6657 Hwa An Announces IND Submission to FDA for Phase II Clinical Trial of Parkinson's Drug ENERGI-F705PD

Release Date: June 27, 2026
Statement Date: June 26, 2026
Statement Time: 17:24:02
Company Code: 6657
Company Name: Hwa An
Subject: The company has received notification from its CRO that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for ENERGI-F705PD, an oral drug for Parkinson’s disease, to initiate a Phase II clinical trial.
Applicable Clause: Clause 10
Factual Date: June 26, 2026

Details:
1. Factual Date: 06/26/2026
2. Name or Code of the New Drug in Development: ENERGI-F705PD Oral Drug for Parkinson’s Disease
3. Intended Use: 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 is application submitted/approved/not approved. If not approved, describe risks and countermeasures. Also state future business direction and cumulative R&D expenses incurred):
(1) Status of application/approval/rejection, clinical trial results (including interim analyses), or other major events affecting drug development:
The company 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 the relevant regulatory authority, clinical trial results fail to achieve statistical significance, or other major events affecting drug development occur:
Not applicable.
(3) Future business direction if approved by the regulatory authority, clinical 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, cumulative R&D expenses are not 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. 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 research report, the global Parkinson’s disease patient population exceeds 10 million. The global market size for Parkinson’s disease treatment reached USD 5.87 billion in 2022 and is projected to reach USD 12.15 billion by 2030.
8. Other Matters to be Disclosed (If the event or resolution involves a publicly listed company and qualifies as a material event under Article 7, Clause 8 of the Enforcement Rules of the Securities and Exchange Act affecting shareholder rights or securities prices): None.
9. New drug development involves long timelines, high investment costs, and no guarantee of success. Investors are advised to carefully assess risks before investing.