Analysis of the Technical Barriers of Harbour BioMed's HarbourMice Antibody Platform

Based on the searched information, I will systematically analyze the

from multiple dimensions:

• One of the world’s only two fully humanized mouse platforms
  : Harbour BioMed acquired the Harbour Mice® platform by purchasing the Dutch company Harbour Antibodies, making it one of the very few enterprises globally with a complete fully humanized transgenic mouse platform [1][2]
• Extremely high technical difficulty
  : Search results show that “technical difficulty constraints have led to very few mature heavy chain antibody platforms worldwide” [1]

HarbourMice® platform includes two core technologies:

Platform Type	Technical Features	Application Areas
H2L2 Platform	Dual, double light chain fully human monoclonal antibodies	Traditional monoclonal antibody drug development
HCAb Platform	Heavy chain-only antibody technology	Innovative antibodies such as bispecific antibodies and nanobodies

• Technical originality
  : The HCAb platform developed by Harbour BioMed is “the world’s first HCAb transgenic mouse platform that produces and is applied to therapeutic antibody discovery” [1]
• Molecular structure advantage
  : HCAb lacks light chains, solving the common heavy-light chain mismatch problem in traditional antibodies when developing bispecific antibodies
• Patent protection
  : On June 5, 2025, the State Intellectual Property Office made a review decision to maintain the validity of HCAb-related patents (Patent No.: CN201210057668.0), which involves “methods for preparing fully human heavy chain-only antibodies using transgenic animals” [3]

• Innovative mechanism
  : HBICE® developed based on the HCAb platform can achieve anti-tumor efficacy that traditional drug combination therapies cannot reach [3][4]
• “2+1” structural design
  : Achieves precise regulation of bispecific antibodies through unique structural design
• Clinical validation
  : Has been applied to the development of multiple bispecific antibody products in clinical stages [1]

• High-efficiency screening capability
  : Complements the HarbourMice® platform, providing a complete solution from antibody discovery to screening [3]
• Technical integration
  : Combined with B cell screening technology and one-stop comprehensive services, forming a complete technical closed loop [5]

• Global patent layout
  : Has built a patent barrier covering core global markets [3]
• Patent enforcement action
  : In September 2024, it sued Biocytogen’s RenNano platform for infringing its “binding molecule” patent; the Supreme People’s Court made a final ruling to reject Biocytogen’s appeal against jurisdiction, confirming that the Shanghai Intellectual Property Court has jurisdiction [3]

• Patent validity confirmation
  : The State Intellectual Property Office maintains the validity of the patent in accordance with Article 22 Paragraph 3, Article 26 Paragraphs 3 and 4, and Article 33 of the Patent Law [3]
• Original innovation protection
  : Harbour BioMed stated that this review decision is a “legitimate protection of the original innovation value of core intellectual property rights” [3]

• Recognition by multinational pharmaceutical companies
  : As of 2023, Nona Bio (a subsidiary of Harbour BioMed) has established partnerships with more than 50 multinational pharmaceutical companies, biotech companies, and scientific research institutions worldwide [1]
• Partnerships with leading enterprises
  : Established strategic partnerships with global pharmaceutical giants such as Pfizer, Bristol-Myers Squibb, and AstraZeneca [4][5]

• Number of projects
  : The HarbourMice® platform has been applied to more than 200 R&D projects [1]
• Clinical progress
  : Among them, more than 19 projects developed based on the H2L2 and HCAb platforms have entered the clinical development stage [1]

• Rapid response capability
  : During the COVID-19 pandemic, Harbour BioMed used the H2L2 Mice platform to screen potential COVID-19 neutralizing antibodies in a short time, and the relevant content was published in Nature Communications in May [2]
• Efficiency outperforms CDR route
  : In principle, the R&D efficiency of the transgenic mouse platform can outperform the CDR route and even the phage library route [2]

• Reducing R&D costs
  : Platform-based operations significantly reduce the marginal cost of antibody discovery
• Shortening development cycle
  : The cycle from target validation to lead compound discovery is significantly shortened

• Platform technology upgrade
  : Based on the acquisition of Harbour Antibodies, it built the Harbour Mice® fully humanized transgenic mouse platform, immune cell engager (HBICE®) platform, and single B cell cloning screening platform [1]
• HBICATM bispecific antibody technology
  : A bispecific immune cell antagonist developed based on the HCAb platform provides strong support for the R&D of innovative biopharmaceuticals in the field of immune and inflammatory diseases [3]

• A³ Strategy
  : Nona Bio announced the appointment of Dr. Hongjiang Miao as Chief Artificial Intelligence Officer to advance the company’s A³ Strategy and AI-driven drug discovery [4]
• Technology integration
  : Deeply integrate AI technology with the antibody discovery platform to maintain technical leading advantages

The technical barriers of Harbour BioMed’s HarbourMice antibody platform are mainly reflected in

:

1. Scarcity barrier
   : One of the world’s only two fully humanized mouse platforms with extremely high technical thresholds
2. Originality barrier
   : The HCAb platform is a global first with independent intellectual property rights
3. Patent barrier
   : A worldwide patent network covering core markets with confirmed patent validity
4. Validation barrier
   : Extensive cooperation with leading multinational pharmaceutical companies and verification by numerous clinical projects
5. Efficiency barrier
   : Significantly higher R&D efficiency than traditional technical routes
6. Iteration barrier
   : Continuous technology upgrades and AI integration to maintain technical leadership

These barriers together form Harbour BioMed’s core competitive advantages in the field of antibody drug discovery, enabling it to occupy a favorable position in global biopharmaceutical competition.

---

[1] First-year profit in the cold winter: What did Harbour BioMed do right? - Pharmcube (https://bydrug.pharmcube.com/news/detail/c2924f0d35b71e800cd358d6636b2d47)
[2] Emphasizing the potential of transgenic mouse platforms to crush with superior technology in the domestic biosimilar and innovative monoclonal antibody field - Eastmoney.com (https://pdf.dfcfw.com/pdf/H3_AP202012281444434952_1.pdf)
[3] Harbour BioMed’s patent validity confirmed by the State Intellectual Property Office; infringement litigation continues to advance - Harbour BioMed official website (https://www.harbourbiomed.cn/news/327.html)
[4] Harbour BioMed and Bristol-Myers Squibb reach global strategic cooperation and licensing agreement - PR Newswire (https://www.prnasia.com/story/516284-1.shtml)
[5] Harbour BioMed joins hands with Pfizer to reach strategic cooperation - Zhihuiya (https://synapse.zhihuiya.com/blog/和铂医药携手辉瑞达成战略合作)