Harbour BioMed and Kelun-Biotech Announce NMPA Approval of IND Application for HBM7575/SKB575 for the Treatment of Asthma

Asthma is a chronic respiratory condition affecting approximately 300 million people worldwide, with prevalence continuing to rise. Despite the availability of treatment options, many patients experience persistent symptoms, frequent exacerbations, and reduced quality of life. Current therapies - mainly inhaled corticosteroids (ICS) and bronchodilators - are inadequate for some patients, underscoring the urgent need for more effective, long-acting treatments that address the underlying disease mechanisms.

"Building on the recent first participant dosing for HBM7575/SKB575 in atopic dermatitis, we are thrilled to see this molecule rapidly advancing into asthma indication." Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed, commented. "With two major indications now cleared for clinical development, we look forward to executing our clinical plan and exploring the full potential of this molecule to redefine treatment paradigms for chronic immune-mediated conditions."

About HBM7575/SKB575

HBM7575/SKB575 is a long-acting bispecific antibody targeting TSLP and an undisclosed antigen, with a dual mechanism of action. On one hand, by blocking the interaction between TSLP and its receptor, it inhibits TSLP-mediated signaling pathways and the activation of Th2 immune cells. On the other hand, binding to and blocking the undisclosed target generates a synergistic effect, with the potential to achieve broader control of inflammation compared to single-target approaches. HBM7575/SKB575 has been engineered to allow for longer dosing intervals and a convenient subcutaneous route of administration. Based on preclinical half-life data, the anticipated human half-life is expected to support dosing intervals of more than three months, positioning it as a potential best-in-class therapy.

According to the collaboration agreement between Harbour BioMed and Kelun-Biotech, HBM7575/SKB575 is led by Kelun-Biotech in its design, global development and commercialization, with Harbour BioMed participating in the investment and development of this asset and sharing the benefits as agreed.

About Harbour BioMed

Harbour BioMed (HKEX: 02142) is a global biopharmaceutical company committed to the discovery and development of novel antibody therapeutics in immunology and oncology. The company is building a robust and differentiated pipeline through internal R&D capabilities, strategic global collaborations in co-discovery and co-development, and selective acquisitions.

Harbour BioMed's proprietary antibody technology platform, Harbour Mice^®, generates fully human monoclonal antibodies in both the conventional two heavy and two light chain (H2L2) format and the heavy chain-only (HCAb) format. Building upon HCAb antibodies, the HCAb-based immune cell engagers (HBICE^®) bispecific antibody technology enables tumor-killing effects that traditional combination therapies cannot achieve. Additionally, the HCAb-based bispecific immune cell antagonist (HBICA^TM) technology empowers the development of innovative biologics for immunological and inflammatory diseases. By integrating Harbour Mice^®, HBICE^®, and HBICA^TM with a single B-cell cloning platform, Harbour BioMed has built a highly efficient and distinctive antibody discovery engine for developing next-generation therapeutic antibodies. For more information, please visit www.harbourbiomed.com.

About Kelun-Biotech

Kelun-Biotech (6990.HK) is a holding subsidiary of Kelun Pharmaceutical, which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. Kelun-Biotech focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. Kelun-Biotech is committed to becoming a leading global enterprise in the field of innovative drugs. At present, Kelun-Biotech has more than 30 ongoing key innovative drug projects, of which 4 projects with 8 indications have been approved for marketing, 1 project is in the NDA stage and more than 10 projects are in the clinical stage. Kelun-Biotech has established one of the world's leading proprietary ADC and novel DC platforms, OptiDC™, and has 2 ADC projects with 5 indications approved for marketing, and multiple ADC and novel DC assets in clinical or preclinical research stage. For more information, please visit https://en.kelun-biotech.com/.

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SOURCE Harbour BioMed