Rockwell Medical Announces Dosing of First Patient in Pivotal Triferic Phase 3 Trial by Partner, Wanbang Biopharmaceuticals, in China

China is a sizable and growing market, with more than 600,000 patients receiving hemodialysis annually

WIXOM, Mich., Jan. 13, 2021 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (Nasdaq: RMTI), a biopharmaceutical company dedicated to transforming the treatment of iron deficiency and iron deficiency anemia management and improving outcomes for patients around the world, today announced that its partner in China, Wanbang Biopharmaceuticals, a subsidiary of Shanghai Fosun Pharmaceutical (Group) Co., Ltd., enrolled the first patient in a pivotal Phase 3 trial for Triferic Dialysate to support a new drug application for regulatory approval in that country.

“The initiation of this pivotal trial is an important milestone in our strategic plan to expand global access to Triferic,” said Russell Ellison, M.D., M.Sc., President and Chief Executive Officer of Rockwell Medical. “In China, hemodialysis has continued to increase at a rapid rate in recent years, with more than 600,000 patients receiving hemodialysis every year, making it the largest single market in the world. Wanbang Biopharmaceuticals is a leading pharmaceutical company and an outstanding partner to bring our therapy to patients in China.”

“We believe Triferic has the potential to greatly improve the lives of patients on dialysis in China, and we are pleased to have dosed the first patient in our pivotal trial,” said Mr. Shibin Wu, Chief Executive Officer of Wanbang Biopharmaceuticals. “Wanbang Biopharmaceuticals is committed to addressing the needs of CKD patients and healthcare providers with a comprehensive range of therapeutic options across home, in-center and hospital dialysis settings. We value our partnership with Rockwell Medical, and our collaboration enhances Wanbang Biopharmaceuticals’ pipeline of innovative product candidates.”

The Phase 3 trial [RMFPC-13] is a prospective, randomized, single-blind (patient), parallel two-arm, placebo-controlled, multicenter, study of the efficacy and safety of Triferic administered via hemodialysate in maintaining iron delivery and hemoglobin concentration in anemic adult patients with chronic kidney disease requiring hemodialysis. The objective of the study is to confirm the efficacy and safety of Triferic administered at each hemodialysis treatment via hemodialysate in maintaining iron delivery for erythropoiesis in anemic iron-replete Chinese CKD-5HD patients.