Caliway Met Dual Milestones with MSCI Global Standard Index Inclusion, and Health Canada has Approved the Phase 3 SUPREME-01 Study

• Caliway (6919) has been added to the Taiwan component of the MSCI Global Standard Index, effective after market close on August 26, 2025, marking recognition from the international capital market.
• CBL-514's global pivotal Phase 3 study SUPREME-01, following U.S. FDA clearance, has now also received approval from Health Canada. The study is expected to begin recruitment in Q3 2025 across the U.S. and Canada, targeting 300 participants.
• CBL-514 is the first 505(b)(1) investigational drug globally to be developed for the proposed indication of "Reduction of Abdominal Subcutaneous Fat," highlighting its innovative positioning and potential medical value.

NEW TAIPEI CITY, Aug. 12, 2025 /PRNewswire/ -- Caliway Biopharmaceuticals (TWSE: 6919) today announced that, in the latest quarterly review last Friday, the Company was added to the Taiwan component of the MSCI Global Standard Index, effective after the Taiwan market close on August 26, 2025.

The MSCI Global Standard Index is highly influential worldwide and widely used as a benchmark for tracking global equity market performance, serving as an important reference for international institutional investors.

Caliway's upgrade from the MSCI Global Small Cap Index to the Global Standard Index is expected to increase investment from large-scale international passive and index-tracking funds and reflects the capital market's recognition of the Company's market capitalization, liquidity, and financial transparency, further enhancing its visibility and appeal in the international capital market.

On the same day, Caliway also announced that its first-in-class injectable drug candidate for large-area, site-specific fat reduction, CBL-514, has now received approval from Health Canada for its global, multi-national, multi-center pivotal Phase 3 study SUPREME-01, following prior clearance by the U.S. FDA. This study is expected to begin recruitment in Q3 2025 at 29 clinical sites across the U.S. and Canada, targeting 300 participants randomized in a 1:1 ratio to receive either CBL-514 or placebo.

SUPREME-01 is a randomized, double-blind, placebo-controlled Phase 3 study. The primary estimand is a multicomponent responder endpoint, comprising: (1) abdominal fat volume change measured by MRI, and (2) abdominal fat level change assessed by Patient Reported-Abdominal Fat Rating Scale (PR-AFRS). These endpoints were previously evaluated and met in Caliway's completed Phase 2b studies, CBL-0204 and CBL-0205.

Caliway's CEO Vivian Ling commented,"Being included in the MSCI Global Standard Index is a strong recognition by the international capital market of our fundamentals, market capitalization, and growth prospects. At the same time, the pivotal Phase 3 SUPREME-01 study has now been approved in both the U.S. and Canada, demonstrating the Company's steadfast core culture of 'delivering on our promises with disciplined execution.' I have full confidence in our team's execution capabilities and in the potential of this Phase 3 study, and I look forward to CBL-514's future marketing approval to provide a truly effective, safe, and innovative non-surgical fat reduction treatment option to people worldwide."

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 without causing any systemic side effects on the central nervous system, cardiovascular system, and respiratory system. As of May 2025, 10 clinical trials with a total of 520 subjects have been completed with all efficacy and safety endpoints met.

Caliway is currently investigating multiple indications for CBL-514, including non-surgical fat reduction, moderate-to-severe cellulite, and weight management (to help reduce post-weight-loss fat rebound). 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.

About AFRS (Abdominal Fat Rating Scale)

AFRS is a five-grade rating scale developed by Caliway and validated in accordance with U.S. FDA guidance and relevant regulations, including the FDA's guideline on Patient-Focused Drug Development. The Clinician Reported-AFRS (CR-AFRS) and the Patient Reported-AFRS (PR-AFRS) are used to assess treatment response based on the physician's evaluation and the participant's self-assessment, respectively.

About Caliway Biopharmaceuticals

Caliway Biopharmaceuticals (Caliway) is a clinical-stage biopharmaceutical company driven to breakthrough drug discovery of novel small-molecule therapeutics. Listed on the Taiwan Exchange (TWSE-6919), Caliway aims to become an innovative pharmaceutical leader in aesthetic medicine and other diseases. For more information, please visit: https://www.caliwaybiopharma.com/en/

Disclaimer 

This article and related information on this site contain forward-looking statements. The forward-looking information requires the Company to make numerous assumptions and is subject to inherent risks, uncertainties, and other factors that are beyond the control of the Company which may cause actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by such forward-looking statements. The Company undertakes no obligation to timely inform, update, or revise the information on this site if circumstances should change.

SOURCE Caliway Biopharmaceuticals