Daewoong Pharmaceutical ‘Nabota’ enters phase 3 clinical studies in China during the second half.

Daewoong Pharmaceutical ‘Nabota’ enters phase 3 clinical studies in China during the second half. - Nabota earned final approval to change the manufacture facilities in China for clinical studies. Daewoong Pharmaceutical’s business for ‘Nabota,’ an independently developed Botulinum Toxin, will be launched soon in China. Daewoong Pharmaceutical (CEO Sengho Jeon) announced on the 13th that the application to change the manufacture facilities for Nabota’s Clinical Trial Application (CTA) was finally approved on the 6th by China Food and Drug Administration (CFDA). Daewoong Pharmaceutical submitted the application to change Nabota’s CTA approval to change the manufacture facilities from Plant 1 to Plant 2 last December.  Plant 2 has the capacity to produce 4,500,000 vials a year and this is more than 9 times greater that the capacity of Plant 1.  Daewoong Pharmaceutical has decided to change the facility to eliminate any uncertainties in the Chinese market and ensure stable product supplies in the massive Botulinum Toxin market. With the approval of CFDA completed faster than expected, Nabota is planning to launch the phase 3 clinical study on ‘improving the appearance of frown lines’ in China during the second half of this year. “With this CTA approval, we would be able to accelerate Nabota’s launch in the Chinese market,” said Seongsoo Park, the Executive director of Neurotoxin Business Division.  “We are going to prepare for the business in China, which is another giant market, with Nabota’s exceptional quality, safety, and efficacies recognized by the U.S. FDA.” Jeuveau became the first Korean Botulinum Toxin formula to get the approval from the U.S. FDA last February and Nuceiva's approval process by EMA has been in smooth progress to launch in the U.S. and European markets during the first half of this year. #  #  # [Photo] ‘Nabota,’ Daewoong Pharmaceutical’s independently developed Botulinum Toxin.

The release as fetched from its publisher. daewoong.co.kr ↗