【Caliway*】Company's new drug CBL-514 injection for reducing abdominal subcutaneous fat, Asia-Pacific Phase II clinical trial CBL-0206, has completed Taiwan TFDA IND application today.
Caliway Biomedical (康霈) announced the completion of its Taiwan TFDA IND application for CBL-514 injection's Asia-Pacific Phase II clinical trial (CBL-0206), aimed at reducing abdominal subcutaneous fat. This marks a significant step towards bringing a new non-invasive fat reduction treatment to market.
📋 Article Processing Timeline
- 📰 Published: April 28, 2026 at 09:00
- 🔍 Collected: April 29, 2026 at 08:00 (23h 0m after Published)
- 🤖 AI Analyzed: April 29, 2026 at 08:31 (31 min after Collected)
1. Date of occurrence: April 28, 2026
2. Name or code of the new drug under development: CBL-514
3. Uses:
A. Reduce subcutaneous fat
B. Improve moderate/severe cellulite
C. Treat the rare disease Dercum's disease
4. All expected research and 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 by Australia HREC, and the Taiwan TFDA IND application has been submitted.
C. Phase 3 clinical trial: The first pivotal Phase 3 trial, CBL-0301, has been approved for execution in the United States and Canada. The second pivotal Phase 3 trial, CBL-0302, has been submitted for application.
D. New Drug Application (NDA) review: Not yet commenced.
5. Current ongoing R&D stage (please explain whether the current R&D stage is an application submission/approval/disapproval. If not approved, please explain the risks faced by the company and countermeasures; also, please explain the future business direction and cumulative R&D expenses invested):
(1) Application submission/approval/disapproval/results of each phase of human trials (including interim analysis)/other significant events affecting new drug R&D:
The company will conduct a Phase 2 clinical trial, CBL-0206, for the new drug CBL-514 injection for reducing abdominal subcutaneous fat in the Asia-Pacific region, including Taiwan and Australia, to increase safety and efficacy data in Asian populations, facilitating future New Drug Application (NDA) and market promotion. The company completed the Taiwan TFDA IND clinical trial application for this Phase 2 trial on April 28, 2026. This trial will simultaneously use MRI to measure changes in abdominal subcutaneous fat volume and the Abdominal Fat Rating Scale (AFRS) to evaluate improvement in abdominal fat grade as efficacy indicators. Approximately 250 subjects are expected to be enrolled in Taiwan and Australia.
A. Introduction to clinical trial design (including trial plan name, trial purpose, trial phase classification, drug name, declared indications, evaluation indicators, number of subjects to be enrolled in the trial plan, etc.).
a. Trial plan name:
A Phase 2, randomized, placebo-controlled clinical trial, including a long-term re-treatment design, to evaluate the efficacy, safety, and tolerability of CBL-514 injection for reducing abdominal subcutaneous fat.
b. Trial purpose: To evaluate the efficacy, safety, and tolerability of CBL-514 injection for reducing abdominal subcutaneous fat.
c. Trial phase classification: Phase 2 clinical trial
d. Drug name: CBL-514
e. Declared indications: Reduction of abdominal subcutaneous fat
f. Evaluation indicators: Efficacy indicators are changes in abdominal subcutaneous fat volume measured by MRI and improvement in abdominal fat grade evaluated by AFRS (Abdominal Fat Rating Scale).
g. Number of subjects to be enrolled in the trial plan: Approximately 250 people
B. Statistical results of primary and secondary evaluation indicators (including but not limited to P-values) and statistical significance (including but not limited to whether statistical significance is achieved). If the company cannot disclose statistical data due to other important reasons, the reasons should be explained: Not applicable.
C. If statistical data of the Phase 3 human clinical trial (including interim analysis) of the new drug are known, please explain the plan for the new drug to enter the market in the future (however, the content described should avoid involving the company's "Criteria for Recognition of Public Companies' Obligation to Disclose Complete Financial Forecasts" which requires the preparation of financial forecasts): Not applicable.
D. The results of a single clinical trial (including the statistical P-value of primary and secondary evaluation indicators and whether statistical significance is achieved) are not sufficient to fully reflect the success or failure of future new drug development and market launch. Investors should carefully evaluate and invest cautiously.
(2) Risks faced by the company and countermeasures if the competent authority's approval is not obtained, statistical significance of each phase of human clinical trials (including interim analysis) is not achieved, or other significant events affecting new drug R&D occur: Not applicable.
(3) Future business direction if the competent authority's approval has been obtained, statistical significance of each phase of human clinical trials (including interim analysis) has been achieved, or other significant events affecting new drug R&D occur: The company is evaluating.
(4) Cumulative R&D expenses invested: For future marketing strategies and to protect the rights and interests of the company and investors, temporary disclosure is not made.
6. Next stage of R&D to be carried out (please explain the estimated completion time and estimated obligations):
CBL-514 for reducing abdominal subcutaneous fat (non-surgical fat reduction). The CBL-0301 clinical trial initiation phase is currently underway.
(1) Estimated completion time: Actual timeline will be adjusted based on the progress of clinical trial execution.
(2) Estimated obligations: None.
7. Market situation:
Currently, over 80% of fat reduction treatments still use invasive surgical procedures, including liposuction and abdominoplasty. Although surgical fat reduction is significantly more effective than currently available non-surgical fat reduction products, it is still associated with many obvious side effects and sequelae, as well as potentially life-threatening severe side effects. Therefore, non-surgical fat reduction products have rapidly emerged in recent years, including cryolipolysis, ultrasound fat reduction, and fat reduction injections (containing deoxycholic acid or its salts). However, most current non-surgical fat reduction products are not very effective, cannot significantly reduce subcutaneous fat in the treated area, and require more than 12 weeks for efficacy to be seen, and are associated with risks of moderate to severe side effects, such as skin necrosis.
2. Name or code of the new drug under development: CBL-514
3. Uses:
A. Reduce subcutaneous fat
B. Improve moderate/severe cellulite
C. Treat the rare disease Dercum's disease
4. All expected research and 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 by Australia HREC, and the Taiwan TFDA IND application has been submitted.
C. Phase 3 clinical trial: The first pivotal Phase 3 trial, CBL-0301, has been approved for execution in the United States and Canada. The second pivotal Phase 3 trial, CBL-0302, has been submitted for application.
D. New Drug Application (NDA) review: Not yet commenced.
5. Current ongoing R&D stage (please explain whether the current R&D stage is an application submission/approval/disapproval. If not approved, please explain the risks faced by the company and countermeasures; also, please explain the future business direction and cumulative R&D expenses invested):
(1) Application submission/approval/disapproval/results of each phase of human trials (including interim analysis)/other significant events affecting new drug R&D:
The company will conduct a Phase 2 clinical trial, CBL-0206, for the new drug CBL-514 injection for reducing abdominal subcutaneous fat in the Asia-Pacific region, including Taiwan and Australia, to increase safety and efficacy data in Asian populations, facilitating future New Drug Application (NDA) and market promotion. The company completed the Taiwan TFDA IND clinical trial application for this Phase 2 trial on April 28, 2026. This trial will simultaneously use MRI to measure changes in abdominal subcutaneous fat volume and the Abdominal Fat Rating Scale (AFRS) to evaluate improvement in abdominal fat grade as efficacy indicators. Approximately 250 subjects are expected to be enrolled in Taiwan and Australia.
A. Introduction to clinical trial design (including trial plan name, trial purpose, trial phase classification, drug name, declared indications, evaluation indicators, number of subjects to be enrolled in the trial plan, etc.).
a. Trial plan name:
A Phase 2, randomized, placebo-controlled clinical trial, including a long-term re-treatment design, to evaluate the efficacy, safety, and tolerability of CBL-514 injection for reducing abdominal subcutaneous fat.
b. Trial purpose: To evaluate the efficacy, safety, and tolerability of CBL-514 injection for reducing abdominal subcutaneous fat.
c. Trial phase classification: Phase 2 clinical trial
d. Drug name: CBL-514
e. Declared indications: Reduction of abdominal subcutaneous fat
f. Evaluation indicators: Efficacy indicators are changes in abdominal subcutaneous fat volume measured by MRI and improvement in abdominal fat grade evaluated by AFRS (Abdominal Fat Rating Scale).
g. Number of subjects to be enrolled in the trial plan: Approximately 250 people
B. Statistical results of primary and secondary evaluation indicators (including but not limited to P-values) and statistical significance (including but not limited to whether statistical significance is achieved). If the company cannot disclose statistical data due to other important reasons, the reasons should be explained: Not applicable.
C. If statistical data of the Phase 3 human clinical trial (including interim analysis) of the new drug are known, please explain the plan for the new drug to enter the market in the future (however, the content described should avoid involving the company's "Criteria for Recognition of Public Companies' Obligation to Disclose Complete Financial Forecasts" which requires the preparation of financial forecasts): Not applicable.
D. The results of a single clinical trial (including the statistical P-value of primary and secondary evaluation indicators and whether statistical significance is achieved) are not sufficient to fully reflect the success or failure of future new drug development and market launch. Investors should carefully evaluate and invest cautiously.
(2) Risks faced by the company and countermeasures if the competent authority's approval is not obtained, statistical significance of each phase of human clinical trials (including interim analysis) is not achieved, or other significant events affecting new drug R&D occur: Not applicable.
(3) Future business direction if the competent authority's approval has been obtained, statistical significance of each phase of human clinical trials (including interim analysis) has been achieved, or other significant events affecting new drug R&D occur: The company is evaluating.
(4) Cumulative R&D expenses invested: For future marketing strategies and to protect the rights and interests of the company and investors, temporary disclosure is not made.
6. Next stage of R&D to be carried out (please explain the estimated completion time and estimated obligations):
CBL-514 for reducing abdominal subcutaneous fat (non-surgical fat reduction). The CBL-0301 clinical trial initiation phase is currently underway.
(1) Estimated completion time: Actual timeline will be adjusted based on the progress of clinical trial execution.
(2) Estimated obligations: None.
7. Market situation:
Currently, over 80% of fat reduction treatments still use invasive surgical procedures, including liposuction and abdominoplasty. Although surgical fat reduction is significantly more effective than currently available non-surgical fat reduction products, it is still associated with many obvious side effects and sequelae, as well as potentially life-threatening severe side effects. Therefore, non-surgical fat reduction products have rapidly emerged in recent years, including cryolipolysis, ultrasound fat reduction, and fat reduction injections (containing deoxycholic acid or its salts). However, most current non-surgical fat reduction products are not very effective, cannot significantly reduce subcutaneous fat in the treated area, and require more than 12 weeks for efficacy to be seen, and are associated with risks of moderate to severe side effects, such as skin necrosis.