Press Release．2025.04.08
AC-203 has received approval from the India to conduct Phase 2/3 clinical trial
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- Date of Occurrence: April 8, 2025
- Name or Code of the New Drug in Development: AC-203
- Purpose: AC-203 is a topical ointment for skin application, intended for the treatment of inflammatory skin diseases such as simplex Epidermolysis Bullosa (EBS) and Bullous Pemphigoid (BP).
- All Planned Development Phases: This trial is a multinational, multicenter Phase II/III clinical trial, part of the same program as the Phase II/III human clinical trial approved by the U.S. Food and Drug Administration (US FDA) on April 7, 2023.
- Current Development Phase:
(1) Status (Application Submitted/Approved/Not Approved, Results of Each Phase of Human Clinical Trials Including Interim Analysis, or Other Significant Events Affecting New Drug Development): The Drug Controller General of India has approved the Phase II/III human clinical trial for the new drug in development, AC-203.
(2) Risks and Countermeasures in Case of Non-Approval by the Competent Authority, Statistically Insignificant Results from Clinical Trials (Including Interim Analysis), or Other Significant Events Affecting New Drug Development: Not applicable.
(3) Future Business Direction in Case of Approval by the Competent Authority, Statistically Significant Results from Clinical Trials (Including Interim Analysis), or Other Significant Events Affecting New Drug Development: Not applicable.
(4) Cumulative R&D Expenses Incurred: To align with future marketing strategies and protect investors’ rights, this information will not be disclosed. - The next phase of research and development will be carried out (please indicate the expected completion time and obligations):
(1) Estimated completion time: This trial is expected to be completed within 3 years, but the actual timetable will be adjusted according to the implementation progress.
(2) Estimated obligations: Not applicable. - Market Overview: Globally, there are approximately 500,000 EB patients, with the majority being EBS patients. Currently, no effective treatments are available for EBS patients. Care for EBS patients is limited to using wound dressings to protect and aid in healing wounds, antibiotics to treat or prevent infections, or painkillers and antihistamines to alleviate discomfort such as pain and itching.
- Other Matters to be Noted: None. (If the entity involved in the event or decision is a publicly listed company or above, this material information also complies with Article 7, Paragraph 8 of the Enforcement Rules of the Securities and Exchange Act, pertaining to matters with a significant impact on shareholders’ equity or securities prices.)
- Disclaimer: The development of new drugs involves long timelines, high investment costs, and no guaranteed success, which may pose risks to investors. Investors are advised to exercise caution and make prudent judgments when investing.