Stock Update (NASDAQ:RMTI): China FDA Accepts Rockwell Medical Inc’s Triferic® Drug Submission for Commercialization in China

Rockwell Medical, Inc. (NASDAQ:RMTI), a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron replacement, secondary hyperparathyroidism and hemodialysis, announced today that its Triferic drug product submission to the China Food and Drug Administration (CFDA) has been accepted. Drug registration must be submitted to and accepted by the CFDA for a product to achieve regulatory approval for commercialization in China.

Robert L. Chioini, Founder, Chairman and CEO of Rockwell stated, “We are pleased that the CFDA has accepted our drug filing and has begun the review process for regulatory approval of Triferic as an iron maintenance therapy in patients with chronic kidney disease on hemodialysis. The drug approval process in China requires we file a Clinical Trial Application, which is based on the same information that was included in our U.S. FDAapproved NDA. 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. 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.”

On February 16, 2016, Rockwell signed exclusive licensing and manufacturing supply agreements with Wanbang Biopharmaceutical Co., Ltd.(Wanbang), a subsidiary of Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (Fosun Pharma, SHA:600196 and HKG:02196), for the rights to commercialize Triferic and Calcitriol for End-Stage-Renal-Disease (ESRD) patients. Triferic is Rockwell’s proprietary iron replacement and hemoglobin maintenance drug for treating anemia. Calcitriol is Rockwell’s generic (active vitamin D) injection for treatment of secondary hyperparathyroidism in dialysis patients.

Under the terms of the agreement, Wanbang will become the exclusive distributor for Triferic and Calcitriol in China for an initial commercial term of 10 years, with an extended term of 10 or more years based on achievement of annual minimum purchase requirements. In consideration for the exclusive rights, Rockwell will receive from Wanbang regulatory and revenue milestone payments totaling USD$39 million in aggregate, of which $4 million has been received. The agreement is structured for Rockwell to receive its primary revenue from ongoing earnings from product sales of Triferic and Calcitriol in China, and other additional Triferic therapeutic indications.  Rockwell retains manufacturing responsibility of all products.  Wanbang is required to achieve annual minimum purchase requirements to retain exclusive commercialization rights. In addition to the hemodialysis indication, Wanbang has the exclusive right to develop and commercialize Triferic for new therapeutic indications for the Chinese market. Wanbang is responsible for all clinical, regulatory and marketing expenses for Triferic and Calcitriol in China as well as development and regulatory costs for new Triferic indications.

Wanbang Biopharmaceuticals is a leading pharmaceutical company in China that specializes in research, production and marketing of medicines for endocrinology, cardiovascular disease and renal diseases. Wanbang is a subsidiary of Fosun Pharma which is listed on the Shanghai Stock Exchange(SHA:600196) and the Stock Exchange of Hong Kong Limited (HKG:02196). Fosun Pharma, one of the major shareholders of Sino Pharma (HKG:1099) who is the largest drug distributor in China, is part of the Fosun Group, the leading non-state owned enterprise group in China which is listed on the Hong Kong stock exchange (HKG:0656). In addition to its comprehensive therapeutic product portfolio, Wanbang and Fosun Pharma have sound relationships with public healthcare institutions and providers and directly own and operate a network of private hospitals in China. (Original Source)

Shares of Rockwell Medical are up nearly 5% in pre-market trading. RMTI has a 1-year high of $18.90 and a 1-year low of $5.47. The stock’s 50-day moving average is $6.96 and its 200-day moving average is $9.22.

On the ratings front, Rockwell Medical has been the subject of a number of recent research reports. In a report issued on March 1, Stifel Nicolaus analyst Annabel Samimy downgraded RMTI to Hold. Separately, on the same day, Craig-Hallum’s Charles Haff downgraded the stock to Hold and has a price target of $7.

According to, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Annabel Samimy and Charles Haff have a total average return of 11.4% and 23.1% respectively. Samimy has a success rate of 56.5% and is ranked #331 out of 3760 analysts, while Haff has a success rate of 71.4% and is ranked #751.

Rockwell Medical Inc is a biopharmaceutical company targeting end-stage renal disease and chronic kidney disease with products and services for the treatment of iron deficiency, secondary hyperparathyroidism and hemodialysis.


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