KangPu's CBL-514 Injectable for Subcutaneous Fat Reduction Approved for Phase 2 Trial by Taiwan TFDA

1. Date of occurrence: May 19, 2026 2. Drug name/code: CBL-514 3. Indication: - Reduction of subcutaneous fat - Improvement of moderate to severe cellulite - Treatment of rare Dercum's disease 4. Development stages: - Phase 1: Completed. - Phase 2: CBL-0205 completed; CBL-0206 approved by HREC (Australia) and TFDA (Taiwan). - Phase 3: CBL-0301 approved in US/Canada; CBL-0302 approved in US. - NDA: Not yet initiated. 5. Current status: KangPu will conduct the Phase 2 clinical trial CBL-0206 for CBL-514 in Taiwan and Australia to gather safety and efficacy data for Asian populations to support future NDA filings. Taiwan TFDA approval was granted on May 19, 2026. The trial, enrolling approximately 250 subjects, uses MRI to measure changes in abdominal fat volume and the Abdominal Fat Rating Scale (AFRS) for efficacy assessment. - Trial design: Phase 2, randomized, placebo-controlled with a long-term re-treatment design. 6. Next steps: Initiating the CBL-0301 clinical trial. 7. Market status: Over 80% of fat reduction procedures are still surgical, which carry significant side effect risks. Non-surgical alternatives are growing but often suffer from poor efficacy or safety concerns (e.g., nerve damage, PAH). ASPS reports indicate over 60% of people avoid existing treatments due to dissatisfaction or fear of side effects.