R&D
- Aesthetics
Localized Fat Reduction, Cellulite,
Hyperpigmentation, Skin Aging
- Therapeutics
Dercum's Disease, Osteoarthritis, Central Obesity
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Discovery
Preclinical
Phase I
Phase II
Phase III
NDA/
Market
Discovery
Preclinical
Phase I
Phase II
Phase III
NDA/
Market -
Discovery
Preclinical
Phase I
Phase II
Phase III
NDA/
Market
Discovery
Preclinical
Phase I
Phase II
Phase III
NDA/
Market -
Discovery
Preclinical
Phase I
Phase II
Phase III
NDA/
Market
Discovery
Preclinical
Phase I
Phase II
Phase III
NDA/
Market
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CBL-514
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CBA-539
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CBF-520
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CBL-539, a long-acting injectable product, is designed for a more efficacious and safe treatment for refractory melasma by inhibiting melanin production. Besides, CBL-539 was evidenced that could recover skin elasticity by increasing collagen production.
Conditions/Indications： Hyperpigmentation, Skin aging
About Caliway
In Caliway, we are driven to breakthrough drug discovery of novel small-molecule therapeutics for medical aesthetics and inflammatory disease. By developing innovative drugs, we aim to provide new treatment options for the indications in which clinical needs remain unmet.
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ADVANTAGE
Well-Experimented Team of Experts
Caliway's research team comprises experts with deep knowledge and experience in drug discovery, business development, and regulatory affairs. We develop innovative new strategies with high safety to address medical conditions with no effective treatments available. -
ADVANTAGE
Target Emerging Markets
In Caliway, the diseases we are targeted on affect millions of people, often in their most productive years. We are on a mission to combine science, medicine, and advocacy with improving people's lives suffering from illnesses or life-threatening diseases. -
ADVANTAGE
Global IP Protection
We have exclusive rights to benefit from the commercial use of our products, such as producing, selling, and exporting worldwide.
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09
2025
Caliway Participates in EASD 2025 – CBL-514 Demonstrates Unique Fat-Reduction Mechanism and Differentiated Advantage in Combination with GLP-1R Therapy
Caliway shared findings from two recently completed preclinical studies (OI22, OI23) with participating experts, highlighting four differentiated advantages of CBL-514 when combined with GLP-1R drugs such as Tirzepatide.
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08
2025
Caliway Met Dual Milestones with MSCI Global Standard Index Inclusion, and Health Canada has Approved the Phase 3 SUPREME-01 Study
Caliway Biopharmaceuticals (TWSE: 6919) announced that, the Company was added to the MSCI Global Standard Index, effective after the Taiwan market close on August 26, 2025. Caliway also announced that its first-in-class injectable drug candidate for large-area fat reduction, CBL-514, has now received approval from Health Canada for its global pivotal Phase 3 study SUPREME-01.
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07
2025
Caliway Announces FDA Clearance of IND Application for CBL-514 to Proceed with SUPREME-01, the First Global Pivotal Phase 3 Study for Reducing Abdominal Subcutaneous Fat
CBL-514 has been granted clearance from the U.S. FDA to proceed with SUPREME-01, a global, multicenter, pivotal Phase 3 study.
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07
2025
Caliway Files Canadian CTA for Global Pivotal Phase 3 SUPREME-01 Study of CBL-514, with U.S.-Canada Recruitment to Begin in Q3
Caliway has submitted the CTA to Health Canada for SUPREME-01, a global, multicenter, pivotal Phase 3 study of CBL-514 for subcutaneous fat reduction, following the IND submission to the FDA.
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06
2025
Caliway Completed FDA IND Submission for Global Pivotal Phase 3 Study SUPREME-01 of CBL-514 for Fat Reduction, Advancing NDA on Schedule
Caliway has submitted the IND application to the U.S. FDA for SUPREME-01 (CBL-0301), the first global, multicenter, pivotal Phase 3 study of CBL-514 for subcutaneous fat reduction, with a planned enrollment of 300 subjects.
