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Rockwell Medical Announces Completion of Patient Enrollment Ahead of Schedule in Pivotal Phase 3 Clinical Trial of Triferic® in China
Trial with over 400 Patients Conducted by Partner Wanbang Pharmaceuticals, a Subsidiary of Fosun Pharma Over 600,000 Patients receive Hemodialysis in China
About this update from Rockwell Medical, Inc.
[{"type":"text","content":"Trial with over 400 Patients Conducted by Partner Wanbang Pharmaceuticals, a Subsidiary of Fosun Pharma \n\n \n \n \n \n \n \n\n \nOver 600,000 Patients receive Hemodialysis in China\nWIXOM, Mich., April 25, 2022 /PRNewswire/ -- Rockwell Medical, Inc. (Nasdaq: RMTI), a biopharmaceutical company dedicated to transforming the treatment of iron deficiency and anemia management, today announced that its partner, Wanbang Biopharmaceuticals enrolled the final patient, ahead of schedule, in its pivotal Phase 3 clinical trial for Triferic® (ferric pyrophosphate citrate) Dialysate to support a new drug application for regulatory approval in China. Wanbang Biopharmaceuticals is a subsidiary of Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (\"Fosun Pharma\"), which is on the Forbes Global 2000 list of the world's largest publicly-traded companies.\n\"This is a major milestone toward approval of Triferic Dialysate in China,\" commented Russell Ellison, M.D., M.Sc., President and CEO of Rockwell Medical. \"Initiated in January of last year, the trial has now enrolled a total of 442 patients at sites across the country. With over 600,000 patients receiving hemodialysis, China represents an enormous potential market opportunity for Rockwell, as we execute on our strategic plan to expand global access to Triferic.\"\nFosun Pharma is targeting submitting a New Drug Approval (NDA) submission to China's National Medical Products Administration (NMPA) in the third quarter of 2023.\nYongchun Zhou, Vice President at Wanbang Biopharmaceuticals stated, \"The study was discussed with regulators from the Center for Drug Evaluation (CDE), part of the NMPA, at a very early stage, and was designed with feedback from those initial meetings top-of-mind. We congratulate our clinical trial team at Wanbang Biopharmaceuticals for executing a project plan for a complex study under challenging circumstances, and we look forward to completion of the trial in 2023.\"\nThe Phase 3 trial (\"RMFPC-13\") is a prospective, randomized, single-blind (patient), parallel two-arm, placebo-controlled, multicenter, study of Triferic administered via hemodialysate in Chinese CKD-5HD (hemodialysis) patients. The objective of the study is to confirm the efficacy and safety of Triferic administered at each hemodialysis treatment via hemodialysate in maintaining hemoglobin in Chine...