News for Everest Medicines Limited (1952.HK)

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    Everest Medicines Announces FDA Clearance of IND Application for Tumor-Associated Antigen Vaccine EVM14

    EVM14 received U.S. FDA clearance for its IND application, becoming Everest's first internally discovered program, and the first mRNA therapeutic cancer vaccine to be cleared for global clinical development. Preclinical highlights: EVM14 induced a dose-dependent, antigen-specific immune response in mice and significantly inhibited tumor growth in multiple syngeneic tumor models. As a therapeutic vaccine, EVM14 demonstrated the ability to induce immune memory and prevent tumor recurrence. In combination with immune checkpoint inhibitors (ICIs), EVM14 significantly enhanced anti-tumor activity, supporting exploration of combination therapies in clinical trials. EVM14, EVM16 and in-vivo CAR-T programs are the core pillars of Everest's oncology and autoimmune disease innovation strategy. SHANGHAI, March 24, 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 U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for EVM14, a Tumor-Associated Antigen (TAA) vaccine. EVM14 is Everest's first internally developed mRNA therapeutic vaccine to receive FDA IND approval, marking a significant milestone in the Company's efforts to develop innovative mRNA therapeutics in oncology.
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    Everest Medicines Announces First Patient Dosed with EVM16, Its First Internally Developed Personalized mRNA Cancer Vaccine

    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.
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    Everest Medicines to Hold Investor Calls with Updates on mRNA Therapeutic Vaccine Programs

    SHANGHAI, Feb. 28, 2025 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK, 'Everest', or the 'Company'), a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing transformative pharmaceutical products and vaccines, today announced that it will hold investor calls to discuss recent developments on its mRNA therapeutic vaccine programs.
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    Everest Medicines Presents Complete Maintenance Period Data for Etrasimod at ECCO 2025

    Data confirms significant clinical and endoscopic benefits of etrasimod 2mg after 40 weeks of maintenance treatment Etrasimod demonstrates robust efficacy across multiple endpoints, including mucosal healing, endoscopic normalization, and histological remission Safety profile remains consistent with previous studies, with no new safety findings were observed SHANGHAI, Feb. 26, 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 the presentation of maintenance data from its multi-center Phase III clinical study of etrasimod (VELSIPITY®) in Asia at the 20th European Crohn's and Colitis Organization Congress (ECCO 2025).
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    Everest Medicines to Announce Full-Year 2024 Financial Results on March 26, 2025

    SHANGHAI, Feb. 25, 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 it will report its financial results for the full year of 2024 ended December 31, 2024, and provide a business update on March 26, 2025. The Company will hold a live conference call in English and Mandarin on March 26, 2025 Beijing Time.
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    Everest Medicines Announces the First Prescription of VELSIPITY® in the Greater Bay Area, Officially Benefiting Mainland China Patients

    SHANGHAI, Dec. 18, 2024 /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 prescription for VELSIPITY® has been written at Foshan Fosun Chancheng Hospital in Guangdong, under the 'Hong Kong and Macau Medicine and Equipment Connect' policy, which marks the official beginning of this new therapy benefiting patients in mainland China.
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    Everest Medicines Announces the First Prescription of VELSIPITY® Issued in Macau, Officially Beginning to Benefit Asian Patients

    SHANGHAI, Dec. 12, 2024 /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 prescription of VELSIPITY® (etrasimod) has been issued on December 11th at Kiang Wu Hospital in Macau. It is also the first prescription issued for VELSIPITY® within Everest Medicines' licensed territories in Asia following its approval, marks the official beginning of this new therapy benefiting patients across Asia.
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    Everest Medicines Announces Positive Results in Preliminary Analysis of Phase 1b/2a Clinical Trial of EVER001, a Novel BTK Inhibitor for the Treatment of Primary Membranous Nephropathy

    Patients in the low-dose cohort who have completed 36 weeks of treatment, 9 out of 11 (81.8%) achieved overall clinical remission and 10 out of 11 (91%) achieved immunological complete remission. In the high dose cohort, 6 out of 7 (85.7%) patients achieved overall clinical remission and all patients achieved immunological complete remission by week 24. EVER001 was generally safe and well tolerated. No clinically significant adverse events typically associated with earlier-generation BTK inhibitors, such as bleeding, arrhythmia, severe infection, leukopenia, thrombocytopenia, or severe liver function impairment, were reported. SHANGHAI, Dec. 4, 2024 /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 positive results in the ongoing Phase 1b/2a clinical trial for the treatment of primary membranous nephropathy (pMN) with EVER001 (previously known as XNW1011), a next-generation covalent reversible Bruton's tyrosine kinase (BTK) inhibitor. In an analysis of the data available as of September 13th, 2024, results from the Phase 1b/2a clinical trial showed that for patients in the low-dose cohort who have completed 36 weeks of treatment, 9 out of 11 (81.8%) achieved overall clinical remission1 and 10 out of 11 (91%) achieved immunological complete remission (ICR)2. In the high dose cohort, 6 out of 7 (85.7%) patients achieved overall clinical remission and all patients achieved ICR by week 24.
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    Everest Medicines Announces Acceptance of VELSIPITY® New Drug Application in Hong Kong

    SHANGHAI, Dec. 2, 2024 /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 Department of Health of the Government of the Hong Kong Special Administrative Region, China, has accepted Everest's New Drug Application (NDA) for VELSIPITY® (etrasimod) for the treatment of adult patients with moderately to severely active ulcerative colitis. VELSIPITY® is an effective and convenient, once-daily, oral treatment for patients with moderately-to-severely active UC that has already been approved in the U.S. and E.U., and other countries, by Everest's licensing partner, Pfizer. In Everest territories, the Pharmaceutical Administration Bureau of the Macau Special Administrative Region, China has approved the NDA for VELSIPITY® in April of this year and was implemented in the Guangdong-Hong Kong-Macau Greater Bay Area this October through the 'Hong Kong and Macau Medicine and Equipment Connect' policy.
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    Everest Medicines Announces NEFECON®, the World's First Approved Treatment for IgA Nephropathy, is Included in China's National Reimbursement Drug List

    SHANGHAI, Nov. 28, 2024 /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 NEFECON® has been included in the National Reimbursement Drug List ('NRDL'). The 2024 NRDL will take effect starting from January 1st, 2025.
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    Two In Vitro Studies on Eravacycline (XERAVA®) Presented at IDWeek, Demonstrating Its Sustained and Robust Antimicrobial Activity

    SHANGHAI, Nov. 22, 2024 /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 data on its critical-care, anti-infective product, eravacycline (XERAVA®), was recently presented in Los Angeles, California at IDWeek 2024. Among the findings, two in vitro study results further demonstrated the broad and consistent antimicrobial activity of eravacycline.