Everest Medicines (HKEX 1952.HK)announced that it has entered into an exclusive licensing agreement with Australia Dimerix Limited (Dimerix), for the development and commercialization of DMX-200 in Greater China (Chinese mainland, Hong Kong SAR, Macao SAR and Taiwan region), South Korea and certain Southeast Asian countries (Singapore, Malaysia, Thailand, Indonesia, Vietnam and Philippines). This collaboration will further strengthen Everest’s nephrology product portfolio and pipeline synergy, reinforce the company’s strategic position in kidney and autoimmune diseases.
Under the terms of the agreement, Everest will pay Dimerix a US$ 10 million upfront payment, and up to US$30 million potential success-based development and regulatory milestone payments, as well as up to US$300 million in commercial milestone payments. In addition, Everest will pay tiered royalties between 10-15% of DMX-200 net sales in Greater China, South Korea, and certain Southeast Asian countries.
DMX-200 is a small molecule inhibitor of the chemokine receptor 2 (CCR2) under development in a pivotal, Phase 3 study, ACTION3, for the treatment of Focal Segmental Glomerulosclerosis (FSGS). Public disclosures show that DMX-200 has received Orphan Drug Designations from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
“This collaboration with Dimerix marks an important step in advancing our strategic focus in kidney disease and further strengthening our innovative renal portfolio,” said Yifang Wu, Chairman of the Board of Everest Medicines. “Patients with FSGS in China have long faced significant unmet medical needs due to the lack of targeted treatment options. The positive interim results from the global pivotal Phase 3 study of DMX-200 underscore its potential to offer a meaningful new therapy for these patients. Leveraging our proven expertise in clinical development and commercialization, we are committed to accelerating access to DMX-200 in China and beyond and exploring other glomerulopathies. We look forward to working closely with Dimerix to bring this innovative therapy to more patients in need.”
Dr Nina Webster, Chief Executive Officer and Managing Director of Dimerix, said: “We are delighted to establish this partnership with Everest Medicines, a company with strong rare renal disease expertise and a proven track record in commercializing in Greater China, South Korea and certain Southeast Asian countries. Importantly, this collaboration significantly expands the potential reach of DMX-200 into a large and underserved patient population. Everest is well positioned to maximize the opportunity in the licensed regions, while allowing Dimerix to retain focus on progressing our global registrational program, delivering value for shareholders and providing real hope for patients with FSGS across the globe in need of treatment options.”
FSGS is a rare, serious kidney disorder characterized by progressive scarring (sclerosis) in parts of the glomeruli—the kidney’s filtering units. This scarring leads to proteinuria, progressive loss of kidney function, and often end-stage renal disease. In China, 500,000 to 1 million people are estimated to be living with FSGS, including both adults and children1,2.
The ACTION3 study, which is titled “Angiotensin II Type 1 Receptor (AT1R) & Chemokine Receptor 2 (CCR2) Targets for Inflammatory Nephrosis”, is a pivotal (Phase 3), multi-centre, randomized, double-blind, placebo-controlled study of the efficacy and safety of DMX-200 in patients with FSGS who are receiving a stable dose of an angiotensin II receptor blocker (ARB). Once the ARB dose is stable, patients will be randomized to receive either DMX-200 (120 mg capsule twice daily) or placebo. The single Phase 3 trial in FSGS patients has two interim analysis points built in that are designed to capture evidence of proteinuria and kidney function (eGFR slope) during the trial, aimed at generating sufficient evidence to support marketing approval.
The ACTION3 study has completed enrollment of 333 patients. In early 2024, Dimerix reported positive interim results from the ACTION3 trial in FSGS, showing DMX-200 was performing better than placebo in reducing proteinuria at that time. There have been no safety concerns to date following 8 reviews by the independent data monitoring committee, the most recent in June 2026. In April 2026, an external statistical blinded review of ACTION3 data achieved its objective by confirming that the study remains appropriately statistically powered (>90%) to demonstrate a treatment effect for the primary study endpoint of proteinuria; meaning that if DMX-200 continues to reduce proteinuria in trial patients as anticipated, then there is a >90% chance that the study will successfully show a statistically significant proteinuria treatment effect at the trial’s conclusion.
Rather than a single product licensing deal, this collaboration is viewed by the industry as a significant step forward for Everest Medicines in deepening its layout in the nephrology field. In recent years, the company has continuously built a nephrology product matrix including Nefecon®, civorebrutinib (EVER001), MT1013, and Bejescin® (MIL62), focusing on areas such as IgA nephropathy and chronic kidney disease (CKD). The introduction of DMX-200 is not only expected to fill the gap in innovative treatments for FSGS in China, but will also further enrich Everest Medicines’ nephrology pipeline, creating synergies with existing products and R&D projects to extend its footprint into the broader CKD sector.
Meanwhile, this partnership covers multiple core markets, including Greater China, South Korea, and Southeast Asia, further reflecting Everest Medicines’ strategic direction to continuously refine its commercialization network across the Asia-Pacific region. With a massive population base in the Asia-Pacific region, the burden of chronic conditions like CKD continues to rise, driving significant unmet medical needs for patients. Everest Medicines is gradually expanding its accumulated commercialization experience into the broader Asia-Pacific market. Driven by its dual-engine strategy of business development partnerships and in-house R&D, the company is poised to further unlock the value of its innovative assets, opening up new horizons for its long-term growth.
Reference:
1.Du X, Xiao D, Ao C, Zhang Y, Xuan J. Disease Burden of IgA Nephropathy in China. ISPOR Europe 2021. (poster/presentation).
2.Yang Y, Zhang Z, Zhuo L, Chen DP, Li WG. The Spectrum of Biopsy-Proven Glomerular Disease in China: A Systematic Review. Chin Med J (Engl). 2018;131(6):731–735.