Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (Kelun-Biotech, 06990.HK) announced that China’s National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application for SKB575/HBM7575, a long-acting bispecific antibody being co-developed with Harbour BioMed for the treatment of atopic dermatitis.
SKB575/HBM7575: Key Attributes • Dual Mechanism: Simultaneously blocks thymic stromal lymphopoietin (TSLP) signaling and a second target, aiming to curb Th2-driven inflammation and address resistance seen with single-target TSLP antibodies. • Extended Half-Life: Preclinical data indicate a projected human half-life that could allow dosing intervals exceeding three months, supporting subcutaneous administration and positioning the candidate as a potential best-in-class therapy. • Collaborative Framework: Kelun-Biotech leads global design, development and commercialization; Harbour BioMed contributes to funding and development and will share future economic returns as stipulated in the collaboration agreement.
Regulatory Milestone and Next Steps The IND clearance permits initiation of clinical trials in China, marking a pivotal step in Kelun-Biotech’s dermatology pipeline expansion. The company cautions, however, that successful development and commercialization are not guaranteed, and investors should exercise prudence when dealing in the company’s securities.
Board and Governance The Board is chaired by non-executive director Mr. Liu Gexin. The announcement was released in Hong Kong on 9 March 2026.