Daewoong Pharmaceutical announced on Jan. 7 that it has filed a request with the China Food and Drug Administration (CFDA) to change the manufacturing facility specified in the clinical trial application (CTA) for its botulinum toxin Nabota.
Daewoong intends to change the production site of Nabota from the existing first plant, which had been approved in January of last year, to the second plant with nine times more capacity than the first one.
Once the CTA is changed as requested, Phase 3 clinical trials are expected to begin in the second half of this year in China to secure the “anti-wrinkle effect,” the representative treatment effect for botulinum toxin.
Park Sung-soo, head of the Nabota business division, said, "We have minimized the risk in China where uncertainties are high and have laid the foundation for more stable market entry." He added, "We hope the CTA change proves to be a better strategy for entry into the Chinese market. Daewoong will do its best to make successful entry into the Chinese market after the U.S. and European markets."
Daewoong Pharmaceutical’s Nabota has been approved in Canada as botulinum toxin product in August last year, becoming the first Korean product of its kind to be allowed to be sold in Canada. Currently, it is waiting for U.S. FDA and European EMA approval and is aiming to advance into the U.S. and European market in the first half of this year.