Press Release．2024.12.09

AC-203 is under development for the treatment of epidermolysis bullosa simplex (EBS), has submitted to the Drug Controller General of India to conduct Phase II/III human clinical trials in India.

Date of occurrence: 2024/12/9
Name or code name of new drug developed: AC-203
Purpose: AC-203 is a topical ointment, suitable for the treatment of inflammatory skin diseases, such as EBS and bullous pemphigoid (BP), etc.
All stages of research and development expected to be carried out: A global, multicenter, randomized, double-blind Phase 2/3 Clinical Trial (EBShield), which is the same plan as the Phase 2/3 clinical trial approved by the United States Food and Drug Administration (US FDA) on 2023/4/7.
The current R&D stage (please indicate whether the current R&D stage belongs to application/approval/not approved. If not, please indicate the risks faced by the company and the counter measures; please also indicate the future business direction and Accumulated R&D expenses invested):
(1) Submission of application/approval/failure of approval/results of various phases of human clinical trials (including interim analysis)/other major events that affect the development of new drugs: Submitted an application to the Drug Controller General of India to conduct Phase 2/3 clinical trials (NCT06073132).
(2) Fail to obtain permission from authority, the results of each phase of clinical trials (including interim analysis) do not reach statistical significance or other major events that affect the development of new drugs occur, Risks faced by the company and countermeasures: Not Applicable.
(3) Success to obtain permission from authority, the results of each phase of clinical trials (including interim analysis) reach statistical significance or other major events that affect the development of new drugs occur, Future business direction: Not Applicable.
(4) Accumulated expenses invested in research and development: Due to future marketing strategies and to protect the rights and interests of investors, so 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 situation: There are approximately 500,000 EB patients worldwide, 70% of whom are diagnosed with the EBS subtype. There are currently no effective treatments for EBS patients, only symptom relief. Current care for EBS patients is limited to the use of wound dressings to protect and promote wound healing, antibiotics to treat or prevent infection, analgesics and antihistamines to relieve pain, itching and other discomfort.
Other matters that should be stated, If the event occurs or the subject of the resolution is a company with public offerings or above, This Announcement information complies with the provisions of Article 7, Paragraph 8 of the Implementing Rules of the Securities and Exchange Act. Matters that have a significant impact on shareholders' equity or security prices: None.
Drug discovery and development is a long, costly, and high-risk process with no guarantee of success. Investors should exercise prudent judgment and make careful investment decisions.

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