Harbour BioMed secured a significant intellectual property victory as China's patent authority upheld the validity of its foundational heavy chain antibody patent, clearing the path for its ongoing infringement lawsuit against competitor Biocytogen Pharmaceuticals to proceed to trial.
Patent Validity Confirmed by Chinese Authorities
The China National Intellectual Property Administration (CNIPA) issued a final decision on June 5, 2025, upholding Harbour BioMed's patent entitled "Binding Molecule" (Patent Application No. CN201210057668.0) under Articles 22.3, 26.3, 26.4, and 33 of China's Patent Law. The HCAb patent covers a method for producing fully human heavy chain-only antibodies (HCAbs) utilizing transgenic animals.
The patent validation came after Biocytogen Pharmaceuticals (Beijing) Co., Ltd. filed an invalidation request challenging the intellectual property rights. CNIPA's decision affirms the technical validity and legal standing of Harbour BioMed's core antibody production technology.
Infringement Lawsuit Advances After Jurisdictional Challenges
Harbour BioMed filed a patent infringement lawsuit on September 27, 2024, with the Shanghai Intellectual Property Court, alleging that Biocytogen's RenNano platform infringes its HCAb Patent. The case faced procedural delays as Biocytogen challenged the court's jurisdiction through multiple legal channels.
Biocytogen first submitted an objection to the Shanghai Intellectual Property Court on November 8, 2024, followed by an appeal to the Supreme People's Court of the People's Republic of China on March 14, 2025. However, on May 27, 2025, China's Supreme Court issued a final ruling dismissing the appeal and affirming the Shanghai Intellectual Property Court's jurisdiction over the infringement lawsuit.
Strategic Implications for Antibody Technology Development
Dr. Jingsong Wang, Founder, Chairman, and CEO of Harbour BioMed, emphasized the broader significance of the legal victory: "CNIPA's decision affirms the rightful protections of the pioneering innovation and core value of Harbour BioMed's intellectual property. We have established a global patent portfolio across key markets, providing robust protection for R&D investments and proprietary innovations enabled by our Harbour Mice® platform and associated technologies."
The company's proprietary Harbour Mice® platform generates fully human monoclonal antibodies in both conventional two heavy and two light chain (H2L2) format and the heavy chain-only (HCAb) format. Building upon HCAb antibodies, Harbour BioMed has developed HCAb-based immune cell engagers (HBICE®) bispecific antibody technology and HCAb-based bispecific immune cell antagonist (HBICA™) technology for immunological and inflammatory diseases.
Company Profile and Technology Platform
Harbour BioMed (HKEX: 02142) operates as a global biopharmaceutical company focused on discovering and developing novel antibody therapeutics in immunology and oncology. The company builds its pipeline through internal R&D capabilities, strategic global collaborations in co-discovery and co-development, and selective acquisitions.
The integration of Harbour Mice®, HBICE®, and HBICA™ technologies with a single B-cell cloning platform creates what the company describes as a highly efficient antibody discovery engine for developing next-generation therapeutic antibodies. Wang indicated the company will continue leveraging its patented HCAb technology to accelerate transformative therapy development through global partnerships.
