Kelun-Biotech's COPD Drug Enters Phase 2 Trials, Expanding Respiratory Portfolio
Event summary
- Windward Bio dosed first patients in Phase 2 SIRIUS study of SKB378/WIN378 for COPD, expanding its respiratory disease pipeline.
- SKB378/WIN378 is a next-generation, fully human monoclonal antibody targeting TSLP, with potential for twice-yearly dosing.
- Initial Phase 2 data for asthma expected in H2 2026, with Phase 3 trials planned for Q4 2026.
- Kelun-Biotech retains Greater China rights, while Windward Bio holds global rights (excluding certain regions).
- COPD is the third leading cause of death worldwide, with over 3 million patients at high risk of recurrent exacerbations.
The big picture
Kelun-Biotech's expansion into COPD with SKB378/WIN378 aligns with the growing focus on targeted therapies for immune-mediated respiratory diseases. The drug's ultra long-acting profile could differentiate it in a market dominated by inhaled therapies, addressing a significant unmet need for patients at high risk of exacerbations. The strategic partnership with Windward Bio underscores the importance of global collaboration in bringing innovative treatments to market.
What we're watching
- Clinical Efficacy
- How SKB378/WIN378's performance in COPD compares to its asthma trial results and market competitors.
- Regulatory Pathway
- The pace at which Phase 3 trials for asthma and COPD will progress, given the twice-yearly dosing advantage.
- Commercial Strategy
- Whether Kelun-Biotech and Windward Bio can effectively navigate the regional rights split for global market penetration.
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