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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11
2026
Caliway's CBL-514 Receives Early IND Clearance in China, Accelerating Development in the World's Fastest-Growing Body Contouring Market
announced that its China clinical trial (CBL-0102) for CBL-514, the Company's first-in-class injectable drug candidate for large-area localized fat reduction, has officially received authorization to proceed from the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA). The program was independently developed and submitted by the Company, an achievement rarely accomplished by Taiwan biotechnology companies. Moreover, the earlier-than-expected regulatory clearance not only reflects regulatory confidence in the study design, but also accelerates the Company's clinical development strategy in China.
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10
2026
Caliway Biopharmaceuticals Clarifies Unauthorized Online Claims Regarding CBL-514
The Company has recently identified information on certain online platforms and third-party websites claiming to offer, supply, market, or sell products related to CBL-514, the Company's investigational drug candidate currently under development. Such information may create confusion among investors, healthcare professionals, and the general public. The Company therefore issues the following clarification: CBL-514 remains an investigational drug candidate in clinical development and has not received marketing approval in any country or jurisdiction. It is not commercially available in any market. The Company has not authorized any third party to supply, distribute, market, or sell CBL-514, nor has it authorized any third party to act on its behalf or imply any affiliation, partnership, licensing, agency, distribution, or other relationship with the Company. Any claim regarding the availability or sale of CBL-514 is unauthorized and is not associated with the Company.
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10
2026
Caliway Advances Dual Global Phase 3 Program as SUPREME-02 Enrollment Begins
Caliway announced the initiation of enrollment in SUPREME-02 (CBL-0302), the Company's second global, multicenter Phase 3 pivotal trial evaluating CBL-514, its first-in-class investigational drug for the reduction of abdominal subcutaneous fat. The launch of SUPREME-02 marks another key milestone in Caliway's global development program and will complement the ongoing SUPREME-01 (CBL-0301) study. Together, the two pivotal Phase 3 trials are expected to generate the clinical evidence required to support future regulatory submissions for CBL-514.
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10
2026
EASD Press Room Features New Data on CBL-514 for Reducing Subcutaneous and Visceral Fat
Studies show that the new drug, CBL-514, reduces levels of subcutaneous and visceral fat. The data also suggest that it helps attenuate weight regain on stopping GLP-1 receptor agonist drugs (GLP1-RAs), says Dr W. Timothy Garvey, of the University of Alabama at Birmingham, Birmingham, USA.
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09
2026
Caliway Announces First Patient Dosed in Global Phase 3 SUPREME-01 Trial of CBL-514; New Preclinical Data Accepted for Presentation at ObesityWeek 2026
Caliway announced that SUPREME-01 (CBL-0301), its global pivotal Phase 3 clinical trial evaluating CBL-514 for large-area abdominal fat reduction, has successfully dosed its first participant (First Patient In, FPI). The trial has now formally entered the treatment phase and continues to enroll participants across North America.
