Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) announced that SKB575/HBM7575, a long-acting bispecific antibody (bsAb) targeting TSLP and an undisclosed second target, has received NMPA IND approval for the treatment of atopic dermatitis (AD). Co-developed with Harbour BioMed (HBM Holdings), the candidate features extended half-life engineering supporting dosing intervals exceeding three months, positioning it as a potential best-in-class therapy that overcomes resistance limitations of single-target TSLP antibodies through synergistic dual-target blockade.
Regulatory Milestone
Item
Detail
Agency
National Medical Products Administration (NMPA)
Approval Type
Investigational New Drug (IND) – Phase I-ready
Product
SKB575/HBM7575
Drug Class
Long-acting bispecific antibody (bsAb)
Targets
TSLP (thymic stromal lymphopoietin) + undisclosed second target
Efficacy in moderate-severe AD; biomarker stratification; combination potential
Phase III
2029-2031
Non-inferiority/superiority vs. tezepelumab; China NDA; global expansion
Global Strategy
2028+
U.S./EU IND filing; Fast Track designation pursuit
Forward‑Looking Statements This brief contains forward‑looking statements regarding clinical development timelines, half-life validation, and competitive positioning for SKB575/HBM7575. Actual results may differ due to target disclosure timing, manufacturing scale-up, and competitive dynamics in the atopic dermatitis biologics market.-Fineline Info & Tech
By Fineline Cube