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 meeting.Crusekitug (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.ASAS40 Response Rate, Over 16-Week Treatment PeriodThe 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.ASAS20 Response Rate, Over 16-Week Treatment PeriodSecondary 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.ASAS20 Response Rate, Over 16-Week Treatment PeriodThe 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.
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.