KEYMED BIO-B (02162): Kangyueda total revenue for the first three quarters reached approximately RMB 660 million, a year-on-year increase of approximately 227%.

KEYMED BIO-B (02162) announced that the revenue of the Company's product Kangyueda (IL-4R monoclonal antibody, stapokibart) for the first three quarters of 2026 totaled approximately RMB 660 million, representing a year-on-year increase of approximately 227%, primarily driven by genuine market demand and a sharp increase in the number of hospitals with access. Thanks to national policy support, effective January 1, 2026, all three approved indications of Kangyueda moderate-to-severe atopic dermatitis (AD) in adults, chronic rhinosinusitis with nasal polyps (CRSwNP), and seasonal allergic rhinitis (SAR) as well as both packaging formats, the vial and the pre-filled autoinjector pen, have been included in China's National Reimbursement Drug List, with a medical insurance payment standard of RMB 1,039 per unit (specification: 300mg/2ml), greatly improving affordability for Chinese patients. Meanwhile, in July 2026, Kangyueda was officially included in the National Essential Medicines List (2026 Edition), effective September 1, 2026. According to relevant essential medicines management regulations, public medical institutions at all levels nationwide are required to stock and prioritize the use of listed medicines, further broadening 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. It has covered 30 provinces and nearly 290 cities, with more than 2,200 hospitals covered, approximately 2,200 hospitals continuously generating prescriptions, and more than 1,300 hospitals capable of in-hospital medication. It has established stable cooperative relationships with nearly 60 first-tier distributors and has deployed in nearly 700 pharmacies. The National Medical Products Administration (NMPA) of China has recently approved the marketing application of stapokibart (anti-IL-4R monoclonal antibody, trade name: Kangyueda, development code: CM310) for a new indication in the treatment of moderate-to-severe atopic dermatitis (AD) in adolescents, with both the vial (300mg [2ml]/vial) and pre-filled autoinjector 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 <18 years. The study 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). In addition, 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 the adult study results, the safety profile in the adolescent moderate-to-severe AD population was favorable, with no new safety signals identified.