Qyuns Therapeutics

What Qyuns Therapeutics does

Qyuns Therapeutics (荃信生物, HKEX: 2509.HK) is a clinical-to-commercial-stage biopharmaceutical company founded in 2015 and headquartered in Taizhou, Jiangsu, China. The company is focused exclusively on developing antibody therapeutics for autoimmune and allergic diseases, with a pipeline spanning four major therapeutic areas: dermatology (psoriasis, atopic dermatitis, prurigo nodularis, chronic spontaneous urticaria), rheumatology (ankylosing spondylitis, systemic lupus erythematosus), respiratory (asthma, COPD, chronic rhinosinusitis with nasal polyps), and gastroenterology (Crohn's disease, ulcerative colitis). Its portfolio includes ten pipeline candidates with 24 IND approvals, one approved product (QX001S, a ustekinumab biosimilar), one NDA under review (QX002N for ankylosing spondylitis), and three candidates in Phase III.

Qyuns operates an integrated R&D-to-commercialization platform anchored by a proprietary rabbit antibody development platform that uses advanced B cell cloning technology to generate high-affinity, low-immunogenicity antibodies. The company's commercial-scale cGMP manufacturing facility at Taizhou features four 2,000L single-use bioreactors with approximately 300 kg annual antibody production capacity, compliant with China, US, and EU cGMP standards. The company has invested in long-acting bispecific antibody technology targeting multiple inflammatory pathways simultaneously (e.g., TSLP/IL-33, TSLP/IL-13, IL-23p19/TL1A).

Qyuns employs a hybrid commercialization model combining direct domestic sales through Chinese pharmaceutical partners (Huadong Medicine for QX001S, Hansoh Pharma for QX004N, Joincare for QX008N) with out-licensing arrangements for global markets. Major international licensing deals include Roche for QX031N ($75M upfront plus up to $995M in milestones), Windward Bio for QX027N (up to $700M potential), and Caldera Therapeutics for QX030N ($10M upfront plus up to $545M in milestones). The company reported over fourfold revenue growth in 2025 with adjusted profit of approximately RMB 356 million, marking its first year-on-year profit turn, driven by QX001S sales of approximately RMB 300 million and significant licensing income.

Name

Qyuns Therapeutics

Legal name

Jiangsu Qyuns Biopharmaceutical Co., Ltd. (江苏荃信生物医药股份有限公司)

Website

https://qyuns.net

Company type

Public

Founded year

2015

Operating status

Operating

Headcount range

251–500 employees

Short description

Qyuns Therapeutics (HKEX: 2509.HK) is a China-based clinical-to-commercial biopharmaceutical company developing antibody therapeutics for autoimmune and allergic diseases, with one approved biosimilar product, multiple Phase III candidates, and global out-licensing partnerships with Roche, Windward Bio, and Caldera.

Ownership category

akta.pro rank

Product category

Biopharmaceutical Therapeutics

NAICS

Biological Product (except Diagnostic) Manufacturing (325414)

SIC

Biological Products, (No Disgnostic Substances) (2836)

akta.pro primary industry

Cytokines, Interferons & Immunomodulatory Proteins (HLAAAAAC)

akta.pro secondary industries

Bispecific & Multispecific Antibodies (HLAAAAAF), Immunology & Autoimmune Specialty Pharmaceuticals (HLAIACAB), Autoimmune & Rheumatology Biosimilars (HLAAAHAI)

Keywords

• Monoclonal antibody therapeutics
• Biopharmaceutical drug development
• Autoimmune disease treatments
• Biosimilar antibody products
• Bispecific antibody technology

Headquarters

HQ city

Taizhou

HQ country

China

HQ region

Asia

Offices3 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Supply Chain, Marketing or Sales, Infrastructure

Revenue model

1. Out-licensing Revenue: Qyuns receives upfront payments, milestone payments tied to development, regulatory approval, and commercialization achievements, plus tiered royalties on net sales from licensed products. Major deals include Roche (QX031N: $75M upfront + up to $995M milestones), Windward Bio (QX027N: up to $700M), and Caldera Therapeutics (QX030N: $10M upfront + up to $545M milestones).
2. Product Sales (QX001S): QX001S (赛乐信/赛捷宁), a ustekinumab biosimilar, is co-commercialized in China with Huadong Medicine. In 2025, domestic sales approached RMB 300 million (including value-added tax).
3. 2025 Financial Performance: Reported more than fourfold increase in 2025 revenue with adjusted profit of approximately RMB 356 million, marking a year-on-year profit turn.

Go-to-market motion1 record

Distribution channels4 records

Marketing channels4 records

Core offering

Qyuns Therapeutics discovers, develops, manufactures, and commercializes innovative monoclonal antibody and bispecific antibody therapeutics for autoimmune and allergic diseases spanning dermatology, rheumatology, respiratory, and gastroenterology indications. The company operates an integrated platform covering rabbit antibody-based drug discovery, preclinical and clinical development, commercial-scale cGMP manufacturing, and partnership-driven commercialization. Its commercial product QX001S (ustekinumab biosimilar) is sold in China for psoriasis and Crohn's disease, while multiple pipeline assets are out-licensed or co-developed with multinational and Chinese pharmaceutical partners for global and domestic markets.

Product overview

Qyuns Therapeutics is a clinical-stage biopharmaceutical company exclusively focused on antibody drugs for autoimmune and allergic diseases. The company has a diversified pipeline spanning four major disease areas: dermatology (psoriasis, atopic dermatitis, prurigo nodularis, chronic spontaneous urticaria), rheumatology (ankylosing spondylitis, systemic lupus erythematosus), respiratory (asthma, COPD, chronic rhinosinusitis with nasal polyps), and gastroenterology (Crohn's disease, ulcerative colitis). The portfolio includes one approved and marketed product (QX001S/赛乐信® for psoriasis and Crohn's disease), one under NDA review (QX002N for ankylosing spondylitis), three products in Phase III (QX005N, QX004N, QX008N), and multiple bispecific antibodies in clinical development (QX027N, QX030N, QX031N). The company operates an integrated platform covering antibody discovery, clinical development, and commercial-scale manufacturing, with strategic out-licensing partnerships including Roche (QX031N), Windward Bio (QX027N), Caldera Therapeutics (QX030N), Hansoh Pharma (QX004N), Joincare (QX008N), and Huadong Medicine (QX001S, QX005N).

Differentiator

Problem solved

Functional benefit

Brands

• 赛乐信 (SAILEXIN): Brand name for QX001S (Ustekinumab biosimilar) approved for psoriasis treatment
• 赛捷宁 (SAI JIE NING)
• Crusekitug
• Oturkibart

Products and services

• QX001S (赛乐信®/赛捷宁®) Ustekinumab biosimilar (IL-12/IL-23p40 inhibitor) approved for psoriasis (subcutaneous injection brand: SAILEXIN) and Crohn's disease (intravenous brand: SAI JIE NING). First domestically-approved ustekinumab biosimilar in China, co-developed and commercialized with Huadong Medicine.
• QX002N (鲁塞奇塔单抗/Crusekitug) High-affinity IL-17A inhibitor monoclonal antibody for ankylosing spondylitis treatment. Phase III trials met primary endpoint with ASAS40 response rate of 40.4% vs 18.9% placebo (P<0.0001) at week 16; NDA accepted by NMPA in March 2026.
• QX005N (奥托奇拜单抗/Oturkibart) IL-4Rα inhibitor for type 2 inflammatory allergic diseases including atopic dermatitis, prurigo nodularis (PN), chronic rhinosinusitis with nasal polyps (CRSwNP), asthma, and chronic spontaneous urticaria (CSU). One of only two IL-4Rα mAbs in China with Breakthrough Therapy Designation (for PN). Co-developed with Zhongmei Huadong.
• QX004N IL-23p19 inhibitor for psoriasis and Crohn's disease. Licensed to Hansoh Pharma for China development, manufacturing, and commercialization; Phase III psoriasis trial underway as of April 2026. Total payments received from Hansoh Pharma totaled RMB 143 million as of April 2026.
• QX031N Long-acting bispecific antibody targeting TSLP and IL-33 for COPD and asthma. Licensed to Roche globally (worldwide development, manufacturing, and commercialization rights). Phase I trial initiated in New Zealand with first subject dosed in 2026, triggering milestone payment.
• QX030N (CLD-423) Long-acting bispecific antibody targeting IL-23p19 and TL1A for inflammatory bowel disease (IBD). Licensed to Caldera Therapeutics globally; Phase I healthy volunteer trial completed first dosing in January 2026.
• QX027N Long-acting bispecific antibody targeting TSLP and IL-13 for atopic dermatitis and asthma. Licensed to Windward Bio globally (excluding mainland China, Hong Kong, Macau, and Taiwan); Phase I initiated in China December 2025.
• QX008N Anti-TSLP monoclonal antibody for moderate-to-severe asthma and COPD. Licensed to Joincare for development, manufacturing, and commercialization in mainland China, Hong Kong SAR, and Macao SAR. Joincare has initiated Phase III clinical trial for COPD in China.
• QX035N Long-acting bispecific antibody targeting c-kit and undisclosed target for mast cell-mediated respiratory and skin diseases. IND application planned for second half of 2026.
• QX006N IFNAR1 inhibitor for systemic lupus erythematosus (SLE). Currently in Phase I clinical trial in healthy individuals.
• QX007N IL-33 inhibitor for COPD. Part of Qyuns' respiratory disease pipeline targeting inflammatory pathways.
• QX010N IL-31R inhibitor for pruritus. Part of Qyuns' skin disease pipeline targeting itch and inflammatory skin conditions.
• QX013N c-kit targeting humanized IgG1 monoclonal antibody for chronic spontaneous urticaria (CSU). IND approved for CSU treatment in China.

Quantifiable outcome

• QX002N Phase III: ASAS40 response rate of 40.4% vs 18.9% placebo (P<0.0001) at week 16 in ankylosing spondylitis patients
• +3 more outcomes

Named customers2 records

Segments3 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Seven partnerships are on record, tiered flagship and core.

• LE2025 Therapeutics AG (Windward Bio Group)flagshipOEM/ Whitelabel/ Licensing Partner · 19 December 2025License and collaboration agreement for QX027N, a long-acting bispecific antibody targeting TSLP and IL-13 for atopic dermatitis and asthma. LE2025 granted exclusive rights to develop and commercialize globally except mainland China, Hong Kong, Macau, and Taiwan. Qyuns entitled to receive up to $700 million including upfront payment, equity interest in Windward Bio, development and commercial milestones, plus tiered royalties.
• Roche (F. Hoffmann-La Roche Ltd)flagshipOEM/ Whitelabel/ Licensing Partner · 28 October 2025Global exclusive collaboration and license agreement for QX031N, a bispecific antibody targeting TSLP and IL-33 for COPD and asthma. Roche received worldwide development, manufacturing, and commercialization rights. Qyuns received $75 million upfront and is eligible for up to $995 million in milestone payments plus tiered royalties on future sales. Phase I trial initiated in New Zealand with first subject dosed in 2026.
• Caldera Therapeutics Inc.coreOEM/ Whitelabel/ Licensing Partner · 23 April 2025Out-license agreement for QX030N (CLD-423), a bispecific antibody targeting IL-23p19 and TL1A for inflammatory bowel disease. Caldera granted global exclusive rights to develop and commercialize. Qyuns received $10 million upfront and equity stake, eligible for up to $545 million in additional milestone payments plus tiered royalties. Caldera has raised $112.5 million total capital.
• Hangzhou Zhongmei Huadong Pharmaceutical (华东医药)coreStrategic or Co-development Partner · 1 July 2024Collaboration agreement for QX005N (Oturkibart/HDM3016), an IL-4Rα inhibitor for multiple indications. Both parties share Phase III clinical trial costs on 50:50 basis for designated indications. Zhongmei Huadong granted exclusive co-development rights, exclusive market promotion option, and right of first refusal for MAH transfer. Product NDAs for PN and AD expected in 2026.
• Hansoh Pharma (Hansoh Pharmaceutical Group)coreOEM/ Whitelabel/ Licensing Partner · 1 April 2024Exclusive out-licensing agreement for QX004N, an IL-23p19 inhibitor for psoriasis and Crohn's disease. Hansoh granted exclusive rights for development, manufacturing, and commercialization in licensed territory. Qyuns received RMB 143 million in payments as of April 2026. Phase III clinical trial for psoriasis is underway.
• Joincare Pharmaceutical GroupcoreOEM/ Whitelabel/ Licensing Partner · 1 January 2024License-out agreement for QX008N, a TSLP-targeted monoclonal antibody for asthma and COPD. Joincare granted exclusive rights to develop, manufacture, and commercialize in mainland China, Hong Kong SAR, and Macao SAR. Joincare has initiated Phase III clinical trial for COPD in China.
• Hangzhou Zhongmei Huadong Pharmaceutical (华东医药)coreChannel Partner/ Reseller/ Distributor · 1 August 2020Original collaboration for QX001S (ustekinumab biosimilar). Zhongmei Huadong serves as marketing authorization holder (MAH) responsible for commercialization in mainland China, while Cellularforce (Qyuns subsidiary) handles production and supply. Product approved and launched, with 2025 sales approaching RMB 300 million. Also received approval for Crohn's disease indication in May 2026.

Scale indicators12 records

Recent moves7 records

Expansion highlights5 records

Direct peers

• Henlius (Shanghai Henlius Biotech): Shanghai Henlius Biotech is a Chinese biopharmaceutical company that, like Qyuns, has developed and commercialized a ustekinumab biosimilar in China, making it the closest direct competitor for QX001S in the China immunology biosimilar market. Henlius also pursues a broader biosimilar and innovative biologics pipeline.
• Junshi Biosciences: Junshi Biosciences is a Shanghai-based Chinese biotech with a ustekinumab biosimilar (and broader autoimmune/oncology pipeline) directly competing with QX001S. Its commercial-scale antibody manufacturing and China commercial infrastructure make it a structurally similar peer to Qyuns.
• Akeso (Akeso, Inc.): Akeso is a leading Chinese bispecific antibody specialist with approved bispecifics (e.g., cadonilimab, ivonescimab) and a pipeline that overlaps Qyuns' emphasis on novel antibody formats. Both companies are China-based innovators with global out-licensing ambitions.
• Innovent Biologics: Innovent is a major Chinese biopharmaceutical company with a marketed autoimmune portfolio (e.g., mazdutide, multiple biosimilars and innovative biologics) and a comparable integrated R&D-to-commercialization model targeting large chronic disease indications in China.
• UCB: UCB is a Belgian biopharma specializing in immunology with bimekizumab (IL-17A/F) — directly comparable to Qyuns' QX002N (IL-17A) — plus a pipeline in atopic dermatitis, psoriasis, and other autoimmune indications overlapping Qyuns' therapeutic areas.
• Hansoh Pharmaceutical Group: Hansoh is a leading Chinese innovative pharma company with autoimmune and oncology biologics programs and is Qyuns' licensing partner for QX004N (IL-23p19). It represents both a commercial partner and a competing developer of immunology biologics in the China market.
• Joincare Pharmaceutical Group: Joincare is a major Chinese pharmaceutical company that has licensed QX008N (anti-TSLP) from Qyuns and is concurrently advancing its own respiratory and immunology biologics pipeline, making it a peer competitor in the China asthma/COPD biologics space.

Broad incumbents

• AbbVie: AbbVie markets Skyrizi (risankizumab, IL-23p19) and Rinvoq (JAK inhibitor) for psoriasis, IBD, and other autoimmune indications, making it the dominant incumbent whose pipeline directly competes with Qyuns' QX004N (IL-23p19) and adjacent programs.
• Sanofi / Regeneron: Sanofi/Regeneron's Dupixent (dupilumab, IL-4Rα) is the market-leading biologic for atopic dermatitis, asthma, CRSwNP, and prurigo nodularis — the same indications targeted by Qyuns' QX005N (Oturkibart), making it the dominant incumbent benchmark.
• Amgen / AstraZeneca: Amgen and AstraZeneca co-developed Tezspire (tezepelumab, anti-TSLP), the first TSLP inhibitor approved in severe asthma. Tezspire competes directly with Qyuns' QX008N and the TSLP-targeting arm of QX027N and QX031N.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

Compliance4 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles6 records

Subsidiaries1 record

Funding overview

Funding rounds7 records

Investors7 records

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M&A

Investments

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Frequently asked questions about Qyuns Therapeutics