Two New IL-1β Drugs Just Launched in China. What Firsekibart and Anfulitamab Mean for Gout

Two New IL-1β Drugs Just Launched in China. Here Is What They Mean for Gout Treatment Worldwide

You probably have not heard of either of these drugs yet. Their names are firsekibart and anfulitamab, and both were approved in China over the past fourteen months for acute gout flares. They target IL-1β, the same inflammatory molecule that canakinumab (Ilaris) goes after. But here is the part that caught my attention: one of them cuts the risk of another flare by roughly 87 percent for six months after a single injection, and it costs a fraction of what canakinumab runs in the United States.

If you have been following the IL-1β story on this site, you already know that blocking interleukin-1 beta can shut down a gout attack at its source. What you may not know is that China has now moved ahead of the rest of the world in bringing new anti-IL-1β antibodies to people with gout. Two separate drugs, from two Chinese pharmaceutical companies, reached the market within about fourteen months of each other. Neither is available in the US or Europe yet. But the data behind them are worth your attention whether you live in Shanghai or Chicago.

Why IL-1β Matters in a Gout Attack

When uric acid crystals form inside a joint, your immune cells notice. They swallow the crystals and activate a protein complex called the NLRP3 inflammasome. Think of it as a fire alarm inside the cell. Once that alarm goes off, the cell pumps out large amounts of IL-1β, a signaling molecule that recruits more immune cells, widens blood vessels, and produces the redness, swelling, and searing pain you know as a gout flare.

NSAIDs like indomethacin work downstream of this process. They block prostaglandins, which are late-stage pain mediators. Colchicine disrupts immune cell movement. Steroids broadly suppress inflammation. None of them directly target IL-1β itself. An IL-1β antibody, on the other hand, neutralizes the molecule at the top of the cascade. It is like cutting the wire to the fire alarm instead of waving a towel at the smoke.

I wrote a detailed breakdown of how this pathway works and where canakinumab fits into the picture in our earlier piece on the new generation of IL-1β inhibitors. This article picks up where that one left off.

Firsekibart (Jinbeixin): The First One Across the Finish Line

Firsekibart, sold under the brand name Jinbeixin, was approved by China’s National Medical Products Administration (NMPA) on June 30, 2025. It is made by Changchun GeneScience Pharmaceutical, and it holds a notable distinction: it was the first IL-1β monoclonal antibody anywhere in the world approved specifically for gouty arthritis (as opposed to being approved for rare fever syndromes and then repurposed, as canakinumab was).

Firsekibart is a fully human IgG4/λ monoclonal antibody. “Fully human” means the antibody protein sequence is entirely human-derived rather than partially mouse, which in theory lowers the chance that your immune system will recognize it as foreign and mount a reaction against it.

The dosing is simple: 200 milligrams as a single subcutaneous injection. No daily pills. No IV infusion. The drug has a half-life of roughly 25.5 to 30.8 days, meaning it stays in your system for weeks after one shot.

What the Phase 3 Trial Showed

The key Phase 3 trial enrolled 313 adults across China. All had at least two gout flares in the previous year and could not take NSAIDs or colchicine because of contraindications, intolerance, or inadequate response. Participants were randomized to either firsekibart 200mg or compound betamethasone (a long-acting steroid injection). The study was double-blind and double-dummy, meaning neither participants nor doctors knew who got which drug.

The results, published in The Innovation in 2025 (Xue et al.), were striking:

• Pain relief was non-inferior to steroid. At 72 hours, the firsekibart group had a VAS pain score reduction of 57.09 mm versus 53.77 mm for betamethasone. Onset of pain relief started within six hours.
• Flare recurrence plummeted. Over 12 weeks, firsekibart reduced the risk of a new flare by about 90 percent. At 24 weeks, the reduction was 87 percent. The median time to first recurrence was not reached in the firsekibart group, compared with 45 days in the steroid group.
• Adverse events were lower overall. The firsekibart group had fewer treatment-related adverse events than the steroid group, and no drug-related serious adverse events were reported during the double-blind phase.

A 48-week open-label extension (Zhu et al., Advances in Therapy, 2026) followed 300 of these participants. By week 48, 44.9 percent of those treated with firsekibart had experienced a flare recurrence, compared with 74.8 percent in the control group (hazard ratio 0.30). No new safety signals appeared during extended follow-up.

Real-World Evidence: 50 People, Zero Flares in 12 Weeks

Beyond the controlled trial, a real-world study by Chen and colleagues published in Clinical Rheumatology in 2026 tracked 50 people treated with 200mg firsekibart against a comparator group receiving compound betamethasone. The findings were even more pronounced: zero firsekibart recipients flared within 12 weeks, compared with 44 percent of the steroid group. At 24 weeks, the hazard ratio for flare was 0.12, an 88 percent risk reduction. C-reactive protein dropped from a median of 14.20 to 3.85 mg/L. Both treatments had acceptable safety profiles.

Several case reports have also described firsekibart working well in particularly difficult situations: a peritoneal dialysis patient with recurrent infections and heart failure, a 73-year-old with tophaceous gout and prostate cancer, and a glucocorticoid-dependent patient who was able to taper off steroids entirely after a single dose. These are individual cases, not controlled data, but they suggest the drug may be useful in populations where traditional options are limited.

In May 2026, GeneScience received approval for a liquid (aqueous) formulation of firsekibart that does not require reconstitution, making it easier to administer in clinic settings. The reported price is approximately 9,000 Chinese yuan per injection, which at mid-2026 exchange rates is roughly 1,250 US dollars.

Anfulitamab (Yisaina): The Second Contender

On August 20, 2026, the NMPA approved a second IL-1β antibody for acute gout: anfulitamab, brand name Yisaina, developed by Sunshine Guojian Pharmaceutical (also known as 3S Guojian or 三生国健) under the research code SSGJ-613. Its approval number is 国药准字S20260064.

Here is where the two drugs differ in an important technical way. While firsekibart is a fully human IgG4/λ antibody, anfulitamab is a humanized IgG1/κ antibody. “Humanized” means the antibody started from a mouse sequence and was engineered to be over 90 percent human, but a small portion of the original mouse framework remains. In practice, both approaches have been used successfully across many approved biologic drugs, and the clinical significance of the difference for these two specific molecules is not yet clear from head-to-head data (no such trial exists).

Anfulitamab Phase 3 Data

The anfulitamab Phase 3 trial was also a multicenter, randomized, double-blind, double-dummy, active-controlled study comparing a single 200mg subcutaneous injection with compound betamethasone. The key findings from the 24-week primary analysis were:

• Analgesia was non-inferior to steroid. Pain VAS scores improved rapidly, with onset within six hours and continued improvement through the first week.
• 12-week flare risk dropped 77 percent. The median time to first flare was not reached in the anfulitamab group, compared with 57 days in the betamethasone group.
• Immunogenicity was very low. No anti-drug antibody-related adverse events were observed.
• Safety compared favorably on metabolic measures. According to the company’s announcement, anfulitamab showed better or similar profiles than steroid for infections, metabolic events, and liver enzyme elevations. Lipid and liver-function adverse events were notably lower than for same-target competitors. The drug can be used in patients with CKD or cardiovascular disease.

Sunshine Guojian has also started a Phase 2 multiple-dose study for the intercritical period (the time between flares), exploring whether repeated dosing could provide ongoing flare prevention rather than just treating individual attacks. That trial is listed as NCT07708181 on ClinicalTrials.gov.

How Do These Two Drugs Compare With Each Other?

At first glance, firsekibart and anfulitamab look like near-twins. Both are 200mg subcutaneous injections. Both target IL-1β. Both were tested against compound betamethasone in Chinese Phase 3 trials of similar design. Both showed non-inferior pain relief plus substantially better flare prevention than steroid. Both carry the same labeled indication: adults with acute gouty arthritis who cannot take NSAIDs, colchicine, or repeated steroid courses.

But dig into the details and a few distinctions emerge:

Feature	Firsekibart (Jinbeixin)	Anfulitamab (Yisaina)
Company	Changchun GeneScience	Sunshine Guojian (3S Guojian)
NMPA approval	June 30, 2025	August 20, 2026
Antibody type	Fully human IgG4/λ	Humanized IgG1/κ
Dose	200mg SC, single	200mg SC, single
Onset	~6 hours	~6 hours
12-week flare reduction	~90%	~77%
24-week flare reduction	~87%	Data not yet published
Median time to first flare	Not reached vs 45 days	Not reached vs 57 days
Longest published follow-up	48 weeks (OLE)	24 weeks (primary analysis)
Reported price	~9,000 RMB (~$1,250 USD)	Not yet announced

A few caveats about those numbers. The 12-week flare reduction figures come from separate trials with slightly different patient populations and statistical methods. You cannot directly compare 90 percent against 77 percent and declare a winner. Firsekibart also has more mature data, with a 48-week extension and a published real-world study, while anfulitamab is newer and has less post-approval evidence so far. Anfulitamab’s humanized IgG1 structure is a different antibody subclass, and the company highlighted favorable lipid and liver enzyme data as a differentiator, but those claims have not yet been independently verified in peer-reviewed publications.

Where Does Canakinumab Stand?

Canakinumab (Ilaris), made by Novartis, was the first IL-1β antibody to reach people with gout. The FDA approved it for gout flares in August 2023, after an advisory committee had rejected the same application back in 2011 over safety and efficacy concerns. The EMA approved it for frequent gouty arthritis attacks (at least three in the prior year) earlier.

The canakinumab dose for gout is 150mg subcutaneously, with at least 12 weeks between retreatment. It is a fully human IgG1/κ antibody. Its gout approval came much later than its original 2009 approval for cryopyrin-associated periodic syndromes (CAPS), a group of rare autoinflammatory diseases.

The biggest barrier to canakinumab in the US is cost. A single 150mg vial runs approximately $18,000. That is for one injection. Even with insurance, prior authorization hurdles are substantial, and many plans place it on a high specialty tier. The CANTOS trial (Ridker et al., NEJM, 2017) showed that canakinumab reduced major cardiovascular events by about 15 percent in patients with prior heart attack and elevated CRP, which generated enormous interest, but the drug was not approved for cardiovascular prevention, and its gout use remains narrow because of the price tag.

I covered canakinumab’s potential role for people with kidney disease in a separate article about whether canakinumab can fill the CKD treatment gap. The short version: it does not require dose adjustment in renal impairment, which makes it attractive for a population where NSAIDs and colchicine are risky. But the cost puts it out of reach for many who might benefit.

Compare that with firsekibart at roughly $1,250 per injection in China. That is a different order of magnitude. If firsekibart or anfulitamab eventually seek FDA or EMA approval, the pricing conversation could shift considerably. Whether they will actually do so is another question. Neither company has publicly announced a US or European filing as of this writing.

The Price and Accessibility Question

Let me be direct about this. If you are reading this from the US, UK, Australia, or anywhere outside China, you cannot walk into a pharmacy and get firsekibart or anfulitamab right now. Both are approved only by the NMPA. They have not been submitted to the FDA or EMA, and no timeline for international approval has been announced.

For people in China, the picture is different but still evolving. Firsekibart is on the market and has been incorporated into the 2024 Chinese Guidelines for the Diagnosis and Management of Hyperuricemia and Gout. It is not yet clear whether either drug will be included in China’s national medical insurance reimbursement catalog, which would significantly lower out-of-pocket costs. At approximately 9,000 yuan per injection, firsekibart is expensive by Chinese healthcare standards but far cheaper than canakinumab’s US price.

The broader question is whether these Chinese drugs could eventually create competitive pressure on canakinumab pricing globally. This has happened before in the pharmaceutical industry. Chinese biologic makers have in recent years begun seeking international approval for innovative drugs, not just manufacturing generics. Sunshine Guojian, for example, already has overseas clinical programs for some of its autoimmune pipeline and struck a major deal with Pfizer in 2025 for a PD-1/VEGF bispecific antibody valued at over $6 billion. But IL-1β gout drugs for Western markets are not on that announced path yet.

For now, the most likely scenario is that these drugs will primarily serve the Chinese market while generating peer-reviewed data that may eventually support international filings. The Phase 3 program for firsekibart is registered as NCT05983445 on ClinicalTrials.gov, and anfulitamab’s Phase 3 is NCT06169891, which at least makes the trial designs and results accessible to global regulators.

What This Means for You

If you are someone with gout whose current treatment is not working, this news matters even if the drugs are not yet available where you live. Here is why:

First, it adds to the evidence that blocking IL-1β is a fundamentally sound approach for gout flares. Canakinumab already showed this. Now two independent drugs from two different companies, with different antibody structures, have replicated the core finding in randomized controlled trials. The mechanism is not a fluke.

Second, the flare prevention data are genuinely impressive. A single injection that reduces flare risk by 77 to 90 percent for three to six months is a meaningful improvement over steroid injections, which treat the current attack but do little to stop the next one. This is particularly relevant for people starting urate-lowering therapy, when flares are common during the first months. If this sounds like your situation, our article on whether you really need daily flare prophylaxis when starting allopurinol discusses the current standard approach.

Third, if you have CKD or cardiovascular disease and your gout treatment options feel limited, IL-1β antibodies are worth discussing with your rheumatologist. These drugs do not require renal dose adjustment and have shown favorable safety in patients with comorbidities. The gap between what is available and what patients need is something I explored in our piece on the gout-CKD treatment gap.

And if your medication simply is not working, you are not alone, and the reasons often go beyond just needing a stronger pill. Our article on why your gout medication is not working breaks down the most common reasons.

What We Still Do Not Know

It would be irresponsible to present these drugs as settled answers. Several important questions remain:

• Long-term safety beyond one year. Firsekibart has 48-week data, which is reassuring but not definitive. IL-1β plays a role in infection defense, and all anti-IL-1 therapies carry some infection risk. Longer post-marketing surveillance will be important.
• Head-to-head comparison. No trial has compared firsekibart directly with anfulitamab or with canakinumab. Indirect comparisons across separate trials have real limitations.
• Repeated dosing for prevention. Both drugs are currently approved as single doses for acute flares. Whether repeated dosing can safely prevent flares over the long term is under study, particularly for anfulitamab’s intercritical period trial.
• International approval prospects. FDA and EMA pathways require their own clinical data or at minimum bridging studies. Neither company has announced such plans.
• Real-world effectiveness outside controlled trials. The Chen et al. real-world study for firsekibart is encouraging but small (50 patients). Larger post-marketing datasets will tell us more.

Frequently Asked Questions

Are firsekibart and anfulitamab available in the United States?

No. Both drugs are approved only in China by the NMPA. They have not been approved by the FDA, and no US filing has been announced. Canakinumab (Ilaris) remains the only IL-1β antibody approved for gout flares in the United States.

How much do these drugs cost compared with canakinumab?

Firsekibart is reported at approximately 9,000 Chinese yuan per injection, or roughly $1,250 USD. A single dose of canakinumab in the US costs approximately $18,000. Anfulitamab’s pricing has not yet been announced. These are list prices and do not account for insurance coverage or reimbursement.

What is the difference between fully human and humanized antibodies?

A fully human antibody has an entirely human protein sequence. A humanized antibody was originally derived from a mouse antibody but was engineered so that more than 90 percent of the sequence is human, leaving only a small mouse-derived portion. Both approaches have produced many safe and effective approved drugs. There is no head-to-head data showing that one type is superior to the other for these specific gout drugs.

Can IL-1β antibodies be used by people with kidney disease?

IL-1β antibodies are not cleared by the kidneys, so they do not require dose adjustment in CKD. This makes them a potential option for people who cannot take NSAIDs (which can harm kidneys) or colchicine (which requires dose reduction in renal impairment). Canakinumab has the most published data in CKD populations, while firsekibart case reports describe use in dialysis patients. Anyone with CKD should discuss these options with a rheumatologist and nephrologist.

How quickly do these drugs work for a gout flare?

Both firsekibart and anfulitamab showed onset of pain relief within about six hours of subcutaneous injection, based on their respective Phase 3 trials. At 72 hours, pain reduction was statistically non-inferior to a compound betamethasone steroid injection.

Will one injection really prevent flares for six months?

In the firsekibart Phase 3 trial, a single 200mg injection reduced flare risk by about 87 percent over 24 weeks compared with steroid. However, the median time to first flare was not reached, meaning that more than half of patients had not flared by the end of the observation period. This does not mean every patient will be flare-free for six months, and individual responses vary. Repeated dosing for ongoing prevention is still being studied.

Reviewed by the GoutSavvy Editorial Team