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Daewoong Pharma gets approval for botox drug Nabota’s clinical trials in China

2018.01.14 10:55:53 | 2018.01.14 10:57:12
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South Korea’s Daewoong Pharmaceutical Co. has received the go-ahead from the Chinese authorities to conduct clinical trials for its self-developed botulinum toxin Nabota in China.

The approval comes about 18 months after the drug maker submitted an application for the clinical tests, unusually faster than other cases, raising expectations that the Korean-made drug may hit the Chinese market earlier than previously forecast.

Daewoong Pharmaceutical said Thursday that it won approval for the clinical trials for Nabota from the China Food and Drug Administration (CFDA). Nobota is the toxin that is better known as botox which is a widely used treatment for wrinkles. Daewoong Pharmaceutical plans to launch the phase three clinical trial for its self-developed botulinum toxin in China this year with an aim to complete the testing next year and commercialize the drug in 2020.

It will first focus to prove the drug’s effectiveness in removing wrinkles on the forehead during the trial, the company said. Daewoong Pharmaceutical’s China office will be responsible for the clinical trials in the vast market.

The company first applied for the clinical test for Nabota in June 2016. Considering that it generally takes about 30 months for other drugs to receive approval for clinical trials in China, Daewoong Pharmaceutical has significantly saved its waiting time to 18 months, a move that will likely help the company expedite the overall process to launch the drug in China, said an unnamed official from the company.

Unlike other countries, China conducts a preliminary review on overall drug production and quality management when granting approval of a clinical trial application. The results of the review affect the authority’s final decision on the approval.

Ever since Nabota began sales in Korea in 2014, it has hit other markets including Thailand, the Philippines, South America, Mexico, and Vietnam. Daewoong Pharmaceutical has also signed agreements with countries in the Middle East including Saudi Arabia and the United Arab Emirates, as well as India to export the drug to the regions this year.

Shares of Daewoong Pharmaceutical ended at 205,500 won ($193.2) on Friday, up 14.8 percent of 26,500 won from the previous day.

By Kim Hyung-hwan and Lee Eun-joo

[ⓒ Pulse by Maeil Business News Korea & mk.co.kr, All rights reserved]

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