Harbour BioMed‘s first AI-enabled drug candidate, LET003, recently demonstrated promising preclinical results, marking a milestone in the company’s integration of generative AI with antibody engineering. Developed using its proprietary Hu-mAtrIx™ platform, the obesity candidate highlights a broader shift in biopharmaceutical R&D toward AI-assisted platforms that can accelerate the design and optimization of therapeutic antibodies.
Harbour BioMed expands partnerships and revenue
Against this backdrop, Harbour BioMed has expanded both its commercial partnerships and financial performance. In FY2025 the company reported revenue of $158 million while securing major partnerships. These included a multi-year agreement with Bristol Myers Squibb to develop multi-specific antibodies, an AstraZeneca oncology alliance for antibody-drug conjugates and T-cell engagers, and a Solstice Oncology licensing deal for HBM4003.
Pipeline expansion and patent validation
Beyond the promising preclinical results for LET003, HBM7004 received U.S. FDA clearance and China NMPA acceptance to begin clinical trials in solid tumors. The company also partnered with Yantai Lannacheng to develop next-generation radionuclide drug conjugates.
The company’s intellectual property has likewise received external validation. In June 2026, a Delaware jury also ruled that Amgen and its subsidiary Teneobio had willfully infringed patents covering the Harbour Mice® Platform, awarding Harbour Antibodies $20.2 million in damages, with potential treble damages of up to $60.6 million.
The Scientific Foundation: The Harbour Mice® Platform
The Harbour Mice® platform is built on transgenic rodent technology designed to generate fully human heavy chain-only antibodies (HCAbs). Unlike conventional antibody discovery methods, which often require extensive humanization to make animal-derived antibodies suitable for patients, the platform produces human antibodies directly. This reduces the risk of immune rejection while avoiding the light-chain pairing challenges that can complicate antibody development.
The platform achieves this by combining engineered llama-derived antibody features with human antibody genes in transgenic mice. Harbour BioMed further refined the technology through its fully human 4HVH transgenic rodent line, which replaces the remaining camelid variable regions with four human germline antibody sequences. This enables the animals to generate fully human antibodies while preserving the stability and small size that make heavy chain-only antibodies attractive drug candidates.
To accelerate drug discovery, Harbour BioMed pairs the platform with an automated, high-throughput screening process that rapidly identifies promising antibodies from immune cells and produces them for testing. The resulting antibodies are highly stable, soluble, and easy to engineer into more advanced formats, including bispecific antibodies that target two disease pathways at once and intracellular “intrabodies” designed to block disease-causing proteins. This combination of transgenic biology and automated screening shortens discovery timelines while expanding the range of therapeutic applications.
Harbour BioMed: Patenting Activity
Global patent filings for Harbour BioMed show a highly active R&D timeline in line with various acquisitions and mergers. Rising sharply to a priority-year spike of 27 filings in 2017 this directly correlates with the integration of Harbour Antibodies BV acquired in December 2016. This critical acquisition brought in the patented transgenic mouse platforms (Harbour Mice®) used for discovering fully human antibodies.
The company entered a sustained period of high patent filing activity from 2019 to 2022, coinciding with its $100 million Series C funding in 2020 and the launch of its wholly owned subsidiary, Nona Biosciences, in 2022. This period reflects the rapid expansion of its metabolic, immunological, and oncology drug candidates. More recent filing activity suggests a strategic shift from early platform development toward advancing clinical-stage programs and managing its existing patent portfolio.
Harbour BioMed: Top Jurisdictions
Harbour BioMed’s IP strategy is focused on major healthcare markets, with China leading the portfolio with 35 total filings. The European Patent Office stands as the second-largest jurisdiction, followed closely by Taiwan and the United States. Secondary biopharmaceutical markets are heavily represented, with Hong Kong, South Korea, Australia, and Japan, showcasing a broad, defensible international footprint.
Harbour BioMed: Top Legal Representatives
Harbour BioMed’s global patent portfolio is managed by a close-knit network of elite legal professionals and agencies. Leading individual representatives, Fazheng Liu and Zhongjun Yin have represented 18 patent filings. The highly prominent Chinese firm Liu, Shen & Associates manages 15 filings. Other Chinese firms like Shanghai Beshining Law Office and Bairui Intellectual Property Co., Ltd. have 11 and 8 filings respectively, reflecting a centralized and robust legal apparatus.
At the same time, the presence of international firms such as Maiwald GmbH in Europe, MUHANN Patent & Law Firm in South Korea, and Wrays IP in Australia indicates a deliberate strategy to secure patent protection across key global markets. This combination of trusted domestic counsel and specialized regional firms suggests Harbour BioMed is building and maintaining a geographically diverse intellectual property portfolio to support its international commercialization and partnership ambitions.
Harbour BioMed: Top Technology Areas
In terms of technology classification, Harbour BioMed’s patent portfolio is heavily concentrated in therapeutic molecular chemistry and biology. Peptides (C07K) represents the largest classification with 192 filings (26.2% of the portfolio), mapping directly to their monoclonal, single-domain, and multi-specific antibody discovery platforms. Clinical applications represent the next major segments, with specific therapeutic activities of compounds (A61P) accounting for 183 filings (25%) and preparations for medical purposes (A61K) holding 181 filings (24.7%). Genetic engineering and cell modification (C12N) accounts for 116 filings (15.8%), while diagnostic processes (G01N) represents 36 filings (4.9%).
Harbour biomed’s foundational patents
To see how these high-level IP trends translate to direct clinical breakthroughs, we must look at the specific, highly specialized patents that protect Harbour BioMed and its subsidiary Nona Biosciences’ core innovations.
Platform for producing fully human heavy chain-only antibodies
U.S. Patent No. 10,993,420 describes a transgenic animal platform designed to solve high inefficiency and B-cell depletion associated with producing human heavy chain-only antibodies (HCAbs) in transgenic animals.
By genetically introducing specific, highly soluble human antibody gene segments into mammals that have had their own antibody machinery silenced, the animals naturally produce stable, fully human, heavy chain-only antibodies upon immunization. This completely eliminates the need for slow and risky post-discovery humanization processes. Natural antibodies are complex molecules composed of multiple paired protein chains. While simplified “heavy-chain-only” antibodies are highly prized because they are structurally smaller and easier to engineer into multi-targeting drugs, human versions are inherently unstable and clump together when produced without their matching light chains.
This patent represents the foundational crown jewel of the Harbour Mice® platform, serving as the core asset behind the company’s out-licensing model. Because these antibodies are small and highly soluble, they are the ideal structural building blocks for next-generation multi-specific therapies, such as dual-action cancer-killing drugs. This is the exact technology validated by the Delaware federal court in the $20.2 million litigation victory against Amgen, securing a massive competitive advantage for Harbour.
The patent, titled ‘Production of heavy chain only antibodies in transgenic mammals’, was filed on March 14, 2014, and published/granted on May 4, 2021 to Harbour Antibodies BV. The inventors are Franklin Grosveld and Richard Janssens. Legal representation was provided by Saul Ewing LLP .
Blocking TSLP at the source to treat asthma
U.S. Pat. App. Pub. No. 2022/0363781 describes a fully human antibody engineered to selectively bind and neutralize TSLP with exceptional precision. The antibody effectively acts as a circuit breaker, binding to TSLP with high affinity and preventing it from locking onto its receptors, thereby stopping the inflammatory cascade before allergic tissue damage can occur.
Severe asthma and chronic respiratory inflammation are frequently driven by an upstream signaling protein called TSLP, which triggers a massive immune cascade. However, developing therapeutic antibodies that selectively block this target with high precision and low patient rejection rates has remained an elusive pharmaceutical hurdle.
These fully human anti-TSLP antibodies represent high-value drug candidates, such as the clinical-stage 43B1-H2L2, for treating asthma, atopic dermatitis, and allergic rhinitis. Their fully human origin minimizes the risk of triggering neutralizing anti-drug antibodies in patients, enabling long-lasting therapeutic efficacy and flexible, low-dose subcutaneous administration schedules.
The patent application, titled ‘Anti-tslp antibody and uses thereof’, was filed on December 8, 2020, and published/granted on November 17, 2022 to Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. and Harbour Biomed Shanghai Co., Ltd. The inventors are Liang Xiao, Jinqiu He, Tongtong Xue, and Hongshui Liu, Jingyi Wang, Hongzhuan Gu, Shuntao Luo, Yiping Rong, Dengnian Liu, and Yun He.
Next-generation CD3 antibody for safer immunotherapy
U.S. Pat. App. Pub. No. 2022/0348661 describes a CD3-targeting antibody engineered to address two major challenges in T-cell engager therapies: severe systemic toxicities, such as cytokine release syndrome (CRS), caused by CD3-mediated T-cell overactivation, and the structural instability that complicates the conversion of CD3 antibodies into simplified, easily manufactured single-chain variable fragments (scFvs).
By introducing precise structural mutations, the antibody binds to T-cells with optimized affinity, preserving its cancer-killing activity while reducing the excessive immune activation that leads to dangerous cytokine release. CD3-targeting antibodies are widely used in bispecific cancer therapies to recruit a patient’s own T-cells to attack tumor cells.
However, early CD3 therapies were often associated with severe cytokine release syndrome, a potentially life-threatening “cytokine storm” caused by excessive T-cell activation. In addition, converting these antibodies into smaller targeting domains for multispecific platforms frequently produced unstable molecules prone to aggregation, resulting in low manufacturing yields and increased production costs.
This technology significantly improves the safety index of T-cell retargeting cancer therapies, making them safer for clinical use. From an operational standpoint, stabilizing the CD3 arm and reducing the bispecific assembly to a three-chain structure (using “knob-in-hole” Fc modifications) drastically decreases purification complexity and expression byproducts, making commercial-scale manufacturing highly efficient.
The patent, titled ‘Cd3-targeting antibody, bispecific antibody and use thereof’, was filed on September 29, 2020, and published on November 3, 2022 to Nona Biosciences (Shanghai) Co., Ltd. The inventors are Yun He and Lei Shi.
Targeting B7H4 with highly selective fully human antibodies
U.S. Pat. App. Pub. No. 2023/0312722 describes fully human antibodies that target B7H4 with high selectivity, binding to the human and primate forms of the protein while avoiding cross-reactivity with healthy tissues.
Once bound, the antibody is rapidly internalized into the cancer cell, making it well suited for targeted therapeutic approaches such as antibody-drug conjugates. B7H4 is an immune checkpoint protein overexpressed in breast, ovarian, and endometrial cancers, where it helps tumors evade immune attack. Although B7H4 has long been recognized as a promising therapeutic target, earlier antibodies often lacked sufficient specificity, leading to off-target binding to healthy tissues expressing related proteins and increasing the risk of unwanted side effects.
This patent application provides background for the HBM7004 with highly selective binders suitable for both ADC development (owing to rapid internalization properties) and bispecific T-cell engager therapies. The fully human sequence minimizes immunogenicity, and the bispecific format provides a long serum half-life and stable hydrophilicity, establishing a robust clinical candidate for triple-negative breast cancer and ovarian cancer.
The patent application, titled ‘Anti-b7h4 antibody, and bispecific antibody and use thereof’, was filed on June 29, 2021, and published/granted on October 5, 2023 to Nona Biosciences (Shanghai) Co., Ltd. The inventors are Xiaodong Wu, Yongqiang Wang, Fei Chen, and Jinqiu He, Gezi Jia, Chuchu Zhao, Qingfang Chen, and Yiping Rong.