enarodustat is a hypoxia-inducible factor prolyl
hydroxylase inhibitor (hif-phi). it is an oral tablet for treating renal anemia
and has independent intellectual property rights in major countries/regions
around the world. this product was developed by japan tobacco inc., japan, and filled
a nda in japan in november 2019. in december 2019, shenzhen salubris
pharmaceuticals co.,ltd. signed an exclusive license agreement with japan
tobacco inc. for the development and commercialization in mainland china, hong
kong, taiwan and macao of enarodustat. the "oxygen sensing mechanism"
which enarodustat is based on won the nobel prize in physiology or medicine in
2019.
salubris received the notice of approval of clinical trials from national medical products administration, and initiated human clinical trials of enarodustat tablets in china.
on september 25, 2020, enarodustat (2mg/4mg) was licensed for production and sales in japan.
on january 7, 2020, salubris formally signed an agreement with japan's japan tobacco inc. at its headquarters in shenzhen
chronic kidney disease (ckd) has become an important public health problem in china, and anemia is one of the most common complications of ckd patients
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