The China Food and Drug Administration has accepted Rockwell Medical Inc.’s product submission for Triferic and has begun the review process for regulatory approval of the drug as an iron maintenance therapy in patients with chronic kidney disease on hemodialysis. The drug approval process in China requires the company to file a clinical trial application, which is based on the same information that was included in the new drug application Rockwell filed with the U.S. Food and Drug Administration.
“We plan to work with our Chinese partner, Wanbang Biopharma, to provide any additional clinical information required to complete the registration process for Triferic commercialization in China,” said Robert L. Chioini, founder, chairman and CEO of Rockwell stated. “We expect that the Chinese dialysis market will become the largest in the world over the next few years and that Triferic, once CFDA approved, should generate substantial revenue for Rockwell.”
In February, Rockwell signed exclusive licensing and manufacturing supply agreements with Wanbang Biopharmaceutical Co. Ltd for the rights to commercialize Triferic and Calcitriol for ESRD patients.
Triferic, which was commercially launched in September 2015, brought in $200,000 in revenue in 2015, which didn’t reach analyst expectations.