Akeso Advances Non-Oncology Portfolio with Ankylosing Spondylitis Phase III Win

Akeso Expands Beyond Oncology

Nanjing-based Akeso (China) announced that Gumokimab (AK111), its IL‑17A monoclonal antibody, met the primary endpoint in a pivotal Phase III trial for ankylosing spondylitis (AS). The company plans to submit a New Drug Application (NDA) in China by year-end 2025. This milestone marks Akeso’s latest late-stage success outside oncology, signaling strategic diversification into autoimmune and inflammatory diseases.

Akeso has been best known in the West for its oncology bispecific cadonilimab (PD‑1/CTLA‑4), licensed to Summit Therapeutics in 2022. Gumokimab underscores its intent to replicate oncology success in immunology.

Clinical Results: Strong Efficacy and Safety

Gumokimab met its primary endpoint (ASAS20 at Week 16) and achieved key secondary measures including ASAS40, with improvements in pain, stiffness, and function sustained through Week 52. Subgroup analyses suggested consistent benefit across patient groups. The therapy was well tolerated, with no new safety signals reported. Taken together, the data support Gumokimab as a credible competitor to established IL-17A agents, while offering a cost-advantaged domestic alternative in China.

Market Relevance: 3.9M Patients in China

AS affects an estimated 3.9 million people in China, many of whom face disability and limited access to biologics. Current treatments such as TNF inhibitors are costly, leaving substantial room for more effective and affordable alternatives. Gumokimab’s success positions Akeso to address this access gap with a domestically developed IL-17A inhibitor.

Scientific Context: IL-17A as a Driver of AS

IL-17A, produced primarily by Th17 cells, plays a central role in AS by driving inflammatory cascades in joints and spinal tissues. Targeting IL-17A has already proven successful globally with drugs like Cosentyx (Novartis) and Taltz (Lilly); Gumokimab could join this class with potential differentiation on safety, efficacy, and cost.

The Competitive IL-17 Landscape in China

China’s ankylosing spondylitis (AS) and psoriasis markets are becoming intensely competitive, with multiple IL-17 inhibitors already approved or advancing through late-stage trials.

Approved Therapies

• Cosentyx (secukinumab, Novartis) – Global IL-17A pioneer, widely used in psoriasis and AS.
• Taltz (ixekizumab, Eli Lilly) – Another imported IL-17A with strong uptake.
• Siliqing (xeligekimab/GR1501, Zhixiang Jintai) – First domestic IL-17A approved in 2024.
• Vunakizumab (Hengrui) – Domestic IL-17A antibody, cleared in mid-2024.

Late-Stage Pipeline (Phase III or NDA)

• SSGJ-608 (3SBio / Sunshine Guojian) – Filed NDA following positive Phase III results in psoriasis; also tested in AS.
• Netakimab (Biocad / Shanghai Pharma-Biocad JV) – Russian-origin IL-17A now in China Phase III trials for psoriasis and AS.
• XKH004 (Livzon / Xinkanghe Biomedicine) – Humanized IL-17A/F bispecific; in Phase III for psoriasis and AS with promising Phase II efficacy.
• JS005 (Junshi Biosciences) – IL-17A candidate in Phase III.
• QX002N (Sinobioway / Sanovo) – Phase III IL-17A antibody program.
• HB0017 (Hobo Bio) – Another IL-17A in Phase III development.

Competitive Outlook
Akeso’s Gumokimab enters a crowded arena. Although it follows domestic frontrunners like Siliqing and Vunakizumab, its successful Phase III trial in AS positions it as a credible challenger—backed by Akeso’s proven biologics engine and BD track record in oncology.

Strengthening a Diversified Pipeline
Gumokimab’s AS success builds on its earlier Phase III readout in plaque psoriasis (NDA accepted by China’s NMPA in Jan 2025). Alongside Ebronucimab (Ixinning®, PCSK9 inhibitor) and Ebdarokimab (Aidaro®, IL-12/IL-23 antibody), Akeso is steadily expanding its non-oncology portfolio across autoimmune, inflammatory, and metabolic diseases.

Strategic Positioning: Beyond Oncology Leadership
Akeso is also known for oncology innovations, including Cadonilimab (PD-1/CTLA-4) and Ivonescimab (PD-1/VEGF), both included in China’s national insurance in 2024. Its $5 billion licensing deal with Summit Therapeutics for Ivonescimab underscores Akeso’s global BD credibility — a precedent that could support future international partnerships for Gumokimab.

Beyond IL-17: Other Therapeutic Approaches in AS
China’s AS pipeline goes beyond IL-17 blockers:

• JAK inhibitors: Suzhou Zelgen’s Jaktinib (JAK/ACVR1, Phase III), Lynk/Simcere’s LNK01001 (JAK1, Phase III), Jiangsu Vcare’s VC005 (JAK1, Phase II).
• PDE4 inhibitor: Tianjin Hemay’s Mufemilast (Phase II), offering a non-immunosuppressive oral option.
• Cell therapy: Asia Cell’s QS 002 (MSC-based, Phase I planned), aiming to address inflammation and regeneration simultaneously.

This diversification highlights the broad therapeutic race in AS, with biologics, orals, and novel modalities competing for different patient subsets.

Strategic Implications for Akeso

• Pipeline Balance: Gumokimab strengthens Akeso’s non-oncology portfolio, complementing its immuno-oncology franchise.
• Market Access: As China’s NRDL increasingly favors domestic biologics, Gumokimab may capture share from imported IL-17 agents.
• BD Potential: With prior success out-licensing Cadonilimab, Gumokimab could attract international partners seeking an IL-17A asset for autoimmune diseases.

Bottom Line
Gumokimab’s Phase III win positions Akeso as a serious contender in China’s autoimmune market, directly competing with domestic and global IL-17 leaders. Along with NDA filing imminent, the drug could reshape the treatment landscape for ankylosing spondylitis — a condition affecting ~3.9 million patients in China — and bolster Akeso’s global BD profile.