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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08
2026
Caliway Initiates CBL-514 Clinical Development in China to Maximize Global Licensing Value in the World's Second-Largest Aesthetics Market
Caliway announced that it has submitted an IND application to the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for the Phase 1 clinical study (CBL-0102) of its first-in-class, large-area localized fat reduction drug candidate, CBL-514. This submission marks the formal debut of the candidate's clinical development program in China.
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07
2026
Caliway Targets First-in-Class FDA "2-Grade Improvement" Claim with Upgraded CBL-514 Phase 3 Trial Enrolling in August
Caliway announced that it has submitted trial design amendments for its first-in-class, large-volume, local fat-reducing new drug, CBL-514. The amendments for the pivotal Phase 3 clinical trial, CBL-0301 (SUPREME-01), have been filed with the U.S. FDA as an IND amendment and with Health Canada as a Clinical Trial Application (CTA) amendment, in accordance with FDA recommendations. The trial protocol is concurrently under review by central Institutional Review Boards (IRBs) in the U.S. and Canada, with the first patient expected to be enrolled in August upon IRB approval.
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07
2026
Targeting the Pain Point of Weight Regain in GLP-1 Receptor Agonists: Caliway Submits Phase 2 IND to US FDA for CBL-514 Combination Therapy; Clinical Data on Visceral Fat Reduction Selected for Oral Presentation at the EASD 2026 Annual Meeting
Caliway announced the submission of an Investigational New Drug (IND) application to the U.S. FDA for CBL-0201WR. This randomized, placebo-controlled, multicenter Phase 2 clinical study will evaluate the company's novel fat-reducing candidate, CBL-514 injection, in combination with Zepbound® (tirzepatide, Eli Lilly). Also, CBL-514’s clinical data on visceral fat reduction has been selected for an oral presentation at the European Association for the Study of Diabetes (EASD) 2026 Annual Meeting.
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07
2026
Caliway’s CBL-514 Follow-Up Study CBL-0303 Allowed by U.S. FDA to Proceed Following Completion of 30-Day IND Review; CBL-0206 Begins Subject Enrollment in Australia
Caliway announced that the U.S. FDA has completed the 30-day review period for the Investigational New Drug (IND) application of CBL-0303, a follow-up clinical study of CBL-514 for abdominal subcutaneous fat reduction. The Company will proceed with study initiation as planned. In addition, the Asia-Pacific Phase 2 clinical trial CBL-0206 has initiated subject enrollment in Australia, further expanding safety and efficacy data in an Asian population.
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06
2026
Clarifying False Online Information
The Company has recently become aware that the website of RCPFARMA contains false statements purporting a partnership with the Company, which may mislead investors and the public.
