UPDATE : Thursday, December 13, 2018
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Daewoong gets approval to start Nabota BTX clinical trials in China
  • By Marian Chu
  • Published 2018.01.11 16:24
  • Updated 2018.01.11 18:17
  • comments 0

Daewoong Pharmaceutical is making inroads into the Chinese market with its botulinum toxin (BTX) type A product, Nabota, by conducting a phase 3 clinical trial there soon, the company said Thursday.

The announcement comes as the China Food and Drug Administration approved the company’s Clinical Trial Application (CTA) for Nabota filed in 2016, Daewoong said.

“The Chinese approval is noteworthy in that it took Nabota only 18 months from product filing to approval, whereas it takes an average of 30 months for existing, competing products. We expect the next steps to proceed just as quickly,” Daewoong Pharma CEO Lee Jong-wook said.

The Korean pharmaceutical said it would launch the trial in China this year, aiming to commercialize the BTX product in China by 2020. The Chinese branch of Daewoong will conduct the Nabota trials to secure an indication for removing forehead wrinkles, known as “frown lines.”

Daewoong's Nabota

Nabota was launched in Korea in 2014, followed by successive launches in Thailand, the Philippines, South America, Mexico, and Vietnam. Daewoong manufactured a total of 19.52 billion won ($18.21 million) worth of Nabota in 2016, and 19.37 billion won in 2015.

The Korean pharmaceutical holds export contracts with major Middle Eastern countries such as Saudi Arabia and the United Arab Emirates, as well as India, and expects an expansive global market launch this year, it said.

Daewoong also applied for marketing rights to the U.S. FDA and the European EMA last year, and is undergoing a review with health regulators to ensure its manufacturing facilities meet the standards of Good Manufacturing Practice, it said.

yjc@docdocdoc.co.kr

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