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EVEREST MED
wrote a post · Mar 26 12:04

Everest Medicines releases full-year 2025 financial results

Everest Medicines (HKEX 1952.HK), a biopharmaceutical company focused on innovative drug research and development, clinical development, manufacturing, and commercialization, today announced its full-year 2025 financial report (as of December 31, 2025) and business updates.
The company's revenue in 2025 surged significantly, achieving a total annual income of RMB 1.707 billion, representing a 142% increase. During the reporting period, operating expenses as a percentage of revenue decreased by 90.1 percentage points year-over-year. Under International Financial Reporting Standards (IFRS), net loss narrowed substantially by 71%, while under non-IFRS measures, the company achieved its first-ever profit of RMB 187 million. Overall operational quality improved steadily. In 2025, the company’s gross margin after excluding non-cash items was 74.1%, reflecting continued optimization of the product mix structure and enhanced economies of scale. As of December 31, 2025, the company maintained robust cash reserves amounting to RMB 2.731 billion, strongly supporting commercial expansion, independent R&D efforts, and medium-to-long-term strategic planning.
Wu Yifang, Chairman of Everest Medicines, stated: 'In 2025, the company delivered remarkable performance driven by exceptional strategic execution, achieving profitability for the first time under non-IFRS standards, turning operating cash flow positive, and maintaining ample cash reserves. This fully demonstrates Everest Medicines' outstanding ability to continuously translate innovation into commercial value, laying a solid foundation for ongoing investments in business development and pipeline construction, as well as long-term value creation. Breakthrough progress in both commercialization and self-developed projects signifies that the company has established sustainable self-sustaining capabilities, elevating overall operational quality to new heights and providing strong support for long-term stable growth.'
Looking ahead, with the release of our 2030 strategic plan, we have clearly defined our development path for the next five years. Leveraging our established capabilities and achievements, Everest Medicines is committed to becoming a globally innovative biopharmaceutical enterprise and building a leading platform for the commercialization of innovative drugs in China, promoting groundbreaking innovations with significant clinical value to benefit patients worldwide.
To achieve this vision, the company plans to exceed RMB 15 billion in revenue by 2030 and will continue to build an “N+X” product portfolio across key strategic areas such as nephrology, cardiovascular and metabolic diseases, autoimmune disorders, ophthalmology, and acute critical care, capitalizing on niche blockbuster opportunities. The company aims to introduce three to five major products annually, targeting regulatory approval within two to three years and reaching peak sales of over RMB 2 billion per product within five to six years through business development collaborations. By leveraging strategic investments and exclusive commercial licensing, the company continues to expand its late-stage pipeline while optimizing the use of its existing commercial platform, which will play a central role in driving long-term value growth. Over the past six months, the company has introduced or partnered on four innovative drugs and six mature original research products, further broadening therapeutic coverage and deepening its pipeline.
Overall, 2026 will be a year of execution and a pivotal year for transformation for Everest Medicines. The company aims to expand its commercial product portfolio, accelerate key assets toward blockbuster status, and continuously enhance the global competitiveness of its self-developed pipeline.
罗永庆,CEO of Everest Medicines, stated: 'In 2025, Everest Medicines’ outstanding commercialization platform was validated, with rapid revenue growth, steady progress in internal R&D pipelines, and significant achievements in business development (BD) collaborations.
In terms of commercialization, annual sales revenue of NEFECON® exceeded 1.4 billion yuan, representing a year-over-year increase of over 300%, while EIALE® achieved 262 million yuan, with hospital sales growing by 44% year-over-year. The systematic platform built by the company, covering 'Access, Medical Affairs, Marketing, Sales' (A2MS), continues to empower products like VESELPINE®, helping realize their commercial value. VESELPINE® is expected to become the next blockbuster product, with anticipated peak sales of 5 billion yuan.
In R&D, EVER001 (Zibutinib) achieved positive results in Phase 1b/2a clinical trials for primary membranous nephropathy (pMN). The project is advancing into later-stage clinical development and basket trials for expanded indications, further strengthening the company’s global R&D pipeline. Two world-leading proprietary technology platforms, mRNA cancer vaccines and In vivo CAR-T, reinforce the company's innovation engine. The personalized mRNA cancer vaccine project EVM16 has completed initial dose escalation in investigator-initiated clinical research (IIT). The off-the-shelf TAA mRNA vaccine EVM14 received dual Investigational New Drug (IND) approvals in China and the US and has dosed the first patients in both countries. The mRNA autologous-generated CAR-T project EVM18 completed proof-of-concept studies in non-human primates and is advancing into clinical development, accelerating the strategic layout of globally competitive technology platforms.
Business development (BD) collaborations continue to play a core role in driving long-term value growth for the company. Over the past year, the company deepened its BD strategy by strategically investing in Sinobridge Biopharma and acquiring VIS-101 to expand into ophthalmology. A CSO collaboration with Haisen Bio led to the introduction of LEREPOL®, strengthening the cardiovascular and metabolic product portfolio. At the start of 2026, the company introduced MT1013 from Maike Aote, enhancing its renal disease portfolio and expanding into chronic kidney disease, significantly enriching its late-stage product pipeline and boosting the synergy and operational efficiency of its commercial platform. Meanwhile, the company acquired an intranasal Etricopamine spray from Jixing Pharma, whose new drug application has been accepted by the National Medical Products Administration in China. Approval is expected in the third quarter of 2026, further solidifying the company’s strategic focus in cardiovascular therapeutics.
Looking ahead, Everest Medicines will continue to drive forward with a 'dual-wheel strategy,' balancing external partnerships with self-developed innovation. Building on this, the company will consolidate its leadership in core therapeutic areas, steadily advance the construction of an innovative drug commercialization platform, and expand its global R&D footprint. This approach lays a solid foundation for sustainable growth, enabling the company to evolve into a leading biopharmaceutical enterprise based in Asia-Pacific and serving the global market.
Latest highlights and anticipated milestones for key products
- Renal Disease Pipeline -
NEFECON®
Nefecon®is a budesonide enteric-coated capsule, the world's first drug for causal treatment of IgA nephropathy. It is an immune modulator targeting mucosal B cells in the intestine, effectively protecting kidney function. A single course of treatment can delay kidney function decline by 66% in the Chinese population and is expected to postpone progression to dialysis or kidney transplantation by 12.8 years. Additionally, budesonide undergoes 90% first-pass metabolism, offering good safety. Nefecon® is specifically developed for IgA nephropathy patients, with each capsule containing 4mg of budesonide. Through a unique dual delayed-release and sustained-release formulation, budesonide is targeted to release at the terminal ileum's mucosal B cells (including Peyer's patches). After the capsule dissolves, triple-coated pellets continuously release budesonide, providing high concentration coverage over the entire target area, thereby reducing the production of galactose-deficient IgA1 antibodies (Gd-IgA1) that trigger IgA nephropathy, thus intervening at an upstream stage of the pathogenesis to achieve therapeutic effects. Nefecon® was approved by the China National Medical Products Administration (NMPA) in November 2023 for treating primary IgA nephropathy and launched in mainland China in May 2024. Starting January 2025, Nefecon® has been officially included in the National Reimbursement Drug List (NRDL), significantly improving patient accessibility to this innovative drug and becoming the first non-oncology drug to break 1 billion yuan in sales revenue during its first year of inclusion in the medical insurance.
2025
In January 2025, Nefecon® began implementing the national medical insurance price, having been included in the National Reimbursement Drug List in November 2024. Patients can purchase Nefecon® at designated medical institutions or pharmacies and enjoy the medical insurance price. The official implementation of the National Reimbursement Drug List enhances the accessibility of Nefecon®, reduces the financial burden on patients, and allows more Chinese IgA nephropathy patients to benefit from this innovative drug.
In May 2025, Nefecon® received full approval from the National Medical Products Administration, transitioning from conditional approval. This milestone means that Nefecon® is now the first and only drug fully approved by the National Medical Products Administration for causal treatment of IgA nephropathy. This approval is based on the complete data from the NefIgArd Phase III clinical study. The NefIgArd Phase III clinical trial is a randomized, double-blind, global multicenter study evaluating the efficacy and safety of Nefecon® (16mg, once daily) compared to placebo in adult patients with primary IgA nephropathy receiving optimized RAS inhibitor supportive care.
In May 2025, Nefecon® was included in the 'Clinical Practice Guidelines for Adult IgA Nephropathy and IgA Vasculitis in China (Pre-review Version),' recommending a 9-month course of budesonide enteric-coated capsules as causal treatment for IgA nephropathy patients at risk of disease progression, without restriction based on proteinuria levels, to reduce pathogenic IgA (Gd-IgA1) (2B). The guidelines recommend renal biopsy and initiating treatment for patients with proteinuria ≥0.5 g/d (or equivalent). For the first time, the guidelines propose intervention against immune-mediated damage, including measures to reduce pathogenic IgA. Nefecon® is the preferred treatment for reducing pathogenic IgA. After achieving short-term treatment goals, i.e., proteinuria remission (proteinuria <0.5 g/d, ideally <0.3 g/d) and stable renal function, low-dose maintenance or repeat safe and effective immunotherapy along with continued supportive therapy can be adopted to ensure an annual eGFR decline of <1 ml/min.
In June 2025, Everest Medicines presented nine latest research findings on Nefecon® at the 62nd European Renal Association (ERA 2025) Congress, including eight oral presentations and one electronic poster. The newly released research results covered evaluations from biomarkers predicting efficacy to assessments of efficacy across different diagnosis times and baseline renal function levels, as well as sustainability analysis of long-term treatment, particularly discussions on mechanism of action and safety. Studies showed that Nefecon® offers significant renal protection for IgA nephropathy patients with varying eGFR baselines and diagnosis times. The multiple latest research findings on Nefecon® announced at this conference indicated that early use of Nefecon® provides patients with more significant renal function protection and delays disease progression, offering strong evidence for initiating upstream intervention in IgA nephropathy as soon as possible, bringing patients more scientific treatment options and better quality of life.
In August 2025, the company announced that the supplemental application for expanding the production capacity of Nefecon® had been approved by the China National Medical Products Administration. This approval for expanded production will further enhance the production capacity of Nefecon®, increase product supply, and more efficiently respond to the growing clinical demand for Nefecon® in China and Asia.
In August 2025, the company announced that Taiwan's pharmaceutical regulatory authorities had approved the supplemental application for Nefecon®, applicable to adult patients with primary IgA nephropathy at risk of disease progression, to slow kidney function decline. Previously, Nefecon® had received full approval in mainland China, Singapore, Hong Kong, Macau, and South Korea. To date, Nefecon® has achieved full approval in all authorized regions covered by Everest Medicines, solidifying its position as a cornerstone of first-line treatment for IgA nephropathy in Asia and promoting standardization and normalization of IgA nephropathy treatment.
In September 2025, Nefecon® showcased seven latest real-world data sets at the 18th International Symposium on IgA Nephropathy (IIgANN), further demonstrating its progress in related in-depth research. The newly published data came from clinical practices at several top hospitals in China, exploring the efficacy and safety of Nefecon® in treating IgA nephropathy from multiple dimensions, further supporting the management strategy of 'causal treatment, early treatment, and long-term treatment' for IgA nephropathy.
In September 2025, Nefecon® was included in the '2025 KDIGO Clinical Practice Guidelines for the Management of IgA Nephropathy and IgA Vasculitis' published by the Kidney Disease: Improving Global Outcomes (KDIGO) organization, recommending a 9-month course of Nefecon® treatment for all IgA nephropathy patients at risk of progressive kidney function decline, affirming its status as a first-line treatment. The guidelines also emphasized that a single 9-month course might not be sufficient to maintain sustained clinical benefits in terms of long-term reduction of proteinuria and stabilization of estimated glomerular filtration rate (eGFR), thus necessitating extended treatment duration.
In October 2025, Nefukang® was included in the 'Clinical Practice Guidelines for Chinese Adult IgA Nephropathy and IgA Vasculitis Nephritis (2025).' The updated guidelines recommend a nine-month course of Nefukang® as a causal treatment for IgA nephropathy patients at risk of disease progression to reduce pathogenic IgA (Gd-IgA1). Nefukang® is the only approved drug recommended by the new guidelines for causal treatment of IgA nephropathy. This follows its recent recommendation by the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines, making it the world’s only IgA nephropathy causal treatment drug endorsed by both international and domestic guidelines.
In November 2025, at the 58th American Society of Nephrology Kidney Week (ASN Kidney Week 2025), Nefukang® presented several latest research findings on IgA nephropathy patients. With accumulating evidence from the Chinese population, these findings further confirmed the significant clinical value of the new management strategy for IgA nephropathy centered on 'causal treatment, early treatment, long-term treatment.' The efficacy of Nefukang® in special populations was also validated, reinforcing its status as a cornerstone in first-line IgA nephropathy treatment.
In December 2025, at the 23rd Asia-Pacific Congress of Nephrology (APCN 2025), Nefukang® showcased 11 new research results, further enriching the evidence supporting its clinical application. Additionally, following Nefukang®'s inclusion in medical insurance, as treatment duration accumulates, clinicians have gradually shifted their focus from 'protein** improvement' to 'kidney function protection,' aiming to provide crucial references for the long-term management of IgA nephropathy patients.
2026
The company plans to obtain regulatory approval for the Gd-IgA1 test kit in 2026, aiming to provide IgA nephropathy patients with a biopsy-free method to assist in disease diagnosis and track disease progression.
EVER001 (Ibrutinib)
EVER001 (Ibrutinib)It is a next-generation innovative covalent reversible BTK inhibitor, potentially used for treating autoimmune kidney diseases, including primary membranous nephropathy, IgA nephropathy, minimal change disease, focal segmental glomerulosclerosis, and lupus nephritis. Compared to covalent irreversible BTK inhibitors, EVER001, as a potential best-in-class product, maintains high activity while demonstrating high selectivity, avoiding toxic side effects caused by sustained inhibition. Everest Medicines holds global rights for this product's use in kidney disease treatment.
2025
In June 2025, Everest Medicines presented positive results from the ongoing Phase 1b/2a clinical trial of EVER001 in China at the 62nd European Renal Association (ERA 2025) conference, including longer-term data from more patients collected as of December 17, 2024. In the low-dose group, 10 patients were followed up to 52 weeks, and in the high-dose group, 10 patients completed 24 weeks of treatment. Relative to baseline, the least squares (LS) geometric mean of anti-PLA2R autoantibodies decreased by 62.1% and 87.3% in the low-dose and high-dose groups at 12 weeks, respectively, and both groups showed a reduction of approximately 93% at 24 weeks. Moreover, in the low-dose group, protein** levels decreased by 78.0% from baseline at 36 weeks and were maintained until week 52 after discontinuation; in the high-dose group, protein** decreased by 70.1% at 24 weeks, with 80.0% of patients achieving clinical remission. Patients in both dose groups maintained stable kidney function during treatment. EVER001 demonstrated good overall safety and tolerability, with no clinically significant adverse events commonly observed with other covalent irreversible BTK inhibitors.
In July 2025, Everest Medicines announced positive interim data from the ongoing Phase 1b/2a clinical trial of EVER001, with data collected as of March 21, 2025 (11 patients in the low-dose group followed up to 52 weeks, 16 and 12 patients in the high-dose group completed 24 and 36 weeks of treatment, respectively, and seven patients followed up to 52 weeks). Relative to baseline, the least squares (LS) geometric mean of anti-PLA2R autoantibodies decreased by 62.1% and 87.3% in the low-dose and high-dose groups at 12 weeks, respectively, and both groups showed a reduction of over 93% at 24 weeks, which was maintained until week 52. At 24 weeks, 76.9% of the low-dose group and 88.2% of the high-dose group achieved complete immunological remission. The LS geometric mean of 24-hour protein** decreased by 57.0% and 67.6% in the low-dose and high-dose groups at 24 weeks, respectively, and the reductions increased to 76.7% and 80.6% at 36 weeks, maintained until week 52. Consistent with previous observations, at 24 weeks, 38.5% of the low-dose group and 70.6% of the high-dose group reached clinical remission, and these proportions further increased to 69.2% and 91.7% at 36 weeks. The average serum albumin levels of patients in both dose groups reached the normal range during treatment while maintaining stable kidney function. Overall, EVER001 demonstrated good safety and tolerability, consistent with previous observations. The majority of reported adverse events were grade 1 or 2, with no clinically significant adverse events commonly observed with other covalent irreversible BTK inhibitors.
2026
The company plans to present detailed Phase 1b/2a clinical research data of EVER001 at an international medical conference in the first half of 2026.
The company plans to initiate a Phase II basket trial for EVER001 targeting multiple indications in 2026.
MT1013
MT1013It is a first-in-class dual-target receptor agonist peptide that can simultaneously target the calcium-sensing receptor (CaSR) and osteogenic growth peptide (OGP) receptor, and is being developed primarily for the treatment of secondary hyperparathyroidism (SHPT). In February 2026, Everest Medicines signed an exclusive commercialization licensing agreement with Maike Aote, granting Everest Medicines exclusive commercial rights to MT1013 in China and the Asia-Pacific region (excluding Japan). This collaboration will create synergies with Everest Medicines' existing renal pipeline, strengthening its product portfolio and expanding coverage from IgA nephropathy to a broader range of chronic kidney disease areas, consolidating the company's leadership position in the Asian renal and autoimmune disease fields. Data shows that the global CKD patient population has increased from 910 million in 2019 to 1.07 billion in 2024 and is projected to exceed 1.2 billion by 2030 and 1.5 billion by 2035; during the same period, the number of SHPT patients worldwide continues to grow, expected to reach approximately 190 million by 2030 and 220 million by 2035, indicating an urgent unmet clinical need.
The Phase III clinical trial of MT1013 has been initiated across more than 100 research centers nationwide, with plans to recruit approximately 424 patients, mainly targeting the patient group with chronic kidney disease undergoing maintenance hemodialysis accompanied by SHPT (relevant R&D expenses will be borne by Maike Aote).
Autoimmune Disease Pipeline -
Vesipity® (Arginine Etrasimod Tablets, VELSIPITY®)
Vesipity® (Arginine Etrasimod Tablets, VELSIPITY®) (VELSIPITY®, etrasimod) is a once-daily oral highly selective sphingosine-1-phosphate (S1P) receptor modulator designed with optimized pharmacology to bind to S1P receptors 1, 4, and 5. Vesipity® has already received new drug approval in the United States, European Union, Canada, Japan, Australia, Singapore, the United Kingdom, Switzerland, Israel, Greater China, and other countries and regions.
2025
In February 2025, complete maintenance phase data from the Asian multicenter Phase III clinical study of etrasimod was presented as an oral report at the 20th Congress of the European Crohn’s and Colitis Organisation (ECCO 2025). Etrasimod is the only advanced UC therapy to date that has completed large-scale randomized controlled pivotal studies in the Asian moderate-to-severe active ulcerative colitis (UC) population. The results of the ES101002 study provide strong evidence supporting the use of etrasimod in Asian patients with moderate-to-severe active UC. The data confirms that after 40 weeks of maintenance treatment, the etrasimod group showed significant clinical and endoscopic benefits, including mucosal healing, endoscopic normalization, and histological improvement. The safety profile of etrasimod was consistent with known characteristics, with no new safety signals observed.
In March 2025, production and construction of etrasimod officially began at the Jiashan plant. With a total investment of 70 million yuan, the project is expected to achieve an annual production capacity of 50 million tablets upon formal operation, with plans to supply regions covered by Everest Medicines' authorized area.
In April 2025, the Hong Kong Department of Health officially approved the new drug application for etrasimod for the treatment of adult patients with moderate-to-severe active ulcerative colitis.
In June 2025, the South Korean Ministry of Food and Drug Safety (MFDS) officially accepted the new drug application for etrasimod for the treatment of patients with moderate-to-severe active ulcerative colitis (UC).
In July 2025, the global four-year safety follow-up data for Etrombod treatment in patients with moderate to severe active ulcerative colitis was presented at the 13th annual meeting of the Asian Organization for Crohn's & Colitis (AOCC 2025). The data showed that long-term treatment with Etrombod maintained good safety and tolerability, with its favorable safety profile remaining unchanged during the extended treatment period.
In August 2025, Taiwan's Ministry of Health and Welfare (TFDA) formally accepted the new drug marketing application for Etrombod to treat patients with moderate to severe active ulcerative colitis. The acceptance of Etrombod by South Korea and Taiwan marks important progress in its market entry in Asia, following approvals in Macau, Singapore, and Hong Kong.
In August 2025, Etrombod was included in the '2025 ACG Clinical Guidelines: Adult Ulcerative Colitis.' The updated guideline strongly recommends Etrombod for induction of remission in patients with moderate to severe active ulcerative colitis (moderate-quality evidence) and suggests continuing Etrombod after induction of remission with a sphingosine-1-phosphate (S1P) receptor modulator to maintain remission (strong recommendation, moderate-quality evidence). This significant advancement reflects the high recognition of Etrombod’s clinical value by international authoritative medical guidelines and further highlights its potential in addressing unmet treatment needs for UC patients, offering a new therapeutic option for UC patients worldwide.
In September 2025, the results of the ENLIGHT UC Phase III clinical study (ES101002) of Etrombod conducted across multiple centers in Asia were published in the prestigious journal, The Lancet Gastroenterology & Hepatology. The study demonstrated that Etrombod has significant clinical advantages in rapid onset, achieving steroid-free remission, and deep mucosal healing, providing robust clinical evidence for Asian UC patients, including those in China.
2026
In February 2026, China's National Medical Products Administration (NMPA) approved Velsipity® (Arginine Etrombod Tablets) for the treatment of adult patients with moderate to severe active ulcerative colitis who have an inadequate response, lost response, or are intolerant to conventional therapies or biologics. As a next-generation highly selective S1P receptor modulator, Velsipity® is taken orally once daily, enabling rapid onset and potent deep mucosal healing with a favorable safety profile, positioning it as a best-in-disease therapy and offering a new first-line treatment option for adult patients with ulcerative colitis.
In March 2026, the first prescription for Velsipity® in mainland China was issued at the First Affiliated Hospital of Sun Yat-sen University, marking the official entry of this innovative therapy into clinical use in China. It provides a novel treatment option for patients with moderate to severe ulcerative colitis, ushering in a new era of deep mucosal healing and long-term disease control.
The company expects Etrombod to receive new drug approval in Taiwan and South Korea in 2026.
The company plans to participate in the national medical insurance negotiation for Velsipity® in the second half of 2026.
-Cardiovascular/Metabolic Product Pipeline-
In December 2025, the company entered the cardiovascular/metabolic disease field through a strategic partnership with Haisen BioPharmaceuticals, which includes commercializing mature products (Edavi®, Bilos®, Beixin®) under a Commercial Service Agreement (CSO), as well as licensing the development and commercialization rights for a next-generation PCSK9 inhibitor, Laribop® in Greater China. This collaboration will fully leverage the company's existing commercial platform to establish comprehensive lifecycle and omnichannel commercial capabilities while laying the groundwork for high-potential therapeutic areas. In March 2026, the company licensed the development, commercialization, and local manufacturing rights for Etripamil Nasal Spray (tentatively named Xinbituo® in Chinese) in Greater China, further strengthening its strategic focus on cardiovascular diseases.
Leribao
Leribaois a new type of small-molecule protein-binding third-generation PCSK9 inhibitor designed to help patients achieve and maintain their LDL-C control goals over the long term. As the first PCSK9 inhibitor fusion protein, Leribao demonstrates low immunogenicity and outstanding safety. Leribao has been developed to better meet patient needs with greater convenience, allowing for self-administration by patients once a month via a single small-volume subcutaneous injection. It also features extended room-temperature stability (up to three months), enabling patients to choose when and where to administer it, making it convenient for storage or carrying whether at home or while traveling. These characteristics make Leribao a next-generation PCSK9 inhibitor solution. In multiple large-scale global Phase 3 clinical trials involving over 2,900 patients, results showed that Leribao can reduce LDL-C levels by ≥60% in cardiovascular disease (CVD) patients or those at very high/high risk, and by 59% in HeFH patients with more severe LDL-C elevations.
2025
In December 2025, the U.S. Food and Drug Administration (FDA) approved the Biologics License Application (BLA) for LIB Therapeutics' cardiovascular disease product Leribao injection. It is indicated for reducing low-density lipoprotein cholesterol (LDL-C) levels in adult patients with hypercholesterolemia (including heterozygous familial hypercholesterolemia (HeFH)) as an adjunct to diet control and exercise. The pivotal Phase 3 clinical trial for Leribao in China for treating hypercholesterolemia (including HeFH) has completed data analysis from the 12-week randomized, double-blind, placebo-controlled treatment phase. It met the primary efficacy endpoint of LDL-C reduction at Week 12 and secondary endpoints showing improvements in other atherogenic lipids and apolipoproteins, demonstrating favorable safety and tolerability profiles compared to placebo.
2026
We expect to submit the Biologics License Application (BLA) in China in the first half of 2026.
Etripamil Nasal Spray
Etripamil Nasal Sprayis a novel calcium channel blocker developed by Milestone Pharmaceuticals, Inc., aimed at providing a fast-acting therapy for patients with paroxysmal cardiovascular diseases. As a nasal spray for patient self-administration, Etripamil Nasal Spray has the potential to transform the current patient treatment experience from emergency department care to out-of-hospital treatment. In May 2021, Jixing and Milestone entered into an exclusive licensing agreement, granting Jixing exclusive rights to develop and commercialize the investigational drug Etripamil Nasal Spray (proposed Chinese trade name: Xingbituo) for treating PSVT and other cardiovascular diseases in Greater China. The drug was approved by the U.S. Food and Drug Administration (FDA) in December 2025, becoming the first and only therapy approved for acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) in adults in over 30 years, opening up new treatment scenarios for PSVT.
2026
In March 2026, the company announced an asset acquisition agreement with Jixing Pharma Hong Kong Limited, obtaining the development, commercialization, and localization rights for Etripamil Nasal Spray in Greater China. The New Drug Application (NDA) for Etripamil Nasal Spray for treating PSVT was officially accepted by China's National Medical Products Administration on January 17, 2025, and is expected to be approved in the third quarter of 2026, potentially offering PSVT patients a new treatment option. This collaboration is a significant step in deepening the company’s strategic layout in the cardiovascular field, further enriching its product pipeline, enhancing synergies, and continuously strengthening its position in the cardiovascular disease sector.
-Critical Care Product Pipeline-
Following the strategic cooperation with Haisen Bio, the company expanded its critical care product portfolio, further leveraging its efficient and excellent commercialization platform to strengthen its presence in this field. In the anti-infective area, the product portfolio includes Eka®, Rocephin® (ceftriaxone), and cefepime-taniborbactam, covering mild to moderate infections from community-acquired infections to moderate to severe infections from hospital-acquired infections. Eka® is the core product in the company's anti-infective domain, often used for treating critically ill patients suffering from multidrug-resistant bacterial infections in ICUs, transplant departments, and hematology departments. It complements the coverage advantages of Rocephin®, which is commonly used in respiratory medicine, pediatrics, neurosurgery, and neurology for community-acquired infections. As a widely recognized third-generation cephalosporin, Rocephin® has been included in China's National Essential Medicines List. The critical care product portfolio also includes Stilamin® (somatostatin, used for acute gastrointestinal bleeding management) and Yaningding® (used for rapid blood pressure control), providing effective treatments for critically ill patients.
Eka® (eravacycline)
Eka® (eravacycline) is the world’s first fluorocycline antibiotic used to treat infections caused by common clinical pathogens, including gram-negative bacteria, gram-positive bacteria, anaerobic bacteria, atypical pathogens, and multidrug-resistant organisms. Eka® has been approved in the United States, the European Union, the United Kingdom, Singapore, mainland China, Hong Kong, and Taiwan for the treatment of complicated intra-abdominal infections (cIAI). Eka® was licensed from Tetraphase Pharmaceuticals (a wholly owned subsidiary of Innoviva, Inc.).
2025
In June 2025, the Chinese Journal of Laboratory Medicine officially published 'Guidelines for In Vitro Drug Susceptibility Testing of Eravacycline (2025),' providing a reference for standardizing the conduct of eravacycline susceptibility testing and interpretation of results, aiming to guide rational clinical use of the drug with evidence-based support. This guideline also helps promote the standardization of methods and accuracy of reporting in clinical microbiology laboratories conducting eravacycline susceptibility tests, reliably supporting eravacycline in addressing clinical challenges posed by multidrug-resistant organisms and complex infections. The guideline was jointly developed by the Expert Committee on Clinical Antimicrobial Susceptibility Breakpoints Research and Standardization under the National Health Commission (ChinaCAST), the Clinical Microbiology Laboratory Professional Committee of the Chinese Hospital Association, and the Chinese Antimicrobial Susceptibility Testing Committee of the European Society of Clinical Microbiology and Infectious Diseases. The newly released guidelines complement the eravacycline clinical breakpoints published by ChinaCAST in 2024, forming a complete technical system with unified standards.
2026
The company plans to participate in national medical insurance negotiations in the second half of 2026 and actively promote localized production.
-Ophthalmic Products-
VIS-101
Everest Medicines expanded its research pipeline into the ophthalmology field by introducing VIS-101 from Visara, a subsidiary of New Bridge Biologics. VIS-101 is a novel bifunctional biologic targeting VEGF-A and ANG-2, demonstrating significantly improved efficacy compared to first-generation therapies, offering the potential for longer-lasting therapeutic benefits for patients with wet age-related macular degeneration (wet AMD), diabetic macular edema (DME), and retinal vein occlusion (RVO). VIS-101 further enriches the company's late-stage product pipeline and expands its business into the ophthalmology sector—an underserved blue ocean therapeutic area with significant unmet clinical needs and innovative opportunities—leveraging its clinical development experience and commercialization capabilities in Greater China and select Asian markets to drive new growth momentum. VIS-101 has completed preliminary safety and dose-escalation studies in the U.S. and China and is currently undergoing a randomized, dose-ranging Phase II clinical trial in China.
2025
In October 2025, the company announced an agreement with Visara, Inc., securing exclusive rights to clinically develop, manufacture, and commercialize VIS-101 in Greater China, Singapore, South Korea, and certain Southeast Asian countries. Under the exclusive license, Everest will pay an upfront fee of $7 million (approximately RMB 49.7 million) and reimburse up to RMB 24 million in out-of-pocket expenses; potential development and sales milestone payments could reach up to $89 million (approximately RMB 632 million); and royalties based on net sales will also be paid.
2026
In March 2026, the Phase IIa study of VIS-101, an investigational ophthalmology pipeline for treating wet age-related macular degeneration (wet AMD), achieved positive topline data. Results showed that VIS-101 demonstrated rapid onset, potent and durable therapeutic responses, along with good safety and tolerability, validating its clinical value as a potential “best-in-class” long-acting therapy. Based on encouraging clinical data, a Phase IIb clinical trial is expected to commence in the second half of 2026.
-mRNA Technology Platform-
As an important component of the company's 'dual-driver' strategy, Everest Medicines has built a leading, fully integrated, and localized AI+mRNA platform in the industry. On this basis, the company is advancing multiple mRNA therapeutic vaccine pipelines for cancer treatment and autologous CAR-T platforms to treat cancer and autoimmune diseases.
EVM16 is based on an AI-driven 'ingenious calculation' tumor neoantigen algorithm, designing mRNA sequences targeting patient-specific mutations, activating T-cell immunity through LNP delivery. Its efficacy has been validated in a mouse melanoma model, showing synergy when combined with PD-1 antibodies. EVM14 targets five tumor-associated antigens, applicable to various squamous cell carcinomas. Preclinical studies have found it capable of inducing immune memory and reducing tumor recurrence. In 2025, it successfully received dual IND approval from the China National Medical Products Administration (NMPA) and the US Food and Drug Administration (FDA). The immuno-modulatory tumor vaccine EVM15 also achieved preclinical proof-of-concept in 2025, identifying a clinical candidate molecule.
The autologous CAR-T platform has proven effective in humanized mice and non-human primate (monkey) models. Compared to traditional CAR-T therapy, it offers advantages such as off-the-shelf availability, no need for lymphodepletion, and controllable dosing, demonstrating potential for development in cancer and autoimmune diseases. This reflects the company’s transformation from 'licensed-in' to 'self-innovation.' A clinical candidate molecule has been identified, and clinical trials will be initiated.
2025
In March 2025, the company announced that its first self-developed novel mRNA personalized cancer therapeutic vaccine, EVM16, had successfully completed the first patient dosing at Peking University Cancer Hospital, marking a milestone in this clinical trial project. Clinical trial EVM16CX01 represents the first human trial of EVM16, initiated by Peking University Cancer Hospital and Fudan University Shanghai Cancer Center, to evaluate the safety, tolerability, immunogenicity, and preliminary efficacy of EVM16 injection alone or in combination with PD-1 antibody treatment in subjects with advanced or recurrent solid tumors through dose escalation and expansion studies.
In March 2025, the company announced that the Investigational New Drug (IND) application for its off-the-shelf universal cancer therapeutic vaccine EVM14 injection was approved by the US Food and Drug Administration (FDA). EVM14 injection is developed based on Everest Medicines’ proprietary mRNA technology platform. As the first self-developed new drug by the company to receive FDA IND approval, EVM14 marks the recognition of the company’s innovative capabilities in the mRNA oncology field by international authoritative institutions, representing an important milestone in the company’s self-innovation journey.
In June 2025, the company announced that its Jiashan facility had successfully released the first batch of clinical samples for the universal off-the-shelf cancer therapeutic vaccine EVM14 project. These samples will support Everest Medicines’ clinical trials of EVM14 in both China and the United States.
In June 2025, the company successfully hosted the '2025 Everest Medicines mRNA Innovation Technology Platform R&D Day,' systematically showcasing the latest advancements of its self-developed AI+mRNA technology platform and core pipelines in the fields of oncology and autoimmune diseases. This event marked a further deepening and upgrade of the 'dual-driver' strategy.
In July 2025, the Investigational New Drug (IND) application for the universal off-the-shelf cancer therapeutic vaccine EVM14 injection was officially accepted by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration. EVM14 became the company’s first mRNA cancer therapeutic vaccine to achieve dual submissions to the China National Medical Products Administration and the US Food and Drug Administration (FDA), marking another key step in the company’s global innovation strategy.
In October 2025, the Investigational New Drug (IND) application for the universal off-the-shelf cancer therapeutic vaccine EVM14 injection was approved by the China National Medical Products Administration. EVM14 became the company’s first mRNA cancer therapeutic vaccine to achieve dual IND approvals from the China National Medical Products Administration and the US Food and Drug Administration. This achievement not only indicates EVM14’s potential for global clinical development and translation but also demonstrates the continuous enhancement of the company’s global clinical development and innovation capabilities, marking an important milestone in the company’s self-innovation journey.
In October 2025, the global multicenter Phase I clinical trial of the universal off-the-shelf cancer therapeutic vaccine EVM14 injection successfully enrolled its first patient at NEXT Oncology Virginia, a US-based clinical research institution. This marks an important clinical advancement following the IND approval of EVM14 by the US Food and Drug Administration and the China National Medical Products Administration.
In November 2025, the global multi-center Phase I clinical trial of EVM14 Injection, a universal off-the-shelf therapeutic cancer vaccine, completed the first patient dosing at NEXT Oncology Virginia, a US-based clinical research institution. This marks an important milestone in its global clinical development process.
2026
The company expects to announce the Phase 1a data from the EVM16 IIT study at an international medical conference in the first half of 2026. The trial has completed dose escalation across low, medium, and high dose groups. We plan to initiate the Phase 1b IIT trial in 2026 to further advance clinical development.
In 2026, the company plans to clinically evaluate EVM18 for multiple autoimmune disease indications through several Investigator-Initiated Trials (IITs) and aims to submit a global Investigational New Drug (IND) application for EVM18 in the same year.
The company expects to complete the dose escalation for the Phase I clinical trial of EVM14 in 2026.
The company plans to advance the preparations for the IND application of EVM15 in 2026.
Commercialization Platform
Through licensing agreements, GentiBio focuses on CKM (cardiovascular, kidney, and metabolic), autoimmune, critical care, and other disease treatment areas. It has built a commercial platform integrating an omnichannel commercial system with full lifecycle drug commercial capabilities. Currently, our commercial product portfolio includes Nefukang, Yijia, and Weishiping. These three products exhibit excellent clinical profiles, addressing significant unmet needs in Asia and holding substantial long-term revenue potential. Additionally, through a strategic collaboration with Haisen Biotech, GentiBio will provide CSO services for six mature acute and critical care as well as cardiovascular/metabolic products, enhancing efficient utilization of the existing commercial platform.
Nefukang
Since being officially included in the National Reimbursement Drug List of China on January 1, 2025, Nefukang's sales revenue has achieved significant growth, becoming the first non-oncology drug to exceed 1 billion yuan in revenue within the first year of inclusion. This accomplishment reflects the company’s highly effective execution across key areas such as market access, market strategy, commercial coverage, and physician-patient education.
During 2025, we expanded Nefukang’s reach to approximately 1,200 core hospitals, covering over 80% of the market potential, through a specialized frontline sales team of about 190 representatives. By facilitating formal hospital entry or dual-channel pharmacy models, we rapidly advanced national reimbursement implementation, achieving price coverage for Nefukang under the national insurance scheme across major core regions by mid-year. This significantly enhanced affordability and accessibility for patients. In August of the previous year, the National Medical Products Administration formally approved Nefukang’s supplementary application for increased production capacity, ensuring stable product supply. This paved the way for substantial sales growth in the second half of 2025 and sustained volume expansion into 2026.
The clinical application and promotion received dual support from the official release of the 2025 IgA Nephropathy Clinical Practice Guidelines by the Kidney Disease: Improving Global Outcomes (KDIGO) organization and China’s first IgA Nephropathy guidelines. Both the '2025 KDIGO IgA Nephropathy and IgA Vasculitis Clinical Management Practice Guidelines' and the 'Chinese Adult IgA Nephropathy and IgA Vasculitis Nephritis Clinical Practice Guidelines (2025)' list Nefukang® as the preferred causal treatment drug. Nefukang® has become the world's only IgA nephropathy causal treatment drug recommended by both international and domestic guidelines. The guidelines recommend a nine-month course of budesonide enteric-coated capsules for IgA nephropathy patients at risk of disease progression, without restrictions based on protein levels, to reduce pathogenic IgA (Gd-IgA1). After achieving short-term treatment goals, such as protein relief (protein <0.5 g/d, ideally <0.3 g/d) and stable renal function, low-dose maintenance or repeated safe and effective immunotherapy along with continued supportive care can be adopted to ensure an annual eGFR decline of less than 1 ml/min/1.73 m². Supported by global Phase III studies, subgroup analyses, and expanding real-world research data on Nefukang®, we have developed a market and disease management strategy for IgA nephropathy, namely 'causal treatment, early treatment, long-term treatment.' These measures have further enhanced physicians’ recognition of Nefukang® as a first-line cornerstone therapy for IgA nephropathy, providing solid support for its earlier and broader application in clinical practice.
In addition, more than 40 papers on Nefukang® have been published in authoritative medical journals, including the following five full-text publications: 'Immunomodulatory Effects and Research Progress of Budesonide Enteric-Coated Capsules in IgA Nephropathy' and 'Predictive Value of Gd-IgA1 and Polymeric IgA in Targeted-Release Budesonide Enteric-Coated Capsule Treatment of IgA Nephropathy' by Professor Ji-Cheng Lu of the Department of Nephrology at Peking University First Hospital; 'Efficacy and Safety of Targeted-Release Budesonide (TRF-budesonide) in the Treatment of IgA Nephropathy: A Meta-Analysis' by Professor Zhi-Guo Mao of the Department of Nephrology at Changzheng Hospital; 'New Advances in Diagnosis and Treatment of IgA Nephropathy' by Professor Wei Chen of the Department of Nephrology at the First Affiliated Hospital of Sun Yat-sen University; and 'Treatment of IgA Nephropathy with Severe Renal Impairment Using Targeted-Release Budesonide Formulation' by Professor Jing-Yuan Xie, Director of the Department of Nephrology at Ruijin Hospital, Shanghai Jiao Tong University School of Medicine.
Eager®
In our anti-infective product pipeline, we have continuously driven the penetration of Yika® (Erlavacycline) into around 300 core hospitals, especially those with high market potential, where patient demand from departments such as ICU and hematology is steadily growing. Meanwhile, we have further optimized the contract sales organization (CSO) model to expand coverage in non-core markets. Following the official publication of the 'Erlavacycline In Vitro Drug Susceptibility Testing Standards (2025)' in the Chinese Journal of Laboratory Medicine, Erlavacycline's breakpoints in China were approved by the CDE and updated in the package insert, providing a reference for the microbiology labs to standardize in vitro susceptibility testing and interpretation of results, aiming to guide rational clinical use with evidence-based support. Last year, over 20 professional articles on Erlavacycline were published in domestic and international medical journals and it was included in multiple guidelines and consensus documents such as the 'Chinese Expert Consensus on Diagnosis, Treatment, and Prevention of Carbapenem-Resistant Enterobacteriaceae (CRE) Infections in Hematological Tumor Patients (2025 Edition)', 'Expert Consensus on Diagnosis, Treatment, and Prevention of High-Virulence Carbapenem-Resistant Klebsiella pneumoniae Infections', and 'Expert Consensus on Diagnosis and Treatment of Carbapenem-Resistant Bacterial Complex Intra-abdominal Infections (2025 Edition)', providing supportive evidence for promoting the wider and rational use of this product.
VISPING®
In 2025, we continued to advance the preparations for the official approval and launch of Veshiping® in mainland China. Last year, under the 'Hong Kong-Macao Medicine and Device Access Scheme' policy, the drug provided early clinical use opportunities at 12 medical institutions in Guangdong Province, laying a solid foundation among doctors and patients for obtaining new drug marketing approval from the China National Medical Products Administration in February 2026. We also initiated a real-world study in the Greater Bay Area to accumulate more evidence-based data to guide clinical practice.
Following December 2024, when Etrolimod was included in the American Gastroenterological Association (AGA) clinical practice guidelines, it was again incorporated into the '2025 ACG Clinical Guidelines: Adult Ulcerative Colitis' in June last year. The new guidelines strongly recommend using Etrolimod for induction of remission in patients with moderate to severe active ulcerative colitis (moderate-quality evidence) and recommend continuing Etrolimod after induction of remission with sphingosine-1-phosphate (S1P) receptor modulators to maintain remission (strong recommendation, moderate-quality evidence). This new version of the guidelines, formulated by the American College of Gastroenterology, systematically summarizes new methods and advances in treating ulcerative colitis and preventing complications based on the latest evidence-based medical evidence from the past five years, aiming to provide clinicians with more standardized and scientific management references. This significant progress reflects the high recognition of the clinical value of Etrolimod by authoritative international medical guidelines.
Additionally, four articles on Etrolimod were published in domestic and international medical journals. Among them, the results of the ENLIGHT UC multicenter Phase III clinical study of Etrolimod in Asian patients with moderate to severe active ulcerative colitis were published in the authoritative international journal The Lancet Gastroenterology & Hepatology in September 2025, with its efficacy and safety recognized by top-tier global academic journals.
To strengthen long-term supply stability and high profit margins, we launched a localization production project at our Jiashan production base last year, with a total investment of 70 million RMB. Upon full production, the annual capacity is expected to reach 5 million bottles.
In December 2025, Yundding reached a strategic cooperation agreement with Haisen Biotech, which includes providing commercialization services for six approved and commercially launched products under Haisen Biotech across three therapeutic areas: critical care, cardiovascular, and metabolism. These six products are: Rocephin® (Ceftriaxone), Sandostatin® (Somatostatin), and Urapidil® (Urapidil) in the critical care field; Azilsartan (Edarbi®) and Candesartan (Biloz®) in the cardiovascular field; and Voglibose (Basen®) in the metabolism field. Yundding will charge service fees ranging from 20% to 55% of the quarterly net sales of the relevant products.
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Commercialization Outlook
Looking ahead to 2026, we will remain focused on deepening the commercial execution in our core therapeutic areas while expanding market access to lay a solid foundation for the next phase of growth in our product pipeline.
As the only drug currently approved in the national medical insurance catalog for the treatment of IgA nephropathy, Nefukang is expected to continue serving as the core growth driver of the company’s revenue in 2026. Leveraging the rapid momentum following its inclusion in the national medical insurance catalog, we plan to further expand coverage in key markets and increase the size of our internal sales team. In collaboration with CSO organizations, we aim to deepen penetration into lower-tier markets, extending our reach to over 90% of accessible markets. Meanwhile, through effective physician and patient education, along with conducting more real-world studies, we will further strengthen awareness among doctors and patients regarding domestic and international guideline recommendations and our disease management strategy of 'treating the cause, early intervention, and long-term treatment.'
For Yika, we will increase the number of target hospitals and deepen penetration in core hospitals, continuously expanding routine antimicrobial susceptibility testing and broadening coverage in intensive care-related departments such as respiratory and surgical ICUs. We will also continue to accumulate real-world evidence across different infection sites to establish Yika as a cornerstone for empirical treatment of multidrug-resistant infections. Additionally, we plan to participate in the national medical insurance drug list negotiation in the second half of 2026 while advancing the localization of production. This aims to benefit more Chinese patients and propel this product into a new growth phase.
Following its approval for marketing in mainland China in February 2026, Veshiping achieved the issuance of the first prescription in mainland China within just 21 working days, showcasing our ability to rapidly introduce cutting-edge innovative therapies into clinical practice in China. In recent years, the incidence of ulcerative colitis in China has continued to rise and shows a trend of affecting younger populations, with the patient population projected to grow from approximately 980,000 in 2025 to around 1.5 million by 2031. Veshiping demonstrated outstanding efficacy and safety in clinical trials, showing rapid and sustained clinical remission and profound mucosal healing, and has been strongly recommended by mainstream international treatment guidelines as a first-line therapy. It also offers the convenience of once-daily oral dosing. We believe this product has the potential to become another blockbuster following Nefukang. The company will invest core market and medical resources in its launch this year, including extensive multi-channel physician and patient education activities, ongoing real-world studies, building a professional and efficient sales team, and actively preparing for negotiations for inclusion in the 2026 national medical insurance directory. Meanwhile, we will push forward with the localization production project, with production expected to commence next year.
In addition to our proprietary commercial product pipeline, providing commercialization services for six mature products under HaiSen Bio will bring stable revenue. Rocephin, a widely recognized third-generation cephalosporin, has been included in China's National Essential Medicines List. As a treatment for community-acquired infections, it complements Yika's focus on severe hospital infections, creating an efficient synergy.
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Business expansion
In December 2025, the company unveiled its 2030 development strategy, comprehensively mapping out the blueprint for the next five years. The company plans to enrich its product pipeline and maximize the value of its innovative drug commercialization platform. The strategy highlights that the company intends to introduce more than 20 high-value assets over the next five years, contributing 6 billion in revenue by 2030 while exploring potential out-licensing income. Under the guidance of this strategy, the company is actively pursuing licensing deals to broaden therapeutic area coverage and enhance resilience for long-term future growth.
Last October, the company signed an agreement with Visara, Inc., securing exclusive rights to clinically develop, manufacture, and commercialize VIS–101 in Greater China, Singapore, South Korea, and several Southeast Asian countries, expanding its business into ophthalmology—a blue ocean therapeutic area with unmet clinical needs and innovative opportunities. VIS–101 is a novel bifunctional biologic targeting VEGF-A and ANG–2, offering significantly improved efficacy compared to first-generation treatments. It is expected to provide longer-lasting therapeutic benefits for patients with wet age-related macular degeneration (wet AMD), diabetic macular edema (DME), and retinal vein occlusion (RVO).
Last December, the company entered into multiple strategic agreements with HaiSen Bio, including a commercialization service agreement covering several mature products and an exclusive licensing contract for Laribop in Greater China. This collaboration enhances the efficient use of the company’s existing commercialization platform, establishes foundational product positioning in the high-potential cardiovascular therapeutic area, and adds a late-stage candidate nearing registration milestones to the company’s R&D pipeline.
In February 2026, Everest Medicines signed an exclusive licensing agreement with Microtech Therapeutics, obtaining rights to commercialize MT1013 in China and the Asia-Pacific region (excluding Japan). MT1013 is a first-in-class dual-target receptor agonist peptide that simultaneously targets the calcium-sensing receptor (CaSR) and osteogenic growth peptide (OGP) receptor, primarily developed for treating secondary hyperparathyroidism. This strategic partnership creates synergies with Everest Medicines' existing renal portfolio, strengthens its product lineup, solidifies the company’s leadership in kidney and autoimmune diseases in Asia, and extends product coverage from IgA nephropathy to a broader range of chronic kidney diseases.
In March 2026, the company announced an asset acquisition agreement with JiXing Pharmaceuticals Hong Kong Limited to obtain development, commercialization, and local production rights for Etripamil Nasal Spray (proposed Chinese brand name: Xingbituo) in Greater China. This collaboration represents a significant step in strengthening the company’s strategic position in the cardiovascular field, further diversifying the product portfolio, enhancing synergies, and reinforcing the company’s presence in cardiovascular disease. In addition to being approved in the United States for acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) in adults, Etripamil Nasal Spray is under development for atrial fibrillation with rapid ventricular response (AFib-RVR) indications.
Looking ahead to 2026, Everest Medicines will continue to implement an aggressive business development strategy in alignment with its 2030 development strategy, steadfastly advancing the construction of its innovative drug commercialization platform. It aims to build a richer and more diversified commercial portfolio to provide a solid foundation for future growth. Everest Medicines will remain focused on its core therapeutic areas, including CKM (cardiovascular, kidney, and metabolic), autoimmune diseases, and critical care, prioritizing products in late-stage clinical trials or nearing commercialization to enhance the efficient use and productivity of its existing commercial platforms. At the same time, it will selectively expand into other high-value therapeutic areas with blockbuster potential.
In terms of out-licensing collaborations, Everest Medicines will continue to seek global partnership opportunities for its internally developed pipeline with global rights. This includes EVER001 (Xibutinib), which has received one-year follow-up data support from Phase Ib/IIa trials, as well as the company’s upcoming mRNA autologous CAR-T project entering clinical research. The company believes that strategic global partnerships can accelerate clinical development, regulatory approvals, and long-term value creation.
With a robust cash reserve and continuous operating cash flow, Everest Medicines has established a solid foundation to steadily advance its business development strategy, continuously expanding its global footprint. This enables the creation of a diversified, globally competitive, and sustainably growing innovative drug portfolio.
self-developed
The year 2025 marks a highly successful period for Everest Medicines' dual-driven strategy and its self-developed mRNA platform. The company achieved significant progress in personalized and off-the-shelf mRNA cancer therapeutic vaccines as well as its autologous CAR-T project, demonstrating efficient execution across discovery, translational research, CMC, and early clinical development phases.
Within our internally developed mRNA platform pipeline, the personalized cancer vaccine EVM16 successfully completed dosing for nine patients last year, finishing dose escalation in low, medium, and high doses in Part 1a of the investigator-initiated trial (IIT). We plan to present the data results at an international academic conference in the first half of 2026 and initiate the Part 1b expansion study within the year.
For our off-the-shelf tumor-associated antigen (TAA) vaccine EVM14, we obtained Investigational New Drug (IND) approvals from the US FDA in March 2025 and China’s CDE in August 2025, marking Everest's first simultaneous IND approval in both the US and China. The company successfully completed and released the first GMP clinical batch production of EVM14 at its Jiashan manufacturing facility, supporting global clinical development. In November of the same year, the first patient was dosed in the US, initiating clinical evaluation of EVM14 in human subjects. Completion of low, medium, and high dose escalation, including cohorts from the US and China, is expected this year.
Everest's autologous mRNA CAR-T platform EVM18 also made significant progress in 2025, completing preclinical proof-of-concept, identifying clinical candidate molecules, and actively advancing clinical development. This year, we plan to initiate multiple investigator-initiated trials (IITs) targeting various autoimmune indications while aggressively moving forward with global IND submissions to begin systematic clinical evaluation.
Financial Highlights
International Financial Reporting Standards figures
Revenue for the year ended December 31, 2025, amounted to RMB 1,706.7 million, representing a significant increase of RMB 1,000.0 million or 141.5% compared to RMB 706.7 million for the year ended December 31, 2024. The revenue growth was primarily driven by continued sales increases of Nefecon in commercialized markets.
In the Chinese market, the inclusion of Nefecon in the National Reimbursement Drug List (NRDL) served as a key growth driver, leading to a substantial increase in Nefecon revenue for the year ended December 31, 2025.
Outside the Chinese market, Nefecon has successfully launched in Taiwan and South Korea, achieving significant milestones, with sales continuing to rise in other Asian markets. Additionally, Velsipity has successfully launched in the Singapore market. These achievements highlight the group's progress in expanding its presence across Asia and improving patient access to medications.
The gross profit margin decreased from 74.6% for the year ended December 31, 2024, to 69.3% for the year ended December 31, 2025. Excluding amortization of intangible assets, the gross profit margin decreased from 82.9% for the year ended December 31, 2024, to 74.1% for the year ended December 31, 2025. This reduction was primarily due to the inclusion of Nefecon in the NRDL in mainland China.
Nevertheless, the group continues to optimize product costs through internal efficiency measures such as process improvements and supply chain streamlining. Moreover, the company is collaborating closely with suppliers (e.g., joint cost-reduction initiatives) to achieve economies of scale.
Research and development expenses for the year ended December 31, 2025, amounted to RMB 511.0 million, a slight decrease compared to RMB 528.0 million for the year ended December 31, 2024. The company successfully achieved several R&D milestones during the year and has been actively optimizing its R&D strategy to accelerate the development of its in-vivo CAR-T and mRNA platforms, advancing to the next stage of research and clinical readiness, while further unlocking the value of EVER001 (Xibutinib). Additionally, leveraging its excellent clinical development capabilities, the company has further enriched its late-stage product pipeline through strategic collaborations and licensed-in projects.
General and administrative expenses increased by RMB 26.4 million from RMB 250.1 million in the previous year to RMB 276.5 million for the year ended December 31, 2025. This increase was mainly due to an increase in headcount as the group strategically invested in talent acquisition to support the advancement of its pipeline development and market expansion plans.
Distribution and sales expenses increased by RMB 272.5 million from RMB 508.1 million for the year ended December 31, 2024, to RMB 780.6 million for the year ended December 31, 2025. The company actively expanded its coverage of medical institutions and enhanced academic promotion and medical education activities. The group is committed to building an omnichannel commercialization system and enhancing its commercial capabilities throughout the drug lifecycle.
The ratio of total operating expenses (including general and administrative expenses, research and development expenses, and distribution and sales expenses) to revenue declined by 90.1 percentage points, reflecting an improvement in the group’s operational efficiency and more focused resource allocation.
The net loss for the year decreased by RMB 743.6 million from RMB 1,041.4 million for the year ended December 31, 2024, to RMB 297.8 million for the year ended December 31, 2025. This decrease was primarily due to (i) strong product revenue growth, (ii) improved operational efficiency, (iii) recognition of deferred tax assets related to accumulated tax losses generated in Singapore, as it is considered likely that sufficient taxable profits will be available in the future to utilize these tax losses, and (iv) impairment losses of RMB 312.3 million on intangible assets related to Zetomipzomib, SPR206, and FGF401, compared to impairment losses of RMB 356.3 million related to the mRNA COVID-19 vaccine for the year ended December 31, 2024.
As of December 31, 2025, cash and cash equivalents and bank deposits amounted to RMB 2,731.5 million.
Non-IFRS Measures
The adjusted profit/(loss) for the year turned from a loss of RMB 537.6 million for the year ended December 31, 2024, to a profit of RMB 187.2 million for the year ended December 31, 2025, an increase of RMB 724.7 million, primarily due to the exclusion of one-off and non-recurring losses from intangible asset impairment, investment gains from associates, as well as non-cash expenses related to share-based compensation and amortization of intangible assets.
Forward-Looking Statements
This press release may contain certain forward-looking statements based on the Company's or management’s current views, beliefs, and expectations regarding the Company's business operations and financial condition at the time the statements were made. Such statements may be expressed using terms such as 'will,' 'expect,' 'forecast,' 'anticipate,' 'intend,' 'plan,' 'believe,' 'estimate,' 'confident,' and similar expressions. These forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties, and other factors, some of which are beyond the Company’s control and difficult to predict. Therefore, actual results may differ materially from the information contained in these forward-looking statements due to various factors and assumptions, including changes and developments in our business, competitive environment, political, economic, legal, and social conditions. Neither the Company nor its subsidiaries, directors, officers, advisors, or agents have any obligation to update the forward-looking statements contained in this press release to reflect subsequent information, future events, or circumstances, unless required by law.
Risk Disclaimer: The above content only represents the author's view. It does not represent any position or investment advice of Futu. Futu makes no representation or warranty.Read more
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