Qyuns Therapeutics Co., Ltd. ("Qyuns" or the "Company", stock code: 2509.HK) is pleased to announce that on December 8, 2025, the Company received a milestone payment of US$ 5 million from its partner, Caldera Therapeutics, Inc. (“Caldera”), which was triggered by the Human Research Ethics Committee (HREC) approval obtained for the Phase I clinical trial of QX030N/CLD-423 (Caldera research code)

Recently, QX030N/CLD-423, a bispecific antibody independently discovered by the Company, received approval from the HREC in Australia, and is scheduled to commence clinical trial in early 2026. The trial is a randomized, double-blind, placebo-controlled and dose escalating Phase I clinical study. Its primary objective is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single and multiple intravenous (IV) and/or subcutaneous (SC) doses of QX030N/CLD-423 in healthy adults.

The approval marks the official entry of the Company’s bispecific antibody portfolio into the clinical stage overseas, which will further strengthen the Company’s leading position in the field of autoimmune and allergic diseases. The Company and Caldera will also accelerate the development pace of this project to achieve further clinical progress as soon as possible.

On April 23, 2025, the Company and Caldera entered into an out-license agreement, pursuant to which Caldera was granted an exclusive right to develop and commercialize QX030N/CLD-423 globally. As of December 8, 2025, the Company has received upfront payment and milestone payment of US$15 million in aggregate, and certain equity interest in Caldera. In the future, the Company may also receive additional payments of up to US$540 million, subject to the achievement of certain clinical development, regulatory and commercial milestones, and may receive tiered royalties on net sales of QX030N/CLD-423.

About Caldera

Caldera is a company incorporated in the United States, focusing on advancing the development and commercialization of QX030N/CLD-423. It was jointly founded by Lilly Asia Ventures, Atlas Venture and venBio, which are globally leading venture capital firms investing in life sciences and healthcare industries.

Disclaimer

*This news release is intended to share the latest progress updates on the R&D efforts of the Company (or its partners) and is not for advertising purposes. It does not constitute a recommendation for any drugs and/or indications. For any related diseases or medication needs, please consult a qualified healthcare professional.

*This news release may contain certain forward-looking statements, which are inherently subject to significant risks and uncertainties. When words such as "anticipate," "believe," "predict," "expect," "plan," "intend" and other similar expressions are used, insofar as they relate to the Company, they shall be deemed to be forward-looking statements. The Company has no obligation to continuously update these predictive statements. These forward-looking statements are based on the current views, assumptions, expectations, estimates, projections and understandings of the Company’s management regarding future events at the time of making such statements. They do not constitute guarantees of future developments nor reliable indicators of future performance. We hereby explicitly caution you that you should not rely on any forward-looking statements. Forward-looking statements are subject to various risks, uncertainties and other factors (including but not limited to general market conditions, regulatory changes, geopolitical tensions, or data limitations and changes), some of which are beyond the Company’s control and difficult to predict. Therefore, due to future changes and developments in our business, competitive environment, political, economic, legal and social conditions, actual results may differ materially from the information contained in the forward-looking statements. The Company, its directors and employee agents shall not be liable for any obligation to update, revise or supplement such forward-looking statements, nor for any liability arising from the failure or inaccuracy of any forward-looking statements.