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.Sample Image of QX027N injectionThe 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 AGWindward 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 the global exclusive collaboration and license agreement with F. Hoffmann-La Roche Ltd ("Roche") in respect of QX031N has completed the relevant regulatory filings and officially became effective. The Company has received an upfront payment of USD75 million from Roche on December 16th.Sample Image of QX031N InjectionQX031N 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” therapyQyuns entered into this collaboration with Roche on October 28, 2025. Pursuant to the License Agreement, Roche has obtained the global exclusive rights to research, develop, seek regulatory approval for, manufacture and commercialize QX031N. In return, The Company will receive a one-time, non-refundable, and non-creditable upfront payment of US$75 million and is eligible to receive up to US$995 million milestone payments associated with the development, regulatory approval, and commercialization of the product, as well as tiered royalties on potential future product salesDISCLAIMER*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.Screenshot of the CDE official websiteMr. 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.
From October 24 to 29, 2025, the American College of Rheumatology (ACR Convergence), a premier global authority conference in the rheumatology and immunology field, was held in Chicago, the United States. Qyuns Therapeutics Co., Ltd. ("Qyuns" or the "Company") presented Phase III clinical trial results in China of its self-developed CRUSEKITUG (QX002N) for the treatment of ankylosing spondylitis (AS) in an oral presentation at the ACR annual meetingCrusekitug (QX002N) Presented at the 2025 ACR Annual MeetingThis study, led by Professor Zeng Xiaofeng of the Rheumatology and Immunology Department at Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, was a multicenter, randomised, double-blind, placebo-controlled Phase III clinical study. The study included a 48-week treatment period (comprising a 16-week double-blind treatment phase and a 32-week open-label treatment phase) and a 4-week safety follow-up period, involving 641 patients randomised in a 1:1 ratio across 58 research centers in China to receive either 160 mg of Crusekitug or a placebo (subcutaneous administration once every four weeks, Q4W). The primary endpoint of the study was the proportion of subjects achieving an ASAS40 response[1] at week 16.CRUSEKITUG (QX002N) DEMONSTRATES OUTSTANDING EFFICACY IN PHASE III TRAIL FOR ANKYLOSING SPONDYLITISStudy results[2] indicated that CRUSEKITUG demonstrated significant and sustained improvements in disease activity, signs and symptoms among patients with active ankylosing spondylitis (AS) who had an inadequate response to or contraindication for nonsteroidal anti-inflammatory drugs (NSAIDs), with favourable safety and tolerability profiles observed over the 16-week treatment period.The results showed that at week 16, the study met its primary endpoint, with the ASAS40 response rate in the Crusekitug group was 40.4%, significantly higher than the 18.9% in the placebo group (P < 0.0001); meanwhile, the ASAS20 response2 [3]rate in the Crusekitug group was 65.2%, also significantly higher than that in the placebo group (P < 0.0001), indicating that Crusekitug effectively alleviates the symptoms and signs of AS patients across multiple dimensions, including pain and spinal function.Secondary endpoint results demonstrated that Crusekitug also exhibited significant superiority across multiple disease assessment measures, including disease activity, physical function, spinal mobility and life quality.IMAGING DATA CONFIRMED A SIGNIFICANT RESOLUTION OF INFLAMMATORY EDEMAIn addition to the improvements in clinical symptoms and spinal function, the study also assessed inflammation in patients’ spine and sacroiliac joints via magnetic resonance imaging (MRI). Intra-articular or intraosseous inflammation, bone destruction and new bone formation are recognized as key pathophysiological processes of axial spondyloarthritis (axSpA). MRI-detectable subchondral bone marrow edema is present in biopsy specimens in the early stages of the disease course, reflecting active inflammation[4,5]. The Spondyloarthritis Research Consortium of Canada (SPARCC) score, as an MRI-specific metric, visually quantifies edema in the spine and sacroiliac joints, thereby objectively reflecting disease activity.The treatment results at week 16 showed that the change from baseline in the spinal score was -8.1 for the Crusekitug group and the change from baseline in the sacroiliac joint score was -6.2, both significantly better than the -1.4 and -2.3 observed in the placebo group, respectively. This indicates that Crusekitug effectively reduces edema and inflammation in the spine and sacroiliac joints of subjects, providing objective imaging evidence for the drug’s ability to suppress disease activity.In terms of safety, at week 16, the incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) in the Crusekitug group was similar to that in the placebo group, and most TEAEs were mild to moderate, indicating overall favourable safety profile.The excellent clinical symptom relief efficacy and clear imaging evidence position Crusekitug as a potential new treatment option for AS patients. The Company will also accelerate the registration and submission process of such drug, striving for its early approval and market launch.ABOUT CRUSEKITUG (QX002N)Crusekitug is a high-affinity monoclonal antibody targeting IL-17A. IL-17A is a member of the IL-17 superfamily of cytokines and a key player in the pathological mechanism of various autoimmune diseases. IL-17A enhances chronic inflammation by inducing the release of and working in synergy with pro-inflammatory cytokines such as interleukin-6 (IL-6) and chemokine CXCL1. Additionally, IL-17A is involved in the regulatory mechanism of bone remodeling and has been identified as a major factor in AS pathogenesis. Crusekitug is designed to specifically bind to IL-17A, including IL-17AA and IL-17AF, thereby blocking their binding to the intended receptor complex, comprised of IL-17RA and IL-17RC, and preventing the subsequent activation of several pro-inflammatory signaling pathways, thereby inhibiting the onset and progression of inflammation.ABOUT ANKYLOSING SPONDYLITISAnkylosing spondylitis (AS) is a chronic progressive inflammatory disease characterized primarily by spinal joint inflammation, which leads to reduced joint mobility and spinal stiffness over time. According to data from Frost & Sullivan, there were 3.9 million AS patients in China in 2021, and the number is projected to reach 4.0 million by 2030. To date, the only biological drugs approved for the clinical treatment of AS in China are TNF inhibitors and IL-17 inhibitors, both of which are recommended therapies for AS patients with persistently active disease following treatment with NSAIDs. Among these two classes of biological therapies, IL-17A inhibitors provide significant clinical benefits to patients who are TNF-α inhibitor-naïve, as well as those who are intolerant to TNF-α inhibitors or unable to achieve adequate disease control.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.NOTES AND REFERENCES[1] At least three out of the four key domains in the Assessment of SpondyloArthritis International Society (ASAS) response criteria achieved a 40% improvement with an absolute increase of ≥2 points, and no worsening was observed in the remaining domain(s).[2] Zeng X, Zhang S, LIU S, Li F, wang x, SUN L, Du H, Shi G, li y, zhang h, Zhang L, Wu J, zhou m, gu z, zhao y, fang m, Song Q, wang t. Effect of QX002N on Clinical and Radiographic Outcomes in Ankylosing Spondylitis: Results from a Phase III Randomized, Double-blind, Placebo-Controlled Study [abstract]. Arthritis Rheumatol. 2025; 77 (suppl 9). https://acrabstracts.org/abstract/effect-of-qx002n-on-clinical-and-radiographic-outcomes-in-ankylosing-spondylitis-results-from-a-phase-iii-randomized-double-blind-placebo-controlled-study/. Accessed October 21, 2025.[3] Under the Assessment of Spondyloarthritis international Society (ASAS) response criteria, at least 3 out of the four key indicators must achieve a 20% improvement with an absolute improvement of ≥1 point, and the remaining indicator(s) must not deteriorate.[4] Navarro-Compán V, Sepriano A, Capelusnik D, Baraliakos X. Axial spondyloarthritis. The Lancet. 2025;405(10473):159-172.[5] Maksymowych WP, Inman RD, Salonen D, et al. Spondyloarthritis research Consortium of Canada magnetic resonance imaging index for assessment of sacroiliac joint inflammation in ankylosing spondylitis. Arthritis & Rheumatism. 2005;53(5):703-709.
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.