CAMBRIDGE, Mass., ROTTERDAM, Netherlands and SHANGHAI, March 30, 2026 /PRNewswire/ -- Harbour BioMed ("HBM" or the "Company"; HKEX: 02142), a global biopharmaceutical company committed to the discovery and development of novel antibody therapeutics in immunology, oncology and other areas, today announced its financial results for the year ended December 31, 2025.

Dr. Jingsong Wang, Founder, Chairman, and CEO of Harbour BioMed, commented: "2025 marked a pivotal year for Harbour BioMed as we entered the third phase of our strategic evolution, with a clear roadmap toward our 2028 vision of becoming a global leading platform-based biopharmaceutical group.

The Company's strategy is powered by three integrated growth engines. These include building a global leading AI-driven antibody discovery 'new infrastructure' through Nona Biosciences, expanding global partnerships through platform-based collaborations with multinational pharmaceutical companies, and unlocking the global value of its mid- to late-stage pipeline in immunology, oncology and other areas through Harbour Therapeutics. These three engines connect technology platforms, global partnerships and pipeline development, forming a scalable model for sustainable innovation and long-term growth.

Leveraging our proprietary antibody discovery platforms and continued innovation in AI-enabled drug development, Harbour BioMed has built a strong global collaboration ecosystem. Looking ahead, we will continue to focus on innovation and accelerate the development of next-generation biologics to deliver transformative therapies for patients worldwide."

2025 Financial Highlights: Strong Growth and Profitability

• Total Revenue reached approximately US$158 million, representing an increase of 314.6% year over year, primarily driven by long-term strategic collaborations with multinational pharmaceutical companies, global licensing agreements, and robust revenue growth fueled by the strong performance of Nona Biosciences.
• Net Profit for the Year surged to approximately US$92 million, a 33-fold increase compared to full year 2024, reflecting strong revenue growth and continuous improvement in operational efficiency.
• Adjusted net profit for the year ^[1] was approximately US$101 million, representing a 11-fold year-over-year increase.
• Cash and Cash Equivalents stood at approximately US$403 million as of December 31, 2025, representing an increase of 141.6% from the end of 2024. The Company maintains strong financial resources and flexibility to execute efficient capital management initiatives.

Strategic Collaborations Fuel Global Expansion

Over the past several years, Harbour BioMed has steadily transformed the strength of its technology platforms into high-value global partnerships, building an expanding international innovation ecosystem. The Company has deepened its ties with global pharmaceutical leaders in antibody discovery and next-generation biologics development, ensuring its innovative platform technologies reached new heights.

In 2025 alone, the Company established multiple collaborations with global biotechnology innovators and multinational pharmaceutical companies, including Windward Bio, AstraZeneca, Otsuka, Pfizer and Bristol Myers Squibb. Among these, Harbour BioMed's expanding collaboration with AstraZeneca stands as a representative example of the Company's evolving partnership model—progressing from product licensing to a deep strategic collaboration covering multiple targets and programs. The collaboration between the two parties in 2025 is further distinguished by an innovative, multi-faceted framework that combines R&D collaboration, equity investment, and the establishment of the Harbour BioMed-AstraZeneca Innovation Lab.

Together, these collaborations underscore Harbour BioMed's evolving platform-driven partnership model, enabling the Company to accelerate global innovation while creating long-term strategic and commercial value.

Advancing a Robust and Differentiated Pipeline

Harbour BioMed continues to advance a diversified pipeline of innovative therapeutics addressing diseases with significant unmet medical needs. With almost 20 drug candidates spanning preclinical to late-stage clinical development, the Company is building a broad portfolio across immunology, oncology and other areas, while expanding into next-generation modalities including bispecific and tri-specific T cell engagers, antibody-drug conjugates, metabolic disease therapies and central nervous system programs.

Key products in the mid-late clinical stage include:

Batoclimab (HBM9161) is the first anti-FcRn monoclonal antibody completed Phase I to pivotal trials in China. As a novel, fully human anti-FcRn monoclonal antibody, batoclimab has the potential to be a breakthrough treatment option for a wide range of autoimmune diseases. The Phase III pivotal clinical trial results of batoclimab were published in JAMA Neurology in March 2024, demonstrating sustained efficacy and safety with long-term use of batoclimab in the treatment of generalized myasthenia gravis (gMG). In July 2024, NMPA accepted the BLA for batoclimab for the treatment of gMG.

HBM9378 is a fully human monoclonal antibody against thymic stromal lymphopoietin (TSLP) generated from the H2L2 Harbour Mice^® platform. It potently binds to the TSLP ligand and inhibits the TSLP mediated signaling pathway by blocking the interaction between TSLP and TSLP receptor. TSLP is a well-validated cytokine that plays a key role in the development and progression of a wide array of immunological conditions, including asthma and COPD where inhibition has demonstrated benefit in a wide array of inflammatory phenotypes. HBM9378 has been engineered to achieve an extended half-life and effector silencing and is subcutaneously administered.

The Company received the IND approval of HBM9378 for moderate-to-severe asthma from the NMPA in February 2022 and completed a Phase I clinical trial in healthy subjects in China. In November 2024, the Company submitted an IND application for HBM9378 for chronic obstructive pulmonary disease (COPD) to the NMPA, which was approved in January 2025.

In January 2025, it was announced that the Company and Kelun-Biotech entered into an exclusive license agreement with Windward Bio, under which Windward Bio was granted an exclusive license for the research, development, manufacturing and commercialization of HBM9378 globally (excluding Greater China and several Southeast and West Asian countries). In July 2025, Windward Bio launched global Phase II POLARIS clinical study, assessing long-acting dosing of HBM9378/WIN378 for people living with asthma.

Note: HBM9378 is known as SKB378 in Kelun-Biotech's pipeline and WIN378 in Windward Bio's pipeline.

Porustobart (HBM4003) is a next-generation, fully human heavy-chain-only anti-CTLA-4 antibody discovered and developed using the HCAb Harbour Mice^® platform. It is also the first fully human heavy-chain-only antibody which entered clinical development globally. Compared with conventional CTLA-4 antibodies, porustobart has unique, favourable properties, including significant Treg cell depletion and optimized pharmacokinetics for improved safety. Additionally, by enhancing antibody-dependent cellular cytotoxicity (ADCC), porustobart increases the potential to selectively deplete intratumoral Treg cells, helping to overcome the efficacy and toxicity bottleneck of current CTLA-4 therapies. The Company has implemented a global development plan for multiple types of solid tumors with an adaptive treatment design for porustobart. Positive efficacy and safety data have been observed in the monotherapy trial targeting advanced solid tumors, as well as in combination trials with PD-1 inhibitors for melanoma, colorectal cancer (CRC), neuroendocrine neoplasm (NEN) and hepatocellular carcinoma (HCC).

In October 2025, the Company published positive Phase II clinical data in combination with tislelizumab, for the treatment of microsatellite stable (MSS) metastatic colorectal cancer (mCRC). Of the 23 evaluable patients, the objective response rate (ORR) is 34.8%, disease control rate (DCR) is 60.9%, and 12-month overall survival (OS) Rate is 84%.

In February 2026, the Company entered a license agreement and equity partnership with Solstice Oncology, a clinical stage biotechnology company established by a syndicate of major venture capital investors, for the exclusive development and commercialization of HBM4003 outside Greater China.

HBM7575 is a long-acting bispecific antibody targeting TSLP and an undisclosed antigen, with a dual mechanism of action. On one hand, by blocking the interaction between TSLP and its receptor, it inhibits TSLP-mediated signaling pathways and the activation of Th2 immune cells. On the other hand, binding to and blocking the undisclosed target generates a synergistic effect, overcoming resistance issues associated with TSLP single-target antibodies. HBM7575 has been engineered to possess an extended half-life and favourable developability, enabling subcutaneous administration. Based on preclinical half-life data, the anticipated human half-life is expected to support dosing intervals of more than three months, positioning it as a potential best-in-class therapy.

In December 2025, NMPA accepted the IND application for HBM7575 for the treatment of atopic dermatitis. In March 2026, the China IND application for the treatment of atopic dermatitis, has been approved by the NMPA.

Key products in the next-generation innovation portfolio include:

HBM7020 is a BCMAxCD3 bispecific antibody generated using the fully human HBICE^® bispecific technology and Harbour Mice^® platform. HBM7020 can crosslink targeted cells and T cells by binding to BCMA and CD3 on the cell surface, leading to potent T cell activation and cell elimination. By incorporating dual anti-BCMA binding sites for optimal cell targeting and monovalent-optimized CD3 activity to minimize CRS, HBM7020 demonstrated potent cytotoxicity with broad applications in both immunological and oncology diseases. In August 2023, HBM7020 obtained IND clearance from the NMPA to commence a Phase I trial for cancer in China. In June 2025, the Company entered a global strategic collaboration with Otsuka Pharmaceutical Co., Ltd. (Otsuka) to advance HBM7020 for the treatment of autoimmune diseases.

HBM7004 is a novel B7H4xCD3 bispecific antibody. Using HBICE^® bispecific technology and Harbour Mice^® platform, this bispecific antibody was designed to provide innovative solutions for cancer immunotherapy from both efficacy and safety perspectives. The development of B7H4xCD3 bispecific HBICE^® further consolidates the Company's bispecific immune cell engager platform, demonstrating the HBICE^® platform's versatility and plug-and-play advantages. In preclinical studies, HBM7004 demonstrated an intratumor B7H4-dependent T cell activation manner. In multiple animal models, HBM7004 showed strong anti-tumor efficacy, remarkable in vivo stability, and reduced systemic toxicity. Additionally, in preclinical models, HBM7004 exhibited a strong synergistic effect when combined with a B7H4x4-1BB bispecific antibody at a low effector-to-target cell ratio, indicating an encouraging therapeutic window. In 2025, the Company continued the development in pre-clinical and advanced to IND-enabling stage for HBM7004.

Metabolic Disease Programs: The Company is developing innovative therapies for obesity-related conditions to address key challenges in current obesity treatments, including muscle preservation and long-term efficacy. Multiple programs currently in preclinical development, each designed to offer innovative mechanisms of action, including targeted hormone modulation and enhanced metabolic regulation. By integrating dual-targeting strategies with enhanced safety profiles, these therapies have the potential to complement and expand upon existing treatment options, including various agonists of GLP-1 receptor, GIP receptor, and GCG receptor. These programs are supported by the Company's antibody discovery platform and Hu-mAtrIx^TM AI platform, with AI applications guiding antibody sequence discovery, enrichment, optimization, bispecific geometry design, and developability/immunogenicity/pharmacokinetics (PK) assessments, as well as patient biomarker studies.

CNS Disease Programs: Resilience Neuroscience, a wholly-owned subsidiary of the Company, is advancing a next-generation central nervous system (CNS) pipeline focused on Alzheimer's disease, Parkinson's disease, and other neurodegenerative disorders. Multiple programs are currently in preclinical development, targeting well-validated CNS pathways. By significantly enhancing central nervous system delivery and extending half-life, these programs aim to amplify therapeutic efficacy and deliver next-generation best-in-class (BIC) and first-in-class (FIC) therapeutics. This approach is enabled by our proprietary platform technologies, including HCAb-based blood-brain barrier (BBB) shuttle platforms for brain-penetrant antibody delivery and BBB shuttle-conjugated ASO/siRNA modalities, designed to overcome the key barriers in CNS drug development.

Powering Next-Generation Therapeutics Through Platform Innovation and Venture Incubation

Technology platform innovation remains a core pillar of Harbour BioMed's long-term strategy and a key driver of its research productivity and business development success. By continuously advancing its proprietary antibody discovery platforms including Harbour Mice^®, HCAb-based antibody technologies and multi-specific antibody engineering capabilities, the Company is enhancing the efficiency of antibody discovery while enabling the development of next-generation biologics across multiple therapeutic areas.

Building on the foundation, Harbour BioMed is increasingly integrating artificial intelligence with advanced antibody engineering to further accelerate discovery. One of Harbour BioMed's most exciting innovations in 2025 has been the launch of its first fully human Generative AI HCAb Model powered by the Hu-mAtrIx™ AI platform. Built on more than nine million next-generation sequencing-derived HCAb sequences, the platform integrates AI-driven design, intelligent screening and wet-lab validation to establish a closed-loop discovery process for antibody development. To further advance AI-enabled innovation, Harbour BioMed also launched the Global AI + Pharmaceutical Ecosystem Alliance in 2025, bringing together technology partners, industry experts and investors to accelerate AI-driven drug discovery.

These platform capabilities have played an important role in supporting the Company's expanding pipeline and global collaborations with leading pharmaceutical partners, further demonstrating the commercial and scientific value of Harbour BioMed's technology platforms.

Beyond advancing internal R&D capabilities, Harbour BioMed is also leveraging its proprietary technologies to drive new innovation models. Through its "technology for equity" approach, the Company continues to incubate next-generation biotechnology ventures, expanding the application scenarios of its platform technologies while creating additional long-term value.

With flexible capital investment, Harbour BioMed has incubated several ventures focused on cutting-edge therapeutic areas, ranging from multivalent antibodies to cell therapies. These include collaborations with NK Cell-Tech in NK cell therapies, as well as incubating Élancé Therapeutics, which focuses on next-generation obesity treatments, and Resilience Neuroscience, dedicated to therapies for neurodegenerative diseases. Harbour BioMed has also co-founded Sobour Biopharma to develop innovative therapies for cancer and inflammatory diseases.

Together, these initiatives highlight the broad potential of Harbour BioMed's technology platforms and demonstrate how the Company's platform-driven innovation model continues to generate new opportunities for scientific advancement and future growth.

Outlook: Driving the Next Phase of Global Growth

Looking ahead, Harbour BioMed will continue to drive sustainable business growth and fulfill its 2028 vision of becoming a global leading platform-based biopharmaceutical group through the three integrated growth engines.

In 2026, the Company expects to advance multiple high-potential assets into mid- to late-stage clinical development and progress additional innovative candidates into the clinical stage across immunology, oncology, and other therapeutic areas with high unmet medical needs. Meanwhile, the Company will actively explore various opportunities to accelerate its portfolio and platform value realization and strengthen its role in the global innovation ecosystem by expanding collaborations with global partners.

By integrating technology platforms, pipeline innovation and global partnerships, Harbour BioMed remains committed to delivering transformative biologic therapies to patients worldwide and further strengthening its position as a globally competitive innovator in next-generation biotherapeutics.

About Harbour BioMed

Harbour BioMed (HKEX: 02142) is a global biopharmaceutical company committed to the discovery and development of novel antibody therapeutics in immunology, oncology and other areas. The Company is building a robust portfolio and differentiated pipeline through internal R&D capability, strategic global collaborations in co-discovery and co-development, and selective acquisitions.

Our proprietary antibody technology platform, Harbour Mice^®, generates fully human monoclonal antibodies in both the conventional two heavy and two light chain (H2L2) format and the heavy chain-only (HCAb) format. Building upon HCAb antibodies, the HCAb-based immune cell engagers (HBICE^®) bispecific antibody technology enables tumor-killing effects that traditional combination therapies cannot achieve. The HCAb-based Antibody Plus technology (HCAb PLUS^TM) provides comprehensive modality solutions for the development of innovative multi-specific medicines in different disease areas. Additionally, building upon the Harbour Mice^® platform, Harbour BioMed launched its first fully human Generative AI HCAb Model powered by its Hu-mAtrIx^TM AI platform, accelerating the development of innovative therapies.

By integrating Harbour Mice^®, HBICE^®, HCAb PLUS^TM, a single B-cell cloning platform and AI technologies, Harbour BioMed has built a highly efficient and distinctive antibody discovery engine for developing next-generation therapeutic antibodies. For more information, please visit www.harbourbiomed.com.

 

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