Gracell Gets FDA Orphan Designation for GC012F in Multiple Myeloma

By Colin Kellaher

Gracell Biotechnologies Inc. on Friday said the U.S. Food and Drug Administration granted orphan-drug designation to GC012F, its lead product candidate, for the treatment of the blood cancer multiple myeloma.

The Shanghai clinical-stage biopharmaceutical company said GC012F has shown fast, deep and durable responses in patients with relapsed/refractory multiple myeloma in an ongoing study in China.

The FDA's orphan-drug program gives special status to drugs and biologics for diseases and disorders that affect fewer than 200,000 people in the U.S. and provides for an extended marketing-exclusivity period against competition.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

11-19-21 0626ET