Harbour BioMed, a global biopharmaceutical company focused on advancing innovative antibody-based therapies in immunology and immune-oncology, has announced the online publication of results from the first-in-human Phase I clinical trial (NCT05790694/CTR20221961) of HBM9378 (also referred to as SKB378 or WIN378).

The study, led by Dr. Min Xu, a respiratory medicine specialist at Chengdu Fifth People’s Hospital, appears in the peer-reviewed journal Drug Design, Development and Therapy. Findings from the trial highlight a strong safety profile and a prolonged half-life, supporting continued investigation of HBM9378 in patients with serious immune-related conditions.

HBM9378 is a fully human monoclonal antibody with an extended half-life that targets thymic stromal lymphopoietin (TSLP). It is being co-developed by Harbour BioMed and Kelun-Biotech. The randomized, double-blind, placebo-controlled, single-ascending-dose (SAD) study enrolled 50 healthy adults to assess safety, tolerability, pharmacokinetics (PK), and immunogenicity. Participants were divided into five dose groups—20 mg, 60 mg, 200 mg, 600 mg, and 900 mg—with each cohort consisting of ten individuals, eight receiving HBM9378 and two receiving a placebo.

Results showed that treatment-emergent adverse events (TEAEs) occurred at similar rates across both the treatment and placebo groups, with no evidence of increased safety concerns at higher doses. The median time to reach peak concentration (Tmax) ranged between 4.05 and 14.1 days, while the average half-life (T1/2) was between 55.0 and 65.8 days. Drug exposure, measured by Cmax and AUC, rose proportionally with increasing doses from 20 mg to 900 mg. Anti-drug antibodies (ADA) were detected in 5% of participants (2 out of 40), with no observed clinical effects or impact on drug exposure. Notably, no injection site reactions were reported in any group.

Dr. Jingsong Wang, Founder, Chairman, and CEO of Harbour BioMed, described the Phase I results as an important step forward in developing new treatments for immune-related diseases. He emphasized that the favorable safety profile and extended half-life strengthen confidence in the drug’s potential to address unmet needs in conditions such as severe asthma and chronic obstructive pulmonary disease (COPD).

Dr. Min Xu, Principal Investigator of the study, noted that HBM9378 was well-tolerated and demonstrated a promising pharmacokinetic profile in healthy volunteers. He added that its long half-life could allow for less frequent dosing, which may improve patient adherence and overall treatment outcomes. The findings pave the way for further clinical trials to evaluate the drug’s effectiveness in individuals with severe immunological disorders.

Advancing Access to Healthcare through Innovation and Partnerships
Expanding access to medicines and healthcare relies on the continuous creation of evidence-driven solutions to address unmet medical needs. To support this mission, we actively engage in collaborative scientific efforts with academic institutions, research organizations, start-ups, pharmaceutical companies, hospitals, and health maintenance groups.

These partnerships help us discover external innovations that complement our internal R&D objectives. This collaborative approach enhances our scientific presence and accelerates the expansion of our innovative drug pipeline, aligning with the Step-up Innovation focus of our Pivot to Growth strategy. Ultimately, these initiatives aim to reduce the time needed for drug discovery and development and improve the likelihood of identifying successful therapeutic candidates.

Our Model for Innovation and Collaboration
Our innovation strategy is multi-faceted—bridging internal priorities (uncovered through team workshops and consultations) with external opportunities identified via detailed mapping, database analysis, AI-based scouting, and traditional methods. By being actively involved in key trade and industry associations, we strengthen our position within the global biotech ecosystem. As a trusted collaborator, we offer access to industry insights and the expertise of our skilled teams.

Partnerships Across the U.S. and Europe
In the United States, we have strategic innovation partnerships with top academic institutions including Harvard University, Thomas Jefferson University, University of Pittsburgh, University of Oklahoma, and University of Pennsylvania.

In Europe, we’ve been an active participant in the Innovative Medicines Initiative (IMI)—Europe’s largest public-private partnership in life sciences—since 2019. This initiative supports the development of advanced vaccines, medicines, and treatment methods. As of 2024, we are involved in over eight IMI consortia, covering the full spectrum of drug development. Two of the latest projects focus on biologics and biomarker research:

Israel as a Strategic Innovation Hub
Given our strong historical roots in Israel, the country plays a vital role in our global innovation efforts. Since re-establishing our focus there in 2020, we have initiated around 50 research collaborations with Israeli scientists. These projects have secured 18 grants from the Israel Innovation Authority, with two receiving additional funding in 2024.

Key Israel-based innovation initiatives include:

Research into Public Health Needs
Our research team gathers and interprets public health and epidemiological data to assess the clinical, economic, and social needs of patients in key therapeutic areas such as neurology, psychiatry, immunology, and oncology. We focus on understanding disease burden, testing innovative clinical education tools, and improving access to treatment. This data also supports trial design by helping to identify the most appropriate patient populations and inclusion criteria. In 2024, we presented findings at 176 scientific conferences and published 55 articles in peer-reviewed medical and scientific journals.

Teva’s 2024 Academic Publications on PubMed (55 total):

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