6794 Hsiang Jung Biotech: Mid-Trial Analysis Added for Adipose-Derived Stem Cell Therapy ELIXCYTE in Knee Osteoarthritis Phase 3 Trial, Approved by Taiwan's Ministry of Health and Welfare

Release Date: July 7, 2026 Statement Date: July 6, 2026 Statement Time: 15:26:41 Company Code: 6794 Company Name: Hsiang Jung Biotech

Subject: The clinical trial design for ELIXCYTE, the company’s adipose-derived stem cell therapy for knee osteoarthritis, has been approved by Taiwan’s Ministry of Health and Welfare to include an interim analysis, enabling earlier access to key efficacy data.

Applicable Clause: Clause 10 Factual Date: July 6, 2026

Details: 1. Factual Date: 07/06/2026 2. Name or Code of the Investigational Drug: ELIXCYTE 3. Indication: Treatment of Knee Osteoarthritis 4. All Planned Development Stages: Phase 3 clinical trial and New Drug Application (NDA) 5. Current Development Stage: (1) Status regarding application/approval/rejection, results of human clinical trials (including interim analyses), or other significant events affecting drug development: A. The company received preliminary approval from the Ministry of Health and Welfare on February 8, 2023, to conduct a Phase 3 clinical trial of ELIXCYTE for knee osteoarthritis, and completed patient enrollment on November 12, 2025. B. Having completed patient enrollment in the Phase 3 clinical trial for ELIXCYTE, the company applied to the Taiwan Food and Drug Administration (TFDA) under the Ministry of Health and Welfare for a protocol amendment to include an interim analysis, considering the future regulatory submission pathway. On July 6, 2026, the Ministry approved the amendment, allowing earlier access to key efficacy data. (2) Risks and mitigation measures if not approved by the competent authority, trial results are not statistically significant, or other major events occur: Not applicable (3) Future business direction if approved and trial results are statistically significant: Not applicable (4) Cumulative R&D expenditure incurred: Not disclosed to protect investor interests, as disclosure could impact ongoing international licensing negotiations. 6. Next Development Stage: (1) Expected completion date: The actual timeline will be adjusted based on progress, and relevant information will be disclosed in accordance with regulations and clinical developments. (2) Expected obligations: Not applicable 7. Market Overview: (i) According to WHO statistics, approximately 528 million people worldwide suffer from osteoarthritis (OA). A report by market research firm Fortune Business Insights indicates that the global osteoarthritis treatment market is projected to grow at a CAGR of 4.96% from 2026 to 2034, reaching an estimated USD 15.3 billion by 2034. (ii) Statistics from Taiwan’s Ministry of Health and Welfare show that the prevalence of knee degeneration in Taiwan is approximately 15%, affecting 3.5 million people with joint pain. Among adults aged 60 and above, one in five suffers from knee degeneration. Current treatments for knee osteoarthritis are primarily palliative, including physical therapy and mobility aids (e.g., canes) to reduce joint stress. Oral anti-inflammatory and analgesic medications are also used, along with periodic injections of hyaluronic acid (classified as a medical device) or platelet-rich plasma (PRP) for pain relief. In advanced cases, total knee replacement surgery is required. There remains no long-term effective pharmacological treatment, indicating a significant unmet medical need. 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 are advised to make careful and prudent decisions.