Daewoong readies wrinkle injection for China Phase III

South Korea-based Daewoong Pharmaceutical is reportedly preparing to enter the final Phase III stage of clinical testing in China for its botulinum toxin product Nabota. According to the source, Daewoong on March 6 secured National Medical Products Administration (NMPA) approval to change Nabota’s manufacturing site to a commercial-scale facility in order to supply the Phase III trials, which means the study is expected to get under way during the second half of 2019. Daewoong’s second facility has a capacity of 4.5 million vials per year.

Nabota, used as a cosmetic therapy, has been commercialized in South Korea since 2014, won approval in the U.S. as a generic version of Allergan’s Botox in January this year, and is also under development for the European market. Daewoong won its first clinical trial approval for the drug in China in January 2018, as reported by GBI.


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