Daewoong said that its clinical trial application for Nabota has been approved by the China Food and Drug Administration. As a result, it will begin phase 3 trials for the drug this year, with aims to commercialize it in China by 2020.
Daewoong Pharmaceutical’s China office will carry out the clinical trials, which will focus on proving Nabota’s effectiveness in removing wrinkles on the forehead.
“Whereas it took rival products an average of 30 months to obtain the CFDA’s approval, Nabota was able to secure the approval within just 18 months. Given this, we expect subsequent approval processes to be carried out quickly,” said Daewoong Pharmaceuticals Vice Chairman Lee Jong-wook.
In China, the local drug regulator reviews a drug’s production and quality control status during the clinical trial application review stage, and does not grant an approval unless such criteria are met. Given this, Daewoong has to clear only the clinical trials before the product can be launched, it said.
Since its debut in Korea in 2014, Nabota has arrived at various markets around the world including Thailand, the Philippines, South America, Mexico and Vietnam. Daewoong has also struck export agreements to sell its BTX treatment in countries in the Middle East, including Saudi Arabia and the United Arab Emirates, as well as India.
In addition, Nabota has been filed for approval by the US Food and Drug Administration and the European Medicines Agency. The US and EU drug regulators are currently reviewing Daewoong’s manufacturing facilities to ensure they comply with Good Manufacturing Practice standards, according to the drugmaker.
By Sohn Ji-young (firstname.lastname@example.org)