KeyMed Bio-B (02162) has announced that revenue from its product Kangyueda® (IL-4Rα monoclonal antibody, stapokibart) totaled approximately RMB 660 million for the first three quarters of 2026, representing a year-on-year increase of approximately 227%, driven primarily by genuine market demand and a sharp rise in the number of hospitals with access.
Thanks to support from national policies, effective January 1, 2026, all three approved indications of Kangyueda®—adult moderate-to-severe atopic dermatitis (AD), chronic rhinosinusitis with nasal polyps (CRSwNP), and seasonal allergic rhinitis (SAR)—along with both the vial and pre-filled auto-injector pen packaging formats, have been included in China's National Reimbursement Drug List, with a reimbursement standard of RMB 1,039 per unit (300mg/2ml specification), greatly improving affordability for Chinese patients.
In July 2026, Kangyueda® was officially included in the National Essential Medicines List (2026 Edition), effective September 1, 2026. Under the relevant essential medicines management regulations, public medical institutions at all levels nationwide are required to stock and prioritize the use of listed drugs, further expanding terminal prescription scenarios and enhancing drug accessibility.
As of September 30, 2026, the commercialization team has grown to more than 550 people, with market access work advancing rapidly. The company now covers 30 provinces, nearly 290 cities, and more than 2,200 hospitals, with approximately 2,200 hospitals consistently generating output, more than 1,300 hospitals capable of in-hospital medication use, stable partnerships with nearly 60 primary distributors, and a presence in nearly 700 pharmacies.
China's National Medical Products Administration (NMPA) has recently approved the marketing application for stapokibart (anti-IL-4Rα monoclonal antibody, trade name: Kangyueda, development code: CM310) for a new indication in the treatment of adolescent moderate-to-severe atopic dermatitis (AD), with both the vial (300mg [2ml]/vial) and pre-filled auto-injector pen (300mg [2ml]/unit) packaging formats approved.
This approval of stapokibart is based on a randomized, double-blind, placebo-controlled Phase III clinical study evaluating the efficacy and safety in 180 adolescent patients aged 12 to less than 18 years. Results showed that at Week 18 of treatment, up to 73.9% of patients achieved EASI-75 response, significantly higher than the placebo group (43.3%, P<0.0001). Up to 57.1% of patients achieved IGA response, significantly superior to the placebo group (25.0%, P<0.0001). Additionally, patients in the stapokibart group showed a PP-NRS improvement from baseline of up to 49.5%.
In terms of safety, the incidence of treatment-emergent adverse events (TEAEs) was comparable between the stapokibart group and the placebo group, and most were mild to moderate. Furthermore, compared with adult study results, the safety profile in the adolescent moderate-to-severe AD population was favorable, with no new safety signals identified.
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