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(Yicai Global) Nov. 21 -- Zhejiang Hisun Pharmaceutical Co. [SHA:600267] has gained approvals from the US Food and Drug Administration for the marketing of its generic drug for the treatment of kidney disease, mycophenolate mofetil tablets, in the US, the company said in a press briefing yesterday.
The approval means the company can produce and market the product in the US. The firm has invested about CNY4 million (USD600,000) in the research and development projects related to the drug up to now.
Mycophenolate mofetil tablets are used for the prevention of allograft rejection in patients and treatment of refractory rejections, which can be applied with ciclosporin and adrenal cortex hormones simultaneously.
The drug was researched and developed by Roche Holding AG [VTX: ROG], while domestic and foreign manufacturers of the drug include Teva Pharmaceutical Industries Ltd. [TLV:TEVA], Shanghai Roche Pharmaceutical Co. and Hangzhou Zhongmei Huadong Pharmaceutical Co.
Global sales of the 500mg tablets reached about USD506 million last year, of which sales in China accounted for USD262 million. Its global sales in the first six months of this year reached about USD238 million, of which China's domestic sales were about USD1.12 million.