Kangpei Biotech's Phase 3b Long-Term Follow-Up Clinical Trial CBL-0303 for CBL-514 Injection to Reduce Abdominal Subcutaneous Fat Has Cleared the U.S. FDA's 30-Day IND Review Period, Trial to Commence

1. Date of Event: 115/07/03 2. Name or Code of the Investigational Drug: CBL-514 3. Indications: A. Reduction of subcutaneous fat B. Improvement of moderate to severe cellulite C. Treatment of the rare disease Tangier disease 4. All Planned Stages of Development: A. Phase 1 Clinical Trial: Completed. B. Phase 2 Clinical Trial: Multiple Phase 2 trials, including CBL-0205, completed. CBL-0206 has been approved for execution by Australia's HREC and Taiwan's TFDA IND. C. Phase 3 Clinical Trial: The first pivotal Phase 3 trial, CBL-0301, has been approved for execution in the U.S. and Canada. The second pivotal Phase 3 trial, CBL-0302, has been approved in the U.S., Canada, and Australia. The Phase 3b long-term follow-up trial, CBL-0303, has been approved for execution in the U.S. D. New Drug Application (NDA) Review: Not yet initiated. 5. Current Stage of Development (Please specify whether the current stage is under application, approved, or not approved. If not approved, describe the risks and mitigation measures. Also describe future business direction and cumulative R&D expenses incurred): (1) Application status/approval status/rejection status, results of human trials at each phase (including interim analysis), or other major events affecting new drug development: The company's Phase 3b long-term follow-up clinical trial CBL-0303 for CBL-514 injection to reduce abdominal subcutaneous fat has passed the U.S. FDA's (Food and Drug Administration) 30-day IND review period on July 3, 2026. The company will initiate the CBL-0303 clinical trial. This trial will enroll participants who have completed one of the company's pivotal Phase 3 clinical trials (CBL-0301 or CBL-0302) to assess the long-term safety and sustained efficacy of CBL-514 in reducing abdominal subcutaneous fat. After completing the long-term follow-up phase, participants who meet the trial evaluation criteria may receive another course of CBL-514 treatment to exploratorily assess the efficacy and safety of repeated dosing. The trial is expected to enroll 300 participants in the U.S. A. Introduction to Clinical Trial Design (including trial protocol name, objective, phase classification, drug name, claimed indication, evaluation endpoints, and number of enrolled participants): a. Trial Protocol Name: A Phase 3b, multicenter, two-stage, double-blind long-term follow-up and open-label extension clinical trial evaluating the long-term safety and sustained efficacy of CBL-514 for reducing abdominal subcutaneous fat in participants who completed CBL-0301 or CBL-0302. b. Trial Objective: To evaluate the long-term safety and sustained efficacy of CBL-514 injection in reducing abdominal subcutaneous fat. c. Trial Phase Classification: Phase 3 Clinical Trial d. Drug Name: CBL-514 e. Claimed Indication: Reduction of abdominal subcutaneous fat f. Evaluation Endpoints: Primary endpoint is the assessment of long-term safety of CBL-514; secondary endpoint is the assessment of long-term sustained efficacy of CBL-514. g. Number of Participants in Trial Protocol: Expected 300 B. Statistical Results of Primary and Secondary Endpoints (including P-values) and Statistical Significance (if applicable). If the company cannot disclose statistical data due to other significant reasons, please state the reason: Not applicable C. If the company becomes aware of statistical data from the Phase 3 human clinical trial (including interim analysis), please describe the future market entry plan (however, content should avoid triggering the requirement for full financial forecasting under the 'Criteria for Public Disclosure of Complete Financial Forecasts for Listed Companies'): Not applicable D. A single clinical trial result (including statistical P-values and significance for primary and secondary endpoints) is insufficient to fully reflect the success or failure of future drug development and commercialization. Investors should carefully evaluate and exercise caution. (2) Risks and mitigation measures if not approved by the relevant regulatory authority, if human clinical trial results (including interim analysis) do not reach statistical significance, or if other major events affecting drug development occur: Not applicable (3) Future business direction if approved by the relevant regulatory authority, if trial results reach statistical significance, or if other major events occur: Under company evaluation (4) Cumulative R&D expenses incurred: For strategic marketing considerations and to protect company and investor interests, this information will not be disclosed at this time. 6. Next Stage of Development (please specify expected completion time and expected obligations): (1) Expected completion time: Actual timeline subject to adjustment based on clinical trial progress. (2) Expected obligations: None. 7. Market Status: The primary purpose of localized fat reduction is to reduce subcutaneous fat in the treated area. Current treatment methods include invasive surgical procedures and non-invasive product regimens. While surgical fat reduction produces more noticeable results, it involves significant tissue and nerve damage, high risk, obvious side effects, and a longer recovery period. Therefore, non-surgical fat reduction products have rapidly emerged in recent years. However, currently marketed non-surgical fat reduction products have limited efficacy, cannot significantly reduce subcutaneous fat in the treated area, require multiple treatment sessions, and may be associated with severe side effects or irreversible risks. The current fat reduction market is large and still has substantial unmet demand. 8. Other Matters to be Disclosed (if the subject of the event or resolution is a publicly traded company, this major information also meets the criteria under Article 7, Paragraph 8 of the Enforcement Rules of the Securities Trading Act regarding matters that significantly affect shareholder rights or securities prices): None. 9. New drug development is a long-term process requiring high investment and does not guarantee success, which may expose investors to risks. Investors should carefully evaluate and exercise caution.