Company Announcements

CAMBRIDGE, Mass., ROTTERDAM, Netherlands and SHANGHAI, Aug. 27, 2025 /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 and oncology, today announced its interim results for the six months ended June 30, 2025.

Dr. Jingsong Wang, Founder, Chairman, and CEO of Harbour BioMed, commented: "In the first half of 2025, Harbour BioMed achieved several significant milestones. During the reporting period, the company's profit grew more than fiftyfold year over year, demonstrating strong growth momentum. Out-licensing and collaborations based on our innovative products have contributed significantly to revenue growth and have become a recurring source of income.

These results underscore the sustainability of our ability to translate innovation into commercial value and reflect the success of our diversified business model, which includes strategic partnerships, licensing collaborations, platform collaborations, and innovation incubation. Leveraging our industry-leading Harbour Mice^® platform and its extended 2.0 technology platform, Harbour BioMed has built a strong global collaboration ecosystem, positioning the Company as a cornerstone of global antibody drug development.

Looking ahead, we will continue to focus on innovation and accelerate the development of next-generation biologics to deliver better treatment options for patients worldwide."

As of June 30, 2025, Harbour BioMed reported total revenue of approximately US$101.3 million for the first half of the year, representing a 327% increase year over year. Net profit reached approximately US$73.0 million, a 51-fold increase compared with the same period in 2024. The Company also reported a strong cash position of about US$320 million, a 92% increase since the end of the previous year.

During the reporting period, the company delivered strong performance, highlighting the success of its business model and solid financial position.

Advancing a Robust and Differentiated Pipeline

Harbour Therapeutics, a sub-brand parallel to Nona Biosciences, is now individually responsible for the development of the Company's products pipeline on immunology and oncology. Harbour Therapeutics has established a rich and differentiated pipeline and continues to expand collaborations with leading global pharmaceutical companies and academic institutions to efficiently advance its programs. During the reporting period, several key clinical-stage projects achieved significant progress, alongside continued advancement of a robust portfolio of next-generation therapies.

Key products in the 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. In December 2023, the Company voluntarily planned to include additional long-term safety data and re-submitted the Biologic License Application (BLA) for batoclimab to the National Medical Products Administration of China (NMPA) in June 2024. In July 2024, NMPA accepted the BLA for batoclimab for the treatment of gMG. 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 gMG.

HBM9378 is a fully human monoclonal antibody against thymic stromal lymphopoietin (TSLP) generated from the H2L2 Harbour Mice^® platform. It 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 chronic obstructive pulmonary disease (COPD), where its 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 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 COPD to the NMPA, which was approved in January 2025.
• In January 2025, 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 initiated the global phase 2 POLARIS trial to evaluate the dosing, safety, and efficacy of HBM9378/WIN378 in patients with asthma. Initial data are expected in mid-2026.

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, CRC, NEN and HCC. Final data from the study of HBM4003 in combination with toripalimab for advanced HCC were published in Clinical Cancer Research in August 2025. Data from the Phase II study of HBM4003 in combination with tislelizumab for the treatment of microsatellite stable (MSS) metastatic colorectal cancer will be presented at the ESMO Congress 2025.

HBM1020 is a first-in-class fully human monoclonal antibody generated from the H2L2 Harbour Mice^® platform targeting B7H7. As a newly discovered member of the B7 family, B7H7 expression is found to be non-overlapping with PD-L1 expression in multiple tumor types, potentially playing a more significant role in tumor immune evasion. With its excellent product design and target features, HBM1020 presents great potential to address significant unmet medical needs for solid tumors. In September 2024, the Company presented the latest clinical data for patients with advanced solid tumors at the ESMO Congress 2024. The data demonstrated excellent safety and tolerability profiles for HBM1020. Of the 15 patients who received post-treatment tumor assessments, 7 patients (46.7%) achieved stable disease (SD), with two patients showing tumor shrinkage of 11% and 25%.

Key products in the next-generation innovation portfolio include:

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. The Company is currently conducting IND-enabling studies for HBM7004.

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 2024, the Company restructured its development strategy to target immunological diseases. In June 2025, Harbour BioMed entered global strategic collaboration with Otsuka. Under the terms of the agreement, Otsuka is granted an exclusive license to develop, manufacture, and commercialize HBM7020 globally, excluding Greater China (Mainland China, Hong Kong, Macau and Taiwan).

R2006 (CD19xCD3 bispecific antibody) and HBM7026 (BCMAxCD19xCD3 trispecific antibody) are two T-cell engagers (TCEs) in preclinical development. TCEs have emerged as an important therapeutic strategy for autoimmune diseases, as B-cell depletion has been shown to help restore immune system balance in multiple autoimmune conditions. TCEs can achieve deep depletion of B cells in peripheral blood, lymph nodes, and bone marrow, thereby resetting the immune system. Newly generated B cells subsequently return to a naïve and non-pathogenic state, potentially reducing inflammation and autoimmune responses. CD19 is a marker broadly expressed on precursor and mature B cells, while BCMA is highly expressed on mature B cells and plasma cells. Leveraging its fully human HCAb technology and optimized anti-CD3 antibodies, Harbour BioMed is developing TCEs with enhanced safety, reduced immunogenicity, and lower risk of cytokine release syndrome.

In March 2025, Harbour BioMed launched Élancé Therapeutics ("Élancé"). Harnessing Harbour BioMed's proprietary HCAb-based bispecific antibody technology, Élancé aims to develop innovative therapies addressing key challenges in current obesity treatment, including muscle preservation and long-term efficacy. Élancé is building a metabolic disease pipeline of multiple preclinical bispecific antibody programs. 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 and further expand the boundaries of obesity treatment.

Harbour BioMed is leveraging its fully human antibody and HCAb platforms to develop next-generation biologics for central nervous system (CNS) disorders, including bispecific antibodies and other "Antibody-Plus (Ab+)" therapies. The pipeline in this area is currently under development, with the goal of creating more complex molecules to address the treatment challenges of CNS disorders, including neurodegenerative diseases and neuroinflammation.

Maximizing Platform Potential Through Diversified Collaborations

Harbour BioMed remains committed to global collaboration. In March 2025, the Company entered into a global strategic collaboration with AstraZeneca to discover and develop next-generation multi-specific antibodies for immunology, oncology and beyond. The strategic collaboration includes an option to license multiple programs utilizing Harbour BioMed's proprietary Harbour Mice^® fully human antibody technology platform in multiple therapeutic areas. Furthermore, AstraZeneca acquired 9.15% newly issued shares of Harbour BioMed with a $105 million equity investment. Harbour BioMed will establish an innovation center in Beijing, China to be co-located with AstraZeneca.

During the reporting period, Harbour BioMed also signed several licensing and collaboration agreements with global partners. In January 2025, the Company and Kelun-Biotech entered into a licensing agreement with Windward Bio for HBM9378/SKB378 (also known as WIN378), granting Windward Bio to research, develop, manufacture, and commercialize HBM9378/SKB378 globally, excluding Greater China and several Southeast and West Asian countries. In June 2025, Harbour BioMed entered a global strategic collaboration with Otsuka Pharmaceutical to advance the development of HBM7020, a BCMA x CD3 bispecific T-cell engager for the treatment of autoimmune diseases.

In February 2025, Harbour BioMed entered into a strategic collaboration with Insilico Medicine, a clinical-stage biotechnology company powered by generative AI, to accelerate the discovery of novel therapeutic antibodies by combining complementary strengths in antibody discovery and artificial intelligence.

Leveraging its technological advantages, Harbour BioMed established Nona Biosciences to better empower industry innovators and support collaborators by providing integrated solutions from "Idea to IND" (I to I^TM). As a global biotechnology company, Nona Biosciences has established innovative platforms in antibody discovery, protein engineering, antibody-drug conjugation, HCAb-CAR screening, and drug delivery technologies, to accelerate the development of next-generation therapies across academic institutions, leading biotech companies, and multinational pharmaceutical companies.

In December 2024, Nona Biosciences entered into a collaboration with Kodiak Sciences (Nasdaq: KOD). This partnership aims to advance the discovery of novel multi-target antibodies to treat ophthalmic diseases, leveraging Nona's proprietary Harbour Mice^® fully human antibody platform. In the same month, Nona Biosciences announced a research collaboration and license agreement with Candid Therapeutics to discover next-generation TCEs. In the first half of 2025, Nona Biosciences further expanded its global partnerships, entering into collaborations with Invetx, the University of Alabama at Birmingham, Atossa Therapeutics, and Visterra, unlocking the potential of its proprietary platforms to support partners in advancing biotherapeutics pipeline development and related research.

In addition, Nona Biosciences continues to expand the capabilities of its technology platforms. In March 2025, Nona Biosciences launched Hu-mAtrIx™, an innovative AI-assisted drug discovery engine integrates seamlessly with the company's proprietary Harbour Mice^® technology platform, aiming to accelerate antibody discovery across multiple key therapeutic areas, including neurodegenerative and metabolic diseases, and more.

These collaborations further highlight the Company's unique strengths in advancing innovation. Building on its industry-leading technology platforms and flexible business model, the Company will continue to expand capabilities, strengthen partnerships, and maximize platform value.

Incubating Breakthrough Therapies  for the Future

Harbour BioMed continues to explore the scalability of its platform applications to fully unlock their potential. The Company is incubating several joint ventures focused on next-generation therapies, including multivalence antibodies, cell therapies, and more. By expanding the application scope of its platform technologies, Harbour BioMed aims to create additional value and accelerate next-generation innovation.

• In November 2024 and July 2025, NK Cell-Tech (an incubated company of Harbour BioMed) announced the completion of its Series A++ and Series A+++ financing rounds, respectively, to further advance its pipeline development and clinical progress.
• In February 2025, HBM Alpha Therapeutics, a joint venture between Harbour BioMed and Boston Children's Hospital (an affiliate of Harvard Medical School), announced a strategic collaboration and license agreement with a business partner.
• In March 2025, Harbour BioMed launched Élancé Therapeutics, a new venture leveraging the Company's proprietary HCAb-based bispecific antibody technology to develop innovative therapies addressing key challenges in current obesity treatment, including muscle preservation and long-term efficacy. In addition, Élancé will refine and expand Nona Biosciences' Hu-mAtrIx^TM AI platform to support bispecific antibody discovery, with AI applications guiding antibody sequence discovery, enrichment, optimization, bispecific geometry design, and developability/immunogenicity/pharmacokinetics (PK) assessments, as well as patient biomarker studies.

Prospects and Outlook: Innovation and Collaboration

The achievements and growth momentum Harbour BioMed demonstrated in the first half of 2025 give us strong confidence in the future. Harbour BioMed has proven its ability to successfully navigate a complex market environment and is well-positioned to deliver innovative therapies for patients with immunology and oncology diseases in the near future.

Since its establishment, Harbour BioMed has been committed to developing innovative therapies for patients worldwide and has grown into an innovative biopharmaceutical company distinguished by its proprietary technologies and differentiated pipeline. In 2024, the Company successfully completed the BLA submission for HBM9161. Harbour BioMed will further accelerate the advancement of its portfolio, progressing multiple clinical trials for innovative programs which target both novel and established pathways, including HBM4003, HBM9378, and HBM1020. In addition, Harbour BioMed is expanding the capabilities of its platforms into immunology and inflammation, leveraging its powerful Harbour Mice^® and HBICE^® drug discovery engines to continue identifying novel high-quality candidates.

The value of Nona Biosciences' antibody discovery platform and flexible collaboration model has been fully validated through a series of partnerships since its establishment in 2022. Building on this foundation, Harbour BioMed continues to strengthen global collaborations, offering one-stop solutions to academic institutions, biotech startups, and multinational pharmaceutical companies, and unlocking the full potential of its platforms through business partnerships. Looking ahead, Harbour BioMed will continue to advance its globalization strategy. As its preclinical products mature, the company expects to welcome more global collaboration opportunities in 2025.

Accordingly, Harbour BioMed will further optimize internal resource allocation, focus on advancing self-developed assets from its proprietary platforms, and continue expanding Nona Biosciences' collaboration network—injecting fresh momentum into the Company's long-term sustainable growth.

About Harbour BioMed

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

Harbour BioMed's 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. Additionally, the HCAb-based bispecific immune cell antagonist (HBICA^TM) technology empowers the development of innovative biologics for immunological and inflammatory diseases. By integrating Harbour Mice^®, HBICE^®, and HBICA^TM with a single B-cell cloning platform, 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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SOURCE Harbour BioMed