2026. 04
Date： 2026.04.24 -
Caliway’s Asia-Pacific Phase 2 Study CBL-0206 Approved by Australia’s HREC to Proceed, Officially Advancing Asia-Pacific Clinical Strategy
- Caliway’s Asia-Pacific Phase 2 study of CBL-514 for reduction of abdominal subcutaneous fat, CBL-0206, has received approval from Australia’s HREC to proceed, officially advancing the Company’s Asia-Pacific clinical strategy.
- The study will be conducted in Taiwan and Australia, with an estimated enrollment of approximately 250 participants, further expanding safety and efficacy data in Asian populations.
- CBL-0206 forms an important part of Caliway’s “global and regional parallel” dual-track clinical and licensing strategy, supporting future NDA filings, regional market expansion, and licensing opportunities.
New Taipei City, April 24, 2026 – Caliway Biopharmaceuticals (TWSE: 6919), a clinical-stage biopharmaceutical company advancing innovative small-molecule therapies in aesthetic medicine, metabolic diseases, and other unmet medical needs, announced that CBL-0206, its Asia-Pacific Phase 2 clinical study of CBL-514 for reduction of abdominal subcutaneous fat, has received approval from Australia’s Human Research Ethics Committee (HREC) to proceed, officially advancing the Company’s Asia-Pacific clinical strategy.
The Company stated that, compared with its previous clinical studies primarily involving Western populations, CBL-0206 will help expand safety and efficacy data in Asian populations, supporting future New Drug Application (NDA) filings and broader commercial planning.
The study adopts a randomized, placebo-controlled design and is expected to enroll approximately 250 participants in Taiwan and Australia. It is intended to evaluate the efficacy, safety, and tolerability of CBL-514 Injection for reduction of abdominal subcutaneous fat. The primary efficacy assessments include abdominal subcutaneous fat volume change measured by MRI and abdominal fat grade improvement assessed by the Abdominal Fat Rating Scale (AFRS). The study design 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.
Vivian Ling, Chief Executive Officer of Caliway, stated, “The approval of CBL-0206 by Australia’s HREC to proceed is an important milestone for Caliway’s Asia-Pacific clinical strategy. It represents the formal transition of our plan to expand clinical data in Asia-Pacific populations into the execution stage. In addition to increasing the treated subject base to better support future regulatory requirements, this study also strengthens the foundation for CBL-514’s future market expansion and licensing discussions, with the aim of enhancing its global commercial value.”
In terms of global clinical development, while continuing to advance the two global pivotal Phase 3 studies, SUPREME-01 and SUPREME-02, Caliway is also planning a Phase 3 clinical study in China (CBL-0304), laying a more comprehensive foundation for future global regulatory filings, international licensing collaborations, and regional market expansion.
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 systemic safety risks identified and good tolerability.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.