens with high immunogenicity potential and predicted by Everest-proprietary algorithm EVER-NEO-1 and uses an LNP delivery system to efficiently deliver neoantigen-expressing mRNAs into the human body. After vaccination with EVM16, neoantigens-encoding mRNAs are delivered into human body to produce neoantigen peptides, which activate neoantigen-specific T cell immune responses to kill tumor cells, thereby inhibiting tumor growth. About EVM16CX01 study The study is a FIH, dose escalation and expansion study to evaluate the safety, tolerability, immunogenicity, and initial efficacy of EVM16 injection as a single and in combination with PD-1 antibody in subjects with advanced or recurrent solid tumors. The primary objectives are to evaluate the safety and tolerability of EVM16 monotherapy and EVM16 in combination with PD-1 antibody in subjects with advanced or recurrent solid tumors, and to determine the recommended phase 2 dose (RP2D) of EVM16. The secondary objectives are to evaluate the immunogenicity of EVM16, and the initial efficacy of EVM16 in combination with PD-1 antibody in subjects with advanced or recurrent solid tumors. About 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 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. Forward-Looking Statements 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. 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. 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 information, future events or circumstances after the date of this news release, except as required by law. Reference: 1. Globocan 2022: https://gco.iarc.who.int/media/globocan/factsheets/populations/900-world-fact-sheet.pdf.
ACT Genomics expands its offerings by exclusively introducing mProbe's OncoOmicsDX, bridging genomics and proteomics for more comprehensive cancer care insights. TAIPEI, March 6, 2025 /PRNewswire/ -- ACT Genomics Co. Limited, Asia's foremost provider of next-generation sequencing (NGS) precision oncology, is proud to announce a new milestone in its mission to improve cancer patient care: the exclusive integration of OncoOmicsDX, an innovative proteomics clinical service developed by mProbe Inc. in Taiwan, Hong Kong, Macau, Singapore, Thailand, Malaysia, Indonesia, Vietnam, and the Philippines. ACT Genomics and mProbe Announces Strategic Integration of Proteomics to Elevate Precision Medicine in Asia This collaboration marks a major advancement in integrating genomics and proteomics—also known as proteogenomics—to enhance molecular insights into cancer biology. By combining NGS-based genomic profiling with proteomics-driven biomarker discovery, this approach provides a more comprehensive understanding of tumor biology, uncovering critical mechanisms of disease progression and treatment response. With these enhanced molecular insights, physicians can make more precise and personalized treatment decisions, optimizing therapy selection based on a patient's unique molecular profile. This proteogenomics approach strengthens the foundation of precision oncology, helping clinicians to identify targeted and effective treatment strategies for cancer patients across the region. "We are excited to partner with mProbe Inc. to deliver a new dimension in precision oncology," said Dr. Hua Chien Chen, CEO of ACT Genomics. "With OncoOmicsDX, healthcare providers gain a holistic view of cancer biology, allowing them to make data-driven decisions that can significantly improve patient cares." OncoOmicsDX harnesses advanced mass spectrometry and AI-driven analytics to identify protein biomarkers linked to cancer progression and treatment response. This additional layer of information complements genomic data, creating a more complete patient profile and potentially increasing the effectiveness of personalized treatments. ACT Genomics aims to offer physicians a more holistic picture of their patients' cancer. This integrated approach can better support therapy selection, predict drug resistance, and uncover new therapeutic targets, ensuring that patients receive the most effective, tailored treatment plans. "This collaboration underscores the critical role proteomics plays in understanding how tumor biology evolves," said Peter Chen, CEO of mProbe Inc. "ACT Genomics' proven track record and extensive network in Asia make them an ideal partner to accelerate the adoption of OncoOmicsDX, ultimately improving patients care across the region." Through the combined expertise and resources, ACT Genomics and mProbe Inc. are committed to driving the future of precision oncology forward, championing research, clinical innovation, and the integration of multi-omic data for better patient outcome scares. Interested clinicians and researchers can learn more about OncoOmicsDX by contacting ACT Genomics directly. About ACT Genomics ACT Genomics is a leading precision medicine company specializing in genomic profiling and advanced molecular diagnostics. Based in Taiwan with operations across Asia, the company provides cutting-edge genomics solutions that empower oncologists to make informed treatment decisions and improve patient care. For more information, please visit https://www.actgenomics.com/. About mProbe mProbe Inc. is a global precision diagnostics company specializing in proteomics. Through its advanced mass spectrometry and AI-based platforms, mProbe delivers actionable insights that enhance cancer treatment strategies and improve patient outcomes. For more information, please visit https://www.mprobe.com/.
Biotechnology
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