Caliway Initiates CBL-514 Clinical Development in China to Maximize Global Licensing Value in the World's Second-Largest Aesthetics Market

• Asia-Pacific Strategic Milestone—Caliway has submitted an Investigational New Drug application for its Phase 1 clinical study (CBL-0102) of CBL-514 to China's NMPA CDE, launching localized fat reduction drug development in the Chinese market. Upon completion, the program will immediately advance into the pivotal Phase 3 study (CBL-0304) and subsequent New Drug Application (NDA) filing.
• Addressing Ethnic Differences—In compliance with NMPA regulations, an ethnicity sensitivity analysis on the Chinese population will be conducted through the CBL-0102 study, providing robust clinical data to support the pivotal Phase 3 study and future NDA submission.
• Capitalizing on a Multi-Billion-Dollar Market Opportunity—China stands as the world's second-largest aesthetics market, with its body contouring market projected to reach RMB 643 billion by 2040. Advancing CBL-514 in China is expected to significantly enhance the product’s global licensing value.

August 3, 2026—a clinical-stage biopharmaceutical company developing innovative small-molecule therapeutics, today 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.

The CBL-0102 study is designed to establish the clinical foundation for advancing CBL-514 into a pivotal Phase 3 clinical trial in China. Following completion of CBL-0102, the Company plans to promptly initiate the Phase 3 clinical trial (CBL-0304) and, upon the data meeting expectations, proceed with the NDA submission in China in accordance with applicable regulatory requirements.

Ethnicity Sensitivity Analysis Conducted in Compliance with NMPA Requirements

CBL-514’s completed Phase 2 studies and ongoing Phase 3 clinical trials have primarily been conducted in North America and Australia, with limited enrollment of Asian participants. In accordance with NMPA regulatory requirements for overseas-developed new drugs seeking approval in China, Caliway will conduct an Ethnicity Sensitivity Analysis through the CBL-0102 study to evaluate the potential impact of ethnic differences.

This randomized, open-label, single-dose, parallel-group Phase 1 clinical study is expected to enroll approximately 30 healthy subjects in China. The primary objectives are to evaluate and establish the pharmacokinetic (PK) profile, safety, and tolerability of CBL-514 across multiple dose levels in Chinese populations, serving as a critical baseline for the subsequent pivotal Phase 3 clinical program.

Targeting the World's Second-Largest Market to Expand Data and Enhance Global Licensing Value

Caliway stated: "China represents one of the world’s fastest-growing medical aesthetics and body contouring markets. In 2025, China’s medical aesthetics market reached RMB 367 billion, while the body contouring sector totaled RMB 76 billion. Driven by the rapid expansion of weight management trends, demand for these procedures continues to accelerate, with this specific market segment projected to grow substantially to RMB 643 billion by 2040. Advancing the CBL-0102 trial is not only a necessary step for entering the Chinese market but also a crucial milestone in strengthening our overall Asia-Pacific strategy."

In parallel with its China program, Caliway continues to expand its clinical footprint across the Asia-Pacific region. Its Phase 2 trial (CBL-0206) is currently enrolling subjects in both Australia and Taiwan. Together with the China IND submission, these clinical milestones will substantially strengthen CBL-514’s clinical database in Asian populations, providing a solid foundation for future regulatory submissions across multiple countries while significantly enhancing the product’s global licensing potential. Caliway ultimately aims to deliver a transformative treatment that will serve as a groundbreaking option for patients worldwide who seek safe and effective local fat reduction therapies.


About CBL-514

CBL-514 is a patented, first-in-class small-molecule 505(b)(1) injection developed by Caliway. It is designed to selectively induce adipocyte apoptosis to precisely reduce subcutaneous fat at the injection site without causing necrosis or damage to surrounding tissues or cells.
CBL-514 possesses therapeutic potential across multiple indications, including non-surgical subcutaneous fat reduction and moderate-to-severe cellulite. A separate formulation, CBL-514D, is being developed for the treatment of Dercum’s Disease, a rare disease. To date, more than 544 subjects have participated in clinical trials related to CBL-514. Across the 10 completed clinical trials with finalized statistical reports, all primary and key secondary efficacy endpoints have been met, demonstrating excellent safety and tolerability.

About Caliway Biopharmaceuticals

Caliway Biopharmaceuticals Co., Ltd. (TWSE: 6919), founded in 2012, is dedicated to developing breakthrough therapeutics that redefine standards of care and transform clinical practices. Caliway aims to leverage Taiwan's robust pharmaceutical research and development capabilities to serve the global aesthetic medicine and biomedical markets. The company was officially listed on the Taiwan Stock Exchange (TWSE: 6919) on October 2, 2024.

Disclaimer

This press release and related web pages contain forward-looking statements that are based on the Company's current expectations, forecasts, and assessments. These statements involve risks, uncertainties, and other factors beyond the Company’s control. Actual events or results may differ materially from those projected in these forward-looking statements due to various external factors. Caliway undertakes no obligation to update or revise any information in this press release.

Media & Investor Relations Contact

ir@caliwaybiopharma.com