Harbour BioMed Receives NMPA IND Clearance for HBM9378/SKB378 in the Treatment of Chronic Obstructive Pulmonary Disease

CAMBRIDGE, Mass., ROTTERDAM, Netherlands and SHANGHAI, Feb. 4, 2025 /PRNewswire/ -- Harbour BioMed (HKEX: 02142, the "Company"), a global biopharmaceutical company committed to the discovery, development and commercialization of novel antibody therapeutics focusing on immune-oncology and immunology, today announced that the National Medical Products Administration (NMPA) of China has approved the Investigational New Drug (IND) application for HBM9378/SKB378 (also known as WIN378), 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.

TSLP plays a critical role in triggering airway inflammation by activating immune responses that contribute to COPD progression. HBM9378/SKB378 is designed to inhibit the TSLP-mediated signaling pathway, aiming to reduce airway inflammation and improve lung function in patients with COPD.

"This regulatory clearance from the NMPA marks an important milestone in advancing our efforts to address significant unmet needs in immunological diseases," said Dr. Jingsong Wang, Founder, Chairman, and CEO of Harbour BioMed. "HBM9378/SKB378 represents a potential best-in-class, long-acting TSLP antibody with exceptional biophysical properties. We will continue exploring its therapeutic potential to benefit patients worldwide."

On January 10, 2025, Harbour BioMed and Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech") entered into a global licensing agreement (excluding Greater China and select Southeast and West Asian countries) with Windward Bio for HBM9378/SKB378. Under the terms of the agreement, Harbour BioMed and Kelun-Biotech are eligible to receive $45 million in upfront and near-term milestone payments, including both cash and equity interest in Windward Bio's parent company. The total potential deal value, including upfront and milestone payments, could reach up to $970 million, in addition to tiered royalties ranging from single to double digits on net sales.

About HBM9378/SKB378

HBM9378/SKB378 (also known as WIN378) is a co-development project jointly conducted by Harbour BioMed and Kelun-Biotech, with both parties equally sharing its rights in Greater China and several Southeast and West Asian countries. It is a fully human monoclonal antibody targeting TSLP, generated from the two heavy chains and two light chains (H2L2) Harbour Mice^® platform. It inhibits the TSLP-mediated signaling pathway by blocking the interaction between TSLP and its receptor, which is a well-validated cytokine plays a key role in the development and progression of various immunological conditions, including asthma and chronic obstructive pulmonary disease (COPD). Inhibition of this pathway has shown benefits across multiple inflammatory phenotypes. The antibody's long half-life optimization and outstanding biophysical properties provide a favorable dosing advantage.

Currently, Harbour BioMed has completed a phase I clinical trial in China under an IND for the treatment of moderate-to-severe asthma. A phase II clinical trial for this indication is set to begin soon.

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 platform 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.

SOURCE Harbour BioMed