Everest Medicines Announces Interim Results for First Half of 2025

SHANGHAI, Aug. 28, 2025 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the development, manufacturing and commercialization of innovative medicines and vaccines, today announced its interim results for the first half of 2025 along with a corporate update.

"In the first half of 2025, Everest Medicines accelerated its transformation into a leading global biopharmaceutical company by deepening our 'dual-engine' strategy," commented Rogers Yongqing Luo, CEO of Everest Medicines. "We have built a commercialization platform anchored by two blockbusters covering high-potential markets and powered by the in-house discovery and clinical translation of in vivo CAR-T and mRNA therapeutic cancer vaccine platforms."

"Our total revenue for the first half of 2025 reached RMB 446 million, representing 48% year-over-year growth, while operating expenses as a percentage of revenue decreased by 40.1 percentage points, reflecting strong operational efficiency. Non-IFRS loss narrowed by 31%, and gross margin excluding non-cash items was 76.4%. As of the end of June, we maintained a solid cash balance of RMB 1.6 billion. Additionally, with the successful completion of a share placement on August 1, we received net proceeds of HK$1.553 billion, providing a strong foundation for future growth.

Our core products continue to demonstrate strong market potential. NEFECON® and XERAVA® are generating sustainable cash flow, while VELSIPITY® (etrasimod), positioned as a potential blockbuster, is expected to become a key new growth driver, together fueling our business momentum.

NEFECON® generated revenue of RMB 303 million in the first half of 2025, representing 81% year-over-year growth. However, our first half revenue was artificially low due to a supply constraint that was rooted in both strong market demand and a delay in regulatory approval of a supplemental application for production scale up designed to ensure supply stability. This has been fully resolved since our supplemental application was approved by the China CDE on Aug 1, 2025. Consequently, we recorded RMB 520 million of NEFECON® revenue in August alone in order to meet the pent-up market demand. Full-year sales are expected to reach RMB 1.2 to 1.4 billion, with continued strong growth projected in 2026, potentially reaching RMB 2.4 to 2.6 billion.

XERAVA®, the world's first fluorocycline antibiotic, continued its steady growth, generating RMB 143 million in the first half of 2025, up 6% year-over-year. In-hospital sales increased 37% year-over-year, driven by our core hospital strategy.

VELSIPITY®, a best-in-disease therapy, has its NDA under review in mainland China, with approval expected in the first half of 2026. The localized production project for VELSIPITY® was officially launched at the Jiashan manufacturing site in March 2025, providing strong support for its future commercialization.

Supported by NEFECON®'s strong growth and XERAVA®'s consistent performance, we remain confident in achieving our full-year revenue guidance of RMB 1.6 to 1.8 billion and expect to turn operating cash flow positive in Q4.

"We continue to focus on achieving key breakthroughs in our core proprietary pipeline, while accelerating the clinical development and global expansion of innovative assets with global rights. Leveraging our industry-leading mRNA therapeutic cancer vaccine platform and mRNA in vivo CAR-T platform, we are 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.

EVM14, an off-the-shelf tumor associated antigen vaccine, has received IND approval from the U.S. FDA and acceptance from China's NMPA. The Phase I trial in the U.S. is currently underway, with first patient enrollment expected by September 2025.

EVM15, the immune-modulatory cancer vaccine, has completed preclinical proof of concept and identified its clinical candidate.

EVER001 (civorebrutinib), the next-generation covalent reversible BTK inhibitor, has delivered encouraging Phase 1b/2a clinical data in primary membranous nephropathy (pMN), with global development advancing steadily.

A series of recent strategic initiatives has further strengthened our foundation for long-term growth. Through a successful top-up placement, we bolstered our capital position to accelerate the development of our innovative pipeline and proprietary AI-enabled mRNA platform, while advancing the commercialization of our existing portfolio. Earlier this year, the Hong Kong Stock Exchange approved the removal of the 'B' marker from our stock short name, reflecting recognition of our robust R&D pipeline, commercialization capabilities, and overall business fundamentals. In August, we completed a strategic equity investment in I-Mab, further advancing our global presence in next-generation immuno-oncology therapies.

Backed by a strong cash position and continuously strengthened R&D and commercialization capabilities, we aim to achieve operating profitability in the second half of 2025.

Looking ahead, we will drive towards our vision through the 'dual-engine' strategy. We will build on our robust commercial platform by focusing on the two core blockbuster products, NEFECON® and VESIPITY®, while leveraging a high-potential portfolio including XERAVA®, Cefepime-taniborbactam, EVER001 (civorebrutinib), and other assets, to generate synergies with total peak sales expected to exceed RMB 25 billion globally.

Meanwhile, we will drive organic pipeline growth through early-stage R&D based on our AI-enabled mRNA platform. By leveraging our in vivo CAR-T and mRNA therapeutic cancer vaccine platforms, we are strengthening our in-house innovation and global development capabilities. We remain committed to delivering innovative therapies to patients, creating long-term value for shareholders, driving forward with the vision of becoming a leading global biopharmaceutical company." Mr. Luo concluded. 

Recent Key Product Highlights and Anticipated Milestones

RENAL PRODUCTS PORTFOLIO

NEFECON®

- In January 2025, NEFECON® pricing was officially implemented under the NRDL after its inclusion in November 2024. Patients are able to obtain NEFECON® at designated medical institutions or pharmacies and benefit from the reimbursed pricing. The official implementation of the NRDL expands the accessibility of NEFECON®, alleviates patient financial burden, and enables more patients with IgAN in China to benefit from this innovative drug.

- In May 2025, the supplemental new drug application for NEFECON® was granted full approval by the China NMPA, irrespective of proteinuria levels. This milestone makes NEFECON® the first and only etiological treatment for IgA nephropathy (IgAN) to receive full approval in China. The full approval by the NMPA is based on data from the global Phase 3 NefIgArd clinical trial, a randomized, double blind, multicenter study that evaluated the efficacy and safety of NEFECON® at a once-daily dose of 16 mg, compared to placebo in adult patients with primary IgAN on optimized RASi therapy.

- In May 2025, NEFECON® was included in the "Clinical Practice Guideline for IgA Nephropathy and IgA Vasculitis in Chinese Adults (For Public Review)", which recommends the etiological treatment with a 9-month course of NEFECON® for all primary patients with IgAN who are at risk for disease progression, irrespective of proteinuria levels. The guideline recommends that patients with proteinuria ≥ 0.5g/day (or equivalent levels) undergo a renal biopsy and initiate treatment. For the first time, the guideline introduces interventions targeting immune-mediated damage, particularly the formation of pathogenic IgA1 (Gd-IgA1), a key driver of pathogenesis to IgAN. NEFECON® is recommended as the preferred treatment to reduce Gd-IgA1. Once short-term treatment goals, namely proteinuria remission (defined as proteinuria < 0.5 g/day, ideally < 0.3 g/day) and stable renal function, are achieved, low-dose maintenance or repeated safe and effective immunotherapy can be considered together with supportive care to ensure that eGFR declines by less than 1 ml/min per year.

- In June 2025, Everest presented 9 new abstracts on NEFECON® at the 62nd European Renal Association Congress (ERA 2025). These included 8 oral presentations and one e-poster. The newly released results provide comprehensive findings, including efficacy predictive biomarkers, efficacy evaluations across patients with varying diagnosis timelines and baseline eGFR, long-term treatment sustainability, and in particular, investigations into the mechanism of action and safety profile. The results show that NEFECON® improves renal function in IgAN patients, regardless of baseline eGFR or time since diagnosis. Additionally, the new results demonstrate that early treatment with NEFECON® can help protect renal function and slow disease progression, leading to improved disease management and an improved quality of life for patients. These findings provide robust support to the new disease management strategy of "Treat the cause, Treat early, Treat all, Treat long-term."

Post-Reporting Period achievements and expected milestones:

- In August 2025, Everest announced that the supplemental application for the production expansion of NEFECON® has been officially approved by China's NMPA. NEFECON® is the first and only etiological treatment for IgA nephropathy to receive full approval in China, the United States, and Europe, providing a foundational first line cornerstone treatment for IgAN patients. This approval for production expansion will further boost capacity and increase product supply, enabling a more efficient response to the growing clinical demand in China and across Asia.

- In August 2025, Everest announced that China Taiwan Food and Drug Administration (the "TFDA") has approved the supplementary application for NEFECON®. NEFECON® is indicated to reduce the loss of kidney function in adults with primary IgAN who are at risk for disease progression, irrespective of proteinuria levels. Taiwan region became the last region across all of Everest's territories to grant full approval for NEFECON®, together with Mainland China, Singapore, Macao SAR, Hong Kong SAR and South Korea. This further demonstrates NEFECON®'s foundational first-line cornerstone treatment for IgAN patients.

- We expect official inclusion of NEFECON® in the KDIGO 2025 guidelines as well as in the first Chinese guideline for IgAN in the second half of 2025.

EVER001 (civorebrutinib) is a next-generation covalent reversible Bruton's tyrosine kinase (BTK) inhibitor with potential best-in-class characteristics for the treatment of autoimmune renal diseases such as primary membranous nephropathy (pMN), IgA nephropathy (IgAN), minimal change disease (MCD), focal segmental glomerulosclerosis (FSGS), and lupus nephritis (LN). Compared to covalent irreversible BTK inhibitors, EVER001 offers improved selectivity while maintaining high potency, thereby potentially avoiding many of the side effects associated with earlier-generation BTK inhibitors. Everest Medicines holds global rights to EVER001 for the treatment of renal diseases.

- In June 2025, Everest presented positive results, including longer-term data as of 17 December 2024, from the ongoing Phase 1b/2a clinical trial of EVER001 in China at ERA 2025. Ten patients in the low-dose cohort completed 52 weeks of follow-up, and 10 patients in the high-dose cohort completed 24 weeks of treatment. Compared to baseline, the least squares (LS) geometric mean levels of anti-PLA2R autoantibodies decreased by 62.1% in the low-dose cohort and 87.3% in the high-dose cohort at week 12. The reductions in both cohorts reached approximately 93% at week 24. Additionally, in the low-dose cohort, a 78.0% reduction in proteinuria was observed by the end of 36 weeks of treatment which was sustained through week 52. In the high-dose cohort, a 70.1% reduction in proteinuria was shown at week 24, with 80.0% of patients achieving clinical remission. Patients in both cohorts maintained stable renal function during the treatment period. EVER001 was generally safe and well tolerated. No clinically significant adverse events commonly associated with covalent irreversible BTK inhibitors were observed.

Post-Reporting Period achievements and expected milestones:

- In July 2025, Everest announced updated positive results from the ongoing Ph1b/2a clinical trial of EVER001, with a data cut off of March 21, 2025 (in Cohort 1, 11 patients completed 52 weeks of follow-up; In Cohort 2, 16 patients completed 24 weeks of treatment, 12 patients completed 36 weeks of treatment, and 7 patients completed 52 weeks of follow-up). Compared to baseline, the geometric least square (LS) mean of anti-PLA2R autoantibody levels decreased by 62.2% in Cohort 1 and 87.3% in Cohort 2 at week 12. The reductions in both cohorts reached more than 93% at week 24 and were sustained through week 52 in both cohorts. 76.9% of patients in Cohort 1 and 88.2% in Cohort 2 achieved immunological complete remission at week 24. Geometric LS mean of 24hr proteinuria levels in cohorts 1 and 2 decreased by 57.0% and 67.6% at week 24, respectively; and further deepened to 76.7% and 80.6% at week 36, respectively; the reductions in both cohorts were sustained through Week 52. Consistent with prior results, 38.5% of patients in Cohort 1 and 70.6% of patients in Cohort 2 reached clinical remission at week 24 and the remission rate improved to 69.2% and 91.7% by week 36. The average serum albumin levels of patients in both cohorts reached the normal range during the treatment period, while maintaining the stable eGFR. EVER001 was generally safe and well tolerated with the most common Treatment-Related Adverse Events (TRAEs) categorized as Grade 1-2. No clinically significant adverse events commonly associated with BTK inhibitors were observed.

- We expect to report EVER001 Phase 1b/2a 1-year follow up data in September.

INFECTIOUS DISEASE PORTFOLIO

XERAVA® (eravacycline)

- In June 2025, the Chinese Journal of Laboratory Medicine officially published "Specifications for Antimicrobial Susceptibility Testing of Eravacycline (2025)", providing standardized protocols for conducting and interpreting the in vitro antimicrobial susceptibility testing (AST) of eravacycline. These protocols support rational clinical use of eravacycline based on standardized evidence and enhance the accuracy and consistency of susceptibility testing results across clinical microbiology laboratories, thereby better addressing the challenges of treating multidrug-resistant (MDR) and complicated infections. The Specifications were jointly developed by the Expert Committee of the National Health Commission on Antimicrobial Susceptibility Testing and Standard Research (hereinafter referred to as the "ChinaCAST"), the Clinical Microbiology Laboratory Specialized Committee of Chinese Hospital Association, and the Chinese Committee on Antimicrobial Susceptibility Testing, affiliated to the European Committee on Antimicrobial Susceptibility Testing (EUCAST). This publication complements the China clinical breakpoints for ...