Release Date: July 4, 2026 Statement Date: July 3, 2026 Statement Time: 17:04:59 Company Code: 6919 Company Name: Kangpei*

Subject: The application for the Phase 3b long-term follow-up clinical trial CBL-0303 of the company's investigational drug CBL-514 injection for reducing abdominal subcutaneous fat has passed the 30-day IND review period by the U.S. FDA, and the company will initiate the CBL-0303 clinical trial.

Applicable Clause: Clause 10 Event Date: July 3, 2026

Details: 1. Event Date: July 3, 2026 2. Name or Code of Investigational Drug: CBL-514 3. Indications: A. Reduction of subcutaneous fat B. Improvement of moderate to severe cellulite C. Treatment of rare disease Dugan Syndrome 4. Planned Development Stages: A. Phase 1 Clinical Trial: Completed. B. Phase 2 Clinical Trial: Multiple Phase 2 trials including CBL-0205 have been 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 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 in the U.S. D. New Drug Application (NDA): Not yet initiated. 5. Current Development Stage: (1) Status of application/approval/rejection, results of human trials (including interim analyses), or other significant events impacting drug development: The Phase 3b long-term follow-up clinical trial CBL-0303 of the company's investigational drug CBL-514 injection for reducing abdominal subcutaneous fat has passed the 30-day IND review period by the U.S. FDA on July 3, 2026. The company will now initiate the CBL-0303 clinical trial. This trial will enroll subjects who have completed one of the company’s pivotal Phase 3 trials (CBL-0301 or CBL-0302) to assess the long-term safety and durability of efficacy of CBL-514 for abdominal subcutaneous fat reduction. After completing the long-term follow-up phase, subjects who meet the trial evaluation criteria may receive another course of CBL-514 treatment to exploratorily evaluate the efficacy and safety of repeated dosing. The trial is expected to enroll 300 subjects in the U.S. A. Clinical Trial Design Overview (including trial name, objective, phase, drug name, indication, endpoints, number of enrolled subjects): a. Trial Name: A Phase 3b, multicenter, two-stage, double-blind long-term follow-up and open-label extension clinical trial in subjects who completed CBL-0301 or CBL-0302 to evaluate the long-term safety and durability of efficacy of CBL-514 for abdominal subcutaneous fat reduction. b. Trial Objective: To evaluate the long-term safety and durability of efficacy of CBL-514 injection for abdominal subcutaneous fat reduction. c. Trial Phase: Phase 3 d. Drug Name: CBL-514 e. Indication: Reduction of abdominal subcutaneous fat f. Endpoints: Primary endpoint is long-term safety of CBL-514; secondary endpoint is durability of long-term efficacy. g. Number of Enrolled Subjects: 300 subjects planned B. Statistical Results of Primary and Secondary Endpoints (including P-values) and Statistical Significance: Not applicable C. Market Entry Plan upon Knowledge of Phase 3 Trial (including interim analysis) Statistical Data: Not applicable D. A single clinical trial result (including P-values and statistical significance of primary and secondary endpoints) alone is insufficient to fully reflect the success or failure of future drug development and approval. Investors should exercise caution and make prudent investment decisions. (2) Risks and countermeasures if not approved by regulatory authorities, trial results do not achieve statistical significance, or other significant events: Not applicable (3) Future business direction if approved, results are statistically significant, or other significant events: Under evaluation (4) Cumulative R&D expenses incurred: Not disclosed, considering future marketing strategy and to protect company and investor interests. 6. Next Development Stage: (1) Expected Completion Time: Adjusted according to clinical trial progress (2) Expected Obligations: None 7. Market Overview: Localized fat reduction primarily aims to reduce subcutaneous fat in targeted areas. Current treatments include invasive surgical procedures and non-invasive product regimens. Surgical methods, while effective, involve significant tissue and nerve damage, high risks, noticeable side effects, and longer recovery periods. Therefore, non-surgical fat reduction products have rapidly emerged in recent years. However, currently available non-surgical products have limited efficacy, cannot significantly reduce subcutaneous fat, require multiple sessions, and may carry severe or irreversible risks. The fat reduction market is large, with substantial unmet demand. 8. Other Disclosures: None 9. Drug development involves long timelines, high investment, and no guarantee of success, posing risks to investors. Investors should carefully assess and make informed decisions.

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  • Source: PR Times
  • Category: New Product