2026. 02
Date： 2026.02.23 -
Caliway Completes Australian HREC Submission for CBL-0206, Advancing Asia-Pacific Clinical Strategy
- CBL-0206 Phase 2 study of Caliway’s first-in-class large-area localized fat reduction drug, CBL-514, has completed Australian HREC submission
- The study will be conducted in Taiwan and Australia, with an estimated enrollment of approximately 250 participants
- The study aims to expand safety and efficacy data in Asian populations, supporting future NDA filings and Caliway’s global and regional dual-track licensing strategy
New Taipei City, February 23, 2026 – Caliway Biopharmaceuticals (TWSE: 6919) announced the completion of its submission to the Australian Human Research Ethics Committee (HREC) for CBL-0206, a Phase 2 clinical study of CBL-514, Caliway’s first-in-class large-area localized fat reduction drug candidate, for reducing abdominal subcutaneous fat in the Asia-Pacific region.
CBL-0206 represents an important step in advancing the Company’s Asia-Pacific clinical development strategy.
The study is planned to be conducted in Taiwan and Australia and is expected to enroll approximately 250 participants. It is designed to evaluate the efficacy, safety, and tolerability of CBL-514 Injection in reducing abdominal subcutaneous fat.
The primary efficacy assessments will include abdominal fat volume change measured by MRI and abdominal fat level change assessed by the Abdominal Fat Rating Scale (AFRS).
The study adopts a randomized, placebo-controlled design and consists of two stages. In Stage 1, participants will be randomized in a 4:1 ratio to receive CBL-514 or placebo. In Stage 2, all participants will receive CBL-514 treatment.
Caliway stated that advancing this Asia-Pacific clinical program will further expand safety and efficacy data in Asian populations, helping support future New Drug Application (NDA) submissions and regional market development strategies.
CBL-0206 forms part of Caliway’s “global and regional parallel” dual-track clinical and licensing strategy. While continuing to advance two global Phase 3 pivotal studies—SUPREME-01 in the United States and Canada, and SUPREME-02 in the United States, Canada, and Australia—the Company is also planning a Phase 3 clinical study in China (CBL-0304) later this year.
Through the parallel advancement of global and Asia-Pacific clinical programs, Caliway aims to deepen region-specific clinical data, expand treated patient numbers to support future regulatory submissions, and enhance flexibility for future licensing collaborations and long-term commercial value.
About CBL-514
CBL-514, a 505(b)(1) and first-in-class small-molecule drug developed by Caliway, is the world's first injectable lipolysis drug that induces adipocyte apoptosis to reduce subcutaneous fat in targeted areas with no systematic safety risks identified and well tolerated.To date, 10 clinical trials with a total of 544 subjects have been completed with all efficacy and safety endpoints met.
CBL-514 is being developed across multiple indications, including reduction of subcutaneous fat (non-surgical localized fat reduction) and moderate-to-severe cellulite. CBL-514D, the same active pharmaceutical ingredients (APIs) but under different formulation, is being studied for additional indications such as Dercum’s disease and more.