Harbour Bio Pharmaceuticals announced the completion of the first subject dosing of a new generation of anti-TSLP fully human monoclonal antibodies

Harbour Bio Pharmaceuticals (stock code: 02142.
HK) announced on September 27 that it and Kolombateo (a subsidiary of Kelun Pharmaceutical), jointly developed a new generation of anti-TSLP fully human monoclonal antibody HBM9378 (KB378), which completed the dosing
of the first subject in a phase I clinical trial in China.

HBM9378 is jointly developed by Harbour Bio Pharmaceuticals and Korum Biotech based on Harbour Bio Pharma's own H2L2 platform, and both parties share their global rights
.
This project targets thymus stromal lymphopoietin (TSLP) for the treatment of moderate to severe asthma, and its long half-life optimization design and excellent physicochemical properties give HBM9378 potential advantages
in drug delivery.

Under the strategic cooperation agreement, Harbour Biomed and Kolumbotai will also jointly develop innovative therapies
for monoclonal antibodies and antibody conjugates.

With strong platform advantages and R&D strength, Harbour Bio will continue to work together with excellent partners in the industry, combined with innovative business models, to empower the development of the industry and meet the needs of
patients.

About HBM9378/SKB378

HBM9378/SKB378 is a fully human monoclonal antibody
based on the Harbour Biomed dual-chain double light chain (H2L2) platform.
The antibody targets thymus stromal lymphopoietin (TSLP), inhibiting the TSLP-mediated signaling pathway
by blocking the interaction between the factor and the receptor.
TSLP is a key epithelial cell-derived cytokine with upstream and central roles in the immune cascade, which plays a key role
in the initiation and persistence of severe asthma in allergy, eosinophilism (T2 inflammation), and other types (non-T2 inflammation).

About asthma

Asthma is a chronic airway inflammatory disease involving a variety of cells and cellular components, with recurrent episodes of wheezing, shortness of breath, with or without chest tightness or cough, accompanied by airway hyperresponsiveness and variable airflow restriction
.
Asthma is a heterogeneous disease with different clinical phenotypes
.
There are more than 300 million asthma patients in the world, about 45.
7 million people with asthma aged 20 and above in China, about 5%-10% of adult asthma patients, and about 20%
of patients with moderate to severe asthma.
The recommended treatment regimens for moderate to severe asthma include medium to high doses of ICS (inhaled corticosteroids)-LABA (long-acting beta-2 agonists), biologics, and oral hormones, and many patients with moderate to severe asthma remain uncontrolled
.
Current biologics target moderate to severe asthma
with T2 inflammation (clinically manifested by elevated peripheral blood and sputum eosinophils and/or FENO).

Moderate to severe asthma exacerbations are more frequent, lung function is severely limited, quality of life is reduced, and the medical burden is also heavy
for these patients.
Therefore, there is still a clear unmet need in patients with moderate to severe asthma, and there is an urgent clinical need for safer and broader coverage of moderate to severe asthma treatment drugs
.