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CR Pharma NIP292 tablets received Orphan Drug Designation issued by FDA

Press time:2020-02-12From:CR Pharma [ Font:BigMediumSmall]

On February 5, CR Pharma NIP292 tablets received the Orphan Drug Designation(ODD) issued by Food and Drug Administration(FDA) for the treatment of idiopathic pulmonary fibrosis(IPF). 

Orphan drug is the drug for the prevention, treatment, and diagnosis of rare disease. Due to the small number of patients with rare diseases, low market demand, high research costs, very few number of pharmaceutical company is willing to pay attention on the research of these drugs, so they are called “orphan drugs”. Once they are designated as orphan drugs, they will have various incentives for the clinical development of rare disease drugs, including tax credits related to clinical trial costs in the United States, FDA fee reductions, and a 7-year market for the identified indications after the drug is launched Exclusive period, etc. 

IPF is a chronic progressive fibrotic interstitial pneumonia whose etiology and pathogenesis are not clear. It is mainly manifested as progressively worsening dyspnea, accompanied by restrictive ventilatory dysfunction and gas exchange disorders, leading to hypoxemia, even respiratory failure, poor prognosis, high mortality, which brings harm to human life and health. 

NIP292 tablet is a new small-molecule drug with multiple mechanisms such as anti-inflammatory, anti-fibrosis, expansion of blood vessels, and repair of vascular endothelial damage. Currently, the Phase 1 clinical study of NIP292 tablet is proceeding smoothly in the United States.

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