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Harbour BioMed Announces Submission of IND Application for HBM9378/SKB378 in the Treatment of Chronic Obstructive Pulmonary Disease

November 08, 2024

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Harbour BioMed Announces Submission of IND Application for HBM9378/SKB378 in the Treatment of Chronic Obstructive Pulmonary Disease

November 08, 2024

Cambridge, MA, Rotterdam, NL, Suzhou, CN – November 8, 2024

 

Harbour BioMed (the "Company”; HKEX: 02142), a global biopharmaceutical company committed to the discovery, development, and commercialization of novel antibody therapeutics focusing on oncology and immunology, today announced the submission of an Investigational New Drug (IND) application to the Centre for Drug Evaluation of the National Medical Products Administration of China for HBM9378/SKB378, a fully human antibody targeting thymic stromal lymphopoietin (TSLP), for the treatment of chronic obstructive pulmonary disease (COPD).

 

COPD is a progressive respiratory condition with major complications, including cardiovascular risk, respiratory failure, and lung cancer. The disease imposes a significant and growing burden both in terms of healthcare costs and societal impact. There is an urgent need for new therapeutic options to alleviate the daily suffering of COPD patients and improve their quality of life.

 

“HBM9378/SKB378 has fully human sequences with less immunogenicity risk and better bioavailability compared to other TSLP-targeting competitors. Its long half-life optimization and outstanding biophysical properties further enhance its dosing and formulation advantages. We are confident in the potential of HBM9378/SKB378 and believe that this novel therapy can meet the diverse needs of COPD patients,” said Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed.

 

About HBM9378/SKB378

 

HBM9378/SKB378 is a co-development project conducted by the Company and Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (6990.HK), who together equally share the global rights in respect of 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. Its long half-life optimization and outstanding biophysical properties support the favorable dosing advantage. Currently, the Company had completed the phase I trial in China under IND for the treatment of moderate-to-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 proprietary antibody technology platforms Harbour Mice® generates fully human monoclonal antibodies in two heavy and two light chains (H2L2) format, as well as heavy chain only (HCAb) format. Building upon the HCAb antibodies, the HCAb-based immune cell engagers (HBICE®) bispecific antibody technology is capable of delivering tumor-killing effects unachievable by traditional combination therapies. Integrating Harbour Mice®, and HBICE® with a single B cell cloning platform, our antibody discovery engine is highly unique and efficient for the development of next-generation therapeutic antibodies. For further information, please refer to www.harbourbiomed.com.

Media Contact:

Harbour BioMed Public Relations

E-mail: pr@harbourbiomed.com