Irbesartan

Novartis has positioned Vanrafia as a “foundational therapy” in IgAN because it can address a broad population of patients with persistent proteinuria, the company’s U.S. president, Victor Bulto, told Fierce Pharma. When Novartis bought kidney disease biotech Chinook Therapeutics in 2023 for $3.2 billion upfront, the deal included a conditional payment tied to the timely FDA approval of atrasentan without a specific safety restriction.Now, investors in Chinook can claim an additional $2-per-share payout, or about $160 million in total, as the milestone has been met.The FDA has granted an accelerated approval for atrasentan to reduce elevated protein in the urine in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid progression, Novartis said Wednesday.Bearing the commercial moniker Vanrafia, the selective endothelin A receptor antagonist (ERA) does not have to be used under an FDA-mandated safety-related program called REMS. A sans-REMS FDA approval for the drug in IgAN before the end of 2025 was needed to trigger a $2-per-share contingent value right (CVR) payment under Novartis’ merger agreement with Chinook.The special CVR arrangement highlights how important having a non-REMS label is for Novartis.The lack of a REMS requirement sets Vanrafia apart from Travere Therapeutics’ Filspari— which acts as both an ERA and an angiotensin receptor blocker (ARB)—for now. Filspari got its IgAN nod in 2023 and is only available through a REMS program mainly because of a potential risk of liver toxicity, which is also reflected as a boxed warning item on the drug’s label.However, a step ahead of Novartis, Travere last fall turned Filspari’s accelerated approval into a full go-ahead based on evidence that it can preserve kidney function. So far, Travere said the REMS program does not appear to pose a barrier for Filspari patients. The drug’s 2024 sales also suggested a good launch progress, with its $132 million beating analysts’ consensus estimates. However, as Leerink Partners analysts pointed out in a March note, “the question is, how many more patients are out there that might be a candidate with a looser REMS?”Both Novartis and Travere are trying to level the playing field against each other.For Travere, the biotech has submitted an application to the FDA to potentially reduce the REMS liver monitoring requirement from monthly testing to quarterly in the first year. The FDA has set a decision date of Aug. 28 this year.For Novartis, the company is collecting longer-term data for Vanrafia in the hopes of also showing a kidney function benefit to support a traditional approval.Novartis has positioned Vanrafia as a “foundational therapy” in IgAN because it can address a broad population of patients with persistent proteinuria, the company’s U.S. president, Victor Bulto, said during a recent interview with Fierce Pharma.In the phase 3 Align trial, Vanrafia led to a 36% reduction in proteinuria as measured by the urine protein-to-creatinine ratio (UPCR) compared with placebo after 36 weeks of treatment.  For Travere's Filspari, the result was a 35% reduction in UPCR at week 36 versus control, in its own IgAN trial called Protect.Because the two meds feature different mechanisms, their trials were designed differently. While Filspari was pitted directly against the ARB drug irbesartan, Vanrafia was tested against placebo in patients who were on maximally tolerated renin angiotensin system inhibitor, such as an ARB.As Filspari is a drug with dual mechanisms, it offers the convenience of a single drug, whereas Vanrafia is used on top of other agents. Novartis has argued that separate dosing allows doctors to adjust the dosage of each drug component, although Travere has contended that titration is more of an academic question than a real-world practice.Vanrafia is Novartis’ second IgAN drug to reach the market. Before that, the company’s complement inhibitor Fabhalta expanded into IgAN in August 2024. Another Chinook agent, the anti-APRIL antibody zigakibart, is also being developed for the rare kidney disease.With Fabhalta’s launch, Novartis is targeting patients with residual inflammation and activation of the complement pathway, Bulto said. This subgroup represents about 15% to 30% of at-risk patients with persistent proteinuria who are typically eligible for novel treatments.By comparison, Novartis believes Vanrafia can be used in all 45,000 U.S. IgAN patients potentially eligible for new therapies.“What we do fully expect is that this is going to be a combination market, given that heterogeneity [of disease manifestation], and that’s why we want to bring all the different tools that physicians may need to treat this disease,” Bulto said. In addition to IgAN, both Novartis and Travere are targeting other rare kidney diseases.Fabhalta a few days ago became the first FDA-approved agent for complement 3 glomerulopathy (C3G). Travere has recently filed Filspari for focal segmental glomeruloscelrosis (FSGS) despite missing the primary endpoint of a phase 3 trial.Novartis believes its commercial prowess and broad offerings may give it an edge.“By constructing the portfolio like this, like a multi-indication, multi-asset, it also creates compounding capabilities and expertise,” Bulto said.There are about 9,000 nephrologists in the U.S. who each treat about three IgAN patients and one C3G patient, so deploying a commercial force “for a single asset is a very difficult task,” the Novartis exec noted.“That’s why we just want to double down here in the space,” Bulto said. “I think that, in itself, will create a good competitive differentiation, which ultimately will help patients.”

SHANGHAI, March 25, 2025 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the discovery, clinical development, manufacturing and commercialization of innovative medicines and vaccines, today announced its financial results for the full year ended December 31, 2024, along with a corporate update. "In 2024, Everest continued to strength the execution of our 'Dual-Engine' strategy, having evolved from a license-in model to a balanced approach that combines in-house discovery with global partnerships and in-licensing, with a focus on high-value programs and the development of first-in-class or best-in-class assets," commented Rogers Yongqing Luo, CEO of Everest Medicines. "Our total revenue reached RMB706.7 million, representing a 461% year-over-year increase and exceeding our revenue guidance of RMB700 million. Operating expenses as a percentage of revenue decreased significantly by 562%. Notably, our non-IFRS net loss narrowed by 25%, and our gross margin, excluding non-cash items, reached 83%. We ended the year with a strong cash balance of RMB1.6 billion. Importantly, we achieved commercial-level profitability for the full year of 2024. The highlight of our commercial execution in 2024 was the successful launch of NEFECON® in mainland China in May, marking the beginning of a new era in the treatment of IgA nephropathy (IgAN). The product generated RMB353.4 million in revenue for the year, representing a year-over-year increase of 1,581%. NEFECON® was also included in China's National Reimbursement Drug List (NRDL), helping to address a significant unmet medical need among Chinese patients. In addition, it received regulatory approvals in Singapore, Hong Kong SAR, Taiwan region, and South Korea during 2024, expanding its regional footprint in Asia. We also delivered robust growth with XERAVA® (eravacycline), a first-in-class fluorocycline antibiotic, which generated RMB352.8 million in revenue in 2024, representing a 256% year-on-year increase. This strong performance was driven by its differentiated clinical profile and rising market demand. In our autoimmune portfolio, we achieved significant progress with VELSIPITY® (etrasimod), which received regulatory approvals in Macau SAR and Singapore in April 2024. The product was subsequently commercially launched in December in Guangdong province under the 'Hong Kong and Macau Medicine and Equipment Connect' policy. In parallel, New Drug Applications (NDAs) for VELSIPITY® have been officially accepted in both mainland China and Hong Kong in December 2024." "We continued to advance our pipeline of assets with global rights, focusing on creating value in high-potential therapeutic areas. EVER001, a covalent reversible BTK inhibitor, delivered positive results from the preliminary analysis of our Phase 1b/2a trial and is progressing steadily through global development. We also achieved a major milestone by advancing our mRNA platform from early-stage research into global clinical development, underscoring both our innovation capabilities and the strategic potential of our AI-powered mRNA technology. EVM16, our personalized therapeutic mRNA cancer vaccine, completed first patient dosing in an investigator-initiated clinical trial (IIT) in March 2025. EVM14, our off-the-shelf tumor-associated antigen (TAA) vaccine, received Investigational New Drug (IND) approval from the U.S. FDA, and we plan to submit an IND application to China's NMPA in the first half of this year. The in vivo CAR-T program is expected to achieve preclinical candidate milestone later this year. These programs are supported by our commercial-scale, GMP-compliant manufacturing facility in Jiashan, Zhejiang, which provides integrated R&D, production, and commercialization capabilities across mRNA and other pipeline platforms. In 2025, we will continue to enhance our commercial excellence and advance our first-in-class and best-in-class assets with global rights to maximize synergies. A key priority will be accelerating the sales of NEFECON®, leveraging its unique position as the only approved IgAN therapy in China and successfully included in the NRDL. With global rights to EVER001, we will actively explore partnership opportunities outside of China to leverage international expertise and optimize commercial value, while further enhancing Everest's global visibility and presence. Our 'Dual-Engine' strategy has entered a new chapter. Under the Board's guidance, Everest will leverage its established efficient commercial platform to solidify our position in key therapeutic areas, advance innovation on our mRNA platform, and strive to become a leading biopharma in the Asia-Pacific region by 2030—delivering greater value for shareholders and breakthrough therapies for patients worldwide." Luo concluded. Recent Key Product Highlights and Anticipated Milestones RENAL PRODUCTS PORTFOLIO Nefecon® 2024 - In March 2024, the Company's partner Calliditas Therapeutics AB ("Calliditas") (which was acquired by Asahi Kasei Corporation in September 2024 ) announced the U.S. FDA has granted an Orphan Drug exclusivity period of seven years for NEFECON®, expiring in December 2030 based on Calliditas obtaining full approval for this drug product in December 2023. - In March 2024, the Singapore Health Sciences Authority ("HSA") approved NEFEGAN®, known in other Everest territories as NEFECON®, for the treatment of primary IgAN in adults at risk of disease progression. Singapore marks the third region in Everest territories that received NDA approval after Macau and mainland China. - In April 2024, Calliditas published additional sub-analyses of NEFECON®'s Phase 3 NefIgArd study. One of the sub-analyses showed that during the 2-year period (9 months of treatment with NEFECON®, followed by a 15-month observation period after discontinuation), significant benefits in estimated glomerular filtration rate ("eGFR") were observed regardless of baseline UPCR levels (<0.8 g/g or ≥0.8 g/g). This study also showed that patients with UPCR <0.8 g/g who received NEFECON® achieved an eGFR slope of -0.25 mL/min/1.73 m3 per year, supporting the treatment target of <1 ml/min/1.73 m3 per year with the objective to avoid kidney failure in their lifetime. Another sub-analyses demonstrated that, irrespective of baseline UPCR levels and use of rescue medication, time to confirmed 30% eGFR reduction or kidney failure was significantly delayed. - In April 2024, Calliditas announced that the global open-label extension (OLE) study to the Phase 3 NefIgArd study showed a treatment response consistent with the NefIgArd study for the endpoints of urine protein to creatinine ratio ("UPCR") and eGFRat 9 months in all IgAN patients, including those who had previously received NEFECON® in the NefIgArd study. The safety data after 9 months of treatment or retreatment with Nefecon® in patients who completed the NefIgArd study were consistent with previously reported safety data. - In May 2024, the Hong Kong Department of Health had approved NEFECON® for the treatment of primary IgAN in adults at risk of disease progression. Hong Kong marks the fourth region in Everest territories where Nefecon® has received NDA approval after Singapore, Macau and mainland China. - In May 2024, Everest announced the successful launch of NEFECON® in mainland China, which has the highest prevalence of primary glomerular diseases in the world. The commercialization of NEFECON® in the Chinese market represents a significant milestone for Everest and a breakthrough for IgAN patients in China. The first prescription of NEFECON® was issued through an internet hospital, enhancing speed and convenience of delivering medication to patients and improving accessibility to the treatment. - In June 2024, Calliditas announced an additional efficacy analysis of NEFECON® in IgAN at the 61st European Renal Association Congress. An anchored matching-adjusted indirect comparison (MAIC) was performed to estimate the relative effect of NEFECON® or sparsentan on the absolute eGFR change from baseline at 9, 12, and 24 months, with common comparators of optimized renin-angiotensin system inhibition for NefIgArd and irbesartan from the phase 3 PROTECT study. Using patient-level data from NefIgArd and trial-level data from PROTECT, the study demonstrated that treatment with NEFECON® 16 mg/day for 9 months was associated with greater eGFR benefit compared with continuous treatment with sparsentan 400 mg/day over 2 years. - In July 2024, China's NMPA accepted the submission of a supplemental New Drug Application seeking full approval of NEFECON® based on the complete clinical data from the global Phase 3 NeflgArd study. - In September 2024, NEFECON® was included in the "KDIGO 2024 Clinical Practice Guideline for the Management of Immunoglobulin A Nephrophthy (IgAN) and Immunoglobulin A Vasculitis (IgAV)" draft for public review. The draft guideline notes that NEFECON® is the only treatment to date proven to reduce the levels of pathogenic forms of IgA and IgA immune complexes and recommends treatment with a 9-month course of NEFECON® for IgAN patients who are at risk of progressive kidney function loss. - In October 2024, the Taiwan Food and Drug Administration approved NEFECON® indicated "to reduce the loss of kidney function in adult patients with primary IgAN who are at risk for disease progression". Taiwan was the fifth region in Everest Medicines' authorized area to approve NEFECON® after Macau, Mainland China, Singapore, and Hong Kong. - In October 2024, "Kidney 360" magazine published the complete two-year subpopulation data from Chinese patients in the Phase 3 NefIgArd clinical trial of NEFECON® under the title "Efficacy and Safety of Nefecon in Patients with Immunoglobulin A Nephropathy from Mainland China: 2-Year NefIgArd Trial Results". The article states that during the 2-year treatment and observation period, the Chinese subpopulation data showed improvements in kidney protection, proteinuria reduction, and microhematuria that were numerically greater than the outcomes of global population. - In October 2024, additional analyses of the NefIgArd study for NEFECON® were presented at the 2024 American Society of Nephrology Kidney Week (ASN Kidney Week 2024). One of the analyses showed that the ability of NEFECON® to specifically modulate pathogenic Gd-IgA1 production in the GALT while leaving systemic IgA responses and total IgA and IgG levels unchanged, supports its use as a generally well tolerated, targeted, locally-acting treatment option for IgAN. Another analysis demonstrated that real-world use of NEFECON® was well-tolerated and can reduce loss of kidney function in patients who receive ≥9 months of treatment. - In November 2024, NEFECON® received full approval from the Ministry of Food and Drug Safety ("MFDS") in South Korea, indicated for the treatment of adults with primary IgAN with a urine protein excretion ≥1.0 g/day (or urine protein-to-creatinine ratio ≥0.8 g/g). - In November 2024, NEFECON® was included in NRDL in mainland China which takes effect on January 1st, 2025. NEFECON®'s inclusion in the NRDL acknowledges its significant clinical value in improving patient care and with approximately 5 million IgAN patients in China and over 100,000 newly diagnosed patients annually, there is a significant unmet clinical demand in the country. - In December 2024, the first prescription for NEFECON® was issued at Hong Kong Gleneagles Hospital, marking a new era for the targeted treatment of IgAN in the region. It represents the third commercial launch of NEFECON® in the year, following its launch in Mainland China and Singapore. 2025 - On January 1, 2025, with the official implementation of the latest update of NRDL, NRDL pricing now applies to NEFECON® which will benefit more IgAN patients. NEFECON® is the only approved treatment for primary IgAN in adults at risk of disease progression in China. - In March 2025, the HSA has granted full approval of NEFEGAN® indicated "to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression with a urine protein excretion ≥1.0 g/day (or urine protein-to-creatinine ratio ≥0.8 g/g)". - We expect to commercially launch NEFECON® in Taiwan region and South Korea in 2025. - We expect to receive NEFECON® full approval from NMPA in 2025. - We expect inclusion of NEFECON® in the KDIGO 2025 guidelines as well as in the first Chinese guideline for IgAN in 2025.® EVER001 is a next-generation covalent reversible Bruton's tyrosine kinase (BTK) inhibitor with potentially best-in-class characteristics for the treatment of autoimmune renal diseases. 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. 2024 - In December 2024, Everest announced positive results in the ongoing Phase 1b/2a clinical trial for the treatment of pMN with EVER001. In an analysis of the data available as of September 13th, 2024, we observed that of the patients in the low-dose cohort who have completed 36 weeks of treatment, 9 out of 11 (81.8%) achieved overall clinical remission and 10 out of 11 (91%) achieved immunological complete remission (ICR). In the high dose cohort, 6 out of 7 (85.7%) patients achieved overall clinical remission and all patients achieved ICR by week 24. EVER001 was generally safe and well tolerated. No clinically significant adverse events typically associated with earlier-generation BTK inhibitors, such as bleeding, arrhythmia, severe infection, leukopenia, thrombocytopenia, or severe liver function impairment, were reported. 2025 - We expect to report one-year follow up data of the Phase 1b/2a clinical trial in 2025. INFECTIOUS DISEASE PORTFOLIO XERAVA® (eravacycline) 2024 - In January 2024, eravacycline's clinical breakpoint was officially approved by the Expert Committee of the National Health Commission on Antimicrobial Susceptibility Testing and Standard Research (ChinaCAST) for clinical use in China. - In November 2024, data on eravacycline (XERAVA®), were presented in Los Angeles, California at IDWeek 2024. The first study evaluated the in vitro antimicrobial activity of eravacycline against Carbapenem-resistant Acinetobacter baumannii (CRAB). Using the recently approved, ChinaCAST breakpoint of 1 µg/mL the results showed a high susceptibility rate of eravacycline against CRAB. The second study evaluated the in vitro activity of eravacycline against 23,127 global clinical isolates of major Gram-positive and Gram-negative bacteria, including drug-resistant strains collected from various regions such as Asia, Europe, and North America from 2018 to 2022. Since its approval in 2018, eravacycline has consistently maintained a high level of susceptibility against clinically relevant pathogens across diverse geographic regions and infection sites which supports eravacycline's use in treating complicated intra-abdominal infections caused by both Gram-negative and Gram-positive bacteria. - In November 2024, in a real-world clinical evaluation led by the National Health Commission's Expert Committee on Clinical Use of Antimicrobials and Evaluation of Antimicrobial Resistance, the final report showed that the overall efficacy rate of eravacycline treatment for 3 days was 91.1%, and the overall treatment efficacy rate at the end of treatment was 90.1%. Cefepime-taniborbactam is an investigational agent that is a combination of cefepime, a fourth-generation cephalosporin, and the novel beta-lactamase inhibitor (BLI), taniborbactam, that exhibits broad coverage of both serine- and metallo-beta-lactamases. In combination with cefepime, taniborbactam is under development as a new treatment option for patients with serious bacterial infections caused by difficult-to-treat drug resistant gram-negative pathogens, including carbapenem-resistant Enterobacterales (CRE) and carbapenem-resistant or multidrug-resistant Pseudomonas aeruginosa (CRPA/MDR-PA). 2024 - In February 2024, The New England Journal of Medicine ("NEJM") published the results of the CERTAIN-1 Phase 3 clinical study of the investigational agent cefepime-taniborbactam for the treatment of adult patients with complicated urinary tract infections ("cUTI"), including acute pyelonephritis. The results showed that cefepime-taniborbactam was superior to meropenem for the treatment of complicated UTI that included acute pyelonephritis, with a similar safety profile to meropenem. 2025 - We expect to submit an NDA for cefepime-taniborbactam in cUTI to China NMPA in 2025. AUTOIMMUNE DISEASE PORTFOLIO VELSIPITY® (etrasimod) 2024 - In February 2024, our licensing partner Pfizer Inc. announced that the European Commission ("EC") granted marketing authorization for VELSIPITY® in the European Union to treat patients 16 years of age and older with moderately to severely active UC who have had an inadequate response, lost response, or were intolerant to either conventional therapy, or a biological agent. - In March 2024, the Pharmaceutical Administration Bureau of the Macau Special Administrative Region, China, accepted Everest's NDA for VELSIPITY® for the treatment of adult patients with moderately to severely active UC. In April, the bureau approved the NDA, marking the first approval of VELSIPITY® in Everest territories. - In July 2024, Everest announced positive topline data results of the maintenance period from a multi-center Phase 3 clinical trial of VELSIPITY® in Asia for the treatment of subjects with moderately-to-severely active UC. The data of maintenance treatment confirmed that, after 40 weeks of treatment of 2mg once-daily VELSIPITY or placebo, VELSIPITY® demonstrated significant clinical and statistical improvements over placebo in the primary and all key secondary endpoints (p<0.0001), and other secondary endpoints (including mucosal healing and endoscopic normalization, both p<0.0001). The safety profile of VELSIPITY® was consistent with previous studies, with no new safety signals observed. - In October 2024, Everest announced that, through the "Hong Kong and Macau Medicine and Equipment Connect" policy, VELSIPITY® was officially been approved for patients with moderately to severely active UC by the Guangdong Provincial Medical Products Administration and the first prescription for VELSIPITY® was written at Foshan Fosun Chancheng Hospital in Guangdong in December. VELSIPITY® is now Everest's third commercialized product. - In November 2024, the full induction period data results from a multi-center Phase 3 clinical trial of VELSIPITY® in Asia on the treatment of moderately to severely active UC with etrasimod was presented in an oral presentation at the 32nd United European Gastroenterology Week (UEGW 2024). The induction period results showed that all primary and key secondary efficacy endpoints in the etrasimod treatment group achieved statistically significant and clinically meaningful improvements compared to the placebo group. The treatment differences in clinical remission, endoscopic improvement, and clinical response rates were 20.4%, 28.6%, and 32.0%, respectively (all P-values <0.0001). Patients treated with etrasimod achieved clinically meaningful and statistically significant improvements in mucosal healing (P<0.0001) and endoscopic normalization (P=0.0003). - In December 2024, the Department of Health of the Government of the Hong Kong Special Administrative Region, China, accepted Everest's NDA for VELSIPITY® for the treatment of adult patients with moderately to severely active UC. - In December 2024, the first prescription of VELSIPITY® in Macau was issued at Kiang Wu Hospital and VELSIPITY® was included in the Catalog of Pharmaceutical and Medical Devices Imported from Hong Kong and Macau for the Nine Municipalities in Guangdong Province within the Guangdong-Hong Kong-Macau Greater Bay Area, published by the Guangdong Provincial Medical Products Administration and Health Commission of Guangdong Province. - In December 2024, the NMPA of China accepted the NDA for VELSIPITY® for the treatment of patients with moderately to severely active UC. We expect to receive NDA approval in 2026. 2025 - In February 2025, Everest announced the presentation of maintenance data from its multi-center Phase 3 clinical trial of etrasimod in Asia at the 20th European Crohn's and Colitis Organization Congress (ECCO 2025). The results demonstrated that treatment with etrasimod 2 mg resulted in a clinically meaningful and statistically significant improvement in the primary and all secondary endpoints at the end of maintenance period. A statistically significant greater proportion of etrasimodtreated patients achieved clinical remission at Week 40 compared with placebo. A statistically significant greater proportion of etrasimod-treated patients achieved endoscopic improvement and clinical response at week 40 compared with placebo. Other secondary endpoints of mucosal healing, endoscopic normalization, and histological remission also significantly favored patients treated with etrasimod compared with placebo. Notably, mucosal healing as measured by a central read endoscopic subscore ≤1 (excluding friability) with a Geboes Index score <2.0, was achieved in 51.9% of the etrasimod treated patients compared to 8.8% in the placebo group (2-sided p-value <0.0001). The safety profile of etrasimod during the maintenance period was consistent with previous studies, with no new safety findings observed. - In March 2025, Everest announced the launch of a construction project for etrasimod's local production at Jiashan factory. The project is expected to achieve an annual production capacity of 50 million tablets upon full operation. The planned supply regions include mainland China, Hong Kong, Macau, Taiwan, South Korea, and Singapore, covering Everest's licensing regions in Asia. - We expect to receive VELSIPITY® NDA approval in UC in Hong Kong in 2025. - We expect to submit NDA for VELSIPITY® in UC in Taiwan region and South Korea in 2025. - We will continue to expand VELSIPITY®'s accessibility in the Greater Bay area through the "Hong Kong and Macau Medicine and Equipment Connect" policy in 2025. Zetomipzomib is a novel, first-in-class, selective immunoproteasome inhibitor currently being evaluated for immune- mediated disorders. It was licensed from Kezar Life Sciences in 2023. Everest and Kezar collaborate on the development of zetomipzomib in autoimmune diseases such as autoimmune hepatitis. - In February 2024, Everest announced that the Center for Drug Evaluation ("CDE") of China's NMPA approved Kezar's IND application for initiation of the Phase 2b PALIZADE trial in China of zetomipzomib in patients with lupus nephritis ("LN"). - In July 2024, Everest announced that the first patient had been dosed in China with zetomipzomib in the global Phase 2b PALIZADE trial for the treatment of active LN. - In September 2024, PALIZADE was placed on clinical hold following the recommendation of the Independent Data Monitoring Committee. In October, Kezar made the strategic decision to terminate the PALIZADE trial and focus clinical development efforts on zetomipzomib in autoimmune hepatitis (AIH). - Zetomipzomib is currently being tested in PORTOLA, a placebo-controlled, randomized, double-blind Phase 2a clinical trial evaluating the efficacy and safety of the molecule in patients with AIH. AIH is a rare chronic disease in which the immune system attacks the liver and causes inflammation and tissue damage, severely impacting patients' physical health and quality of life. The study has completed enrollment of 24 patients, and Kezar expects to report topline results in 1H 2025. mRNA PLATFORM Everest has built end-to-end capabilities across its proprietary mRNA platform. Our R&D team is developing multiple mRNA-based therapeutic products including personalized cancer vaccines, tumor-associated antigen vaccines, immunomodulatory cancer vaccines, in vivo CAR-T program, as well as next generation lipid nanoparticle ("LNP") delivery systems to enhance cell-mediated immune response. Our mRNA manufacturing facility in Jiashan, Zhejiang Province in China is designed to comply with global good manufacturing practice ("GMP") standards and is able to produce at clinical- and commercial-scale. Everest owns full global intellectual property rights to its mRNA therapeutic programs. In 2024, the Company advanced its self-developed mRNA pipeline products, the first of which is EVM16, a novel personalized therapeutic mRNA cancer vaccine independently developed by Everest. It contains neoantigens with high immunogenicity potential, predicted based on the unique tumor mutations of each patient using Everest's proprietary AI-based neoantigen prediction algorithm, EVER-NEO-1. The vaccine is designed to encode dozens of tumor neoantigens. This platform will be an important part of our discovery efforts going forward. 2024 - In Feb. 2024, Everest announced the termination of the collaboration and license agreements with Providence Therapeutics Holdings Inc. Everest continues to develop its own therapeutic vaccine products utilizing the mRNA platform. - In August 2024, Everest announced the launch of an IIT for a personalized mRNA cancer vaccine, EVM16, under the study EVM16CX01, at the Peking University Cancer Hospital and Fudan University's Cancer Hospital. This trial is designed to assess the safety, tolerability, immunogenicity, and preliminary efficacy of EVM16 injection as a monotherapy and in combination with PD-1 antibody for patients with advanced or recurrent solid tumors. EVM16CX01 is the first-in-human ("FIH") trial for EVM16. 2025 - 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. - In March 2025, the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (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. - We expect to submit IND application for EVM14 in China in 2025. PRODUCT PIPELINE Everest has built a strong product pipeline across renal, anti-infective, and autoimmune diseases that are all potentially first-in-class treatment or best-in-class assets. These programs encompass short-term, mid-term and long-term opportunities which are collectively expected to generate significant revenue growth for the Company and create value for its shareholders. Pipeline Outlook 2025 promises to be a year of important data readouts and significant advancement in our best-in-class programs which carry global rights. In 2024 we were pleased to report positive data from a preliminary analysis of a Phase 1b/2a clinical trial of EVER001, a novel BTK Inhibitor for the treatment of primary membranous nephropathy. We expect to advance this trial further in 2025 and plan to report one-year follow-up data in the second half of 2025. Among our self-developed programs, the first patients have been dosed in our IIT for personalized cancer vaccine and preliminary data on safety and immunogenicity are expected this year. In parallel, we have received FDA's IND approval for EVM14, our off-the-shelf TAA cancer vaccine. We also plan to submit IND application to China's NMPA for EVM14 in the first half of this year. It marks the first U.S. IND submission and approval for Everest, and the first IND applications for Everest's self-developed pipeline. With respect to our late-stage programs, we plan to submit the NDA for cefepime-taniborbactam to the NMPA in mainland China for the treatment of cUTI in 2025. We will also submit NDAs for VELSIPITY® in South Korea and Taiwan and expect to receive NDA approval for this product in Hong Kong in the second half of the year. Commercialization Our commercial organization continued to flourish in 2024 as we launched and grew three commercial products, NEFECON®, XERAVA®, and VELSIPITY®. In our renal franchise, our team successfully launched our leading drug product, NEFECON® in mainland China in May 2024. We employed a broad array of sales channels, including traditional in-person detailing of hospitals as well as the innovative channel of online prescribing, to meet the urgent and significant unmet needs of an estimated 5 million IgAN patients. Our 150-person sales team had penetrated more than 600-700 hospitals by the end-of 2024, which encompass over 60% of the addressable IgAN population. To further broaden IgAN patient access, NEFECON® was included in China's 2024 NRDL which went into effect on January 1, 2025. We expect this significantly increased affordability to drive rapid penetration of NEFECON® throughout its patient population. Another highlight for NEFECON® in 2024 was its inclusion in the "KDIGO 2024 Clinical Practice Guideline for the Management of Immunoglobulin A Nephrophthy (IgAN) and Immunoglobulin A Vasculitis (IgAV)" draft for public review. The draft guideline points out that NEFECON® is the only treatment to date proven to reduce the levels of pathogenic forms of IgA and IgA immune complexes and recommends treatment with a 9-month course of NEFECON® for patients who are at risk of progressive kidney function loss with IgAN. It also suggests that many patients may need either repeated 9-month treatment cycles or a reduced-dose maintenance regimen in order to produce a sustained clinical response in terms of proteinuria reduction or stabilization of eGFR. The safety and efficacy of repeated treatment was also supported by our partner Calliditas' global OLE study which showed consistent treatment response across endpoints of UPCR and eGFR at 9 months across all IgAN patients, including those who had previously received NEFECON® in the NefIgArd study. In our anti-infective portfolio, Everest continued to grow XERAVA® sales through deeper penetration of our covered core hospitals and we began partnering with Contract Sales Organizations to benefit patients outside of our core target hospitals, although we still anticipate our own commercial team to generate the majority of sales for XERAVA®. Eravacycline's clinical breakpoint was officially approved by ChinaCAST for clinical use in China, and more than 100 hospitals in China have already adopted the new breakpoint in 2024, facilitating wider use of the drug in clinical practice. Inclusion of eravacycline in the Catalogue of Hierarchical Management of Clinical Application of Antimicrobial Drugs in Shanghai, Beijing and Guangdong last year underscores recognition of the drug's clinical benefits by China's key opinion leaders. In addition, eravacycline was included into The Surgical Infection Society Guidelines on the Management of Intra-Abdominal Infection: 2024 Update and China's Clinical Diagnosis and Treatment Guidelines for Multidrug-resistant Bacterial Infections in Renal Transplantation, Infectious Diseases Society of America 2024 Guidance on the Treatment of Antimicrobial-Resistant Gram-Negative Infections and Chinese Expert Consensus on the Diagnosis and Treatment of Pneumonia in the Elderly (2024 Edition). Inclusion in these guidelines is expected to broaden 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 2024. These publications have significantly enhanced awareness and provided more references for broader clinical applications. We were pleased to have launched our first autoimmune therapeutic, VELSIPITY® which was approved in Macau in April and in Singapore in May, and successfully launched for sales in those regions. Under the "Hong Kong and Macau Medicine and Equipment Connect" policy ("the Connect Policy"), VELSITPITY® was qualified for early access in nine cities in Guangdong province and its first prescription was written at Foshan Fosun Chancheng Hospital in December. To date, VELSIPITY® has been made available at five designated medical institutions in Guangdong (First Affiliated Hospital of Sun Yat-sen University, Foshan Fosun Chancheng Hospital, Shenzhen Hospital of Southern Medical University, Guangzhou United Family Healthcare and Shenzhen Qianhai Shekou Free Trade Zone Hospital) to benefit patients in mainland China with urgent needs for advanced innovative medicines in UC. In 2025 we will continue to build on the strong commercial foundation established in 2024. In our renal franchise, we will work to rapidly ramp NEFECON® sales after its inclusion on the NRDL which makes the medicine much more affordable and broadly accessible to patients. We are targeting rapid progress in NRDL implementation through either hospital listing or dual-channel pharmacies in the first quarter of 2025. We are also aiming to expand our list of core coverage hospitals to about 800 in 2025, which includes over 80% of the potential NEFECON® market with about 200 sales representatives. Everest also anticipates official inclusion of NEFECON® in the 2025 revised Kidney Disease Improving Global Outcomes (KDIGO) guidelines as well as the first Chinese guideline for IgAN as a first-line treatment for IgAN patients. This is expected to help further grow our sales volumes by giving treating physicians an industry standard reference which instills in them more confidence in NEFECON®. While we focus on maximizing the NRDL opportunity in mainland China, we also plan to expand availability of this first-in-disease medication to more IgAN patients across other valuable Asian regions including Taiwan and South Korea. Within our anti-infective portfolio, we will continue to drive penetration of XERAVA® among our core hospitals by enhancing doctors' awareness, which would lead to more prescriptions at hospitals with significant growth potential. We will also drive early and appropriate use of XERAVA® to establish the medicine as a fundamental option in empirical multi-drug resistant bacteria infection therapy. In addition to our own sales network, we will further optimize promotion through the contract sales organization model in non-core markets where we believe XERAVA® prescription can be broadened. VELSIPITY® is our newest launch and in 2025, while we will facilitate the NDA review by NMPA with approval expected in 2026, we will also accelerate its availability in designated medical institutions under the Connect Policy for early access to VELSIPITY® in mainland China. Additionally, VELSIPITY®'s real-world study is planned in Greater Bay to provide physicians with more clinical guidance with the product. Discovery 2024 marked a remarkable year of progress in our mRNA platform as we started the first in-human trial with an investigator-initiated program for our personalized cancer vaccine, EVM16 in two top cancer hospitals in China. EVM16 is independently developed by Everest which contains neoantigens with high immunogenicity potential, predicted based on the unique tumor mutations of each patient using Everest's proprietary AI-based neoantigen prediction algorithm, EVER-NEO-1. The vaccine is designed to encode dozens of tumor neoantigens, and uses an LNP delivery system to efficiently deliver neoantigen-encoded mRNA in vivo, activating neoantigen-specific tumor-killing T cells and inhibiting tumor growth. In preclinical studies, vaccination with EVM16 stimulated a strong neoantigen-specific T cell response in different mouse models and showed significant tumor growth inhibition in the syngeneic B16F10 mouse melanoma model. EVER-NEO-1, the AI-based neoantigen prediction algorithm developed in-house by Everest, can identify the majority of reported tumor neoantigens, as well as several previously unreported neoantigens. Furthermore, the neoantigen prediction capability of EVER-NEO-1 was shown to be either comparable to or superior to leading industry algorithms in multiple independent validation studies. We are expecting a catalyst-rich 2025 with a preliminary human data readout from EVM16, for which we achieved first patient dosing in March. Additionally, we have received U.S. FDA's IND approval for EVM14, our off-the-shelf tumor-associated antigen vaccine, marking Everest's first internally discovered program and the first mRNA therapeutic cancer vaccine to be cleared for global clinical development. With IND application to China's NMPA expected in the first half of this year, this asset is designed to treat various cancers, including non-small cell lung cancer and head and neck cancer. In preclinical studies, EVM14 induced a dosedependent antigen-specific immune response in mice and significantly inhibited tumor growth in multiple syngeneic tumor models. Lastly, the in vivo CAR-T program is also expected to achieve preclinical candidate milestone later this year, which may create a pathway to future global partnership opportunities. Business Development With the promising data generated by EVER001, our most advanced product with global rights, we will look to potentially engage in out-licensing activities to create value for all our early-stage assets with global rights. For these assets, we plan to pursue global partnership opportunities and seek ways to maximize shareholder value with entities who have global expertise and deals that offer attractive economics. Our business development strategy for in-licensing remains focused on first-in-class or best-in-class assets in less crowded, high value therapeutic areas such as renal diseases, autoimmune disorders, and anti-infective categories. We intend to leverage the strength of our existing commercial platforms to pursue commercial-stage or near-commercial-stage assets in China to create operational synergies and build scale. In parallel, we plan to evaluate earlier-stage assets with global rights, where we can deliver clinical proof-of-concept results and build substantial shareholder value. Financial Highlights IFRS Numbers: Revenue for the year ended 31 December 2024 increased significantly by RMB580.7 million, or 461%, to RMB706.7 million, compared with RMB125.9 million for the year ended 31 December 2023. The revenue growth was primarily driven by the strong ramp up of XERAVA® sales and the successful launch of NEFECON® in mainland China. Additionally, in markets outside of Mainland China, XERAVA® sales continued to build in Hong Kong and Singapore, NEFECON® was successfully launched in Hong Kong and Singapore, and VELSIPITY® was first launched in Macau and made available in Guangdong province through the "Hong Kong and Macau Medicines and Equipment Connect" policy. Gross profit margin rose from 72.7% for the year ended 31 December 2023 to 74.6% for the year ended 31 December 2024. Excluding the amortisation of intangible assets, the gross profit margin increased from 79.9% in 2023 to 82.9% in 2024. The improvement was mainly due to the commercial launch of NEFECON® and the optimisation of product costs. R&D expenses for the year ended 31 December 2024 amounted to RMB528.0 million, decreasing slightly from RMB540.1 million for the year ended 31 December 2023. The Company remains committed to strategic R&D investments across various product pipelines to support long-term sustainable growth. General and administrative expenses increased by RMB84.9 million, from RMB165.2 million for the year ended 31 December 2023 to RMB250.1 million for the year ended 31 December 2024. This increase was primarily due to higher remuneration expenses and professional service expenses in order to support the Company's business expansion and continued pipeline growth. Distribution and selling expenses increased by RMB276.7 million from RMB231.4 million for the year ended 31 December 2023 to RMB508.1 million for the year ended 31 December 2024, primarily due to expansion of the commercial team and additional commercial activities, which helped the successful launch of new products and encouraged the growth of existing product sales. Our commercial operational efficiency increased as commercialization expenses-to-sales ratio decreased by 111.9%, with our continued efforts to build a more efficient and focused commercialization model. The ratio of total operating expenses (including general and administrative expenses, research and development expenses, and distribution and selling expenses) to sales decreased by 561.8%, showing operational efficiency improvement. Net loss for the year increased by RMB196.9 million from RMB844.5 million for the year ended 31 December 2023 to RMB1,041.4 million for the year ended 31 December 2024. This increase was primarily due to a one-time, non-recurring impairment loss from an intangible asset related to mRNA COVID-19 vaccines in the first half of 2024. Excluding this impairment loss of an intangible asset, net loss narrowed by RMB107.5 million, from RMB792.5 million for the year ended 31 December 2023 to RMB685.0 million for the year ended 31 December 2024. This was primarily due to the strong product sales and improvements in operational efficiency. Cash and cash equivalents and bank deposits amounted to RMB1,603.3 million as of 31 December 2024. Non-IFRS Measure: Adjusted loss for the year narrowed by RMB176.1 million, from RMB713.6 million for the year ended 31 December 2023 to RMB537.6 million for the year ended 31 December 2024, 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 . 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. SOURCE Everest Medicines WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED