KEYMED BIO-B (02162.HK): Nine-Month Product Revenue up 227%, Teen AD Indication Approved

NewTimeSpace News: Keymed Biosciences Inc. (stock code: 02162) announced on 16 October 2026 inside information that product rademarks of Kangyueda (IL-4Rα monoclonal antibody, stapokibart) recorded total revenue of approximately RMB 660 million in the first nine months of 2026, up approximately 227% year on year, driven mainly by genuine market demand and a sharp increase in the number of accessible hospitals. The Company said that, thanks to policy support, the three approved indications of adult moderate-to-severe atopic dermatitis, chronic rhinosinusitis with nasal polyps and seasonal allergic rhinitis, together with both vial and pre-filled auto-injector presentations, have been included in the National Reimbursement Drug List in China since 1 January 2026, with a reimbursement standard of RMB 1,039 per unit (300mg/2ml). In July 2026, Kangyueda was formally included in the National Essential Drugs List (2026 Edition), effective 1 September 2026.

The Company further disclosed that as at 30 September 2026, its commercialisation team exceeded 550 members, with market access covering 30 provinces and nearly 290 cities, over 2,200 hospitals covered including approximately 2,200 hospitals actively producing prescriptions, over 1,300 hospitals able to administer the product in-house, stable cooperation with nearly 60 tier-one distributors and presence in nearly 700 pharmacies.

The announcement also disclosed that the National Medical Products Administration has recently approved stapokibart (anti-IL-4Rα monoclonal antibody, brand name Kangyueda, development code CM310) for the new indication of treating moderate-to-severe atopic dermatitis in adolescents, with both the vial (300mg/2ml/vial) and pre-filled auto-injector (300mg/2ml/injection) presentations approved. The approval was based on a randomised, double-blind, placebo-controlled Phase III study in 180 patients aged 12 to under 18, in which up to 73.9% of patients achieved an EASI-75 response at week 18, significantly higher than the placebo group of 43.3% (P<0.0001); up to 57.1% achieved an IGA response, superior to the placebo group of 25.0% (P<0.0001). Improvement in PP-NRS from baseline reached 49.5%, while treatment-emergent adverse events were comparable between the two groups and mostly mild to moderate.

The Company introduced stapokibart as a highly potent humanised antibody targeting the interleukin-4 receptor alpha subunit, being the first domestic IL-4Rα antibody approved by the NMPA and the world's first IL-4Rα antibody approved for seasonal allergic rhinitis. It said the marketing application for stapokibart injection for prurigo nodularis was accepted by the NMPA in March 2026, a Phase III study in paediatric patients with moderate-to-severe atopic dermatitis is under enrolment, and a Phase III study in adolescent seasonal allergic rhinitis patients on background therapy commenced in July 2026. The Company cautioned that the financial information is prepared from internal management records and has not been audited or reviewed by the external auditor.