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 eravacycline released by ChinaCAST in 2024, creating a unified technical framework that integrates breakpoint definitions with standardized testing protocols.

AUTOIMMUNE DISEASE PORTFOLIO

VELSIPITY^® (etrasimod)

- In February 2025, the data from the maintenance phase of the multi-center Phase III clinical study of etrasimod in Asia were presented at the 20th European Crohn's and Colitis Organization Congress (ECCO 2025). To date, etrasimod is the only advanced therapy for UC that has completed a large-scale, randomized, controlled pivotal study in the Asia-Pacific region. The ES101002 study provides robust evidence supporting the use of etrasimod in patients with UC and confirms the significant clinical and endoscopic benefits after 40 weeks of maintenance treatment with 2 mg etrasimod, including mucosal healing, endoscopic normalization, and histological remission. The safety profile of etrasimod remained consistent with previous studies, with no new safety findings observed.

- In March 2025, the localized production project for etrasimod was officially launched at the Jiashan factory. With a total investment of RMB70 million, the project is expected to reach an annual production capacity of 50 million tablets once fully operational. The expected supply scope will cover Everest's licensing regions, including Greater China, South Korea, and Singapore.

- In April 2025, the Department of Health of the Government of the Hong Kong Special Administrative Region, China, officially approved the NDA for VELSIPITY^® for the treatment of adult patients with moderately to severely active UC.

- In June 2025, the Ministry of Food and Drug Safety (MFDS) of South Korea officially accepted the NDA for VELSIPITY^® for the treatment of patients with moderate-to-severely active UC.

- In June 2025, etrasimod was included in the ACG Clinical Guideline Update: Ulcerative Colitis in Adults (the "Updated Guidelines"). S1P receptor modulators, including etrasimod, are recommended for induction of remission in patients with moderately to severely active UC, and are recommended to be continued for maintenance of remission as compared with no treatment after induction of remission with these agents. Both recommendations are strong, with moderate quality of evidence.

• Post-Reporting Period achievements and expected milestones:

- In July 2025, four-year global safety follow-up data for etrasimod in the treatment of patients with moderate-to-severe active UC were presented at the 13th Annual Congress of the Asian Organization for Crohn's and Colitis (AOCC 2025). These data were previously presented at the European Crohn's and Colitis Organization (ECCO) Congress and the Digestive Disease Week (DDW) conference. The data demonstrated a favorable long-term safety and tolerability profile for etrasimod in patients with moderately to severely active UC, with no changes in safety characteristics among patients receiving long-term treatment of etrasimod.

- In August 2025, China Taiwan Food Drug Administration (TFDA) officially accepted the NDA for VELSIPITY^® for the treatment of patients with moderately to severely active UC. The regulatory acceptance in South Korea and Taiwan, China marks a significant milestone in VELSIPITY^®'s market access across Asia, following prior approvals in Macau, Singapore, and China Hong Kong.

- We expect VELSIPITY^® to receive NDA approval in China in the first half of 2026.

mRNA PLATFORM

Everest has built an industry-leading, fully integrated, and localized AI+mRNA platform that accelerates mRNA product development in mRNA therapeutic cancer vaccines and mRNA in vivo CAR-T platform.

Among our mRNA cancer vaccines, EVM16 is built upon a proprietary AI-based neoantigen prediction algorithm, EVER-NEO-1, and the third generation mRNA sequence optimization model. mRNA sequences encoding each patient's tumor-specific neoantigens are encapsulated into lipid nanoparticles (LNP) and administered to the patient to elicit an antigen specific T cell immune response. Preclinical studies of EVM16 in mouse melanoma models demonstrated efficacy and synergistic effects when combined with PD-1 antibody. EVM14, an off-the-shelf therapeutic mRNA cancer vaccine, targets five tumor-associated antigens and is applicable across multiple types of squamous cell carcinomas. Preclinical studies have demonstrated its potential to induce immune memory and reduce tumor recurrence. EVM14 has received a U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) clearance and has received IND acceptance in China. Preclinical studies for immune-modulatory cancer vaccine EVM15 is ongoing and expects to achieve preclinical proof of concept in 2025.

Everest's mRNA in vivo CAR-T platform, which can be developed for both cancer and autoimmune diseases, is built upon its proprietary targeted LNP (tLNP) delivery system and has shown promising results in both humanized mouse models and non human primates. The in vivo CAR-T platform offers key advantages over traditional CAR-T therapy including off-the-shelf availability, lymphodepletion-free administration, and dose controllability.

- In March 2025, Everest 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 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.

- In March 2025, Everest announced that the U.S. FDA has cleared its IND application for EVM14, a 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.

- In June 2025, Everest announced the successful release of the first clinical batch of EVM14 from its Jiashan manufacturing site, Zhejiang Province in China. This batch will support the clinical trials of EVM14 in both China and the United States.

- In June 2025, Everest hosted the "2025 Everest Medicines mRNA Platform R&D Day" in Shanghai. The event unveiled significant advancements in the Company's proprietary AI+mRNA platform and highlighted key cancer and autoimmune pipeline programs developed through the platform, substantially progressing the Company's "dual-engine" strategy.

• Post-Reporting Period achievements and expected milestones:

- In July 2025, the IND application for EVM14 was officially accepted by China's CDE.

- We expect to enroll first patient in the EVM14 program in the U.S. in the second half of 2025.

- We expect to receive IND approval on EVM14 from China's NMPA in the second half of 2025.

- We expect to achieve preclinical candidate milestone in the mRNA in vivo CAR-T program in the second half of 2025.

-  We expect to complete patient enrollment of EVM16 IIT study in the second half of 2025.

Commercialization

Our commercial portfolio now includes NEFECON^®, XERAVA^®, and VELSIPITY^®, three products that have strong revenue potential and strategic market positioning. NEFECON^® and XERAVA^® generated RMB446 million revenues in the first half of 2025.

We witnessed a significant acceleration in NEFECON^® sales following its inclusion in China's NRDL effective from 1 January 2025. This growth was driven by the rapid expansion of core hospital coverage, which now includes 800 institutions, representing over 80% of the market potential and is supported by a dedicated team of approximately 160 sales representatives. Implementation of NRDL pricing across these hospitals progressed quickly, either through formal hospital listing or dual-channel pharmacies, with approximately 80% of core hospitals adopting NRDL pricing by the end of June. As a result, more than 20,000 new patients initiated on NEFECON^® treatment in the first half of the year.

Support for NEFECON^®'s clinical value also continues to grow. China's first treatment guideline draft for IgAN recommends a 9-month course of NEFECON for all patients with primary IgAN who are at risk of disease progression, irrespective of proteinuria levels, which will enable broad utilization by treating physicians. For the first time, the draft guideline introduces disease-modifying treatment, referring to interventions targeting immune-mediated damage particularly the formation of pathogenic IgA1 (Gd-IgA1), a key driver of pathogenesis to IgAN, and 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. Accordingly, we initiated a unified marketing and disease management strategy for IgAN, namely "Treat the cause, Treat early, Treat all, Treat long-term", and is supported by robust data from our global Phase 3 study and subgroup analyses. In addition, we launched multiple real world studies in the first half year including ones on different combination use scenarios with NEFECON^®.

Multiple articles on NEFECON^® were published in authoritative medical journals including "Immunomodulatory effects and research progresses of budesonide enteric-coated capsules in IgA nephropathy" and "Predictive Value of Gd-IgA1, Poly-IgA in the Treatment of IgA Nephropathy with Targeted Release Formulation-Budesonide" by Prof. Lv Jicheng (Department of Nephrology, Peking University First Hospital), "Efficacy and safety of TRF-budesonide in IgA nephropathy treatment: a meta-analysis" by Prof. Mao Zhiguo (Division of Nephrology, Department of Nephrology, Shanghai Changzheng Hospital), "Recent Development in the Diagnosis and Treatment of IgA Nephropathy" by Prof. Chen Wei (Department of Nephrology, the First Affiliated Hospital of Sun Yat-sen University) and "A Targeted-Release Formulation of Budesonide for the Treatment of IgA Nephropathy Patients With Severe Renal Impairment" by Prof. Jingyuan Xie (Department of Nephrology, School of Medicine, Ruijin Hospital, Shanghai Jiao Tong University).

We also drove increased penetration of XERAVA^®(eravacycline) in our core hospitals, especially those with significant commercial market potential, and achieved stable revenue growth, facilitated by an optimized contract sales organization (CSO) model that extends access to benefit patients outside of core hospitals and underserved markets. The Chinese breakpoints for eravacycline are now fully accepted by CDE and are reflected in the product label. Eravacycline was also included in the Chinese expert consensus on the diagnosis, treatment, and prevention of Carbapenem-Resistant Enterobacteriaceae (CRE) infection in patients with hematological malignancies (2025). Inclusion in these guidelines broadens physician awareness of XERAVA^® while also encouraging broader product utilization. With the accumulation of clinical experience and the conduct of clinical studies by Chinese doctors, the following articles were published in the first six months of 2025. These publications have significantly enhanced awareness and provided more references for broader clinical applications.

 

VELSIPITY^® is now available in nine medical institutions in Guangdong province under the "Hong Kong and Macau Medicine and Equipment Connect" policy, paving the way for its pending NDA approval in China that is expected in the first half of 2026. To support broader physician adoption of VELSIPITY^®, we have initiated real-world studies in the Greater Bay Area to generate additional clinical insights and help inform treatment guidance. Following its inclusion in the American Gastroenterological Association (AGA) clinical practice guideline in December 2024, etrasimod was included in the American College of Gastroenterology (ACG) clinical guidelines in June 2025, strongly recommended for induction of remission in patients with moderately to severely active UC, and for maintenance of remission as compared with no treatment after induction of remission with these agents. Furthermore, to strengthen our VELSIPITY^® supply chain, we launched a localized production project at our Jiashan facility with a total investment of RMB70 million. Once operational, the site will have the capacity to produce up to 5 million bottles of VELSIPITY^® annually and ensure long-term supply reliability.

Commercialization Outlook

We remain focused on accelerating commercial execution and expanding access to our innovative therapies in the second half of 2025. We are actively expanding NRDL coverage of NEFECON^® across all core hospitals, while simultaneously enhancing physician and patient awareness of the "Treat the cause, Treat early, Treat all, Treat long-term" disease management strategy through targeted education initiatives and real-world evidence generation. We anticipate NEFECON^® to be officially included in the 2025 revised Kidney Disease: Improving Global Outcomes (KDIGO) guidelines, and China's first national clinical guideline for IgAN. The inclusion in these treatment guidelines is expected to position NEFECON as the foundational first-line treatment for patients with IgAN by targeting the root cause of the disease. Looking beyond the domestic market, NEFECON^® has received full approvals across Everest's licensing territories. We expect overseas contributions to NEFECON^® sales to begin making a meaningful impact starting in 2026 when reimbursement regimes in Taiwan and South Korea are implemented.

In August 2025, China's National Medical Products Administration officially approved the supplemental application for the production expansion of NEFECON^®. As the first and only etiological treatment for IgAN to receive full approval in China, the United States, and Europe, this approval for production expansion will further boost NEFECON^® capacity and increase product supply, enabling a more efficient response to the growing clinical demand in China and across Asia. The production expansion approval paved the way for a significant sales ramp in the second half of 2025. We now expect full year NEFECON^® sales to reach RMB1.2 to 1.4 billion.

We continue to drive deeper penetration of XERAVA^® in our covered core hospitals, particularly those with significant market potential and strong demand from Intensive Care Units (ICUs). We are further optimizing our CSO model in non-core markets as part of our commercial strategy and advancing initiatives to position XERAVA^® for earlier-line use. These efforts are aimed to establish XERAVA^® as an indispensable empirical treatment for multidrug-resistant infections. Full-year revenue guidance of NEFECON^® and XERAVA^® combined is targeted at RMB1.6 to 1.8 billion.

Preparations for the launch of VELSIPITY^® are well underway. In the second half of 2025, we are focused on pre-commercial activities and generating real-world evidence in the Greater Bay Area, laying the foundation for successful entry into the Chinese market in the first half of 2026, upon receiving NMPA approval.

Discovery

The first half of 2025 marked a highly productive and critical period for both our dual-engine approach and our mRNA platform including mRNA therapeutic cancer vaccines and in vivo CAR-T platform, and reflected our strong execution and sustained innovation across our pipeline. In June, we hosted the "2025 Everest Medicines mRNA Platform R&D Day" in Shanghai to showcase breakthroughs and key milestones in our proprietary AI-powered mRNA platform and its three leading pipeline assets in cancer and autoimmune disease.

In our personalized cancer vaccine (PCV) program, nine cancer patients with advanced disease were successfully dosed in our investigator-initiated trial (IIT) for EVM16, a personalized mRNA vaccine that is powered by our proprietary neoantigen predication algorithm, EVER-NEO-1, and third-generation mRNA sequence design. EVM16 encodes individualized tumor-specific neoantigens encapsulated within lipid nanoparticles (LNPs) to activate a targeted T-cell immune response. Early clinical data demonstrated strong immunogenicity and neoantigen-specific T-cell activation, even at a low starting dose, which validates our EVER-NEO-1 algorithm and reinforces confidence in our personalized mRNA cancer vaccine strategy.

We also gained regulatory momentum by receiving FDA IND clearance and CDE IND filing acceptance for EVM14, our off-the-shelf TAA mRNA cancer vaccine. EVM14 targets five TAAs highly expressed in multiple types of squamous cell carcinomas including non small cell lung cancer and head and neck cancer. In June, we completed the successful release of the first clinical batch of EVM14 at our Jiashan manufacturing site, which will support the clinical trials in both China and the U.S, and we remain on track to deliver this first batch to U.S. clinical centers later this year. The release marks another milestone in advancing Everest's proprietary mRNA platform with end-to-end capabilities spanning antigen design, LNP-based delivery, CMC process development, and GMP manufacturing, laying a solid foundation for future pipeline and commercialization. We expect clinical data readouts from this program in 2026.

Our mRNA in vivo CAR-T platform also made notable progress in the first half of 2025. Based on our proprietary targeted LNP (tLNP) delivery system, the in vivo CAR-T program offers key advantages over traditional CAR-T therapy including off-the-shelf availability, dose controllability, and lymphodepletion-free administration. Preclinical data in humanized mouse models and non-human primates showed high T-cell transfection rates, strong CAR expression, and effective B-cell depletion. This modality, while still in early stages, is a potentially disruptive innovation with advantages in patient accessibility, manufacturing, and scalability.

Looking ahead to the second half of 2025, we expect to reach multiple important milestones across our mRNA cancer vaccine pipeline and in vivo CAR-T platform. EVM16, our personalized cancer vaccine, is on track to complete Part Ia patient enrollment and deliver preliminary human data on safety and immunogenicity. For EVM14, we anticipate dosing first patient in U.S. and securing IND approval from China's NMPA. Preclinical studies for immune-modulatory cancer vaccine is ongoing and expects to achieve preclinical proof of concept in 2025. In parallel, our in vivo CAR-T platform is expected to achieve candidate selection, setting a clear path toward generating first-in-human data in 2026.

Business Development

In 2025, our business development strategy remains sharply focused on first-in-class or best-in-class assets within high-value, less crowded therapeutic areas — particularly renal diseases, autoimmune disorders, and anti-infectives.

On the in-licensing front, we will continue to pursue commercial or near-commercial stage assets where we can leverage our established commercial platform in China to create operational synergies and build scale. At the same time, we remain actively engaged in identifying earlier-stage assets with global rights, where we can rapidly deliver clinical proof-of-concept (POC) data and generate substantial shareholder value.

On the out-licensing side, we are actively exploring global partnership opportunities for our innovative assets with global rights. These include EVER001 (civorebrutinib), our next-generation covalent reversible BTK inhibitor, which will soon complete one-year follow-up data in patients with pMN, with a data readout from the Phase 1b/2a trial expected in September. Given its promising safety and clinical profile, EVER001 has the potential to advance into the next clinical phase for pMN and support a basket trial across multiple autoimmune renal diseases, which could accelerate development and broaden its commercial reach. The mRNA platform-based therapeutic cancer vaccine programs EVM16 (personalized cancer vaccine) and EVM14 (TAA vaccine) are expected to generate key preliminary human data in the second half of this year and the first half of next year, respectively, laying a solid foundation for potential global partnerships. We are also advancing our in vivo CAR-T program, which is on track to demonstrate proof-of-concept in non-human primates (NHPs), which may create a pathway to future global partnership opportunities. We believe that strategic global partnerships will be key to maximizing the long-term value of our pipeline innovations.

In August 2025, we were very pleased to make a strategic equity investment in I-Mab, a company listed on the Nasdaq Global Market. With an investment of US$30.9 million, Everest increased its ownership to approximately 16.1% of the total issued share capital of I-Mab, inclusive of ordinary shares already held by Everest, making us I-Mab's largest single shareholder. I-Mab is a global biotechnology company focused on precision immunotherapy for cancer. This strategic equity investment in I-Mab further advances our global pipeline of next-generation immuno-oncology therapies and marks a key step in Everest's strategic expansion into the field. Both parties are expected to leverage their respective expertise in China and the United States to collaborate on future clinical development and business expansion.

Key Corporate Developments:

- In April 2025, Everest secured removal of the "B" marker affixed to the Company's stock short name, which went into effect from 2 May 2025. The removal of "B" marker was granted by the Stock Exchange. The removal of the "B" marker reflects a comprehensive evaluation of Everest Medicines' robust R&D pipeline, commercialization capabilities, and overall business fundamentals.

- In July 2025, Everest successfully completed a top up placement of approximately 22.56 million Shares, raising net proceeds of approximately HK$1.55 billion. The transaction was significantly oversubscribed and attracted strong interest from leading international long-only investors, reflecting broad confidence in the Company's strategic direction and execution capabilities. We expect to use the proceeds to accelerate the development of our innovative pipeline and our proprietary AI-enabled mRNA platform, while advancing the commercialization of our existing portfolio. With a strengthened capital base, we are poised to drive both commercialization and innovation, delivering greater value to patients and shareholders.

- In August 2025, Everest made a strategic equity investment in I-Mab, a company listed on the Nasdaq Global Market. With an increased investment of US$30.9 million, Everest now owns approximately 16.1% of the total issued share capital of I-Mab, inclusive of ordinary shares already held by Everest, making us I-Mab's largest single shareholder.

Financial Highlights

IFRS Numbers:

• Revenue for the six months ended 30 June 2025 significantly increased by RMB144.6 million, or 48.0%, to RMB446.1 million, compared with RMB301.5 million for the six months ended 30 June 2024. The revenue growth was primarily attributable to continuing ramp-up of NEFECON^® and XERAVA^® in the commercialized markets.

In China market, the inclusion of NEFECON^® in the NRDL and served as a key growth driver, leading to a substantial increase in NEFECON^®'s revenue for the six months ended 30 June 2025. The continued deepening of XERAVA^®'s market penetration contributed to sustained revenue growth. Meanwhile, NEFECON^® achieved milestone with its successful launch in Taiwan.

In markets outside of China, VELSIPITY^® was successfully introduced to the Singapore market in the first half of 2025. These achievements highlight the Group's progress in expanding its international presence and enhance medicine accessibility.

• Gross profit margin decreased from 76.6% for the six months ended 30 June 2024 to 67.1% for the six months ended 30 June 2025. Excluding the amortisation of intangible assets, the gross profit margin decreased from 83.0% for the six months ended 30 June 2024 to 76.4% for the six months ended 30 June 2025. The decrease was mainly due to the NRDL price reduction of NEFECON^® in mainland China and the optimisation of product costs.
• Research and development ("R&D") expenses for the six months ended 30 June 2025 amounted to RMB195.2 million, decreasing from RMB253.2 million for the six months ended 30 June 2024, reflecting strategic resource optimization to focus on core pipeline breakthroughs.

While achieving several R&D milestones for the first half of the year, the Company is actively optimizing its R&D strategy to accelerate the development of in vivo CAR-T and mRNA platforms positioning for next-phase research and clinical readiness, and continue to develop the value of EVER001 (Civorebrutinib).

• General and administrative expenses increased by RMB23.8 million, from RMB87.0 million for the six months ended 30 June 2024 to RMB110.8 million for the six months ended 30 June 2025. This increase was primarily due to an increase in the number of employees, reflecting targeted talent investments to support pipeline development and market expansion, in line with our strategic growth initiative.
• Distribution and selling expenses increased by RMB114.4 million from RMB200.4 million for the six months ended 30 June 2024 to RMB314.7 million for the six months ended 30 June 2025. This increase was primarily driven by: (i) NEFECON^®'s inclusion in China's NRDL and its full approval across Asia regions, the Company proactively increased the coverage in medical institutions, academic promotion and medical education; and (ii) expanded commercial activities to support XERAVA^®'s market penetration.
• The ratio of total operating expenses (including general and administrative expenses, research and development expenses, and distribution and selling expenses) to sales decreased by 40.1 percentage points, reflecting business and operation efficiency improvement and focused resource allocation.
• Net loss for the period decreased by RMB382.6 million from RMB632.4 million for the six months ended 30 June 2024 to RMB249.8 million for the six months ended 30 June 2025. This decrease was primarily due to the strong product sale, improvements in business and operation efficiency and a one-time, non-recurring impairment loss from an intangible asset related to mRNA COVID-19 vaccines for the six months ended 30 June 2024.
• Cash and cash equivalents and bank deposits amounted to RMB1,585.9 million as of 30 June 2025.

Non-IFRS Measure:

• Adjusted loss for the period^[1] narrowed by RMB65.7 million, from RMB212.6 million for the six months ended 30 June 2024 to RMB146.9 million for the six months ended 30 June 2025, primarily excluding the one-time and non-recurring loss on impairment of an intangible asset, and non-cash expenses of share-based compensation and amortization of intangible assets.

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.

 

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SOURCE Everest Medicines