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Everest Medicines Reports Strong H1 2025 Growth with Advanced mRNA Platform and Pipeline Expansion

6 days ago6 min read

Key Insights

  • Everest Medicines achieved 48% year-over-year revenue growth to RMB 446 million in H1 2025, driven by strong performance of NEFECON® and XERAVA®.

  • The company's proprietary AI-enabled mRNA platform advanced significantly with EVM16 personalized cancer vaccine entering first-in-human trials and EVM14 receiving FDA IND clearance.

  • NEFECON® became the first etiological treatment for IgA nephropathy to receive full approval in China, with production expansion approved to meet growing demand.

Everest Medicines delivered robust financial performance in the first half of 2025, with total revenue reaching RMB 446 million, representing a 48% year-over-year increase. The biopharmaceutical company's growth was anchored by its "dual-engine" strategy combining commercial success with innovative pipeline development through its proprietary AI-enabled mRNA platform.

Strong Commercial Performance Drives Revenue Growth

NEFECON®, the company's flagship treatment for IgA nephropathy (IgAN), generated RMB 303 million in revenue during the first half of 2025, marking an 81% year-over-year increase. The drug's inclusion in China's National Reimbursement Drug List (NRDL) in January 2025 significantly accelerated market adoption, with over 20,000 new patients initiating treatment during the period.
"NEFECON® generated revenue of RMB 303 million in the first half of 2025, representing 81% year-over-year growth," said Rogers Yongqing Luo, CEO of Everest Medicines. However, he noted that first-half revenue was constrained by supply limitations due to strong market demand and regulatory delays for production scale-up approval.
The supply constraint was resolved in August 2025 when China's National Medical Products Administration approved the supplemental application for production expansion. Following this approval, the company recorded RMB 520 million in NEFECON® revenue in August alone to address pent-up market demand. Full-year sales projections for NEFECON® range from RMB 1.2 to 1.4 billion, with continued growth expected in 2026, potentially reaching RMB 2.4 to 2.6 billion.
XERAVA®, the world's first fluorocycline antibiotic, maintained steady growth with RMB 143 million in revenue for the first half of 2025, representing a 6% year-over-year increase. In-hospital sales grew 37% year-over-year, driven by the company's core hospital strategy focusing on institutions with significant market potential.

Breakthrough mRNA Platform Advances

Everest's proprietary AI-enabled mRNA platform achieved significant milestones across multiple therapeutic programs. The platform encompasses mRNA therapeutic cancer vaccines and in vivo CAR-T technologies, positioning the company at the forefront of next-generation immunotherapy development.

Personalized Cancer Vaccine Program

EVM16, the company's personalized mRNA cancer vaccine, successfully dosed its first patient at Peking University Cancer Hospital in March 2025. The investigator-initiated trial represents the first-in-human study for EVM16, evaluating safety, tolerability, immunogenicity, and preliminary efficacy as both monotherapy and in combination with PD-1 antibodies in patients with advanced solid tumors.
The vaccine is built upon Everest's proprietary AI-based neoantigen prediction algorithm, EVER-NEO-1, and third-generation mRNA sequence optimization. Early clinical data demonstrated strong immunogenicity and neoantigen-specific T-cell activation even at low starting doses, validating the company's algorithmic approach and reinforcing confidence in the personalized vaccine strategy.

Off-the-Shelf Cancer Vaccine

EVM14, an off-the-shelf tumor-associated antigen (TAA) vaccine, received FDA Investigational New Drug (IND) clearance in March 2025 and IND acceptance from China's NMPA in July 2025. The vaccine targets five TAAs highly expressed across multiple squamous cell carcinoma types, including non-small cell lung cancer and head and neck cancer.
In June 2025, Everest successfully released the first clinical batch of EVM14 from its Jiashan manufacturing site, supporting clinical trials in both China and the United States. First patient enrollment in the U.S. Phase I trial is expected by September 2025.

In Vivo CAR-T Platform

The company's mRNA in vivo CAR-T platform, designated EVM18, completed multiple non-human primate trials and achieved preclinical proof-of-concept. Built upon proprietary targeted lipid nanoparticle (tLNP) delivery systems, the platform offers key advantages over traditional CAR-T therapy, including off-the-shelf availability, lymphodepletion-free administration, and dose controllability.
Preclinical data in humanized mouse models and non-human primates demonstrated high T-cell transfection rates, strong CAR expression, and effective B-cell depletion. First-in-human data initiation is expected by the end of 2025.

EVER001 Shows Promise in Autoimmune Renal Disease

EVER001 (civorebrutinib), a next-generation covalent reversible Bruton's tyrosine kinase (BTK) inhibitor, delivered encouraging Phase 1b/2a clinical results in primary membranous nephropathy (pMN). Updated data presented in July 2025 showed sustained efficacy through 52 weeks of follow-up.
In the ongoing trial, anti-PLA2R autoantibody levels decreased by 62.2% in the low-dose cohort and 87.3% in the high-dose cohort at week 12, with reductions exceeding 93% at week 24 and sustained through week 52 in both cohorts. Proteinuria levels showed geometric least square mean decreases of 57.0% and 67.6% at week 24 in cohorts 1 and 2, respectively, deepening to 76.7% and 80.6% at week 36.
Clinical remission rates improved significantly over time, with 38.5% of patients in cohort 1 and 70.6% in cohort 2 achieving remission at week 24, increasing to 69.2% and 91.7% respectively by week 36. EVER001 demonstrated a favorable safety profile with most treatment-related adverse events categorized as Grade 1-2.

Regulatory Milestones and Market Expansion

NEFECON® achieved several regulatory milestones during the reporting period. In May 2025, the drug received full approval from China's NMPA for IgAN treatment irrespective of proteinuria levels, making it the first and only etiological treatment for the condition to receive full approval in China.
The drug was also included in China's first clinical practice guideline for IgA nephropathy, which recommends a 9-month course of NEFECON® for all primary IgAN patients at risk for disease progression. The guideline introduces disease-modifying treatment targeting immune-mediated damage, particularly the formation of pathogenic IgA1 (Gd-IgA1), with NEFECON® recommended as the preferred treatment.
VELSIPITY® (etrasimod), positioned as a potential blockbuster therapy for ulcerative colitis, has its New Drug Application under review in mainland China, with approval expected in the first half of 2026. The drug received regulatory acceptance in South Korea and Taiwan during the reporting period, following prior approvals in Hong Kong, Singapore, and Macau.

Financial Performance and Outlook

The company's operational efficiency improved significantly, with operating expenses as a percentage of revenue decreasing by 40.1 percentage points. Non-IFRS adjusted loss narrowed by 31% to RMB 146.9 million, while gross margin excluding non-cash items reached 76.4%.
Everest maintained a solid cash position of RMB 1.6 billion as of June 30, 2025, further strengthened by HK$1.553 billion in net proceeds from a successful share placement completed in August 2025. The company expects to achieve operating cash flow positivity in Q4 2025 and full operating profitability in the second half of 2025.
Full-year revenue guidance for the combined NEFECON® and XERAVA® portfolio targets RMB 1.6 to 1.8 billion. Looking ahead, the company projects total peak sales exceeding RMB 25 billion globally across its portfolio, including the two core blockbuster products and high-potential assets such as Cefepime-taniborbactam and EVER001.
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