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Daewoong Reveals Key Results of 'Nabota' Phase 3 Clinical Trial in China... Demonstrates Non-Inferiority Compared to Existing Products

Daewoong Reveals Key Results of 'Nabota' Phase 3 Clinical Trial in China... Demonstrates Non-Inferiority Compared to Existing Products Daewoong Pharmaceutical Botulinum Toxin Product 'Nabota' (Photo by Daewoong Pharmaceutical)

[Asia Economy Reporter Chunhee Lee] The major results of Daewoong Pharmaceutical's botulinum toxin product 'Nabota' from its Phase 3 clinical trial in China have been announced. In terms of glabellar wrinkle improvement, the Nabota treatment group showed 92%, while the control group (Botox group) showed 87%, demonstrating non-inferiority.


On the 28th, Daewoong Pharmaceutical disclosed the topline (key results) of its botulinum toxin product 'Nabota' clinical trial in China. According to the company, this Phase 3 clinical trial, conducted in accordance with the guidelines of the China National Medical Products Administration (NMPA), involved 473 patients with moderate to severe glabellar wrinkles who were administered a single dose of either Nabota or the control drug (Botox) at the same dosage. The improvement effect on glabellar wrinkles was assessed every 4 weeks up to 16 weeks.


As a result, the primary endpoint showed that at 4 weeks post-administration, the glabellar wrinkle improvement rate was 92.2% in the Nabota group and 86.8% in the control group, confirming the non-inferiority of Nabota compared to the existing product.


Nabota is the only botulinum toxin product in Asia to have obtained approval from the U.S. Food and Drug Administration (FDA) (U.S. product name 'Jeuveau'). It has received marketing authorization in 55 countries worldwide including the United States, Europe, and Canada, and has signed export contracts with about 80 countries.


According to Goldman Sachs, the Chinese botulinum toxin market is expected to grow from $672 million (approximately 775.5 billion KRW) in 2018 to $1.555 billion (approximately 1.7945 trillion KRW) by 2025. Due to its large population, continuous economic growth, and high interest in aesthetics, the Chinese market is regarded as a key market expected to grow the fastest worldwide over the next decade.


Park Seong-su, Head of Nabota Business Division at Daewoong Pharmaceutical, stated, “The Chinese market is the second largest after the U.S., but the experience rate of botulinum toxin products is only in the 1% range, indicating explosive growth potential. We plan to accelerate our entry into China aiming for a launch next year, and through differentiated business strategies, we will achieve the number one sales position in China within three years.”


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