1. What Happened?

On July 30, 2025, Daewoong Pharmaceutical withdrew its application for Nabota’s product license from China’s National Medical Products Administration (NMPA). While officially attributed to exceeding the approval timeframe, the withdrawal is interpreted as a strategic move to reassess and resubmit a stronger application.

2. Why Does it Matter?

Nabota’s success in China is crucial for Daewoong’s future growth. This withdrawal could negatively impact stock prices and investor sentiment in the short term. The long-term impact hinges on the resubmission’s success and the competitive landscape.

3. What’s Next?

  • Short-term impact: Potential stock decline, decreased investor confidence, and possible short-term earnings dip.
  • Long-term impact: Shifting growth potential depending on China market entry success, increased competition, and potential R&D strategy adjustments.
  • Macroeconomic factors: Consideration of variables such as exchange rates, raw material prices, and global economic slowdown.

4. What Should Investors Do?

Investors should closely monitor Daewoong’s resubmission timeline and outcome, along with their global market expansion strategy. The clinical results and commercialization success of Hanall Biopharma’s HL161 and HL161ANS are also key factors to consider for Daewoong’s long-term growth. A cautious and comprehensive approach is recommended before making any investment decisions.