On a September day in 2026, word traveled out of Chengdu that a drug built to arrive only twice a year had shown its first promising face in people living with asthma. Kelun-Biotech and its partner Windward Bio reported interim findings from an early-stage trial, a reminder that the long human effort to quiet a stubbornly inflamed airway continues to find new paths. The early signs are encouraging but not yet final, since the real measure of any asthma therapy is whether fewer attacks come to those who live with it.
Windward Bio's Ultra-Long-Acting TSLP Antibody Shows Twice-Yearly Asthma Potential in Phase 2
One shot, effects near maximal by Week 2 and still holding at Week 24
Mark
So what's actually new here? TSLP drugs already exist.
Mimi
The target is established, yes. What's new is the dosing: a half-life of up to 75 days, which supports shots twice a year rather than more often.
Mark
And the lung function numbers?
Mimi
FEV1 rose by up to 174 mL, or 256 mL after placebo adjustment, at Week 24 after a single dose. FeNO fell up to 43 percent, eosinophils up to 51 percent.
Luke
Worth flagging that this is an interim look at 98 of 147 patients, and the announcement comes from Kelun-Biotech, a partner with a stake, not an independent party.
Mark
Does the FEV1 result hold up statistically?
Luke
The report gives p=0.033 for FEV1 and p=0.006 for FeNO. The eosinophil p-value is cut off in the text we have, so I can't say anything about it. Also, 'up to' means the best dose, not every dose.
Mimi
Safety looked clean so far: no treatment-related serious events, under 1 percent injection site reactions, 2 percent anti-drug antibodies.
Luke
Clean as of the cutoff date, in a small, short-term dataset. Nothing here shows fewer asthma attacks yet.
Mark
Which is what Phase 3 measures?
Mimi
Yes, annualized exacerbation rate, with two twice-yearly doses. POLARIS-2 follows in the first half of 2027.
Luke
And the full data hasn't been presented or peer reviewed yet. That's the next checkpoint.
Le Pouls
- Interim numbers from 98 of 147 patients show lung function rising and airway inflammation markers falling after a single dose.
- Improvements appear within two weeks and hold through week 24, which sets this drug apart in the crowded asthma field.
- No treatment-related serious adverse events or withdrawals have been recorded so far, easing early safety concerns.
- A Phase 3 study has already begun, and a second trial, POLARIS-2, is planned for the first half of 2027.
- The decisive question remains open: whether these biomarker gains will translate into fewer asthma exacerbations.
On a September day in 2026, word traveled out of Chengdu that a drug built to arrive only twice a year had shown its first promising face in people living with asthma. Kelun-Biotech and its partner Windward Bio reported interim findings from an early-stage trial, a reminder that the long human effort to quiet a stubbornly inflamed airway continues to find new paths. The early signs are encouraging but not yet final, since the real measure of any asthma therapy is whether fewer attacks come to those who live with it.
On September 8, 2026, Kelun-Biotech announced that its partner Windward Bio had produced positive interim results from the Phase 2 portion of POLARIS-1, a trial of SKB378/WIN378, an asthma drug designed to be dosed just twice a year. The trial enrolled 147 adults with uncontrolled, moderate-to-severe asthma, and the interim analysis covered the first 98 of them.
The antibody targets thymic stromal lymphopoietin, a signaling protein that drives airway inflammation. Its engineers gave it greater potency and a longer half-life, and the company describes it as blocking TSLP at two distinct sites. At Week 24 after a single dose, patients showed dose-dependent gains in lung function, with FEV1 rising by up to 256 mL after placebo adjustment. Markers of airway inflammation fell sharply, with FeNO dropping by 43 percent and blood eosinophils by 51 percent. Much of this benefit appeared as early as Week 2.
Safety data were reassuring so far. No treatment-related serious adverse events or discontinuations were reported, and adverse events were balanced with placebo. Anti-drug antibodies appeared in 2 percent of participants without affecting the drug's action. Modeling points to a half-life of up to 75 days, which supports the twice-yearly schedule.
Kelun-Biotech CEO Dr. Michael Ge expressed satisfaction and credited the partner's work. The Phase 3 portion is already underway, testing two twice-yearly doses against placebo with annualized exacerbation rate as the primary endpoint. The molecule began as a joint project of Kelun-Biotech and Harbour BioMed, and its story now moves toward the congress where full data will be shown, and toward the exacerbation results that will reveal whether these gains truly protect patients from attacks.
On September 8, 2026, from Chengdu, Sichuan Kelun-Biotech Biopharmaceutical announced that its partner Windward Bio had produced positive interim results from the Phase 2 portion of POLARIS-1, a trial of an asthma drug designed to be dosed just twice a year. The drug is called SKB378/WIN378, and the numbers behind the announcement are specific enough to be worth walking through.
POLARIS-1 is a global, operationally seamless Phase 2/3 study in adults with uncontrolled, moderate-to-severe asthma. Its Phase 2 portion is a 48-week, randomized, double-blind trial testing three dose levels against placebo, with the aim of characterizing pharmacokinetics, safety, immunogenicity and pharmacodynamic activity, and of informing which doses to carry into Phase 3. Enrollment came in at 147 patients, above the initial target of 120. The interim analysis covered the first 98 of them.
The drug is a fully human monoclonal antibody that targets thymic stromal lymphopoietin, or TSLP. It was engineered for greater potency, a longer half-life and silenced effector function. The company describes it as the only known investigational drug that blocks TSLP signaling by binding two different sites on the molecule, interfering with TSLP's attachment to both of its co-receptors on the surface of epithelial cells.
At Week 24 after a single dose, the interim analysis showed dose-dependent gains in FEV1, a core measure of lung function: a mean increase of up to 174 mL, or up to 256 mL when adjusted for placebo (p=0.033). FeNO, a marker of airway inflammation, fell by up to 24 ppb, a 43 percent change (p=0.006). Mean blood eosinophil counts dropped by up to 200 cells per microliter, a 51 percent change. Near-maximal effects appeared as early as Week 2 and held through Week 24. FeNO and eosinophils are markers that correlate with asthma exacerbations.
On safety, the report says there were no treatment-related serious adverse events, withdrawals or discontinuations as of the data cutoff. Adverse events were balanced between the active arms and placebo. Fewer than 1 percent of participants had injection site reactions, and 2 percent developed anti-drug antibodies, which the report says had no effect on the drug's pharmacology. The analysis and population pharmacokinetic modeling point to a half-life of up to 75 days, which underpins the case for twice-yearly dosing.
Kelun-Biotech CEO Dr. Michael Ge said the company was pleased with the result, crediting its partner's efforts. He described the antibody as differentiated and ultra-long-acting, balancing efficacy, safety and patient compliance, with potential to address unmet needs in moderate-to-severe asthma.
The Phase 3 portion has already begun under Windward Bio. It will test two twice-yearly doses against placebo, with annualized asthma exacerbation rate as the primary endpoint in patients with severe asthma. A second Phase 3 trial, POLARIS-2, is planned for the first half of 2027. The drug is also being studied in COPD in the Phase 2 SIRIUS study.
The molecule began as a joint project between Kelun-Biotech and Harbour BioMed, which share global rights equally. Windward Bio licensed global rights, excluding Greater China and several Southeast and West Asian countries, from the two companies. The full Phase 2 data are to be presented at an upcoming medical congress, and the Phase 3 exacerbation results will be the real test of whether lung-function and biomarker gains translate into fewer attacks.
Citations marquantes
The antibody balances efficacy, safety and patient compliance and could address unmet needs in moderate-to-severe asthma (paraphrased).— Dr. Michael Ge, CEO, Kelun-Biotech
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