SHANGHAI :
Chinese Yifan's Transplant Rejection Reversal Drug Gets Boost From FDA's Orphan Drug Status
Tang Shihua
DATE:  Oct 23 2019
/ SOURCE:  yicai
Chinese Yifan's Transplant Rejection Reversal Drug Gets Boost From FDA's Orphan Drug Status Chinese Yifan's Transplant Rejection Reversal Drug Gets Boost From FDA's Orphan Drug Status

(Yicai Global) Oct. 23 -- The US Food and Drug Administration has given a transplant rejection reversal medicine that China's Yifan Pharmaceutical has developed an orphan drug status, granting the firm an exclusive right to develop the medicine further with an aim to bring it to market.

Yifan will pursue more clinical trials and seek to get the green light to sell the recombinant human interleukin 22-human immunoglobulin Fc fusion protein as soon as possible, the Hangzhou-based company said in a statement today. The firm has so far spent CNY91.6 million (USD12.9 million) to develop the treatment. 

A medicine that is labeled as an orphan drug due to its target group of patients with rare diseases will receive a seven-year window of tax reductions and exclusive development rights, according to the US Orphan Drug Act of 1983. The policy seeks to encourage research into rare diseases.

Preliminary clinical trials in China and the US have proven that the drug helps to overcome the body's rejection of a new organ, such as liver or pancreas, by protecting and recovering tissue to avoid life-threatening damages.

Yifan's [SHE: 002019] share price dropped by 2.45 percent to CNY14.34 (USD2.02) in the afternoon.

Editor: Emmi Laine

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Keywords:   Orphan Drug,FDA,Yifan Pharmaceutical,Transplant Rejection Reversal