Daewoong’s ‘NABOTA’ submitted the form to change clinical test plans in China.

Daewoong’s ‘NABOTA’ submitted the form to change clinical test plans in China. - Changed the facility to Plant 2 with greater production capacities for stable business in China’s massive market. - Clinical studies for ‘frown lines’ expected to begin in the second half of 2019. Daewoong Pharmaceutical (CEO Sengho Jeon) announced on the 7th that they submitted to the China Food and Drug Administration (CFDA) the form to change the production facilities on the Clinical Trial Application (CTA) for ‘NABOTA,’ the Botulinum Toxin agent,’ on December 25. The production facility approved for NABOTA on CTA of China in January last year was Plant 1, but the new application has replaced it with Plant 2 with 9 times greater production capacities.  Once CTA is updated with the new plant, the three-phase clinical test should be able to begin during the second half of this year for the treatment of frown lines, which is the major application of Botulinum Toxin in China. “We have laid a foundation to minimize risks and launch a stable business in China’s massive market with great uncertainties,” said Shawn Seongsoo Park, head of Neurotoxin Business Division.  “This change on CTA is our strategy to accelerate our business in China and Daewoong will do our best to successfully launch in the Chinese market after the U.S. and European markets.” NABOTA is the first Botulunim Toxin agent in Korea to acquire an approval in Canada last August.  Currently, it is undergoing deliberation for approval at the U.S. FDA and the European EMA to be able to launch in America and Europe during the first half of this year. #  #  # [Photo] ‘NABOTA,’ the Botulinum Toxin agent independently developed by Daewoong

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