The randomized, double-blind, placebo-controlled trial enrolled 327 participants aged 12 to 65 with house dust mite allergic rhinitis or rhinoconjunctivitis, with or without asthma. On the primary endpoint, a combined score of symptoms and medication use, Acarizax outperformed placebo by 1.11 points, a relative difference of 19.1%. This was well above the success criterion agreed with the Chinese authorities. The effect was seen from week 8, and participants on Acarizax were 4.3 times more likely than those on placebo to report feeling better by the end of the trial. The tablet was safe and well tolerated, in line with more than ten years of earlier data.

The trial was designed to generate local clinical data that, together with existing global data, can support approval in China. If approved, Acarizax will join GenSci’s portfolio under the partnership the companies signed in September 2025. According to ALK, China has the world’s largest number of people with house dust mite allergy, more than 100 million, yet fewer than 1 million currently receive allergy immunotherapy. The results do not affect ALK’s 2026 financial guidance.

“The results of our phase 3 clinical trial in China are robust and highly consistent with more than a decade of data on our house dust mite tablet, confirming that it is both efficacious and safe for Chinese patients,” says Jacob Glenting, Executive Vice President and Head of Global R&D at ALK.