Qyuns Therapeutics Co., Ltd. (“Qyuns” or the “Company”, stock code: 2509.HK) is pleased to announce that on December 19, 2025, the Company and LE2025 Therapeutics AG (“LE2025”), an affiliate of Windward Bio Group AG (“Windward Bio”), have entered into a license and collaboration agreement (the “Agreement”) for the Company’s independently developed QX027N.The Agreement grants LE2025 an exclusive right to develop and commercialize QX027N globally, except from mainland China, Taiwan, the Special Administrative Region of Hong Kong and the Special Administrative Region of Macau (the “Licensed Territory”). In return, the Company or its designated affiliate(s) (collectively, the “Group”) will be entitled to receive a total of up to USD$700 million payments, including an upfront payment, an equity interest of Windward Bio, development and commercial milestone payments, plus tiered royalties on net sales of QX027N in the Licensed Territory.QX027N is a long-acting anti-TSLPxIL-13 bispecific antibody independently developed by the Company. QX027N has obtained clinical trial approvals from the Center for Drug Evaluation of the National Medical Products Administration (Acceptance Nos.: CXSL2500757, CXSL2500758), intended for the treatment of asthma and atopic dermatitis. The Company successfully initiated the Phase I clinical trial for QX027N by enrolling the first subject in China.ABOUT WINDWARD BIO GROUP AG Windward Bio is a clinical-stage biotechnology company with deep discovery, development, and commercialization expertise committed to transforming the treatment of people living with advanced immunological conditions. Its lead program is WIN378, a potential best-in-disease, long-acting anti-TSLP monoclonal antibody currently in Phase II trials for asthma. The pipeline also includes WIN027, a clinical-stage, long-acting anti-TSLPxIL-13 bispecific, which has potential broad therapeutic application across immunological diseases. The company is building a pipeline of long-acting bispecific antibodies, targeting validated biology in respiratory and dermatological conditions.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.
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 CalderaCaldera 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.
Qyuns Therapeutics Co., Ltd. (Qyuns/the “Company”, Stock Code: 2509.HK) is pleased to announce that the long-acting bispecific antibody QX027N injection independently developed by the Company has obtained clinical trial approvals from the Center for Drug Evaluation of the National Medical Products Administration (Acceptance Nos.: CXSL2500757, CXSL2500758), intended for the treatment of asthma and atopic dermatitis. The clinical approvals of this drug candidate signify that the Company’s innovative bispecific antibody pipeline for autoimmune and allergic diseases has officially entered the clinical stage.Mr. Qiu Jiwan, Founder, Chairman of the Board and General Manager of Qyuns, stated that the clinical approvals of QX027N represent a significant milestone in the Company’s bispecific antibody pipeline, marking further progress in the synergistic development across respiratory and dermatological disease areas. To address the unmet clinical needs of hundreds of millions of patients with asthma and atopic dermatitis worldwide, the Company will continue to advance the research, development and clinical translation of innovative therapies, thereby providing patients with more effective, safer and more convenient treatment options. STATEMENT*The purpose of this news is to share cutting-edge information on the research and development work of the company (or its partners), not for advertising purposes, and not to recommend any drugs and/or indications. If you have any related diseases or medication needs, please consult a professional physician. *The press release may contain certain forward-looking statements that are inherently risky and uncertain. When using "expectation", "belief", "forecast", "expectation", "plan", "intention" and other similar words, all statements related to the company are forward-looking statements. The company is not obligated to keep these predictive statements updated. These forward-looking statements are based on the existing views, assumptions, expectations, estimates, forecasts and understandings of the company's management on future affairs when making statements, and are not a guarantee for future development or a reliable indicator of future performance. It is hereby expressly cautioned 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 restrictions and changes), some of which are beyond the company's control and difficult to predict. Therefore, the actual results may be significantly different from the information contained in the forward-looking statements due to future changes and developments in our business, competitive environment, political, economic, legal and social conditions. The company, its directors and employee agents do not assume any obligation to update, amend or supplement such forward-looking statements and any liability arising from the failure or inaccuracy of any forward-looking statements.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.
Qyuns Therapeutics Co., Ltd.( Qyuns/the “Company”, Stock Code: 2509.HK)is pleased to announce that on October 28, 2025 the Company entered into a global exclusive collaboration and license agreement (the “Agreement”) with F. Hoffmann-La Roche Ltd (“Roche”), pursuant to which the Company grants Roche the global exclusive right to develop, manufacture, and commercialize QX031N (the “Product”).Under this agreement, Roche shall be granted the global exclusive license to research, develop, register, manufacture, and commercialize OX031N. In consideration thereof, Qyuns shall receive a one-time, non-refundable, and non-creditable upfront payment of USD 75million and shall be eligible to receive milestone payments of upto USD 995 million related to product’s development, regulatory approval, and commercialization, as well as tiered royalties on potential future product sales.QX031N is an investigational long-acting bispecific antibody that targets both human thymic stromal lymphopoietin (TSLP) and human interleukin-33 (IL-33).TSLP and IL-33 are proteins called alarmins that are released in the body in response to external factors such as allergens, viruses, pollution, and mechanical stimuli. They have been shown to be involved in respiratory diseases like chronic obstructive pulmonary disease (“COPD”) and asthma, and play important roles in the inflammatory processes. QX031N is expected to be developed for the treatment of respiratory diseases such as COPD and asthma, and holds the potential to become a “First-in-class” and “Best-in-disease” therapy.Mr. Qiu Jiwan, Founder, Chairman of the Board and General Manager of Qyuns, stated that global expansion is the Company's unwavering strategic goal. With its decade of expertise accumulation in the field of autoimmune diseases, Qyuns isnow yielding promising momentum. The landmark collaboration with Roche is a strong endorsement of the Company’s in-house R&D platform and is expected to maximize the global value of QX031N. . Supported by the highly efficient and integrated R&D and CMC systems, the Company will continue to strengthen its product pipeline, in order to deliver superior therapeutic solutions for patients worldwide.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.
A Decade of Persistent Steps, Aspiring for a Thousand Miles! From June 13th to 14th, 2025, Qyuns' 10th Anniversary Celebration was successfully held in Taizhou. All employees of Qyuns, along with representatives from research institutions, industry partners, and investment firms, gathered together to review the company's decade-long journey of endeavor and look forward to a new chapter of innovation and exploration.Qyuns' Grand 10th Anniversary Celebration Held SuccessfullyA Decade in the Autoimmune FieldTen years of relentless honing, solely to explore the boundless unknowns of new scientific challenges; ten years of continuous breakthroughs, solely to redraw the boundaries of drug accessibility. Looking back on the past decade, it has been a journey for Qyuns from inception to establishment, and from exploration to breakthrough. Holding fast to its original aspiration of "Innovation for the great majority," the company has diligently cultivated the field of autoimmune diseases, achieving abundant fruitful results.Over the past decade, Qyuns has remained focused on the autoimmune field, continuously enriching its product pipeline. Leveraging its proprietary integrated innovation platform and robust independent R&D capabilities, the company has built a diversified and synergistic comprehensive product pipeline covering four major disease areas: dermatology, respiratory, gastroenterology, and rheumatology. Qyuns enhanced its leading position in the autoimmune and allergic disease in China. Co-developed with Huadong Medicine (Stock Code: 000963.SZ), SAILEXIN, is the first ustekinumab biosimilar approved in China, with estimated sales reaching RMB 300 million in 2025. Qyuns' core product QX005N (an IL-4Rα monoclonal antibody) is the first candidate biologic drug for prurigo nodularis developed by a domestic Chinese company. It has received Breakthrough Therapy Designation and is advancing multiple key clinical trials. The core product QX002N (an IL-17A inhibitor) has met the primary endpoint for its Phase III clinical trial for ankylosing spondylitis, with a Biologics License Application (BLA) submission anticipated in the second half of 2025. QX004N (an IL-23 monoclonal antibody), developed under a strategic collaboration with Hansoh Pharma (Stock Code: 3692.HK), is about to commence patient enrollment for its Phase III clinical trial in psoriasis. QX008N (a TSLP monoclonal antibody), developed in partnership with Joincare (Stock Code: 600380.SH), is leading the domestic development race for the chronic obstructive pulmonary disease (COPD) indication.Over the past decade, Qyuns has continuously strengthened its innovation breakthroughs and refined its governance systems. Building on its monoclonal antibody R&D foundation, the company is actively exploring technological iterations. Its strategic layout in the autoimmune bispecific antibody field is taking shape, laying a solid foundation for innovation in the next decade. The strategic transformation of its subsidiary Cellularforce(赛孚士) from a cost center to a profit center demonstrates its strong business development and operational management capabilities. Highly efficient and mature CMC (Chemistry, Manufacturing, and Controls) capabilities also provide robust support for the company's rapid innovation. From a startup team of nearly a dozen people to today's professional organization gathering numerous elite talents, Qyuns has established efficient R&D, production, and business development systems, providing a solid guarantee for the company's sustainable development. On March 20, 2024, Qyuns successfully listed on the Hong Kong Stock Exchange , opening a new chapter in the capital market with Stock Code 2509.HK.Over the past decade, Qyuns has continuously expanded business collaborations, consistently validating its value. Adhering to a development philosophy of "win-win cooperation," the company actively pursues diversified strategic partnerships, having established collaborations with Huadong Medicine, Joincare, and Hansoh Pharma to jointly explore future commercial opportunities. Qyuns has also entered into a NewCo partnership with internationally renowned venture capital institutions for its self-developed bispecific antibodies, taking a solid step towards global expansion. These ongoing business collaborations affirm the company's value and recognize the future commercial potential of its products.Autoimmunity SummitDuring the celebration events, Qyuns co-hosted an Autoimmune Academic Summit with representatives from research institutions, medical organizations, and industry partners. This unique "Academic Summit" commemorated the company's 10th anniversary and fostered discussions on industry innovation and development. Experts, scholars, and partners from academia, industry, and investment circles gathered to delve into the unmet medical needs and evolving treatment landscape of autoimmune diseases, decode the pathway from patient needs to research topics, explore optimal strategies for accelerating the development of innovative antibody drugs, and analyze the intrinsic logic of investment and growth in the autoimmune field.Joyous Anniversary CelebrationQyuns held a grand 10th-anniversary gala filled with a festive and grateful atmosphere. The company's 10th-anniversary theme film, "Innovation for the Great Majority," was premiered at the event. A play reviewing the company's growth journey, warm and touching employee awards, and joyful entertainment performances... All Qyuns members shared the fruits of a decade of contributions. Every segment embodied the pride Qyuns members feel in past achievements and their aspirations for the future, deepening bonds and a sense of belonging amidst laughter and joy.Looking Forward to the Next DecadeStanding at this glorious ten-year milestone, Mr. Qiu Jiwan, Founder, Chairman and General Manager of Qyuns, expressed gratitude to all parties who have continuously supported the company. "In the next decade, Qyuns will continue to deepen innovation in the autoimmune field, accelerate the development and commercialization of its pipeline candidates, actively explore new opportunities for global expansion, and further achieve sustainable development for the company," stated Qiu Jiwan. He emphasized that Qyuns will steadfastly uphold its development philosophy of "Innovation for the great majority," committed to enhancing the drug accessibility so that more patients will benefit from more advanced cutting-edge biotechnology. Qyuns team will embark on the next golden decade of innovation and breakthroughs.A decade of persistent steps, accumulating into a thousand miles. Qyuns 10th Anniversary Celebration was not only a grand tribute to past glorious achievements but also a clarion call for the magnificent journey ahead. Standing at the threshold of a new decade, Qyuns draws strength from its ten years of foundation. It will undoubtedly stride forward with more resolute steps towards its vision of "becoming a leader in the autoimmune field," writing an even more brilliant chapter for the cause of human health in the future!
On April 23, 2025, Qyuns Therapeutics(“the Company”)and Caldera Therapeutics have entered into an out-license agreement (the “License Agreement”). The License Agreement grants Caldera Therapeutics an exclusive right to develop and commercialize QX030N globally.Subject to terms and conditions of the License Agreement, Caldera Therapeutics is granted an exclusive, royalty-bearing, transferable, sublicensable right to research, develop, register, manufacture and commercialize QX030N worldwide. In return, the Company or its designated affiliate(s) (collectively, the“Group”) will be entitled to receive a one-time, non-refundable, and non-creditable upfront payment of USD$10 million, and to receive approximately 24.88% of the equity interest in Caldera Therapeutics. The Group may also receive additional payments of up to USD$545 million, subject to the achievement of certain clinical development, regulatory and commercial milestones. The Group will also be entitled to receive tiered royalties on net sales from Caldera Therapeutics during a specified time period after the first commercial sales of QX030N.QX030N is a long-acting bispecific antibody in the pre-clinical stage for the treatment of immunologic disorders.Mr. Qiu Jiwan, Founder, Chairman of the Board, and General Manager of Qyuns Therapeutics, said that gobalexpansion is a crucial business goal for the company this year. The team is thrilled to have achieved the strategic cooperation with Caldera, which once again demonstrates the company's strong and highly efficient business development execution capabilities. Leveraging the resources background of Caldera and the technological expertise of Qyuns, the global development of QX030N is poised for rapid advancement. Qyuns remains committed to its development philosophy of "innovation for the great majority", and will continue to strengthen its autoimmune pipeline matrix. Through diversified global collaborations, Qyuns aims to accelerate the delivery of innovative therapies to patients worldwide.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.