Akeso’s gumokimab enters NMPA review for ankylosing spondylitis after positive Phase III trial

Akeso Inc. (HKEX: 9926.HK) has secured review acceptance from the National Medical Products Administration (NMPA) for a supplemental New Drug Application (sNDA) of gumokimab (AK111) in the treatment of active ankylosing spondylitis (AS). This marks gumokimab’s second NMPA filing after its psoriasis application and reinforces Akeso’s non-oncology diversification and ambition to build a long-cycle immunology portfolio targeting China’s large autoimmune burden.

The company’s Phase III study met all primary and secondary endpoints, including ASAS20 and ASAS40 response rates, with statistical significance across subgroups. If approved, gumokimab could emerge as a new alternative to entrenched biologics like secukinumab, especially in a market where pricing, formulary access, and biosimilar pressure are reshaping treatment dynamics. More broadly, the filing reflects Akeso’s growing pipeline confidence in immunology and its bid to translate clinical validation into commercial breadth beyond its core oncology franchise.

How does gumokimab’s NDA in ankylosing spondylitis fit into Akeso’s non-oncology expansion strategy?

Akeso’s portfolio evolution away from oncology is no longer an experimental sideline—it’s a deliberate buildout. With gumokimab now under regulatory review for both psoriasis and ankylosing spondylitis, the company is moving into competitive territory traditionally dominated by multinational players like Novartis, AbbVie, Eli Lilly, and Johnson & Johnson. Ankylosing spondylitis, a chronic axial spondyloarthritis with high prevalence in younger male patients in Asia, presents an opportunity for Akeso to leverage its domestic manufacturing and formulary negotiation advantages in China.

Gumokimab’s IL-17A mechanism directly challenges existing treatments like secukinumab (Cosentyx) and ixekizumab (Taltz), which have enjoyed first-mover advantages globally but face pricing and access headwinds in emerging markets. The Phase III AK111-303 trial offers Akeso a data-driven edge, showing not just symptom relief but quality-of-life improvements that may appeal to both payers and prescribers. If reimbursement terms align, gumokimab could find an addressable niche particularly in cost-sensitive public hospital settings across Tier 2–3 Chinese cities.

Crucially, the regulatory acceptance in a high-burden indication also boosts investor visibility into Akeso’s broader autoimmune pipeline, which includes manfidokimab (IL-4R), AK139 (IL-4Rα/ST2 bispecific), and ebdarokimab (IL-12/23), the latter of which has already secured National Reimbursement Drug List (NRDL) inclusion.

Why does this move signal deeper competitive pressure on incumbents in China’s biologics market?

Akeso’s gumokimab trajectory is being closely watched by competitors for its potential to reframe biologics pricing in China’s autoimmune segments. With estimated ankylosing spondylitis prevalence around 4 million patients, even low penetration rates can justify full-scale commercial infrastructure. Moreover, the Chinese autoimmune biologics market is expected to grow at over 12 percent CAGR through 2030, creating ample room for domestic challengers who can match efficacy while undercutting price.

Akeso’s recent track record suggests it is willing to adopt aggressive pricing strategies—both ebronucimab (PCSK9) and ebdarokimab (IL-12/23) were launched into crowded markets but achieved rapid NRDL access, accelerating uptake in hospitals. Should gumokimab follow the same playbook, it could exert downward pressure on originator pricing, potentially forcing multinationals to reevaluate discounting policies or local licensing strategies.

The therapeutic area itself is also evolving. IL-17A inhibitors, while effective, have recently seen competition from newer mechanisms such as IL-23 inhibitors and TYK2 inhibitors. For Akeso, timing is critical. A prompt approval and launch could give gumokimab sufficient runway before more differentiated competitors gain traction. Conversely, regulatory or reimbursement delays may risk commoditization before brand equity is established.

What does gumokimab’s development path reveal about Akeso’s internal pipeline confidence and platform maturity?

Unlike many of its domestic peers, Akeso is not pursuing a volume-over-value strategy in biologics. Its internal platform development—anchored by its ACE discovery engine and Tetrabody bispecific technology—has produced over 50 clinical assets, 26 of which are in trials and 7 already commercialized. What distinguishes gumokimab is not just its efficacy, but the efficiency of its regulatory progression and clinical signal strength in a highly symptomatic chronic disease.

The AK111-303 trial reported comprehensive endpoint success, from ASAS20 and ASAS40 scores to physical function and quality-of-life metrics. This level of clinical clarity is uncommon in crowded immunology registrational trials, particularly in Asia, where real-world relevance often overrides trial purity. The successful readout lends credibility to Akeso’s trial design, regulatory engagement strategy, and translational capability in immune-mediated inflammatory diseases.

From a pipeline architecture standpoint, gumokimab’s trajectory is instructive. It shows how Akeso is increasingly clustering assets around shared immunological pathways—IL-17A, IL-4R, IL-12/23—rather than chasing uncorrelated innovation for headline impact. This not only streamlines development but may unlock manufacturing efficiencies and commercialization synergies, especially if future combination trials are pursued.

How are investors reacting to Akeso’s pipeline diversification into autoimmune markets?

Akeso’s Hong Kong-listed shares (HKEX: 9926.HK) have traded in a tight range since the start of 2026, reflecting both muted broader biotech sentiment and investor wait-and-see posture on execution outside oncology. However, recent regulatory progress—gumokimab’s dual NDA track, plus NRDL wins for ebronucimab and ebdarokimab—has led to incremental bullish positioning among local institutional holders.

The near-term valuation question hinges less on the quality of the assets and more on the scale and speed of commercial conversion. Analysts tracking the China biotech sector have noted that Akeso’s base business remains oncology-heavy, with the PD-1/CTLA-4 bispecific cadonilimab anchoring near-term revenue. While gumokimab represents diversification, it must translate into material topline contribution to shift revenue mix and reduce single-franchise dependence.

Execution risk remains. The autoimmune market is crowded, physician loyalty can be entrenched, and formulary access is often delayed by regional reimbursement lag. That said, Akeso’s immunology pipeline now presents a more bankable path to revenue than earlier perceived, especially if supported by real-world data post-launch.

Key takeaways: What does gumokimab’s NDA for ankylosing spondylitis mean for Akeso and the autoimmune sector?

• Akeso Inc. has secured NMPA review acceptance for gumokimab in ankylosing spondylitis, its second NDA filing after psoriasis.

• The drug’s Phase III data showed strong efficacy across both ASAS20 and ASAS40 endpoints, boosting approval probability.

• Gumokimab marks a deliberate pivot into autoimmune diseases and positions Akeso against entrenched biologics like secukinumab.

• Success could enable Akeso to replicate its NRDL-access playbook used for ebronucimab and ebdarokimab.

• China’s AS patient population of approximately 4 million presents a meaningful market, especially in Tier 2–3 hospitals.

• Akeso’s pipeline strategy is maturing, with rational clustering of IL-17, IL-4R, and IL-12/23 pathway assets across indications.

• Commercial and clinical alignment improves Akeso’s chances of sustained, multi-indication autoimmune franchise growth.

• Competitive pressure on multinationals may increase if Akeso undercuts pricing while matching efficacy.

• Execution risks include slow regional reimbursement, clinician inertia, and therapeutic interchangeability in a crowded market.

• Investor sentiment remains cautious but increasingly supportive as Akeso proves pipeline-to-market execution in non-oncology.