Xiangrong Biotech Receives Approval to Add Interim Analysis in Phase 3 Clinical Trial of Adipose-Derived Stem Cell Therapy ELIXCYTE for Knee Osteoarthritis

1. Date of Event: July 6, 2026

2. Name or Code of the Investigational Drug: ELIXCYTE

3. Indication: Treatment of Knee Osteoarthritis

4. All Planned Stages of Development: Phase 3 clinical trial and New Drug Application (NDA).

5. Current Stage of Development (Please specify whether the current stage is under application, approved, or not approved. If not approved, please describe the risks and mitigation measures. Also include future business direction and cumulative R&D expenses incurred):

(1) Application status / approval status / non-approval status / results of human clinical trials (including interim analyses) / other significant events affecting drug development:

A. The company received preliminary approval from Taiwan's 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. The company’s investigational product ELIXCYTE has completed patient enrollment in the Phase 3 clinical trial. Considering the subsequent regulatory submission pathway, the company applied to the Taiwan Food and Drug Administration (TFDA) under the Ministry of Health and Welfare for a clinical trial design amendment, which was approved on July 6, 2026. This approval allows the addition of an interim analysis, enabling earlier access to pivotal efficacy data.

(2) Risks and mitigation measures if not approved by the competent authority, if clinical trial results (including interim analyses) do not reach statistical significance, or if other significant events affecting drug development occur: Not applicable.

(3) Future business direction if approved by the competent authority, if clinical trial results (including interim analyses) reach statistical significance, or if other significant events affecting drug development occur: Not applicable.

(4) Cumulative R&D expenses incurred: Not disclosed, as this information pertains to future international licensing negotiations. Disclosure could affect licensing terms and compromise investor interests.

6. Next Stage of Development (Please specify expected completion timeline and anticipated obligations):

(1) Expected completion timeline: The actual schedule will be adjusted based on progress. The company will disclose relevant information in accordance with regulatory requirements and clinical developments.

(2) Anticipated obligations: Not applicable.

7. Market Overview:

(i) According to WHO statistics, approximately 528 million people worldwide suffer from osteoarthritis (OA). A report by global market research firm Fortune Business Insights indicates that the global osteoarthritis treatment market is projected to grow at a compound annual growth rate (CAGR) of 4.96% from 2026 to 2034, reaching an estimated market size of USD 15.3 billion by 2034.

(ii) According to statistics from Taiwan’s Ministry of Health and Welfare, the prevalence of knee joint degeneration in Taiwan is approximately 15%, with 3.5 million people suffering from joint pain. Among individuals aged 60 and above, one in five experiences joint degeneration. Current treatments for knee osteoarthritis are primarily palliative, including physical therapy or the use of assistive devices (e.g., canes) to reduce joint load. Oral anti-inflammatory and analgesic medications are also used. Additionally, hyaluronic acid (Hyaluronic acid), classified as a medical device, or platelet-rich plasma (PRP) can be periodically injected to alleviate pain. In advanced cases, total knee replacement surgery is required. Currently, there are no long-term effective pharmacological treatments, highlighting a significant unmet medical need in this disease area.

8. Other Matters to be Disclosed (If the event or resolution involves a publicly listed company or above, and this material information qualifies as a matter under Article 7, Paragraph 8 of the Enforcement Rules of the Securities and Exchange Act that significantly affects shareholder rights or securities prices): None.

9. Drug development involves long timelines, high investment costs, and no guarantee of success. These factors may expose investors to risks. Investors are advised to carefully assess and prudently make investment decisions.