Harbour BioMed Reports 2026 Interim Results: Three Integrated Growth Engines Accelerate Execution of Its Platform-Based Strategy

CAMBRIDGE, Mass., ROTTERDAM, Netherlands and SHANGHAI, Aug. 27, 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 interim results for the six months ended June 30, 2026.

Dr. Jingsong Wang, Founder, Chairman, and CEO of Harbour BioMed, commented: "In the first half of 2026, Harbour BioMed continued to advance our Phase 3.0 strategy, with meaningful progress across all three integrated growth engines. We continued to advance the global value of our mid- to late-stage innovative assets, further strengthened our technology platform capabilities, particularly in AI-driven next-generation antibody discovery capability, and continued to deepen long-term strategic partnerships with leading global pharmaceutical companies. The three growth engines are mutually reinforcing, creating stronger connections among our technology platforms, innovative pipeline and global partnership network, and continuously translating these capabilities into long-term value.

We also achieved a landmark milestone in intellectual property protection. Our historic and decisive victory in the U.S. patent litigation not only reaffirmed the validity of the intellectual property underlying our core antibody discovery platforms, but also demonstrated our firm commitment to protecting our core innovations and building global competitive advantages.

In terms of talent and organizational development, we have further streamlined our global management and scientific teams over the past six months. We have appointed experienced industry leaders, experts across multiple therapeutic areas, and world-renowned scientific advisors, who provide enhanced support for R&D innovation, portfolio strategy, and global collaboration.

Looking ahead, we will continue to drive strategic execution across our three integrated growth engines, accelerate the advancement of high-potential innovative assets into mid- to late-stage clinical development, unlock the global value of our technology platforms and pipeline, and further expand high-quality global partnerships. We are steadily advancing toward our 2028 vision of becoming a globally leading platform-based biopharmaceutical group."

2026 Interim Financial Highlights: Strong Revenue Growth and Sustained Profitability for Seven Consecutive Half-Years

• Total revenue reached US$122.5 million, representing a 20.9% year-over-year increase, primarily driven by continued strategic collaborations with global multinational pharmaceutical companies, newly established out-licensing agreements for innovative products, and strong business growth of Nona Biosciences;
• Profit for the period reached US$64.9 million, and adjusted net profit for the period^[1] was approximately US$71.6 million, marking seven consecutive profitable half-years and confirming that Harbour BioMed has officially entered a phase of "normalized profitability," further validating the sustainability and replicability of the business model underpinning this platform-based biopharmaceutical group;
• Cash and cash equivalents stood at approximately US$359.2 million as of June 30, 2026. The Company maintains strong financial resources and flexibility to support its strategic execution.

[1] Adjusted items of profit are mainly from share-based compensation expenses and other one-time expenses.

Multiple Milestones Achieved, Unlocking the Global Value of Mid- to Late-Stage Innovative Assets

Harbour BioMed continued to advance a differentiated portfolio across immunology, oncology, obesity and metabolic diseases, and central nervous system (CNS) disorders, with multiple high-potential programs progressing toward key clinical development milestones.

Key programs in mid- to late-stage clinical development

Batoclimab (HBM9161) is the first anti-FcRn monoclonal antibody to have completed Phase I to pivotal trials in China. The Biologics License Application (BLA) for the treatment of generalized myasthenia gravis (gMG) was accepted by China's National Medical Products Administration (NMPA) in July 2024 and is currently under review. Batoclimab has the potential to be a breakthrough treatment option for a wide range of autoimmune diseases.

HBM9378 is an ultra-long-acting fully human monoclonal antibody against TSLP generated from the H2L2 Harbour Mice^® platform, engineered to achieve an extended half-life and effector silencing with subcutaneous administration. In March 2026, the Company published first-in-human Phase I trial results in the peer-reviewed journal Drug Design, Development and Therapy, demonstrating favorable safety and an extended half-life (mean T1/2: 55.0–65.8 days).

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, our partner Windward Bio launched the Phase II/III POLARIS clinical study in asthma, with initial data expected in the second half of 2026 and the first Phase III study of HBM9378 in asthma is expected to begin in the fourth quarter of 2026. In June 2026, Windward Bio dosed the first patients in the Phase II SIRIUS study in COPD.

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. In October 2025, the Company published positive Phase II 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. Following this agreement, HBM4003 made meaningful global development progress during the reporting period.

HBM7575 is an ultra-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, with the potential to achieve broader control of inflammation compared to single-target approaches. HBM7575 has been engineered to allow for longer dosing intervals and a convenient subcutaneous route of 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 March 2026, an IND application for HBM7575 for the treatment of atopic dermatitis was approved by the NMPA, and the first participant has been dosed in a Phase 1 clinical study. In July 2026, an IND application for HBM7575 for the treatment of asthma was approved by the NMPA.

Note: HBM7575 is known as SKB575 in Kelun-Biotech's pipeline. According to the collaboration agreement between Harbour BioMed and Kelun-Biotech, HBM7575 is led by Kelun-Biotech in its design, global development and commercialization, with Harbour BioMed participating in the investment and development of this asset and sharing the benefits as agreed.

Key products in the next-generation innovation portfolio include:

HBM2001 is a potent TL1A×IL-23p19 bispecific antibody generated using the proprietary HBICA^® bispecific technology and Harbour Mice^® platform, offering a differentiated mechanism to address both inflammatory and fibrotic pathways in inflammatory bowel disease. In April 2026, HBM2001 obtained FDA IND clearance to commence a Phase I trial in the United States. In July 2026, HBM2001 obtained NMPA IND clearance to commence a Phase I trial in China.

HBM7020 is a BCMA×CD3 bispecific antibody generated using the HBICE^® technology and Harbour Mice^® platform. Following the global strategic collaboration with Otsuka Pharmaceutical established in June 2025, HBM7020 continued to advance product development as planned during the reporting period, with the Phase I clinical trial expected to initiate overseas in the second half of the year.

HBM7004 is a novel B7H4×CD3 bispecific antibody demonstrating strong anti-tumor efficacy and favorable safety in preclinical studies. In May 2026, the FDA cleared the IND application for HBM7004, enabling the initiation of a first-in-human Phase I clinical trial in the United States. In August 2026, the NMPA approved the IND application for HBM7004 for the treatment of advanced solid tumors.

LET003 is the first ACVR2A/2B dual-target blocking antibody developed using the Hu-mAtrIx™ artificial intelligence platform. ACVR2A and ACVR2B play critical roles in regulating muscle-fat metabolic homeostasis. Extensive preclinical and clinical studies have demonstrated that combining receptor-blocking antibodies targeting ACVR2A/2B with GLP-1-based weight loss therapies can further reduce body fat while effectively mitigating lean mass loss. In May 2026, the Company announced promising preclinical data for LET003. Data showed that LET003 exhibited superior pharmacokinetic characteristics compared to multiple competitor molecules. When combined with semaglutide, LET003 significantly enhanced fat reduction while effectively preserving lean mass. In addition, LET003 achieved lean mass-promoting effects at lower dose level comparable to bimagrumab at higher dose level, highlighting its potential to become a best-in-class therapy for obesity treatment. LET003 has advanced to the IND-enabling stage, with an IND submission expected in the third quarter of 2026.

CNS Disease Programs: the Company is advancing a next-generation CNS pipeline focused on Alzheimer's disease, Parkinson's disease, and other neurodegenerative disorders. Multiple programs are in preclinical development, with NEU2005 expected to file an IND application in the first half of 2027.

HBM9013 (CRH Neutralizing Antibody): HBM9013/HAT001 is a potent and selective anti-CRH neutralizing antibody for various disorders including congenital adrenal hyperplasia (CAH). In February 2025, HBM Alpha Therapeutics (HBMAT), an innovative biotechnology company incubated by the Company, announced a strategic collaboration and license agreement with Spruce Biosciences. Under the agreement, Spruce Biosciences gains exclusive global rights, excluding Greater China (mainland China, Taiwan, Hong Kong, and Macau), to develop and commercialize HBM9013/HAT001.

AI-Driven Next-Generation R&D Infrastructure Continues to Enhance Innovation Efficiency

Technology platform innovation remains a core pillar of Harbour BioMed's long-term strategy. The Company continues to integrate its Hu-mAtrIx™ AI platform with core antibody technology platforms including Harbour Mice^®, further embedding AI capabilities across the antibody drug discovery and development process to enhance R&D efficiency. The Company has established a technology platform matrix spanning a broad range of therapeutic modalities, including bispecific and multi-specific antibodies, T-cell engagers (TCEs), antibody-drug conjugates (ADCs) and more, providing technological support for the development of innovative therapies across multiple therapeutic areas.

During the Reporting Period, the Company continued to enhance the Hu-mAtrIx™ AI platform, strengthening capabilities including a fully human heavy-chain-only antibody model based on large-scale next-generation sequencing (NGS) HCAb sequence data, de novo design model, developability prediction, in silico screening and AI-guided engineering. The Company also continued to integrate AI with wet-lab experimental validation to explore more efficient approaches to drug discovery and development.

AI-enabled R&D capabilities are increasingly translating into tangible innovation. In May 2026, the Company announced positive preclinical data for LET003, its first next-generation candidate developed using the Hu-mAtrIx™ AI platform. The results showed promising pharmacokinetic characteristics, while combination with semaglutide significantly enhanced fat reduction and effectively preserved lean mass, highlighting its potential to become a best-in-class therapy for obesity.

Building on these capabilities, the Company is also exploring new R&D models powered by AI. In June 2026, Harbour BioMed entered into a long-term global strategic partnership with BioMap and jointly initiated MegaStream TechBio, focused on AI-driven discovery and development of complex biologics. MegaStream will integrate proprietary datasets, purpose-built large models, innovative pipeline assets and an intelligent dry-wet closed-loop R&D platform, further advancing AI-enabled discovery and development of next-generation complex biologics.

Deepening Long-Term Platform-Based Strategic Partnerships to Expand the Global Innovation Ecosystem

Leveraging its differentiated technology platforms and R&D capabilities, Harbour BioMed continued to establish multi-level partnerships with leading global pharmaceutical companies and biotechnology companies, and through diversified collaboration models including strategic collaboration, co-development, product licensing, technology licensing and technology services, has built a complete R&D chain spanning early discovery, clinical development and commercialization.

In December 2025, the Company entered into global strategic collaboration and license agreement with Bristol Myers Squibb (BMS) to discover and develop next-generation multi-specific antibodies. Under the terms of the agreement, Harbour BioMed could receive payments totaling $90 million, as well as development and commercial milestones of up to $1.035 billion, along with tiered royalties should BMS elect to advance all potential programs.

In the first half of 2026, the Company entered into a license agreement and equity partnership with Solstice Oncology for HBM4003. Under the terms of the agreement, the Company received upfront consideration valued at over $105 million and is eligible for additional development, regulatory and commercial milestones up to approximately $1.1 billion, plus tiered royalties on net sales outside Greater China. The Company also participated in Windward Bio's US$165 million financing and continued to deepen collaboration with global partners in antibody discovery, CNS delivery and other innovative areas.

Additionally, Nona Biosciences, the wholly owned subsidiary of Harbour BioMed, entered into a multi-target antibody discovery collaboration with Link Cell Therapies in January 2026, leveraging Nona's proprietary fully human HCAb Harbour Mice^® platform and its innovative direct CAR-function-based HCAb library screening platform, NonaCarFx™, to generate novel CAR-T cell therapy candidates.

In June 2026, Nona Biosciences entered into a strategic collaboration with Lonza. This collaboration leverages Nona's proprietary Harbour Mice^® fully human HCAb platform to discover and develop next-generation single-domain antibody-based blood-brain barrier (BBB)-crossing technologies. Leveraging the platform's proven ability to generate fully human HCAbs and VHH binders with exceptional affinity and developability, the partnership aims to establish a best-in-class BBB-crossing technology capable of enabling the delivery of a diverse range of therapeutic modalities into the central nervous system (CNS) and unlocking new opportunities in CNS drug development and technology licensing. Under the terms of the agreement, Nona is entitled to receive upfront and option payments from Lonza. The parties will also share revenues generated from future licensing agreements pursuant to the collaboration.

This multi-level approach creates a resilient, scalable business model designed to generate long-term, predictable value.

Continuously Strengthening Innovation and Intellectual Property Barriers, Further Enhancing Global Team Capabilities

Alongside continued progress in pipeline development and business collaborations, Harbour BioMed further strengthened the technology, intellectual property and talent foundation supporting its long-term innovation.

As of June 30, 2026, the Company had filed 706 patent applications, including 19 invention patents granted by the China National Intellectual Property Administration, with 521 patent applications under review. At the same time, the Company continued to strengthen its global management and scientific team by bringing together experienced industry leaders, experts across multiple therapeutic areas, and world-renowned scientific advisors, further enhancing its professional capabilities in R&D innovation, asset strategy, external innovation and global collaboration.

During the Reporting Period, the Company achieved a decisive victory in its core U.S. patent litigation. The jury upheld the validity of the relevant core patent, found Amgen's infringement to be willful and awarded Harbour BioMed US$20.20 million in damages – the full amount requested. The findings of willful infringement also entitle the Company to petition the judge to treble the award, potentially increasing the award to up to $60.6 million. The verdict further validated the validity and enforceability of the intellectual property underlying the Company's core antibody discovery platform and provided important support for the Company's continued expansion of global collaborations and platform value.

Accelerating 2026 Strategic Execution Toward the 2028 Vision

Looking ahead, Harbour BioMed will continue to drive business growth through its three integrated growth engines and steadily advance toward its 2028 vision of becoming a globally leading platform-based biopharmaceutical group.

In the second half of 2026, the Company expects to advance multiple high-potential programs toward key clinical milestones, including the initial data readout from the Phase II/III POLARIS study of HBM9378/WIN378, as well as potential significant milestones for porustobart (HBM4003). The Company will also continue to accelerate next-generation innovative candidates into clinical development and advance its differentiated pipeline across immunology, oncology, obesity and metabolic diseases, and central nervous system disorders. Additionally, the Company will actively explore diverse collaboration opportunities and further strengthen its position in the global innovation ecosystem by expanding strategic partnerships with global partners, continuing to bring transformative biotherapeutics to patients worldwide.

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.

SOURCE Harbour BioMed