Daewoong Pharmaceutical Applies for Sales Approval of Botulinum Toxin 'Nabota' in China

[Asia Economy Reporter Seo Sojeong] Daewoong Pharmaceutical (CEO Jeon Seungho) has applied for the launch approval of the botulinum toxin 'Nabota' to the Chinese food and drug authority.

Daewoong Pharmaceutical announced on the 31st that it submitted clinical data of Nabota to the National Medical Products Administration (NMPA) of China and filed a Biologics License Application (BLA).

In July, Daewoong Pharmaceutical completed the Phase 3 clinical trial of Nabota locally in China according to NMPA guidelines. The trial involved 473 patients with moderate to severe glabellar lines, who were administered a single dose of either Nabota or a comparator drug (Botox), and the effects were compared over 16 weeks. As a result, for the primary endpoint set as 'degree of improvement in glabellar lines at 4 weeks after administration,' the Nabota group showed a 92.2% improvement rate, while the comparator group showed 86.8%.

Park Seongsu, Vice President of Daewoong Pharmaceutical, said, "With the botulinum toxin experience rate still only in the 1% range, we will proactively enter the Chinese market, which has explosive potential, to secure future profits," and added, "Leveraging business experience gained in advanced countries and other major countries worldwide, we will implement a differentiated business strategy and aim to achieve the number one sales position in the Chinese botulinum toxin market within three years after launch."

This content was produced with the assistance of AI translation services.