Nona Biosciences Enhances Clinical Development Framework for Biopharma

Nona Biosciences, a biotechnology firm based in Cambridge, Massachusetts, has announced a significant enhancement of its integrated discovery and development framework. On December 24, 2025, the company revealed that it will expand its capabilities to support early clinical development and Investigator-Initiated Trials (IITs). This expansion aims to bolster Nona’s offerings beyond initial discovery stages, enhancing its strengths in Chemistry, Manufacturing, and Controls (CMC) development, toxicology, and good manufacturing practices (GMP) manufacturing.

The firm plans to achieve this through strategic partnerships, platform acquisitions, and advancements in internal technologies. With these improvements, Nona aims to assist global biopharmaceutical companies in accelerating the initiation of clinical trials while adhering to rigorous scientific and quality standards. Nona’s expanded framework integrates its proprietary platforms, which include Harbour Mice®, HBICE®, Hu-mAtrIxTM, NonaCarFxTM, and Modalities-on-DemandTM. The integration will enhance preclinical and early clinical development capabilities across various areas, including CMC, toxicology, and clinical operations.

Through extensive collaborations in China, Nona is positioned to provide its partners with access to established infrastructure and operational efficiency. This strategic approach is designed to enable faster clinical trial initiation and ensure compliance with global development and regulatory standards.

Dr. Di Hong, Chief Executive Officer of Nona Biosciences, commented on the expansion, stating, “Expanding Nona’s technology platforms and capabilities from antibody discovery to early clinic development represents a natural progression of our strategic vision.” He emphasized that the combination of proprietary platforms with strategic external collaborations and internal development efforts strengthens Nona’s capacity for efficient clinical translation.

The company’s experience spans over 300 discovery programs, supported by a growing portfolio of clinically validated platforms. This expertise positions Nona Biosciences as a leader in advancing biologic innovation, empowering partners to navigate the process from discovery to early clinical development through integrated, high-performance platforms.

Nona Biosciences is committed to pioneering technological innovations and providing comprehensive solutions that extend from discovery to early clinical development and IITs. Notably, its proprietary Harbour Mice® technology platform is groundbreaking in generating fully human monoclonal antibodies in both the classical two light and two heavy chain (H2L2) format and the heavy chain-only (HCAb) format. The HCAb Harbour Mice® stands out as the world’s first fully human HCAb transgenic mouse, achieving clinical validation.

The versatility of this platform allows for a wide array of applications. These include fully human VH single-domain antibodies as a plug-and-play system, which can be utilized in various advanced therapies such as bispecific antibodies, multi-specific antibodies, CAR-T therapies, antibody-drug conjugates (ADCs), and mRNA-based therapeutics.

By integrating various technologies, including single-B cell screening, NonaCarFxTM, Hu-mAtrIxTM, and Modalities-on-DemandTM, alongside end-to-end preclinical drug development services, Nona Biosciences is poised to drive the global evolution of next-generation drugs.

For further details about Nona Biosciences and its innovative platforms, please visit their official website at www.nonabio.com.