Rotterdam-Linked Biotech Firm Secures Approval for New Asthma Drug Trials
Rotterdam, Wednesday 15 July 2026
Harbour BioMed has secured Chinese approval to trial a novel asthma treatment, which preclinically supports an impressive dosing interval of over three months.
Regulatory Milestone in China
On 14 July 2026, China’s National Medical Products Administration (NMPA) officially approved the Investigational New Drug (IND) application for HBM7575 (also designated as SKB575), a novel therapeutic candidate designed to treat asthma [1]. Developed through a strategic partnership between Harbour BioMed and Kelun-Biotech, this clinical asset is a long-acting bispecific antibody that targets Thymic Stromal Lymphopoietin (TSLP) and an undisclosed antigen [1]. This regulatory milestone marks a significant step forward in translating the laboratory-developed asset into a viable commercial treatment for global markets [GPT].
Preclinical Promise and Patient Compliance
The therapeutic profile of HBM7575/SKB575 stands out due to its potential to dramatically improve the quality of life for chronic asthma sufferers [GPT]. Designed for subcutaneous administration, preclinical testing has revealed a robust half-life that supports dosing intervals exceeding three months [1]. If successfully replicated in upcoming human trials, this extended dosing window could drastically reduce the burden of frequent clinical visits and daily medication regimes for patients, offering a highly competitive edge in the respiratory therapeutic space [GPT].
A Strategic Alliance for Global Commercialisation
The commercialisation pathway for HBM7575/SKB575 is structured around a clear division of operational responsibilities to maximise global reach [1][GPT]. Under their collaboration agreement, Kelun-Biotech (6990.HK) holds the primary responsibility for the design, global development, and commercialisation of the drug [1]. Harbour BioMed (HKEX: 02142) provides essential investment and shares in the subsequent benefits, leveraging its highly specialised, proprietary discovery platforms—including Harbour Mice® (H2L2 and HCAb formats), HBICE® (bispecific immune cell engagers), and HBICATM (bispecific immune cell antagonists) [1]. Similar high-profile licensing and development deals have increasingly characterised the region’s biotech sector, such as AstraZeneca’s global licensing agreement with China’s Dizal Pharmaceutical for lung cancer treatments [2].
Kelun-Biotech’s Scaling Pipeline
For Harbour BioMed, partnering with an established player like Kelun-Biotech mitigates the inherent risks of clinical scaling [GPT]. Kelun-Biotech’s pipeline contains over 30 innovative drug projects, with 4 projects covering 8 indications already approved for marketing, 1 project currently in the New Drug Application (NDA) stage, and over 10 undergoing clinical development [1]. Furthermore, its proprietary OptiDC™ platform has secured approvals for 2 Antibody-Drug Conjugate (ADC) projects across 5 distinct indications [1]. Combining these approvals, Kelun-Biotech has achieved regulatory success across a total of 13 approved indications within these key segments [1].
Expanding the Clinical Footprint
Asthma is the second major chronic immune-mediated condition targeted by this bispecific antibody [1]. The co-developers have already initiated a Phase 1 clinical study for atopic dermatitis, where the first participant has already been successfully dosed [1]. Dr. Jingsong Wang, Founder, Chairman, and CEO of Harbour BioMed, expressed optimism regarding the molecule’s rapid progression, noting that having two major indications cleared for clinical development allows the teams to execute their clinical plans and explore the therapeutic potential to redefine chronic disease treatment paradigms [1].
From Rotterdam Roots to Global Horizons
The scaling of HBM7575/SKB575 represents a notable triumph for European academic spin-offs, particularly those linked to the Erasmus Medical Centre in Rotterdam, where Harbour BioMed’s foundational antibody discovery technologies were first developed [GPT]. While the NMPA approval on 14 July 2026 establishes the regulatory framework to proceed, the exact clinical trial commencement dates for the asthma indication remain unstated [alert! ‘exact start dates for the asthma clinical trials have not yet been announced’]. Nonetheless, the transition from local university research to global clinical trials underscores the commercial viability of Benelux life sciences innovation [GPT].