Dimerix Ltd (ASX:DXB, OTC:SBMJF) has entered into an exclusive licence agreement with Everest Medicines for the commercialisation of its Phase 3 drug candidate DMX-200 across Greater China, South Korea and parts of Southeast Asia.
The agreement covers 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 deal, Dimerix will receive a US$10 million, or around A$14.1 million, upfront payment within 45 business days of execution.
The company is also eligible for up to US$330 million, or around A$467 million, in potential success-based development, regulatory and commercial milestone payments, plus tiered royalties of 10-15% on net sales in the licensed territories.
Fifth regional licensing deal
The Everest agreement is the fifth licensing transaction for DMX-200, following earlier deals with Advanz Pharma, Taiba Rare, Fuso Pharmaceutical Industries and Amicus Therapeutics, now BioMarin.
More than A$65 million had been received before the Everest transaction, and across the five licensing agreements the company may be eligible to receive up to around A$1.9 billion in aggregate upfront and potential milestone payments, in addition to royalties on net sales.
The company retains rights to DMX-200 in all other unlicensed territories.
Dimerix CEO and managing director Dr Nina Webster said the partnership significantly expanded the potential reach of DMX-200 into large underserved Asian markets, while allowing the company to maintain its focus on the global registrational program.
“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 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 maximise 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.”
What it means for Dimerix
Everest will be responsible for supporting regulatory submissions and maintaining the regulatory dossier in the licensed territories, as well as all commercialisation costs.
Dimerix will continue to fund and execute the global ACTION3 study, with the two companies to form a joint steering committee to align development and commercialisation of DMX-200 for FSGS in the licensed territories.
"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 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, Yifang Wu, Chairman of the Board, Everest Medicines, said.
"Leveraging our proven expertise in clinical development and commercialisation, 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.”
The agreement provides Dimerix with near-term non-dilutive funding through the upfront payment, as well as potential longer-term exposure to milestone payments and royalties if DMX-200 progresses through regulatory and commercial milestones.
The licensed regions represent a substantial target market, with an estimated 500,000 to 1 million people living with FSGS in the territories and no approved therapies for the disease across these regions.
About DMX-200 and FSGS
DMX-200 is a small molecule inhibitor of chemokine receptor 2, or CCR2, being developed for FSGS, a rare and serious kidney disease.
The treatment is being evaluated in the pivotal Phase 3 ACTION3 clinical trial, which is fully recruited in its adult cohort with 333 patients enrolled across 21 countries, including Chinese mainland, Hong Kong SAR, Taiwan region, Thailand and Malaysia.
FSGS causes progressive scarring in the kidney’s filtering units, leading to proteinuria, loss of kidney function and, in some cases, end-stage renal disease.
Dimerix is a clinical-stage biopharmaceutical company focused on inflammatory diseases, including kidney diseases. Its lead program is DMX-200 for FSGS, which was identified using the company’s proprietary Receptor-HIT technology platform.
What’s next
Dimerix will continue progressing the ACTION3 Phase 3 trial, while Everest prepares to support regulatory and commercialisation activities in its licensed territories.
The trial has reported positive interim results, with DMX-200 performing better than placebo in reducing proteinuria at that time. Dimerix also said there had been no safety concerns to date after 8 reviews by the independent data monitoring committee, the latest in June 2026.
An external statistical blinded review in April 2026 confirmed the study remained appropriately powered at more than 90% to demonstrate a treatment effect for the primary endpoint of proteinuria, if DMX-200 continues to reduce proteinuria as anticipated.