[Kangpe] CBL-514 Injection Files for the Second Multi-national Pivotal Phase 3 Clinical Trial (CBL-0302) with Australian HREC
Kangpe Biotechnology announced on May 20, 2026, that it has completed the clinical trial application to the Australian HREC for its second multi-national pivotal phase 3 clinical trial (SUPREME-02/CBL-0302) of CBL-514 injection for reducing abdominal subcutaneous fat.
📋 Article Processing Timeline
- 📰 Published: May 20, 2026 at 09:00
- 🔍 Collected: May 21, 2026 at 08:00 (23h 0m after Published)
- 🤖 AI Analyzed: May 21, 2026 at 08:22 (21 min after Collected)
1. Date of occurrence: May 20, 2026
2. Name or code of new drug: CBL-514
3. Purpose:
A. Reducing subcutaneous fat
B. Improving moderate/severe cellulite
C. Treating Dercum's disease (a rare disease)
4. Planned development stages:
A. Phase 1 clinical trial: Completed.
B. Phase 2 clinical trial: Multiple trials including CBL-0205 completed; CBL-0206 application approved by Australian HREC and Taiwan TFDA.
C. Phase 3 clinical trial: The first pivotal trial CBL-0301 is approved in the US and Canada; the second pivotal trial CBL-0302 is approved in the US and applied in Canada and Australia.
D. New Drug Application (NDA): Not yet started.
5. Current development status:
(1) The second multi-national pivotal phase 3 clinical trial (CBL-0302, SUPREME-02) for CBL-514 injection to reduce abdominal subcutaneous fat has submitted its clinical trial application to the Australian Human Research Ethics Committee (HREC) on May 20, 2026. The trial uses both MRI measurement of abdominal subcutaneous fat volume and the Patient Report-Abdominal Fat Rating Scale (PR-AFRS) as primary endpoints, expecting to enroll 320 subjects in the US, Canada, and Australia.
A. Trial design:
a. Trial name: A phase 3, randomized, double-blind, placebo-controlled trial to evaluate the efficacy, safety, and tolerability of CBL-514 injection for abdominal subcutaneous fat reduction (SUPREME-02).
b. Objective: Evaluate efficacy, safety, and tolerability.
c. Trial phase: Phase 3 clinical trial.
d. Drug name: CBL-514.
e. Indication: Reducing abdominal subcutaneous fat.
f. Endpoints: Abdominal subcutaneous fat volume change measured by MRI and improvement in fat grade via PR-AFRS.
g. Expected enrollment: Approximately 320 subjects.
B. Statistics of primary/secondary endpoints: Not applicable.
C. Market entry plan: Not applicable.
D. Investment caution: A single clinical trial result is insufficient to reflect the ultimate success of drug development; investors should be cautious.
(3) Future operations: Under evaluation.
(4) Accumulated R&D expenditure: Temporarily withheld from disclosure for market strategy.
6. Next steps: Timing adjusted based on trial progress.
7. Market status: Over 80% of fat reduction treatments are invasive surgeries. Non-surgical alternatives often show poor efficacy or significant risks. Studies from the American Society of Plastic Surgeons (ASPS) indicate that over 60% of people are hesitant due to dissatisfaction or fear of side effects, indicating a large unmet market need.
2. Name or code of new drug: CBL-514
3. Purpose:
A. Reducing subcutaneous fat
B. Improving moderate/severe cellulite
C. Treating Dercum's disease (a rare disease)
4. Planned development stages:
A. Phase 1 clinical trial: Completed.
B. Phase 2 clinical trial: Multiple trials including CBL-0205 completed; CBL-0206 application approved by Australian HREC and Taiwan TFDA.
C. Phase 3 clinical trial: The first pivotal trial CBL-0301 is approved in the US and Canada; the second pivotal trial CBL-0302 is approved in the US and applied in Canada and Australia.
D. New Drug Application (NDA): Not yet started.
5. Current development status:
(1) The second multi-national pivotal phase 3 clinical trial (CBL-0302, SUPREME-02) for CBL-514 injection to reduce abdominal subcutaneous fat has submitted its clinical trial application to the Australian Human Research Ethics Committee (HREC) on May 20, 2026. The trial uses both MRI measurement of abdominal subcutaneous fat volume and the Patient Report-Abdominal Fat Rating Scale (PR-AFRS) as primary endpoints, expecting to enroll 320 subjects in the US, Canada, and Australia.
A. Trial design:
a. Trial name: A phase 3, randomized, double-blind, placebo-controlled trial to evaluate the efficacy, safety, and tolerability of CBL-514 injection for abdominal subcutaneous fat reduction (SUPREME-02).
b. Objective: Evaluate efficacy, safety, and tolerability.
c. Trial phase: Phase 3 clinical trial.
d. Drug name: CBL-514.
e. Indication: Reducing abdominal subcutaneous fat.
f. Endpoints: Abdominal subcutaneous fat volume change measured by MRI and improvement in fat grade via PR-AFRS.
g. Expected enrollment: Approximately 320 subjects.
B. Statistics of primary/secondary endpoints: Not applicable.
C. Market entry plan: Not applicable.
D. Investment caution: A single clinical trial result is insufficient to reflect the ultimate success of drug development; investors should be cautious.
(3) Future operations: Under evaluation.
(4) Accumulated R&D expenditure: Temporarily withheld from disclosure for market strategy.
6. Next steps: Timing adjusted based on trial progress.
7. Market status: Over 80% of fat reduction treatments are invasive surgeries. Non-surgical alternatives often show poor efficacy or significant risks. Studies from the American Society of Plastic Surgeons (ASPS) indicate that over 60% of people are hesitant due to dissatisfaction or fear of side effects, indicating a large unmet market need.
FAQ
What phase of clinical trials is Kangpe's CBL-514 currently in?
CBL-514 is currently in phase 3 clinical trials, with the SUPREME-02 (CBL-0302) trial filing submitted to the Australian HREC.
How many subjects are expected for this clinical trial?
The phase 3 clinical trial SUPREME-02 is expected to enroll approximately 320 subjects across the US, Canada, and Australia.
Why is this new drug being developed?
Most current fat reduction treatments are invasive surgeries with side effects; existing non-surgical products suffer from poor efficacy and risks, leaving a large unmet market need.