** Shares of U.S. drug developer CASI Pharmaceuticals Inc
CASI.O up 4.5% at $1.85 premarket
** Company says the Chinese health regulator has accepted
its partner Juventas Cell Therapy's application seeking approval
for its cancer therapy
** The drug, CNCT19, belongs to a class of drugs called
chimeric antigen receptor T-cell therapy that uses cells from
one's own immune system to fight cancer - CASI
** CNCT19 is seeking approval for a type of blood cancer
called relapsed B-Cell Acute Lymphoblastic Leukemia, according
to CASI
** CNCT19 has been granted the "orphan drug" status by the
U.S. FDA and the breakthrough designation by the China Center of
Drug Evaluation (CDE) - CASI
** FDA awards "orphan drug" status to drugs that treat rare
conditions and are protected through a series of government
incentives once they reach the market
** Chinese CDE grants "Breakthrough Therapy" status to
expedite development and review of therapies that target
treatment of serious diseases for which there is no existing
treatment
** Up to Wednesday's close, CASI shares down ~77.9% YTD
(Reporting by Mariam E Sunny)
((Mariam.ESunny@thomsonreuters.com))