Biocytogen Responds to Harbour BioMed’s Patent Claims: RenNano® is an Independently Developed Platform with Distinct Innovation and Full Legal Standing

In response to Harbour BioMed’s recent press release regarding a procedural development in their ongoing legal claim, Biocytogen issues the following statement:

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Figure 1. Biocytogen’s RenNano® Platform Genetic Engineering Strategy (Source: https://biocytogen.com/antibody-drug-development/rennano）

Biocytogen stands by its core values of independent innovation, respect for intellectual property, and a commitment to fair competition. The RenNano® platform is the result of independent, original R&D, based on Biocytogen’s proprietary genome editing technologies. Its technical principles, design strategy, and IP scope are fundamentally different from the patents in dispute.

120 vs. 9 – A Significant Technical Divide of RenNano® Platform; Biocytogen Will Resolutely Take Legal Actions to Protect Its Rights

The RenNano® platform employs a large-fragment knock-in strategy that incorporates over 120 human V genes in situ, enabling a complete and functional human heavy chain antibody repertoire. In stark contrast, Harbour BioMed’s HCAb platform introduces only 9 V genes through a small-fragment transgenic approach. This key difference reflects not only divergent technical strategies but also the depth, innovation, and translational potential of Biocytogen’s antibody discovery platforms.

The decision referenced in Harbour BioMed’s PR involves a procedural ruling on jurisdiction only and does not address the substance of the patent infringement case. Furthermore, the CNIPA’s affirmation of patent validity is a routine administrative process that does not imply infringement. The underlying lawsuit has not yet entered the trial phase.

Biocytogen is currently evaluating all legal options and will resolutely defend its IP rights and scientific reputation. The RenNano® platform has been fully validated and is supported by a robust portfolio of domestic and international patents, clearly documenting its originality and independence.

We remain confident in:

• The technical integrity and legal foundation of the RenNano® platform;
• The non-infringement of any third-party IP;
• Our continued leadership in antibody discovery and therapeutic innovation.

According to public records, the Chinese patent related to Harbour BioMed’s HCAb platform is set to expire on July 22, 2025, further underscoring the short-sighted nature of any speculative claims. Regardless, Biocytogen will continue to uphold its rights, ensure business continuity, and deliver transformative technologies for global partners and patients.

Any misleading allegations or speculative narratives will not deter our team from advancing the RenMice® platform series with world-class innovation and delivering on our mission to accelerate therapeutic discovery.

Key Technical Differences Between Biocytogen’s RenNano® Platform and Harbour BioMed’s HCAb Platform

• Biocytogen RenNano® Platform: Uses large-fragment knock-in technology to replace mouse genes with over 120 human V genes in situ, resulting in a full and functional human heavy chain variable region genomic repertoire.
• Harbour BioMed HCAb Platform: Introduces only 9 V genes using small-fragment transgenic approaches.

About Biocytogen

Biocytogen (HKEX: 02315) is a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies. Founded on gene editing technology, Biocytogen leverages genetically engineered proprietary RenMice® (RenMab™/ RenLite®/ RenNano®/ RenTCR-mimic™ ) platforms for fully human monoclonal/bispecific/multispecific antibody discovery, bispecific antibody-drug conjugate discovery, nanobody discovery and TCR-mimic antibody discovery, and has established a sub-brand, RenBiologics™, to explore global partnerships for an off-the-shelf library of >1,000,000 fully human antibody sequences against over 1000 targets for worldwide collaboration. As of December 31, 2024, approximately 200 therapeutic antibody and multiple clinical asset co-development/out-licensing/transfer agreements and over 50 target-nominated RenMice® licensing projects have been established around the globe, including several partnerships with multinational pharmaceutical companies (MNCs). Biocytogen pioneered the generation of drug target knock-in humanized models for preclinical research, and currently provides a few thousand off-the-shelf animal and cell models under the company's sub-brand, BioMice™, along with preclinical pharmacology and gene-editing services for clients worldwide. Headquartered in Beijing, Biocytogen has branches in China (Haimen Jiangsu, Shanghai), USA (Boston, San Francisco, San Diego), and Germany (Heidelberg). For more information, please visit http://en.biocytogen.com.cn.

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