1. What Happened? : Withdrawal of Nabota’s China Approval Application

Daewoong Pharmaceutical voluntarily withdrew its application for Nabota (100 unit)’s product approval in China on July 30, 2025.

2. Why? : Approval Delay and Strategic Adjustments

The company cited the delay in the approval process and adjustments to its business development strategy as reasons for the withdrawal, emphasizing its plan to reapply after sufficient supplementation.

3. What’s Next? : Short-term Negative Impact, Long-term Potential

This decision is expected to negatively impact the stock price in the short term. Delays in entering the Chinese market could lead to slower sales growth. However, the plan to reapply for ‘certain approval’ could be a positive factor in the long run.

  • Key Positives: Nabota’s 13% market share in the US (30% YoY growth), Fexuprazan and Envlo growth
  • Key Risks: High R&D expenses, fluctuations in raw material prices and exchange rates, intensified global competition, macroeconomic uncertainties (exchange rates, interest rates, raw material prices, shipping costs)

4. What Should Investors Do? : Prudent Approach, Continuous Monitoring

Investment decisions should be made carefully, considering risk management and long-term growth prospects. It is crucial to supplement investment strategies through re-analysis after obtaining additional information, such as the Q2 2025 report. Pay close attention to the success of the re-entry plan into the Chinese market.