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Daewoong to kick off P3 trial of Nabota in China
  • By Lee Han-soo
  • Published 2020.01.02 17:36
  • Updated 2020.01.02 17:57
  • comments 0

Daewoong Pharmaceutical said Tuesday that it held a meeting with Chinese researchers ahead of its phase 3 clinical trials of Nabota, its botulinum toxin (BTX) product, in China.

Daewoong Pharmaceutical's botulinum toxin Nabota

The company plans to launch its product in China by 2022.

About 60 researchers, including clinical researchers and hospital staff, participated in the event. During the meeting, the company announced its plans for phase 3 clinical trials in China and provided answers to questions from the researchers.

Besides, the company provided an educational session to improve the understanding of products and clinical trials, including the introduction of Nabota and clinical trial experiences, and a demonstration.

Daewoong plans to enter the Chinese market BTX product that has indications for improving moderate to severe forehead wrinkles.

In clinical trials, the company will compare non-inferiority and product safety by comparing the effects with a control drug for 16 weeks in about 500 patients with moderate to severe forehead wrinkles. The trial will be conducted at 12 institutions, including the Shanghai Ninth People's Hospital affiliated with Shanghai Jiaotong University School, which is famous for plastic surgery in China.

"China is the market expected to grow the most in the future, as the number of patients is the highest in the world and has a low market penetration rate of 2 percent as there are only two licensed medicines," said Park Sung-soo, head of Daewoong's Nabota business division.

If high-quality, affordable products such as Nabota are officially approved and supplied to the market, potential Chinese patients will be able to receive botulinum toxin easily and safely, Park added.

corea022@docdocdoc.co.kr

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