Rockwell’s Triferic drug submission accepted by China FDA

Rockwell Medical recently announced that the China Food and Drug Administration (CFDA) has accepted its Triferic drug product submission.

For a product to be approved for commercialization in China, its drug registration must be submitted and accepted by the CFDA. Rockwell Medical is a biopharmaceutical company that develops innovative products to target end-stage renal disease (ESRD) and chronic kidney disease (CKD).

Triferic was developed by Rockwell as an iron maintenance therapy for patients suffering from chronic kidney disease who are on hemodialysis. The CFDA process requires that a company submits a Clinical Trial Application for potential products. The Clinical Trial Application for Triferic includes the same data that was submitted to the U.S. Food and Drug Administration.

Rockwell signed an exclusive licensing and manufacturing supply agreement with Shanghai Fosun Pharmaceutical subsidiary, Wanbang Biopharmaceutical. The agreement gives Wanbang the rights for the commercialization of Triferic and Calcitriol for ESRD patients. Calcitriol is Rockwell’s generic brand active Vitamin D injection designed to treat secondary hyperparathyroidism in patients on dialysis.

According to the terms of the agreement, Wanbang will hold the rights to distribute Triferic and Calcitriol exclusively in China for a 10-year commercial term.