On March 31, 2026, Qyuns Therapeutics Co., Ltd. (hereinafter referred to as "Qyuns" or the "Company") held its 2025 Annual Results Meeting. During the presentation, Mr. Qiu Jiwan, Chairman of the Board and General Manager, Mr. Lin Weidong, Deputy General Manager, and Mr. Hu Yanbao, Board Secretary, jointly presented the Company's strong performance achieved in 2025 and addressed key issues of concern to investors. A summary of the Q&A session of the 2025 Annual Results Meeting is set out below:

Financial Performance

Q:Qyuns recorded total revenue of RMB 807 million in 2025, representing a year-on-year increase of 408.2%. What is the Company’s financial outlook for 2026? Is profitability expected to continue?

A:In 2026, the Company expects full-year revenue of no less than RMB 500 million and is on track to sustain the profitability achieved in 2025. In terms of business development (BD), upfront payments and partial milestone payments from overseas collaboration projects with partners including Windward and Roche are expected to be progressively recognized in 2026. For the CDMO business, backed by the order backlog carried over from 2025 and new orders, CDMO revenue is projected to maintain rapid growth throughout 2026. On the commercial product front, sales of SAILEXIN in 2026 are expected to generate over RMB 20 million in supply revenue and approximately RMB 40 to 50 million in profit sharing. If the Company’s overseas BD performance exceeds expectations, the Company could reach a higher revenue target. Accordingly, even with sustained high-intensity R&D investment, the Company remains on track to maintain profitability going forward, and there is no need for concern over a performance decline.

Q:The Company acquired an approximate 24.88% equity interest in Caldera through its first overseas out-licensing transaction. Is there any expectation for the future appreciation of this equity interest?

A:As disclosed in the annual results announcement, the value of this equity interest had appreciated by approximately RMB 38 million by the end of 2025. The Company is highly optimistic about the appreciation potential of this equity interest, mainly based on the following aspects: first, the inflammatory bowel disease (IBD) sector features vast market space and growth potential. While multinational corporations (MNCs) have built extensive portfolios of monoclonal antibody therapies, bispecific antibody products remain highly scarce in this field. As one of the earlier IL-23p19/TL1A bispecific antibodies to enter clinical stage, QX030N has prominent scarcity value and first-mover advantages. Second, the Caldera team has accumulated extensive clinical development experience in the field of IBD therapeutics with its α4β7 small molecule inhibitor program, which can provide strong professional support for the clinical advancement and subsequent strategic layout of QX030N. Third, Caldera has a high-profile investor base and has completed its financing rounds with oversubscription, with cumulative financing proceeds totaling USD 112.5 million. Caldera has earned strong recognition from the US capital market, providing solid financial backing for the follow-up development of the program.

Q:Ustekinumab (SAILEXIN) recorded sales of nearly RMB 300 million in 2025, marking a solid performance in its first launch year. What is the sales outlook for this year? What contribution will it make to the Company’s revenue?

A:SAILEXIN delivered strong sales performance in 2025. Despite its relatively short launch period, its full-year sales reached nearly RMB 300 million. This result validates the product’s strong market competitiveness and robust clinical demand for its relevant indications, while also highlighting Huadong Medicine’s outstanding commercialization and marketing capabilities. The overall performance is in line with earlier expectations.

For 2026, SAILEXIN is expected to achieve sales of approximately RMB 500 million. The Company’s related revenue consists of two main components: product supply revenue and pre-tax profit sharing from sales. Together, they are expected to contribute approximately RMB 60 to 70 million in revenue to the Company. In addition, the Crohn’s disease (CD) indication for SAILEXIN is expected to receive approval in the first half of 2026, which will generate incremental in sales.

Q:The annual results announcement shows that the Company still has a considerable amount of bank debt. Will this pose financial risks going forward?

A:In 2025, the Company recorded substantial revenue growth, driving a notable increase in total assets and a significant improvement in cash flow. The aggregate value of cash and cash equivalents, time deposits and financial assets measured at fair value through profit or loss amounted to RMB 1,042 million, representing an 87.4% increase from the beginning of the year. The debt-to-asset ratio decreased from 77.5% in 2024 to 57.6%, with debt servicing capacity significantly strengthened. Approximately 92% of the company's working capital loans have a maturity of 2-3 years, featuring a relatively long debt repayment cycle. These obligations can be gradually settled by leveraging the sustained growth of various revenue streams in the future. The Company’s overall financial position remains sound and robust.

Q: What is the Company’s R&D expense outlook for 2026?

A:Currently, the Company’s R&D pipeline is advancing in an orderly manner. Monoclonal antibody pipeline programs have gradually entered their final stage, while bispecific antibody products are successively entering clinical stages, with its R&D portfolio demonstrating a sound momentum of tiered advancement and breakthroughs across multiple fronts. For 2026, the Company will not scale back its R&D investment; instead, it will continue to ramp up such investment to fully drive the delivery of its innovative pipeline. The Company will initiate Phase I or Phase II clinical trials for multiple bispecific antibody programs in both China and overseas markets, accelerating the global deployment of its bispecific antibody pipeline and deepening its engagement in international clinical development. Meanwhile, the Company will further step up R&D investment in pre-clinical innovative products.

Business Portfolio

Q:Over the past decade, the Company has built its core commercial foundation with proven commercial certainty through monoclonal antibody products, while strengthening its global competitiveness in the autoimmune sector with a pipeline of bispecific antibody programs. Looking ahead to the next decade, how will the Company further consolidate its leading position in the autoimmune field?

A:Over the past decade, Qyuns has steadily advanced the foundational layout of monoclonal antibody products across four therapeutic areas — skin, respiratory, digestive and rheumatology — in line with its established strategy, further deepening its understanding of clinical treatment needs across these fields. Looking ahead to the next decade, building on its long-term outlook on disease treatment trends and leveraging its technological accumulation and proven experience in the autoimmune sector, the Company will drive continuous, high-efficiency R&D and product iteration centered on the goal of long-term disease management.

On the international front, the Company will unswervingly pursue its internationalization roadmap while securing its domestic core market base, continue to advance overseas BD transactions, and further unlock the global BD value of its pipeline assets. Meanwhile, through partnerships with international counterparts, Qyuns will steadily build out its overseas clinical team, consolidate its global clinical development capabilities, and strive to proactively participate in and independently lead international clinical trials going forward.

Over the past decade, the Company has developed 5 monoclonal antibody products with strong commercial certainty. Over the next decade, the Company aims to have 3 to 5 innovative products launched globally or enter pivotal clinical stages.

Q:The combination of IL-23p19 and TL1A has attracted considerable attention. How does the Company view the synergistic effect of these two targets? What is the development outlook for the QX030N (IL-23p19/TL1A bispecific antibody) program going forward?

A:In the field of inflammatory bowel disease(IBD), monoclonal antibody therapies have demonstrated a clear efficacy ceiling, leaving a substantial unmet clinical need. Bispecific antibody therapies are increasingly recognized as a superior therapeutic option. A comprehensive analysis of clinical data across multiple potential IBD targets (including IL-23p19, IL-12/23p40, α4β7 and TL1A) has revealed that IL-23p19 monoclonal antibodies and TL1A monoclonal antibodies exhibit differentiated efficacy advantages over other agents. From a mechanistic standpoint, the IL-23 and TL1A signaling pathways regulate partially overlapping effector cell repertoires while also engaging distinct specific cell populations. A bispecific antibody strategy that concurrently blocks both IL-23 and TL1A is theoretically positioned to cover a broader spectrum of pathogenic pathways, thereby offering deeper clinical improvement for patients. Based on these synergistic advantages, Qyuns believes that dual targeting of these two pathways represents the current optimal solution for IBD therapy, with the potential to alleviate intestinal fibrosis and achieve meaningful disease-modifying outcomes.

The clinical development of QX030N is progressing smoothly. In Australia, the Phase Ⅰ trial has completed enrollment of two cohorts, placing us at a globally leading stage. Qyuns expects to complete the primary deliverables of the Phase Ib component within this year, with an international Phase Ⅱ initiation targeted for early next year. In parallel, we will support the launch of a domestic Phase Ⅰ trial in Crohn’s disease (CD) in China during the second half of this year.

Q:According to public information, the transaction between the Company and Roche was completed highly efficiently in approximately five months. What preparations did the Company make during this process to facilitate such efficient collaboration?

A:Chronic obstructive pulmonary disease (COPD) is one of Roche’s core priority indications. Both parties share high consensus on the mechanistic potential of the TSLP/IL-33 target combination in the respiratory field, with seamless communication on scientific mechanisms, and Roche has strong intent to incorporate this asset into its pipeline. Accordingly, the subsequent due diligence and internal decision-making processes of both sides progressed rapidly.

Meanwhile, the Company’s comprehensive, high-quality pre-clinical research and data reserves laid a solid foundation for this collaboration. Its robust and reliable CMC system enabled the Company to successfully pass Roche’s on-site due diligence. Ultimately, led by the high-performing BD team and with the concerted efforts of the entire company, this collaboration was advanced efficiently.

Q:Very few companies are developing the TSLP/IL-33 target combination. What was the Company’s initial rationale for designing this combination? What are the follow-up development plans for this program? 

A:Thymic stromal lymphopoietin (TSLP) and IL-33 have long attracted substantial R&D attention and demonstrated considerable clinical promise in COPD. Mechanistically, both are key upstream regulatory targets of the inflammatory cascade, co‑mediating the initiation of inflammatory signals. Notably, they can reciprocally promote each other’s release and expression, thereby amplifying the downstream inflammatory response. Accordingly, concurrent blockade of both TSLP and IL-33 pathways is theoretically expected to confer significant therapeutic synergy and development potential.

From a clinical data perspective, currently available TSLP monoclonal antibodies have shown limited efficacy in patients with the non-eosinophilic phenotype of COPD. Conversely, while IL-33 monoclonal antibodies are highly anticipated in COPD therapy, single-target inhibitors of IL-33 have demonstrated relatively modest clinical benefit as monotherapies. By simultaneously neutralizing both targets, the Company aims to develop a bestinclass product with superior efficacy and broader patient coverage, to break through the limitations of current therapies and reshape the treatment landscape of respiratory diseases.

The QX031N program has reached a key milestone. The first subject was successfully enrolled in the Phase I clinical in New Zealand in March 2026. Preliminary human safety and pharmacokinetic (PK) data from this trial are expected to be obtained within 2026.

Q:Besides QX027N, the TSLP/IL-13 bispecific antibody, the Company’s partner Windward also has a TSLP monoclonal antibody in its pipeline. It does not appear to be a pure NewCo. What is the rationale behind Windward’s pipeline portfolio setup? What are the follow-up development plans for QX027N?

A:Windward is a high-caliber, high-quality partner with in-depth understanding of the pathogenesis of inflammatory diseases. Its TSLP monoclonal antibody focuses on respiratory diseases, and Windward is actively expanding its pipeline portfolio and indication coverage to include dermatology and other therapeutic areas. In light of this, the two parties entered into a collaboration on the TSLP/IL-13 bispecific antibody. Meanwhile, as a long-acting bispecific antibody, QX027N is designed to be a next-generation alternative to IL-4Rα monoclonal antibodies, with the goal of delivering significant improvements in both efficacy and patient compliance.

In terms of clinical advancement, the domestic Phase I clinical trial of QX027N is progressing smoothly. Single-dose cohort dosing in healthy subjects has been completed, with a preliminary estimated half-life of 50 to 70 days, supporting a Q12W dosing interval. One cohort of the multiple-dose group in patients with atopic dermatitis (AD) has also completed dosing. The Company plans to sequentially initiate domestic Phase II clinical trials for AD and asthma in the second half of 2026, and aims to launch the domestic Phase III clinical trial within 2027. Building on QX027N’s domestic clinical data, Windward is evaluating the feasibility of initiating a Phase II multi-regional clinical trial (MRCT) together with the Company within 2026.

Q:Given that the Company has QX005N, an IL-4Rα monoclonal antibody, has the Company considered developing IL-4Rα-based bispecific antibodies?

A:The IL-4Rα target demonstrates high in vivo expression abundance and is subject to pronounced target-mediated drug disposition (TMDD), necessitating high-dose, high-frequent-dosing regimens to maintain therapeutic efficacy. Accordingly, IL4Rα monoclonal antibodies, which exhibit nonlinear pharmacokinetic profiles attributable to TMDD, are suboptimal for long-acting maintenance therapy. Similar challenges are highly likely to be encountered by IL-4Rα-targeting bispecific antibodies as well.

In response, The Company’s core bispecific development strategy is centered on further enhancing clinical efficacy, optimizing dosing convenience (targeting at least Q12W schedule) and reducing treatment costs. Mechanistically, targeting the ligands such as IL-13 or IL-4 is a more favorable option.

Q:The Company’s c-kit monoclonal antibody was previously at a leading development stage, but it is no longer included in the currently disclosed pipeline. What was the Company’s rationale for discontinuing this program?

A:Mast cells are key effector cells in type 2 inflammation. Targeting ckit directly engages these cells, offering the potential more direct and rapid therapeutic improvement as well as deeper allergy relief. While IgE antibodies have demonstrated meaningful efficacy in allergy diseases, they are largely ineffective in conditions driven by non-IgE-mediated mast cell activation. In contrast, c-kit-directed therapies may cover a broader spectrum of allergic diseases and potentially yield superior clinical outcomes. However, c-kit is widely expressed across multiple cell lineages, and its inhibition affects melanocytes, hematopoietic stem cells and spermatogonia, resulting in adverse events such as hair depigmentation. Although these side effects are reversible upon treatment discontinuation, they impose significant psychological burden and raise patient concerns regarding long‑term treatment.

In light of these considerations, despite QX013N being currently the only c-kit monoclonal antibody in development in China, the Company has chosen to pause this program and pivot toward the development of a series of bispecific antibodies targeting this pathway, including QX035N.

Q:The Company expects to submit the IND for QX035N in the second half of 2026. What are follow-up clinical advancement plans for both domestic and overseas markets? Do the pre-clinical data demonstrate further advantages over c-kit monoclonal antibodies?

A:Pre-clinical animal studies have demonstrated that QX035N effectively addresses the safety limitations associated with c-kit monoclonal antibody, significantly mitigating hair depigmentation as well as the adverse effects on hematopoietic stem cells and spermatogonia. These findings confirm that QX035N achieves precise and selective modulation of mast cells.

The Company plans to submit the IND application in September 2026. Leveraging its accumulated clinical trial experience in Australia, the Company will initiate enrollment in the overseas Phase I clinical trial as soon as possible to obtain human safety and PK data at the earliest opportunity.

Q:The Company is a leading player in autoimmune bispecific antibody development. What are the Company’s key considerations for its subsequent indication portfolio layout? What is the BD outlook for 2026?

A:The Company’s pipeline portfolio will prioritize four core therapeutic areas. It will continue to expand and advance product R&D centered on full-lifecycle disease management, to continuously develop safer and more effective therapies, with key indication focuses including hidradenitis suppurativa (HS), pulmonary fibrosis, and related kidney diseases driven by abnormal B-cell activity.

BD will remain a core pathway for the Company’s internationalization strategy. In 2025, the Company secured strong validation through three overseas BD transactions, with its technical capabilities and product value gaining international recognition. In 2026, the Company will adopt a more comprehensive BD strategy: it will proactively engage deeply in partnership projects, strengthen its R&D engagement and product ownership, and be deeply involved in the protocol design, operational management and execution of international clinical trials.

Q:The Company plans to commercialize its IL-17A monoclonal antibody QX002N in-house. What preparations has the Company made for this commercialization to date? Is there a preliminary sales outlook for the product?

A:The Phase III clinical trial data of Crusekitug (QX002N) in ankylosing spondylitis (AS), including its full-year long-term efficacy, safety profile and imaging evidence, has been highly recognized by the trial’s principal investigators (PIs). The Company plans to build a lean and professional commercial team, adopting a hybrid model of "in-house professional team + multi-channel collaboration", with a focus on covering core rheumatology diagnosis and treatment centers across China, to ensure efficient market reach during the initial launch period and deliver cost-controlled commercialization.

For sales targets, the Company expects that within three years of marketing approval, sales of Crusekitug will gradually reach approximately RMB 500 million. The Company’s core strategic goal is to establish it as a foundational therapy for long-term chronic disease management of AS, addressing the current domestic treatment landscape where the average patient treatment course is less than one year, and driving 3 to 5 years of standardized long-term medication for patients, to truly halt disease progression and reduce joint damage, rather than only relieving symptoms. Additionally, most competing products targeting the same IL-17A pathway are focused on psoriasis, resulting in a relatively favorable competitive landscape for the AS indication.

Q:Recently, domestic IL-4Rα monoclonal antibodies have successively received NDA acceptance. What are the Company’s strategic considerations for Oturkibart (QX005N) amid upcoming commercial competition? 

A:First, IL-4Rα class agents have a broad range of approved indications and cover a large patient population. The substantial patient base is sufficient to support the co-existence of multiple products in this category, while there remains substantial room for growth in market penetration for this drug class.

Second, as one of only two IL-4Rα products in China granted Breakthrough Therapy Designation (BTD), Oturkibart leads in development progress for its prurigo nodularis (PN) indication, with its NDA expected to be submitted by June 2026. Meanwhile, the NDA for its adolescent and adult atopic dermatitis (AD) indication is expected to be submitted by December 2026, enabling the product to further cover the adolescent patient population upon launch.

Third, Qyuns has established a collaboration with Huadong Medicine for Oturkibart (Huadong Medicine R&D code: HDM3016). As both PN and AD are core dermatology indications, this product is highly aligned with Huadong Medicine’s comprehensive dermatology development strategy. On one hand, in combination with Huadong Medicine’s existing portfolio of oral and topical products, Oturkibart can form strong combination therapy advantages, further expand combination disease management scenarios, and enhance treatment efficacy. On the other hand, supported by Huadong Medicine’s deep commercial channel resources and mature promotion capabilities in dermatology, the Company is fully confident in the post-launch sales performance of Oturkibart.

Q:With existing IL-17 products and other competing products already on the market, what is the Company’s outlook on the future competitive landscape for QX004N (IL-23p19 monoclonal antibody)?

A:The Company has entered into a strategic collaboration with Hansoh Pharma for the QX004N program (Hansoh R&D code: HS-20137). Among all products targeting the same IL-23p19 target, QX004N currently ranks among the top two domestically developed products in terms of development progress. Hansoh Pharma has strong innovative drug incubation capabilities and mature commercialization strength, which will deliver additional empowerment to QX004N.

The Company is firmly confident in the long-term dominant position of the IL-23 pathway in psoriasis treatment, and believes this target represents the optimal solution for current psoriasis therapy. As a chronic disease requiring long-term standardized management, psoriasis treatment places critical importance on long-term efficacy, safety profile and patient compliance. According to overseas real-world studies (RWS), IL-17 antibodies have a significantly lower drug retention rate (e.g., measured over a 5-year period) compared to IL-23 antibodies, creating clear demand for treatment switching among a subset of patients. In addition, Risankizumab, the landmark IL-23 product, reached global sales of USD 17.6 billion in 2025, approaching Dupilumab’s USD 18.2 billion sales in the same year. Given that Dupilumab covers a broader range of indications and larger patient populations with far fewer competitors, this further confirms the dominance of IL-23 antibodies in both psoriasis and IBD indications.

Q:What is the Company’s outlook on the competitive landscape and future potential of QX008N (TSLP monoclonal antibody)?

A:QX008N (Joincare R&D code: JKN2401) will be a highly competitive product. First, the treatment paradigm in respiratory medicine is evolving, with biologics seeing increasing clinical adoption. Tezepelumab has delivered strong annual sales growth, with global sales approaching USD 2 billion last year. Second, Joincare holds a strong leading position in the COPD field: it currently ranks first in domestic development progress among all same-target products (including Tezepelumab), with highly efficient clinical advancement. Patient enrollment for its Phase III clinical trial has already commenced, and the program is expected to sustain its competitive advantage going forward. Accordingly, the evolving treatment landscape, prominent leading competitive position, and Joincare’s robust commercial resources in the respiratory field endow this product with highly promising future prospects.