Daewoong Pharmaceutical said it has voluntarily withdrawn its application for Chinese marketing approval of Nabota, its botulinum toxin (BTX) product, to revise its regulatory and product strategy. 

The company said in a public filing on Wednesday that it withdrew the application originally submitted to the National Medical Products Administration (NMPA) on December 30, 2021.

Daewoong made the decision after the standard review period had passed, prompting a comprehensive internal assessment and strategic adjustment.

“We voluntarily withdrew the filing to resubmit a fully updated dossier and ensure approval in China,” a Daewoong official told Korea Biomedical Review. “We plan to refile the application in the near future to expedite the process.”

The company also cited changes in China’s market environment, particularly the implementation of the "One Patient, One Vial" policy, which limits use to single-vial units.

“To meet patient-specific demand under this policy, we decided to seek approval for multiple vial sizes, including a 50-unit format, in addition to the current 100-unit product,” the official said.

Nabota is the first botulinum toxin developed in Asia to win U.S.FDA approval. It is marketed in the U.S. as Jeuveau through partner Evolus and in Europe under the brand name Nuceiva. The product has received approval in 69 countries, including Canada and Brazil, with launches in many key markets.

In the U.S., the world’s largest botulinum toxin market, Nabota has secured a 13 percent market share, ranking second.

Its presence is also expanding in major European countries. Daewoong reported that Nabota generated 186.4 billion won ($133.9 million) in sales last year, with exports accounting for approximately 84 percent. The company aims to exceed 200 billion won in annual sales this year.

Nabota posted 45.6 billion won in sales in the first quarter of this year, up 23 percent from a year earlier, keeping it on track to meet its annual revenue target.

Daewoong emphasized that the revised strategy, including filing for additional vial sizes, will strengthen Nabota’s competitiveness and facilitate a smoother regulatory pathway in China, where the company is seeking to establish a significant foothold in the fast-growing aesthetics market.