Qyuns Therapeutics Co., Ltd. announced that on May 29, 2024, the first subject was enrolled for the Phase III clinical trial of QX005N, an injection for prurigo nodularis ("PN") independently discovered and developed by the Company. This is the first Phase III clinical trial conducted by a Chinese domestic enterprise for the indication of PN in China. On January 31, 2024, QX005N obtained Breakthrough Therapy Designation from the Center for Drug Evaluation of the National Medical Products Administration with the corresponding indication being PN. This is a multi-center, randomized, double-blind, placebo-controlled Phase III clinical study evaluating the efficacy and safety of QX005N in adult subjects with PN. Its primary purpose is to assess the efficacy of QX005N in itching relief in PN subjects. In the prior Phase II clinical study for PN, the effective subject proportion on the Worst Itch Numeric Rating Scale (WI-NRS) at week 16 in each group of QX005N (300 mg group, 450 mg group, and 600 mg group) was significantly higher than that in the placebo group, which proves statistically differences and overall good safety and tolerability. PN is a chronic pruritus and inflammatory skin disease, which is clinically manifested as pruritus papules and nodules that are highly keratotic and symmetrically distributed on the limbs. Pruritus-induced scratching exacerbates the condition further. Long-standing refractory pruritus has a profound psychological impact on patients and significantly impairs their quality of life. The etiology of the disease is currently unknown, and it can be induced by skin disorders, systemic diseases as well as neurological or psychogenic/psychological factors. According to Frost & Sullivan, the number of PN patients in China was approximately 2,000,000 in 2022. There exists urgent and substantial unmet clinical needs for treatment of the disease. QX005N is an innovative humanized monoclonal antibody targeting the human IL-4 receptor alpha subunit (IL-4R). Through specific binding with IL-4R, QX005N blocks the binding of IL-4R with
both IL-4 and IL-13, and also inhibits the signaling pathways and biological effects mediated by IL-4 and IL-13, thus exerting therapeutic effects on type 2 inflammatory allergic diseases. QX005N injection has received seven IND approvals for various indications, including moderate-to-severe atopic dermatitis in adults, atopic dermatitis in adolescents aged 12-17, PN, chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria, asthma, and chronic obstructive pulmonary disease. On May 10, 2024, the first subject was enrolled for the Phase III clinical trial of QX005N for moderate-to-severe atopic dermatitis in adults.