Harbour BioMed Gets NMPA IND Clearance for HBM9378/SKB378 for COPD Treatment

Cambridge, MA, Rotterdam, NL, Shanghai, CN — February 4, 2025 — Harbour BioMed (HKEX: 02142), a prominent player in the global biopharmaceutical landscape, has achieved a significant milestone with the approval from China's National Medical Products Administration (NMPA) for its Investigational New Drug (IND) application. This approval pertains to HBM9378/SKB378, also referred to as WIN378, a fully human antibody developed to target thymic stromal lymphopoietin (TSLP) for the treatment of chronic obstructive pulmonary disease (COPD).

COPD, a chronic and progressive respiratory condition, presents severe health challenges, including heightened cardiovascular risks, potential respiratory failure, and an increased likelihood of lung cancer. The disease continues to impose substantial healthcare costs and societal burdens worldwide. There remains an urgent demand for innovative therapeutic solutions to reduce the daily hardships faced by COPD patients and enhance their living standards.

The role of TSLP is pivotal in the progression of COPD, as it instigates airway inflammation by provoking immune responses. The innovative therapy, HBM9378/SKB378, has been developed with the intention to block the TSLP-mediated signaling pathway, thereby reducing inflammation in the airways and improving lung function in those afflicted with COPD.

Dr. Jingsong Wang, the founder, chairman, and CEO of Harbour BioMed, emphasized the importance of this regulatory approval, seeing it as a crucial step in addressing unmet needs in immunological diseases. Dr. Wang described HBM9378/SKB378 as potentially best-in-class, highlighting its long-acting properties and superior biophysical attributes. The company remains dedicated to further exploring its therapeutic capabilities to benefit patients on a global scale.

In a strategic move on January 10, 2025, Harbour BioMed partnered with Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (Kelun-Biotech) through a global licensing agreement (excluding Greater China and selected Southeast and West Asian countries) with Windward Bio for HBM9378/SKB378. This agreement promises Harbour BioMed and Kelun-Biotech up to $45 million in initial and near-term milestone payments, in both cash and equity in Windward Bio's parent entity. The agreement's total potential value, encompassing these payments, could reach approximately $970 million, supplemented by tiered royalties on net sales.

HBM9378/SKB378 is the result of a collaborative development initiative between Harbour BioMed and Kelun-Biotech. This partnership ensures equal rights to the product in Greater China and certain Southeast and West Asian countries. The antibody is fully human and monoclonal, crafted using the Harbour Mice® platform that employs two heavy and two light chains (H2L2). It functions by interrupting the interaction between TSLP and its receptor, a crucial cytokine linked to the emergence and progression of various immunological conditions, such as asthma and COPD. Blocking this pathway has shown potential benefits across multiple inflammatory conditions. The antibody is optimized for a prolonged half-life, offering advantageous dosing properties.

Harbour BioMed has already concluded a phase I clinical trial in China under an IND, targeting moderate-to-severe asthma. Plans for a phase II clinical trial are underway, marking continued progress in this therapeutic area.

Harbour BioMed stands as a global biopharmaceutical firm dedicated to discovering, developing, and commercializing pioneering antibody therapeutics with a focus on immunology and oncology. The company boasts a robust pipeline and distinct portfolio, facilitated by internal research and development capabilities, strategic collaborations, and selective acquisitions. Its proprietary Harbour Mice® technology platform produces fully human monoclonal antibodies in both H2L2 and heavy chain only (HCAb) formats. Building on HCAb antibodies, the HBICE® bispecific antibody technology offers tumor-targeting capabilities beyond the reach of conventional combination therapies. This cutting-edge technology, in conjunction with a unique single B cell cloning platform, ensures efficient and innovative development of next-generation therapeutic antibodies.