Dimerix Limited (ASX: DXB), a biopharmaceutical company developing innovative therapies for rare inflammatory diseases, has entered into an exclusive licensing agreement with Everest Medicines for the commercialisation of its Phase 3 drug candidate, DMX-200, across Greater China, South Korea, and key Southeast Asian markets.

The agreement grants Everest Medicines exclusive rights to develop, register, and commercialise DMX-200 for all indications, including Focal Segmental Glomerulosclerosis (FSGS), in Chinese mainland, Hong Kong SAR, Macao SAR, Taiwan region, South Korea, Singapore, Malaysia, Thailand, Indonesia, Vietnam, and the Philippines.

Under the terms of the agreement, Dimerix will receive an upfront payment of US$10 million, with the potential to earn up to US$330 million in development, regulatory, and commercial milestone payments, in addition to tiered royalties ranging from 10 to 15 percent on net sales. The total deal value could reach approximately AU$481 million.

The transaction marks Dimerix's fifth international licensing agreement for DMX-200, following previous partnerships with Advanz Pharma, Taiba Rare, Fuso Pharmaceutical Industries, and Amicus Therapeutics (now BioMarin). Collectively, these agreements represent potential aggregate deal value of approximately AU$1.9 billion, excluding future royalty streams.

DMX-200 is a first-in-class small molecule inhibitor targeting CCR2 and is currently being evaluated in the pivotal ACTION3 Phase 3 clinical trial for FSGS, a rare and progressive kidney disease affecting an estimated 500,000 to one million patients across the licensed territories. There are currently no approved therapies specifically indicated for FSGS in these markets.

The ACTION3 study has completed enrolment of 333 patients across 21 countries, including China, Hong Kong SAR, Taiwan region, Thailand, and Malaysia. Interim results reported in 2024 demonstrated that DMX-200 outperformed placebo in reducing proteinuria, a key marker of kidney disease progression. To date, eight independent safety reviews have reported no significant concerns, with the most recent assessment completed in June 2026.

A blinded external statistical review conducted in April 2026 further confirmed that the ACTION3 trial maintains greater than 90 percent statistical power to detect a clinically meaningful treatment effect on proteinuria, reinforcing confidence in the programme's path toward completion.

"We are delighted to establish this partnership with Everest Medicines, a company with strong rare renal disease expertise and a proven track record in commercialising therapies across Greater China, South Korea, and Southeast Asia," said Dr Nina Webster, Chief Executive Officer and Managing Director of Dimerix.

"Importantly, this collaboration significantly expands the potential reach of DMX-200 into a large and underserved patient population. Everest is exceptionally well positioned to maximise the opportunity in the licensed territories while allowing Dimerix to remain focused on executing our global registrational strategy and delivering hope to patients living with FSGS worldwide."

Yifang Wu, Chairman of Everest Medicines, added, "This collaboration with Dimerix marks an important step in advancing our strategic focus in kidney disease and further strengthening our innovative renal portfolio. Patients with FSGS across Asia continue to face substantial unmet medical needs due to the absence of targeted treatment options."

"The encouraging interim Phase 3 data for DMX-200 highlight its potential to become a meaningful new therapeutic option for these patients. Leveraging our expertise in clinical development and commercialisation, we look forward to accelerating access to this promising therapy across China and other Asian markets while exploring opportunities in additional glomerular diseases."

Under the agreement, Dimerix will continue to lead and fund the global ACTION3 Phase 3 programme, while Everest Medicines will assume responsibility for regulatory submissions, approvals, and commercialisation activities within the licensed territories. The companies will establish a Joint Steering Committee to coordinate development and commercialisation strategies.

The partnership further strengthens Dimerix's position as it advances DMX-200 toward potential regulatory approval and expands access to innovative treatments for patients suffering from rare kidney diseases worldwide.