Harbour BioMed Announces IND Approval for Next-Gen Anti-TSLP Fully Human Monoclonal Antibody

CAMBRIDGE,Mass. and ROTTERDAM,Netherlands and SUZHOU,China,Feb. 21,2022 -- Harbour BioMed ("HBM",HKEX: 02142) announced that China National Medical Products Administration (NMPA) had approved its investigational new drug (IND) application for HBM9378 (or SKB378 as referred to by Sichuan Kelun-Biotech Biopharmaceutical Co.,Ltd. ("Kelun-Biotech"),a subsidiary of Sichuan Kelun Pharmaceutical Co.,Ltd (SZSE: 002422),and HBM's partner in the development of HBM9378),a next-gen fully human antibody targeting thymic stromal lymphopoietin (TSLP),for the treatment of moderate-to-severe asthma.

HBM9378/SKB378 is a co-development project conducted by HBM and Kelun-Biotech,who together equally share the global rights in respect of HBM9378. The IND approval of HBM9378 is an achievement of the strategic collaboration between the parties. According to the strategic collaboration and license agreement between HBM and Kelun-Biotech,the parties will jointly explore innovative therapies of monoclonal antibodies and antibody-drug conjugate.

Building on HBM's innovative business model leveraging its productive R&D platform to lead the next generation of valuable and innovative therapies and its mission to address the unmet medical needs,HBM will continue to expand its collaboration with industry leading partners and further leverage on the combined capabilities of HBM and its collaborators.

"HBM9378/SKB378,a next-gen fully human monoclonal antibody,is developed from HBM's H2L2 platform. Its long half-life optimization and outstanding biophysical properties support the favorable dosing advantage. The approval of this IND application once again proves HBM's powerful innovation capability. Unleashing the power of our unique R&D engine,we are highly confident and determined to defeat intractable diseases across the world." said Dr. Jingsong Wang,Founder,Chairman and CEO of Harbour BioMed.

About HBM9378/SKB378

HBM9378/SKB378 is a fully human monoclonal antibody against TSLP generated from two heavy chains and two light chains (H2L2) platform. It inhibits the TSLP mediated signaling pathway by blocking the interaction between TSLP and TSLP receptor. TSLP plays important roles in DC cell maturation,T helper 2 (Th2) cell polarization and inflammation,particularly in both eosinophilic and non-eosinophilic inflammation asthma.

About Asthma

Asthma is a heterogeneous disease defined by the history of respiratory symptoms (e.g.,wheeze,shortness of breath,chest tightness and cough) that vary over time and in intensity,together with variable expiratory airflow limitation. The disease is estimated to affect more than 300 million people worldwide and affect more than 45.7 million adult people (≥20 years) in China. Approximately 5-10% of those afflicted with asthma have severe disease that is poorly controlled. Despite the use of medium to high dose inhaled corticosteroids (ICS) in combination with a long-acting β2-agonist (LABA),currently available biologic therapies and oral corticosteroids (OCS),many severe asthma remain uncontrolled. Current biologics are mainly targeting Type 2 severe asthma which manifests clinically with a combination of peripheral eosinophilia,sputum eosinophilia and/or elevated fractional exhaled nitric oxide (FENO).

Severe asthma patients experience frequent exacerbations,significant limitations on lung function and a reduced quality of life. The healthcare burden associated with care for these patients is also high. Therefore,there are still significant unmet needs to develop safer and broader therapies for severe asthma.

About Harbour BioMed

Harbour BioMed (HKEX: 02142) is a global biopharmaceutical company committed to the discovery,development and commercialization of novel antibody therapeutics focusing on immunology and oncology. The Company is building its robust portfolio and differentiated pipeline through internal R&D capability,collaborations with co-discovery and co-development partners and select acquisitions.

The Company's proprietary antibody technology platforms Harbour Mice®generate fully human monoclonal antibodies in two heavy and two light chain (H2L2) format,as well as heavy chain only (HCAb) format. Building upon the HCAb antibodies,the HCAb-based immune cell engagers (HBICE®) are capable of delivering tumor killing effects unachievable by traditional combination therapies. Integrating Harbour Mice®with single B cell cloning platform,our antibody discovery engine is highly unique and efficient for development of next generation therapeutic antibodies.

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