Hwa An Announces FDA Clinical Hold on Phase II Trial Application for Parkinson's Drug ENERGI-F705PD

1. Date of Event: July 27, 2026

2. Name or Code of Investigational Drug: ENERGI-F705PD Oral Drug for Parkinson's Disease

3. Indication: Treatment of Parkinson's Disease

4. Planned Development Stages: Phase II Clinical Trial and subsequent clinical trials

5. Current Development Stage (Please specify whether the current stage is application submitted/approved/rejected. If rejected, describe risks and countermeasures. Also state future business direction and cumulative R&D expenses incurred):

(1) Status of application/approval/rejection, results of human trials (including interim analyses), or other significant events affecting drug development:

Hwa An has received a clinical hold notification from the U.S. FDA regarding its Phase II clinical trial application for ENERGI-F705PD, an investigational oral drug for Parkinson's disease. The company will revise and respond upon receipt of the complete feedback.

(2) Risks and countermeasures if not approved by the relevant regulatory authority, trial results fail to achieve statistical significance, or other major events occur:

Not applicable.

(3) Future business direction if approved by regulatory authority, trial results achieve statistical significance, or other major events occur:

Not applicable.

(4) Cumulative R&D expenses incurred:

Due to sensitivity related to future international licensing negotiations, the cumulative R&D expenditure will not be disclosed to protect company and investor interests.

6. Next Development Stage (Please specify expected completion date and expected obligations):

(1) Expected completion date:

The actual timeline will be adjusted based on progress, and the company will disclose relevant information in accordance with regulations and clinical developments.

(2) Expected obligations: Not applicable.

7. Market Overview:

According to The Brainy Insights market report, the global Parkinson's disease patient population exceeds 10 million. The global treatment market was valued at USD 5.87 billion in 2022 and is projected to reach USD 12.15 billion by 2030.

8. Other Matters to be Disclosed: None.

9. Drug development involves long timelines, high costs, and no guarantee of success, which may pose investment risks. Investors should exercise caution.