Caliway's CBL-514 Receives Early IND Clearance in China, Accelerating Development in the World's Fastest-Growing Body Contouring Market

• China Clinical Trial Cleared Ahead of Schedule—CBL-514's China clinical study (CBL-0102) received authorization to proceed from the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) ahead of the anticipated timeline, reflecting regulatory recognition of the study design and accelerating the Company's development timeline in China.
• Subject Enrollment Expected to Begin in December 2026; Clinical Data Anticipated in Q2 2027—The study is expected to commence subject enrollment in December 2026, with clinical data expected in the second quarter of 2027, supporting subsequent clinical development activities and regulatory submissions.
• Expanding Presence in China's Fast-Growing Body Contouring Market—Driven by its novel mechanism of action and encouraging clinical outcomes, CBL-514 has attracted extensive attention from major Chinese media outlets as development progresses.

November 6, 2026—Caliway Biopharmaceuticals (TWSE: 6919), a clinical-stage biopharmaceutical company developing innovative small-molecule therapeutics, 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.

The trial is expected to begin subject enrollment in December 2026 and is planned to be completed in the second quarter of 2027, with clinical data expected shortly thereafter. Upon completion, the Company intends to promptly advance to the next stage of clinical development and regulatory submissions.

Accelerating Ethnicity Sensitivity Analysis to Strengthen Asian Development Strategy

In accordance with NMPA regulatory requirements, the CBL-0102 study is designed to evaluate ethnicity sensitivity in a Chinese population, assessing the potential impact of ethnic factors on the pharmacokinetic (PK) profile, safety, and tolerability of CBL-514 across different dose levels.

The clinical data generated from Asian subjects will not only provide important support for future pivotal Phase 3 studies and regulatory approval applications in China, but may also serve as a valuable reference for regulatory submissions across other Asian markets. The Company believes these data could support the broader development and commercialization strategy of CBL-514 throughout Asia.

CBL-0102 is a randomized, open-label, single-dose, parallel-design clinical study expected to enroll approximately 30 healthy subjects across two clinical sites in China.

Expanding CBL-514's Presence in China's RMB 643 Billion Body Contouring Market

China represents one of the world's fastest-growing and most promising markets for aesthetic medicine and body contouring. The market opportunity for CBL-514 in China is expected to be comparable to that of the United States, with the potential to reach an even larger target population. As demand for body contouring procedures continues to rise, China's body contouring market is projected to expand 8.5-fold between 2025 and 2040, reaching an estimated market size of RMB 643 billion.

The Company believes this rapidly expanding market represents a significant growth opportunity for CBL-514. Successful completion of clinical development and future regulatory approval in China would not only complement the Company's ongoing development programs in North America, Australia, and Taiwan, but also further strengthen CBL-514's global development strategy and regional market presence. In addition, CBL-514 has the potential to provide Chinese patients seeking a non-surgical, safe, and effective localized fat reduction treatment with a novel therapeutic option.

At the same time, CBL-514's novel mechanism of action and compelling clinical data have garnered significant international attention. Following its presentation at the European Association for the Study of Diabetes (EASD) Annual Meeting earlier this year, CBL-514 received extensive coverage from major media outlets across Europe and the United States, while also drawing significant interest from leading media organizations in China.

The initiation of the China clinical trial marks an important milestone in CBL-514's global development program. The China study is expected to further strengthen CBL-514's global development momentum by creating meaningful strategic value across the Company's worldwide clinical development programs, expanding partnering opportunities, and enhancing its overall licensing potential, particularly in Asia-Pacific markets.


*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 has demonstrated broad therapeutic potential across multiple indications, including non-surgical subcutaneous fat reduction and moderate-to-severe cellulite. A separate formulation, designated as 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