By Fineline Cube Harbour BioMed (HKG: 2142) and Kelun-Biotech (HKG: 6990) announced today that the Investigational New Drug (IND) application for HBM7575/SKB575—a co-developed long-acting bispecific antibody targeting thymic stromal lymphopoietin (TSLP) and an undisclosed target—has been approved by China’s National Medical Products Administration (NMPA) for the treatment of asthma.
Regulatory Milestone | Key Details
| Component | Specification |
|---|---|
| Companies | Harbour BioMed (HKG: 2142) and Kelun-Biotech (HKG: 6990) |
| Drug Candidate | HBM7575/SKB575 |
| Regulatory Authority | NMPA (China) |
| Approval Type | IND approval |
| Indication | Asthma |
| Announcement Date | July 15, 2026 |
| Development Stage | Phase I (asthma indication) |
Drug Profile & Mechanism of Action
Molecular Characteristics
- Class: Long-acting bispecific antibody
- Primary Target: Thymic stromal lymphopoietin (TSLP)
- Secondary Target: Undisclosed (confidential competitive advantage)
- Administration: Subcutaneous injection
- Dosing Interval: Expected to exceed three months based on preclinical half-life data
Therapeutic Innovation
HBM7575/SKB575 represents a next-generation approach to asthma management:
- Dual Targeting: Simultaneous inhibition of TSLP and secondary pathway
- Extended Duration: Potential for quarterly or less frequent dosing
- Convenience: Subcutaneous administration suitable for outpatient settings
- Best-in-Class Potential: Superior half-life profile compared to existing biologics
Clinical Development Status
- Atopic Dermatitis: Phase I trial successfully completed first subject dosing
- Asthma: IND approval enables Phase I initiation in China
- Half-Life Data: Preclinical studies support >3-month dosing intervals in humans
Strategic Collaboration Framework
Partnership Structure
The collaboration between Harbour BioMed and Kelun-Biotech leverages complementary strengths:
| Company | Role |
|---|---|
| Kelun-Biotech | Leading design, global development, and commercialization |
| Harbour BioMed | Co-investing and co-developing the project |
| Both Parties | Sharing profits as agreed in collaboration agreement |
Strategic Rationale
- Kelun-Biotech: Expands biologics pipeline beyond oncology into respiratory diseases
- Harbour BioMed: Leverages proprietary bispecific antibody platforms for new indications
- Synergy: Combines Harbour’s discovery expertise with Kelun’s development and commercial capabilities
Market Opportunity & Competitive Landscape
Asthma Therapeutics Market
- Prevalence: Affects over 300 million people globally
- Severe Asthma: Represents 5-10% of total asthma cases but drives significant healthcare costs
- Biologics Market: Current anti-TSLP (tezepelumab), anti-IL5/5R, anti-IgE, and anti-IL4R therapies
- Market Size: Global severe asthma biologics market projected to reach $15+ billion by 2030
Competitive Differentiation
HBM7575/SKB575’s unique positioning includes:
- Bispecific Advantage: Dual targeting may provide superior efficacy vs. single-target biologics
- Dosing Convenience: >3-month intervals vs. monthly or bi-weekly dosing of current biologics
- Patient Compliance: Reduced injection frequency improves long-term adherence
- Cost-Effectiveness: Less frequent administration reduces healthcare resource utilization
TSLP Target Validation
Thymic stromal lymphopoietin represents a validated upstream target in asthma pathogenesis:
- Upstream Cytokine: TSLP initiates inflammatory cascade affecting multiple downstream pathways
- Broad Applicability: Effective across different asthma phenotypes regardless of eosinophil levels
- Clinical Proof: Tezepelumab (anti-TSLP) demonstrated efficacy in broad asthma population
The undisclosed second target provides potential for enhanced efficacy or safety beyond TSLP inhibition alone.
Development Outlook & Commercial Potential
The successful completion of first subject dosing in atopic dermatitis provides early clinical validation of the molecule’s safety profile, de-risking the asthma development program. The extended half-life profile positions HBM7575/SKB575 to potentially become a best-in-class therapy with significant commercial advantages:
- Premium Pricing: Extended dosing intervals support higher per-dose pricing
- Market Share Capture: Convenience factor attracts patients from more frequently dosed competitors
- Global Expansion: Strong intellectual property position supports international development
- Indication Expansion: Potential for other TSLP-mediated diseases (chronic rhinosinusitis, COPD)
The partnership structure enables both companies to share development risks while maintaining significant commercial upside in one of the most valuable specialty pharmaceutical markets.
Forward-Looking Statements
This brief contains forward-looking statements regarding clinical development, regulatory approvals, and market opportunities. Actual results may differ due to risks including clinical trial outcomes, regulatory decisions, and competitive dynamics.-Fineline Info & Tech