Daewoong terminates Nabota clinical trial plans in China, plans refiling

South Korea’s Daewoong Pharmaceutical said Thursday that it had voluntarily terminated its clinical trial application for its type A botulinum toxin drug Nabota that was approved by China’s drug regulator in January, citing the need for a production site change. The firm plans to submit a revised CTA by the year’s end, it added.

After submitting the CTA and successfully obtaining approval, Daewoong expects that it can initiate phase 3 trials for Nabota, to prove the drug’s efficacy in treating forehead wrinkles, by next year.

Daewoong had obtained approval for phase 3 clinical trials of Nabota from the Chinese Food and Drug Administration, which cited plans to manufacture the BTX drug at the firm’s first plant.

However, the Korean drugmaker said it decided that the production site needed to be moved to its second plant with a production capacity nine times that of the first, to ensure a stable supply for the Chinese market upon commercialization.

“It’s a decision made to ensure that we can supply embark onto the Chinese market with minimal risk and uncertainties. Daewoong plans to continue to do its best to ensure Nabota’s successful market launch in the US, Europe and China,” Daewoong Pharmaceutical said in a statement.

Daewoong’s Nabota was approved by Health Canada in August this year, and is currently awaiting marketing approval by the European Medicines Commission and the US Food and Drug Administration.

By Sohn Ji-young (jys@heraldcorp.com)