Harbour BioMed and Kelun-Biotech secure NMPA IND clearance for HBM7575/SKB575, advancing a novel asthma biologic into clinical trials in China
Executive summary: Harbour BioMed and Kelun-Biotech announced that the NMPA approved their IND application for HBM7575/SKB575, an antibody therapeutic for asthma. The approval clears the way for first‑in‑human trials in China, advancing a potential new treatment in a $30 billion global asthma biologics market and strengthening the companies’ immunology portfolios.
Who is involved: Harbour BioMed (HKEX:02142), Kelun-Biotech (6990.HK), and the National Medical Products Administration (NMPA) of China.
Likely next: The partners will initiate Phase I clinical trials, expected to start in Q4 2026, followed by dose‑escalation studies and eventual Phase II planning contingent on interim results.
The National Medical Products Administration of China has cleared the investigational new drug application for the jointly developed antibody HBM7575/SKB575, allowing the partners to begin human studies for asthma treatment. This IND approval marks a key regulatory milestone for a biologic targeting a large, uncontrolled asthma patient pool and validates the companies’ immunology pipeline. While the clearance enables trial initiation, subsequent phases will depend on safety and efficacy data, with a potential NDA submission several years ahead.
Timeline
- — Harbour BioMed and Kelun-Biotech Announce NMPA Approval of IND Application for HBM7575/SKB575 for the Treatment of Asthma (PR Newswire)
- — Quoin Pharmaceuticals Receives FDA IND Clearance to Initiate Phase 2 Study of QRX003 in Peeling Skin Syndrome (GlobeNewswire)
Analysis — what this means
Likely next events
- Phase I trial of HBM7575/SKB575 expected to commence Q4 2026 in Chinese clinical sites
- NMPA may request additional pharmacology data before IND‑enabling studies conclude
- Potential co‑development expansion agreement between Harbour BioMed and Kelun-Biotech by mid‑2027
Sectors affected
- biopharmaceuticals
- asthma therapeutics
Regulatory implications
- NMPA IND approval permits clinical investigation under China’s Drug Administration Law; a future NDA will require pivotal trial data and safety reporting
- Post‑IND, the companies must comply with NMPA’s GCP and pharmacovigilance standards for ongoing trials
Historical parallels
- Jiangsu Hengrui’s asthma biologic received NMPA IND clearance in March 2023, leading to Phase I initiation later that year
Key entities
Sources
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