Daewoong Pharmaceutical Withdraws Chinese Approval Filing for Nabota 100 Units to Refine Market Strategy
Kim Jisun
stockmk2020@alphabiz.co.kr | 2025-07-31 03:49:58
Photo: Daewoong Pharmaceutical
[Alpha Biz= Kim Jisun] SEOUL – Daewoong Pharmaceutical announced on July 30 that it has voluntarily withdrawn its marketing application for its botulinum toxin product Nabota 100 Units in China, as the company recalibrates its approach to the world’s largest aesthetic medicine market.
The application, originally submitted to China’s National Medical Products Administration (NMPA) in December 2021, sought approval for Nabota’s use in treating moderate-to-severe glabellar (frown) lines in adults.
Daewoong stressed that the withdrawal was not due to regulatory or clinical issues, but rather a strategic business decision. A company spokesperson explained:
“The review process exceeded the typical timeline, and after evaluating business viability and market conditions, we concluded a strategic reset was necessary.”
A key factor in the decision was China’s “one vial per patient” policy, which restricts flexibility in clinical use when only a 100-unit formulation is available.
Daewoong now plans to return with a broader product portfolio, including 50-unit vials, to better align with market needs. The company confirmed it is preparing new marketing applications as part of a refreshed China strategy.
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