1. Date of Event: July 21, 2026 2. Company Name: Xiangrong Biomedical Technology Co., Ltd. 3. Relationship with Company (Parent or Subsidiary): Parent Company 4. Cross-shareholding Ratio: Not applicable 5. Reason for Event: The company's allogeneic adipose-derived stem cell therapy ELIXCYTE-OA for the treatment of knee osteoarthritis was initially submitted for a Phase III clinical trial application to the U.S. Food and Drug Administration (US FDA) on September 13, 2022. Considering the future regulatory approval pathway, the company has now submitted a protocol amendment to the US FDA to modify the clinical trial design, including the addition of an interim analysis to obtain pivotal efficacy data earlier. 6. Response Measures: Not applicable 7. Other Matters to be Disclosed (This announcement qualifies as material information under Article 7, Clause 9 of the Enforcement Rules of the Securities and Exchange Act, as it concerns a publicly listed company and may significantly impact shareholders' rights or stock prices): a. Name or Code of the Investigational Drug: ELIXCYTE-OA. b. Indication: Treatment of knee osteoarthritis (Knee Osteoarthritis). c. All Planned Development Stages: Phase III clinical trial. d. Current Development Stage: (i) Application submitted / approved / not approved / results of human clinical trials (including interim analyses) / other major events affecting drug development: Submitted application to the US FDA for amendment of Phase III human clinical trial design. (ii) Risks and response measures if not approved by the competent authority, clinical trial results fail to achieve statistical significance, or other major events occur: Not applicable. (iii) Future business direction if approved by the competent authority, clinical trial results achieve statistical significance, or other major events occur: Not applicable. (iv) Cumulative R&D expenses incurred: Not disclosed, as this information pertains to future licensing negotiations and its disclosure could affect licensing terms and investor interests. e. Next Development Stage: (i) Expected completion time: To be determined based on the US FDA review timeline. (ii) Expected obligations: R&D and administrative costs associated with the clinical trial. f. Market Overview: According to statistics, over 528 million people worldwide suffer from osteoarthritis (OA). A report by international 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. g. Drug development involves long timelines, high investment, and no guarantee of success, which may pose investment risks. Investors are advised to make cautious and informed decisions.
FACT BOX
- Source: PR Times
- Category: News
- Organizations: Fortune Business Insights
- Products / services: ELIXCYTE-OA