Hwa An Announces IND Submission to FDA for Phase II Clinical Trial of Parkinson's Oral Drug ENERGI-F705PD

1. Date of Event: June 26, 2026

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

3. Indication: Treatment of Parkinson's Disease

4. All Planned Development Stages: Phase II clinical trial and subsequent clinical trials

5. Current Development Stage (Please specify whether the current stage involves application submission, approval, or rejection. If rejected, describe risks and countermeasures. Also state future business direction and cumulative R&D costs incurred):

(1) Application Submission / Approval / Rejection / Results of Human Trials (including interim analyses) / Other Major Events Impacting Drug Development:
Hwa An has submitted an application to the U.S. FDA to conduct a Phase II clinical trial for ENERGI-F705PD, an oral drug for Parkinson's disease.

(2) Risks and Countermeasures if Not Approved by Regulatory Authority, Clinical Trial Results Fail to Achieve Statistical Significance, or Other Major Events Affecting Drug Development:
Not applicable.

(3) Future Business Direction if Approved by Regulatory Authority, Clinical Trial Results Achieve Statistical Significance, or Other Major Events Occur:
Not applicable.

(4) Cumulative R&D Costs Incurred: Due to the sensitivity of information related to future international licensing negotiations, and to avoid influencing licensing terms and to protect the interests of the company and investors, this information is not disclosed.

6. Next Planned Development Stage (Specify expected completion time and expected obligations):

(1) Expected Completion Time: The actual timeline will be adjusted based on progress. The company will disclose relevant information in accordance with regulatory requirements and clinical development milestones.

(2) Expected Obligations: Not applicable.

7. Market Overview:
According to The Brainy Insights market research report, the global Parkinson's disease patient population exceeds 10 million. The global market size for Parkinson's disease treatments reached 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 investment, and no guarantee of success, which may pose risks to investors. Investors are advised to make careful and informed decisions.