Leios Therapeutics Announces Exclusive Licensing Agreement and Strategic Investment with Subsidiaries of China Medical System Holdings Ltd. for 10XB-101

10XB-101 is a Novel Potential Best-in-Class Injectable Drug Being Developed for Focal Fat Reduction and Body Contouring 

Second Major Regional Licensing and Strategic Investment Agreement in 2026; Further Validates 10XB-101 Global Commercial Market Potential

LA JOLLA, Calif., Aug. 30, 2026 (GLOBE NEWSWIRE) -- Leios Therapeutics (“Leios” or “The Company”), a clinical-stage biotechnology company focused on innovative aesthetic therapies, today announced an exclusive licensing agreement for 10XB-101, a proprietary injectable therapy containing polidocanol, and a related strategic equity investment, by subsidiaries of China Medical System Holdings Limited (“CMS”) (Hong Kong Stock Code: 867, Singapore Stock Code: 8A8), an innovative pharmaceutical company focused on the identification, building, and full lifecycle management of differentiated specialty pharmaceuticals.

“The agreement with CMS represents an important strategic milestone for Leios Therapeutics, validating our market-by-market commercialization model and the scientific promise of 10XB-101,” said Ted White, Chief Executive Officer of Leios Therapeutics. “CMS is an established pharmaceutical company with growing international activities, and this partnership will enable us to reach one of the world’s largest markets. Their decision to license 10XB-101 following a rigorous diligence process underscores the strength of our clinical data and commercial potential. Together with CMS, we look forward to accelerating development and expanding access to 10XB-101 in China. We are progressing our trial initiation activities and expect to commence the trial in early 2027.”

This is the second major licensing and investment agreement signed in 2026 for the Company, and follows its partnership with BNC Korea. Together, the agreements establish Leios's presence in two of the most important markets for cosmetic procedures and skin care innovation outside the United States. South Korea serves as the global trendsetter in aesthetics, while China represents the volume powerhouse.

Under the licensing agreement, CMS receives exclusive rights to develop, manufacture and commercialize 10XB-101 in mainland China (including Hong Kong and Macau). Leios will receive an upfront payment, regulatory and commercial milestone payments, and royalties on future net sales, and will support the advancement of its 10XB-101 clinical development program. In a separate transaction, CMS agreed to make a strategic equity investment in Leios.

In its Phase 2b study in submental fat reduction, 10XB-101 demonstrated compelling efficacy, with 64% and 70% of completers in the higher dose groups (3.0% and 4.5%) achieving a grade 2 or greater improvement on both the clinician-reported and patient-reported submental fat scales (CSFS and PSFS), compared to 0% on placebo. Importantly, 10XB-101 demonstrated a clean safety profile across the study¹. Trial initiation activities are well underway, and the Company expects to commence the trial in early 2027.

Vault Advisors acted as the exclusive financial advisor to Leios Therapeutics for this transaction.

About 10XB-101

10XB-101 is being developed as a best-in-class minimally invasive injectable treatment designed to reduce focal fat deposits and enhance body contouring outcomes. Its active ingredient, polidocanol, is a synthetic, non-ionic detergent that induces targeted adipolysis: following injection in a defined pattern, it disrupts fat cell membranes, allowing the destroyed cells to be naturally absorbed by the body. Leios has completed Phase 2 trials in the submental fat reduction indication.

About Leios Therapeutics

Leios Therapeutics is a clinical-stage biotechnology company dedicated to developing innovative therapies for aesthetic indications. The company's mission is to deliver scientifically differentiated products that offer meaningful benefits to patients, healthcare providers and partners.

For more information, please visit www.leiostherapeutics.com.

About CMS

CMS is an innovative pharmaceutical company focused on the identification, building, and full lifecycle management of differentiated specialty pharmaceuticals. With a dual-engine approach of in-house R&D and collaborative R&D, and leveraging its core capability to build markets and brands from the ground up, CMS enables each medicine to fully realize both its clinical value and commercial value.

CMS focuses on advantaged specialties including cardiovascular-kidney-metabolic, central nervous system, gastroenterology, ophthalmology, and skin health. Through professional academic promotion and academic resources across multiple disease areas, CMS has built sustainable scale advantages in specialties, with its skin health business becoming a leading player in its segment. Meanwhile, CMS continues to strengthen its international replication capabilities, validating the transferability of its business model in emerging markets such as Southeast Asia and the Middle East, and injecting long-term momentum for CMS’s high-quality, sustainable development.

Forward-Looking Statements

This press release contains forward-looking statements, including statements regarding the development, regulatory approval, manufacturing and commercialization of 10XB-101; the timing, design and initiation of future clinical trials, including a potential Phase 3 clinical trial; future interactions with and decisions by regulatory authorities; the potential benefits and commercial opportunity of 10XB-101; the expected benefits of Leios’s agreements with CMS and its affiliates; and the potential receipt of milestone payments and royalties. Forward-looking statements are based on Leios’s current expectations and assumptions and involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, among others, the outcomes and timing of clinical trials and regulatory interactions; the ability to obtain and maintain regulatory approvals; the safety and efficacy of 10XB-101; the ability of Leios and its partners to perform their respective obligations; manufacturing and commercialization risks; market acceptance and competition; and other risks inherent in the development and commercialization of pharmaceutical products. Forward-looking statements speak only as of the date of this press release. Leios undertakes no obligation to update any forward-looking statement, except as required by applicable law.

FOR MORE INFORMATION, PLEASE CONTACT:

Ryan Kelly
rkelly@leiostherapeutics.com

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