Daewoong Pharmaceutical said Wednesday that the China Food and Drug Administration (CFDA) has approved its phase 3 clinical trial into Nabota, its botulinum toxin (BTX) product, on March 6.
|Daewoong's botulinum toxin Nabota|
The approval comes after the company refiled its clinical trial application (CTA) with an update in production site from its first plant to a second one in December.
The second plant has an annual production capacity of 4.5 million vials, which is nine times more than the first. The company decided to change the production site to meet the growing needs of BTX and remove any uncertainties in entering the Chinese market.
With the CFDA’s green light, the company will test Nabota to treat forehead wrinkles in China in the second half of the year.
“The launch of Nabota in China will be accelerated,” said Park Sung-soo, head of Daewoong’s Nabota business division. “Based on the excellent quality, safety and efficacy of the Nabota, recognized by the U.S. Food and Drug Administration (FDA), we will make preparations to enter the Chinese market smoothly.”
Nabota became the first local BTX to acquire sale approval from the FDA in February. The company is also seeking to receive regulatory approval in Europe and roll out the product in the U.S and EU in the first half of the year.