【康霈】FDA Submission Completed for Phase 3b Long-Term Follow-up Clinical Trial of CBL-514 for Abdominal Fat Reduction

1. Date of Occurrence: 2026/06/03 2. Drug Name/Code: CBL-514 3. Indications: A. Reduction of subcutaneous fat B. Improvement of moderate/severe cellulite C. Treatment of rare diseases 4. R&D Stages: A. Phase 1: Completed. B. Phase 2: Completed. C. Phase 3: Pivotal trials CBL-0301/CBL-0302 approved in US/Canada. Phase 3b long-term trial CBL-0303 submitted to FDA. D. NDA: Not yet conducted. 5. Current Status: On June 3, 2026, the company submitted an IND application to the US FDA for the Phase 3b long-term follow-up clinical trial (CBL-0303) of CBL-514. This trial will enroll subjects who completed one of the pivotal Phase 3 trials to evaluate long-term safety and efficacy maintenance. Subjects may undergo repeat treatment if criteria are met. The trial expects to enroll 300 subjects in the US. 6. Market Situation: Local fat reduction currently relies on invasive surgery or non-invasive products. Surgery carries higher risks and longer recovery. Non-invasive products have risen in popularity but often face limitations in efficacy or safety concerns. The market for fat reduction remains vast with significant unmet needs.