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Q&A Transcript of the 2026 Interim Results Meeting of Qyuns Therapeutics

time:2026-08-31article Source:Qyunshit: 次

On August 21, 2026, Qyuns Therapeutics Co., Ltd. (hereinafter referred to as "Qyuns" or the "Company") held its Interim Results 2026 Meeting. During the meeting, 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 the first half of 2026 and addressed key issues of concern to investors. A summary of the Q&A session of the Interim Results 2026 Meeting is set out below:

 

Financial Part

Q:Sales of SAILEXIN/SAIJIENING in 2026H1 have already exceeded full-year 2025 sales. Will the full-year 2026 sales guidance be updated?

A:This product has contributed over RMB 40 million in profit-sharing income and more than RMB 9 million in supply income in 2026H1, with excellent sales performance. Benefiting from robust sales growth in 2026H1, the Company will further raise its full-year sales expectation for this product from the previous guidance of RMB 500 million at the beginning of the year. Meanwhile, our commercialization partner Huadong Medicine continues to intensify its promotion and channel coverage efforts. To date, the product has been covered by over 2,000 hospitals, further validating our judgment at the project initiation stage: the efficacy and convenience of this product are highly aligned with China's commercialization environment.

 

Q:How has the full-year revenue expectation changed compared with the beginning of the year? What are the revenue expectations for R&D services and CDMO business? Is it possible to remain profitable this year?

A:The Company set a revenue target of no less than RMB 500 million at the beginning of the year, and 80% of this target has already been achieved within 2026H1. As shown in our latest interim results 2026 announcement, CDMO and R&D services revenue has increased significantly year-on-year. Last year, the Company concluded several influential international BD collaborations, and our partners highly recognize the Company's CMC capabilities. Process development and clinical trial sample supply for certain collaboration projects have been entrusted to the Company, and BD business has effectively driven growth in the R&D services segment. Meanwhile, the Company continues to expand its base of high-quality, stable customers in both domestic and overseas markets, with a more diversified customer structure. Newly signed order value in 2026H1 exceeded RMB 170 million, and the Company's CDMO business has overall maintained a steady and upward development trend.

In terms of profitability, the Company expects to remain profitable this year. Looking ahead over the next three years, the Company will target sustained profitability as its operating objective, balancing income and expenditure while steadily advancing product development.

 

Q:The Company has formed a revenue structure comprising product BD licensing, R&D services (CDMO), and product profit-sharing, but BD licensing revenue still dominates. How does the Company expect the proportion of these three revenue streams to evolve in the future?

A:Over the next 2-3 years, BD licensing revenue will remain the Company's primary revenue source. As SAILEXIN/SAIJIENING (Ustekinumab injection) sales ramp up, product profit-sharing revenue is expected to grow year by year. CDMO and other R&D services revenue will maintain steady growth. Following the approval of QX002N, product sales revenue will also become an important part of the Company's revenue. It is foreseeable that, in terms of revenue structure, the proportion of more deterministic and stable revenue categories (such as product profit-sharing income and supply revenue) will increase year by year, gradually smoothing the volatility caused by BD licensing revenue, and driving the Company's revenue sources toward a more deterministic and diversified structure.

 

Q:Does the Company have a rough expectation for revenue over the three years from 2026 to 2028?

A:In 2025, the Company achieved explosive revenue growth and became profitable, supported by the successful conclusion of multiple overseas BD transactions. Given that revenue from BD transactions is characterized by its irregularity, the Company does not wish for such performance to be a short-lived, stage-specific phenomenon, and has internally formulated clear plans and targets for revenue stability. The Company expects annual revenue of no less than RMB 500 million over the next three years. If additional BD collaborations are subsequently concluded, or if existing NewCo companies are acquired, this will further augment the Company's revenue and create a value-accretive effect.

Meanwhile, with the rapid advancement of bispecific antibody projects in clinical development, R&D investment is expected to increase year by year. The Company will strengthen capital management, balance revenue and expenditure, and ensure sustained profitability over the next three years.

 

Q:The Company's R&D expenditure in 2026H1 was approximately RMB 100 million, which does not appear high. Is R&D expenditure mainly concentrated in 2026H2? What is the expected total expenditure for this year?

A:In 2026, the Company is in a transition period in which Phase III clinical trials of monoclonal antibody projects are gradually concluding and bispecific antibody projects are initially entering clinical trials. Given this pace of pipeline transition, R&D investment has experienced a stage-specific short-term decline, which is a normal phenomenon in the pipeline iteration process. In addition, R&D expenses corresponding to certain overseas-licensed projects are borne by the partners and recorded in cost of sales, and therefore are not reflected in the R&D expenses in this interim financial report. The Company expects full-year 2026 R&D expenditure to be not less than the prior year's level. Starting in H2 this year, the Company will sequentially advance multiple Phase II clinical trials for several bispecific antibody projects, and R&D investment is expected to increase significantly.

 

Business Part

Q:QX004N (IL-23p19 monoclonal antibody) and QX008N (TSLP monoclonal antibody) still maintain favorable competitive positions. What is the Company's expectation for subsequent milestone payments?

A:Both projects maintain leading positions in their respective fields. QX004N/HS-20137 maintains a top-two position among domestic players, and QX008N/JKN2401 aims to complete Phase III clinical enrollment within this year. Milestones for both projects will continue to be triggered as the projects progress. For example, the Company has already received RMB 20 million in milestone payments from Joincare this year, and the certainty of receiving subsequent milestones is also relatively high.

 

Q:QX027N (TSLP/IL-13 bispecific antibody) is in a globally leading position in terms of R&D progress. What are its next domestic and overseas development plans? What are the partner's subsequent capital market plans? What is the Company's expected return?

A:The clinical development progress of QX027N/WIN027 is at a relatively advanced position, and project advancement is in line with the expectations of both parties. In the collaboration with Windward Bio, the Company has retained all domestic development and commercialization rights for this product, and plans to sequentially initiate four domestic Phase II clinical trials in 2026H2. The partner's overseas clinical development work is also under planning. Windward Bio has raised a total of US$365 million in financing to date, with its enterprise value continuously increasing. It is expected to bring favorable returns to Qyuns in the future. Specific information will be announced by the collaboration partner in due course.

 

Q:

There are many developers of IL-23p19/TL1A bispecific antibodies, and four overseas BD deals have already been concluded. How does the Company view the competitive landscape of this product? What are the molecular design features of QX030N? What are the partner Caldera's subsequent capital market plans? What is the Company's expected return?

A:Our partner Caldera has successively completed multiple rounds of financing, with cumulative announced financing of nearly US$400 million (completed and in process), fully validating the high recognition of the product value and clinical potential of QX030N/CLD-423 by overseas capital markets. Currently, the overall R&D progress of this project ranks among the industry leaders, with an excellent competitive landscape.

QX030N/CLD-423 adopts a native IgG structure and a rationally designed monovalent 1+1 format, precisely targeting the TL1A and IL-23p19 pathways. Since TL1A readily forms trimers, the 1+1 format can effectively avoid the formation of large-scale immune complexes (one TL1A trimer can bind at most three drug molecules and will no longer form larger composite structures, whereas conventional TL1A monoclonal antibodies or 2+2 format bispecific antibodies may link multiple trimers through their two TL1A arms), thereby reducing the incidence of ADA. Preliminary clinical data at this stage also provide strong support for this logic.

Overall, the R&D progress, molecular characteristics, and clinical performance of this project fully meet the expectations of both teams. Both parties believe that this product has outstanding core competitiveness and is expected to become a high-quality asset with significant differentiated advantages in its class.

In addition, Caldera has announced that it expects to complete the merger transaction and list on the Nasdaq Capital Market in early 2027. If subsequent capital market performance is favorable, it will also bring considerable returns to the Company. Specific information will be announced by the collaboration partner in due course.

 

Q:What is the progress of QX031N (TSLP/IL-33 bispecific antibody) within Roche's R&D pipeline? Are there any updates to subsequent development plans?

A:QX031N/RG6981 has been incorporated into Roche's R&D pipeline (as reflected in its Q1 2026 and interim reports). The Phase I clinical trial conducted in New Zealand is proceeding smoothly, and subsequent progress will be disclosed by Roche.

 

Q:What is the current R&D progress of QX035N (c-kit bispecific antibody)? What are the next advancement plans? Which indications will be covered first? Is there any expectation for external collaboration?

A:QX035N is one of the core assets in the Company's 2.0 innovation pipeline. The Company highly recognizes the mechanism of action and future potential of this product, and also expects an overseas BD collaboration to materialize. The Company plans to submit the IND application in September and initiate clinical trials in Australia within the year, initially covering chronic urticaria (CU), asthma, food allergy, and intestinal inflammation, among other diseases.

 

Q:According to public reports, multiple bispecific antibodies in the industry carry high ADA risk. How does the Company reduce the risk of ADA occurrence at the early research stage?

A:The occurrence of ADA is mainly related to the physicochemical properties of antibody molecules, including glycosylation, charge distribution, and hydrophobicity. The bispecific antibody molecules developed by the Company are constructed based on monoclonal antibodies generated from the rabbit antibody platform, which features high throughput and outstanding screening efficiency. At the initial stage of molecular structure design, the Company also tends to adopt relatively conservative structural designs to reduce the risk of immunogenicity. In addition, the Company has established a scientific evaluation system for potential human immunogenicity, equipped with AI-assisted analysis, which can effectively assess and avoid potential immunogenicity risks of bispecific antibody molecules in humans. To date, numerous antibody molecules derived from this platform have been demonstrated to possess low immunogenicity characteristics at the clinical stage.

 

Q:After the Company's early-stage bispecific antibodies concluded overseas BD collaborations, they all rapidly advanced to overseas clinical stages and generated milestone revenue. What aspects of preparation does the Company believe have contributed to this high-efficiency advancement?

A:The seamless integration between the early research team and the CMC team has improved overall project advancement efficiency. In particular, the stable CMC system provides continuous support in molecular drug formation evaluation, manufacturing process development, and trial sample supply. In addition, the clinical teams of both collaboration parties work very closely together, and the partners have strong project advancement capabilities and a strong willingness to invest resources. All these factors have jointly contributed to the rapid initiation of clinical trials.

 

Q:Does the Company have expectations for expanding into other indications, and has it considered modalities other than antibodies?

A:On the one hand, the Company will continue to build a multi-pipeline portfolio around its advantageous indications, continuously improving efficacy levels compared with existing therapies and forming product matrices in certain areas. On the other hand, the Company will continue to assess the potential scale and development trends of other autoimmune indications, developing new products with stronger competitiveness in efficacy and convenience. The Company is also continuously monitoring other drug modalities. In this process, we will continue to increase R&D and innovation investment and continuously expand our capability boundaries.