OPKO Health Expands Nicoya Agreement to Support RAYALDEE® Commercialization in Greater China
MIAMI, April 30, 2026 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ:OPK) (OPKO) today announced that its subsidiary EirGen Pharma Limited (EirGen) has entered into an amendment to its agreement with Nicoya Therapeutics (Macau) Limited, an affiliate of Nicoya Therapeutics (Nicoya), which grants OPKO an equity stake in Nicoya and reinforces Nicoya's commitment to commercialize RAYALDEE® in Greater China. RAYALDEE is approved in Macau, and the companies expect regulatory approvals in China and related territories in 2027.
In June 2021, EirGen and Nicoya entered into an agreement for the development and commercialization in Greater China of RAYALDEE® for the treatment of secondary hyperparathyroidism (SHPT) in patients with stage 3 or 4 chronic kidney disease (CKD). Nicoya is a leading biotechnology company incubated by 6 Dimensions Capital and its successor fund 120 Capital, and is focused on the China nephrology market.
Under the amended agreement, OPKO received a 15% equity stake in Nicoya in exchange for a revised tiered royalty and transfer price schedule. The equity issuance of Series A-2 Preferred Shares is set to close in two tranches. The amended arrangement also expands the field of use while reinforcing Nicoya's commitment to commercialize RAYALDEE in the Greater China. The milestone structure under the original agreement remains unchanged with OPKO eligible to receive up to $115 million upon the achievement of certain development, regulatory and sales-based milestones. Through EirGen, OPKO has developed an integrated supply chain that enables it to efficiently manufacture and package RAYALDEE for distribution.
"We are deepening the strategic alignment of our relationship with Nicoya and creating an opportunity for OPKO to participate more broadly in the value Nicoya intends to build in China," said Phillip Frost, M.D., Chairman and Chief Executive Officer of OPKO. "China is a major growth opportunity with over 20 million adults affected by stage 3 or 4 chronic kidney disease. With Nicoya's focus on the nephrology market and commitment to commercial success in the territory, this amendment supports our strategy to extend RAYALDEE into Asia and broaden patient access."
"We are pleased to expand our collaboration with OPKO as we advance RAYALDEE in China. The amendment reflects our shared confidence of the product's potential to improve kidney health," said Dr. Leon Chen, Chairman of Nicoya Therapeutics. "RAYALDEE's approval in Macau marks an important step in the program's regional progress, and we believe potential approvals in China and related territories in 2027 would meaningfully expand access in a very large market with substantial unmet need."
RAYALDEE is an extended-release formulation of calcifediol, a prohormone of calcitriol, the active form of vitamin D3. The product is the only medicine approved by the U.S. Food and Drug Administration that sufficiently raises serum total 25-hydroxyvitamin D to effectively lower blood levels of intact parathyroid hormone. RAYALDEE, approved to treat SHPT in adults with stage 3 or 4 CKD and vitamin D insufficiency, was launched in the U.S. in November 2016.
About Nicoya Therapeutics
Nicoya Therapeutics group is a renal-focused biopharma company based in China. Led by a market-leading management team, Nicoya has capabilities spanning from research and development to clinical trial execution to marketing and sales of in-licensed and wholly owned products. Nicoya Therapeutics is incubated by 6 Dimensions Capital and its successor fund 120 Capital, a group of leading investment funds in the healthcare industry, with strong capability and proven track record in newco incubation both in China and in the US.
About OPKO Health
OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise and novel and proprietary technologies. For more information, visit www.opko.com.
Cautionary Statement Regarding Forward Looking Statements
This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements regarding product development efforts as well as other non-historical statements about our expectations, products, beliefs or intentions regarding our business, financial condition, strategies or prospects including statements regarding expectations about RAYALDEE and the success of the collaboration and licensing agreement with Nicoya, whether Nicoya will successfully develop, obtain regulatory approval for, launch and commercialize RAYALDEE in Greater China whether the parties will successfully develop RAYALDEE for the treatment of SHPT in dialysis patients, whether we will be successful in accelerating adoption of RAYALDEE in Greater China, whether payment milestones and royalty obligations will ever be triggered, and the expected market for RAYALDEE, and whether the equity stake will provide any value. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in our Annual Reports on Form 10-K filed and to be filed with the Securities and Exchange Commission and under the heading "Risk Factors" in our other filings with the Securities and Exchange Commission as well as risks inherent in funding, developing and obtaining regulatory approvals of new, commercially-viable products and treatments, including the risks that others may develop products which are superior to RAYALDEE, and that RAYALDEE may not have advantages or prove to be superior over presently marketed products, including the currently used high monthly doses of prescription vitamin D2, activated vitamin D hormone and over-the-counter vitamin D supplements. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.
Contacts:
Alliance Advisors IR
Yvonne Briggs, 310-691-7100
ybriggs@allianceadvisors.com
or
Bruce Voss, 310-691-7100
bvoss@allianceadvisors.com
