Daewoong Pharmaceutical said Monday that the China Food and Drug Administration (CFDA) accepted its revised clinical trial application to change the manufacturing location of Nabota, its botulinum toxin product.
Daewoong requested to change the production site of Nabota, approved for its first plant in January of last year, to its second factory, which has nine times larger production capacity than the first plant.
As the company changed the application to the new facility, Daewoong expects to conduct phase 3 clinical trials to confirm the BTX’s efficacy in treating forehead wrinkles in the second half of this year.
“Daewoong has set the stage for minimizing risk and making it possible to enter the big market more reliably in the Chinese market where uncertainties are high,” said Park Sung-soo, head of Daewoong’s Nabota business division. “We expect that the change in the clinical trial application will provide us with a better strategy to advance into China.”