Fresenius Kabi Oncology Ltd.

As artificial intelligence continues to reshape drug discovery, Nona Biosciences is broadening its positioning beyond AI-enabled discovery alone. The global biotechnology company has recently announced an expansion of its integrated discovery and development framework to support early clinical development and Investigator-Initiated Trials (IITs). The move extends Nona’s capabilities beyond discovery and IND-enabling activities, strengthening key areas such as CMC development, toxicology, and GMP manufacturing. Known for its integrated “Idea to IND” solutions, Nona is now expanding its platform-driven approach to support programs from discovery into early clinical development. The strategy combines AI, proprietary antibody technology platforms, and strengthened development capabilities to better support global biopharmaceutical partners navigating increasingly complex development pathways. This strategic evolution comes as Nona continues to build momentum following the appointment of Dr. Di Hong as Chief Executive Officer . Under his leadership, the company is sharpening its focus on scalable platform development, deeper AI integration, and an ecosystem-based delivery model designed to support partners across a wider span of the drug development lifecycle. A Modalities-on-Demand TM Platform Matrix Built on Harbour Mice ® At the foundation of Nona’s technology stack is its proprietary Harbour Mice ® platform , a fully human antibody discovery platform capable of generating both conventional antibodies and fully human heavy chain-only antibodies (HCAb), which has received global biotech and pharma recognition highlighted by the licensing and partnership agreement with Visterra (a wholly-owned subsidiary of Otsuka) and Pfizer in 2025. Building on this foundation, Nona has developed a core technology matrix, Modalities-on-Demonad TM , to provide integrated solutions for next-generation therapeutic modalities . This includes HBICE ® , a platform focused on bispecific and multi-specific antibodies, XDC for antibody drug conjugates (ADCs) and radioconjugates (RDCs), and NonaCarFx™ , a direct CAR-function-based screening platform which supports CAR-T discovery. Complementing these platforms is Hu-mAtrIx™ , an AI assisted discovery engine designed to integrate directly with Harbour Mice ® and accelerate antibody discovery across multiple disease areas. Expanding Partnerships and Clinical Momentum Nona’s platform strategy has attracted a growing network of global partners. To date, the company has collaborated with more than 110 partners worldwide and supported over 300 drug discovery programs , with more than 19 molecules advancing into clinical development. These programs span multiple therapeutic areas, including oncology, immunology, neuroscience and more, reflecting the versatility and clinical relevance of Nona’s platform portfolio. In parallel, the company is expanding into emerging therapeutic areas. One notable example is its collaboration with Umoja Biopharma in the field of in vivo CAR-T therapy . By combining Nona’s fully human Harbour Mice ® and NonaCarFx™ platforms with Umoja’s VivoVec™ technology, the partners aim to address some of the complexity associated with current cell therapy approaches. Alongside these technical advances, Nona’s platform innovation has received growing international recognition. The company has been nominated in the Best Startup category for the 2025 Prix Galien USA , one of the most prestigious honors in life sciences recognizing innovation and excellence in advancing human health. Embedding AI into the Discovery Engine AI plays a central role in Nona’s long-term vision. Following Dr. Hong’s appointment, Nona articulated its A³ strategy , which brings together Antibody Engineering, Artificial Intelligence, and Automation into a unified discovery framework. Rather than positioning AI as a standalone tool, the company is embedding it directly into its workflows. Hu-mAtrIx™ plays a key role in Nona’s AI initiatives, functioning as an AI-assisted drug discovery engine that integrates with Harbour Mice ® to accelerate antibody discovery across multiple key therapeutic areas. In parallel, its parent company Harbour BioMed has also released its first fully human Generative AI HCAb (Heavy Chain-Only Antibody) Model , powered by Hu-mAtrIx™ and built on the Harbour Mice ® platform, enabling a closed-loop discovery workflow that connects AI-driven sequence generation, intelligent screening, and wet-lab validation. To further institutionalize AI capabilities, Nona appointed Dr. Hongjiang Miao as Chief AI Officer in December 2025. Dr. Miao brings experience in AI and biocomputing, including work in protein structure prediction and AI-assisted protein design. His mandate is to build Nona’s AI platform and drive deeper integration of AI technologies across the company’s Idea to IND pipeline. “We see AI as a key driver of how Nona continues to evolve,” Dr. Hong noted. “By integrating AI and automation with our antibody platforms, we are building a more scalable and data driven research environment that supports sustained innovation.” Beyond IND: Expanding Toward Early Clinical Development As partner needs evolve, Nona is extending its integrated framework beyond discovery and IND-enabling activities. The company ’ s expansion of its discovery-to-development capabilities to support early clinical development and Investigator-Initiated Trials (IITs) , marks a significant step toward a more end-to-end delivery model. This expanded framework strengthens Nona’s capabilities across CMC development, toxicology, and GMP manufacturing, while integrating these functions with its existing proprietary platforms, including Harbour Mice ® , HBICE ® , Hu-mAtrIx™, NonaCarFx™, and Modalities-on-Demand™. Through a combination of strategic partnerships, platform acquisitions, and internal technology development, Nona aims to help global biopharmaceutical partners accelerate clinical trial initiation without compromising scientific rigor or quality standards. By extending its role beyond antibody discovery and IND preparation, the company aims to support programs through later stages of development through more flexible collaboration structures, continued platform upgrades across antibody and cell therapy modalities, and deeper integration of AI and automation to improve development efficiency and reduce operational complexity. “Expanding Nona ’s technology platforms and capabilities from antibody discovery to early c linic development represents a natural progression of our strategic vision,” said Dr. Di Hong . “By combining our proprietary platforms with strategic external collaborations and internal development efforts, we are strengthening our ability to enable efficient clinical translation while remaining focused on building differentiated, scalable technologies.” As Nona continues to advance its A³ strategy , the company is steadily strengthening its platform capabilities to better support global partners in accelerating the discovery of innovative therapeutics and clinical trial initiation while maintaining high scientific and quality standards.

Palo Alto, CA – December 2025 Cibus Therapeutics, a clinical-stage biotechnology company specializing in small-molecule therapies for inflammatory diseases, announced a strategic collaboration with Mission: Cure and Greenstone Biosciences to advance CBT-101 , an investigational oral therapy targeting chronic pancreatitis, a disease with significant unmet medical need and no currently approved disease-modifying treatments. Chronic pancreatitis affects hundreds of thousands of patients globally, characterized by chronic inflammation, irreversible pancreatic damage, and debilitating pain, leading to substantial healthcare burden and unmet demand for effective therapies. To date, patients receive only standard of care focused on symptom management, as no approved treatments exist that target the underlying disease. CBT-101 utilizes a multi-targeted mechanism of action designed to modulate key inflammatory pathways implicated in disease progression, positioning it as a potentially first-in-class therapeutic option. CBT-101 is currently in IND-enabling studies, the critical final preclinical phase required for regulatory submission. Pending FDA or equivalent regulatory clearance, Cibus Therapeutics expects to dose the first participant in a Phase 1 trial assessing safety, pharmacokinetics, and dosing parameters in 2026. The collaboration integrates Cibus Therapeutics’ drug development capabilities, Greenstone Biosciences’ expertise in stem cell and AI-based drug discovery, and Mission: Cure’s strong patient engagement, which collectively enhance clinical strategy and future trial recruitment efforts. Key Highlights: Large unmet medical need: No approved therapies currently target chronic pancreatitis disease biology. Innovative therapeutic approach: CBT-101’s multi-pathway targeting strategy addresses core disease drivers. Clear regulatory pathway: IND-enabling studies underway; Phase 1 trial initiation expected in 2026. Strong strategic partnerships: Combined strengths in drug discovery, clinical development, and patient advocacy. “This collaboration marks a pivotal step in advancing CBT-101 towards clinical development,” said Joseph Wu, Co-founder of Greenstone Biosciences. “Combining Cibus’ expertise in small-molecule drug development with Greenstone Biosciences’ innovative discovery platforms and Mission: Cure’s patient advocacy accelerates our ability to address a significant market opportunity. We are on track to initiate Phase 1 clinical trials by Q3 2026, setting the stage for value creation through clinical milestones.” “For patients living with chronic pancreatitis, this partnership represents a critical step toward therapies that go beyond managing symptoms to targeting the disease itself,” said Megan Golden, CEO and Co-founder of Mission: Cure. “Mission: Cure is proud to bring the patient voice directly into drug development to help improve the likelihood that new treatments reach patients and reflect what matters most to them.” About Cibus Therapeutics Based in Palo Alto, California, Cibus Therapeutics is committed to developing innovative small-molecule therapies for inflammatory and fibrotic diseases. The company focuses on delivering novel, safe, and effective medicines that meet critical unmet needs and create long-term value for patients and investors. For more information, visit [ ]

在全球范围内，乙肝仍然是一个难以根除的公共卫生难题，影响着超过2.5亿感染者，其中中国就有约7000万携带者。 尽管如此，乙肝的治疗与预防已迈入关键转折点，尤其在新药研发和疫苗创新方面，出现了令人振奋的突破。 目前，乙肝最大的医学难题在于病毒储存在肝细胞内的cccDNA（成环状共价DNA），它像是病毒的“复印机”，反复复制病毒，使得现有药物喘不过气来。 传统抗病毒药物虽然可以控制病毒复制，但难以根除，导致很多携带者持续面临肝硬化和肝癌的威胁。 正是在这种背景下，研究人员不断寻求突破，力求找到“根治”的钥匙。 近日，全球首创的免疫调节新药——贺普拉肽，成为关注焦点。 这款药物已进入临床Ⅱ期试验，数据显示其表面抗原清除率高达30%，比传统药物效果显著。 据最新消息，贺普拉肽的Ⅲ期临床试验已全面展开，预计2025年第一季度将公布最终数据。 这不仅成为乙肝治疗史上的一大里程碑，也促使美国FDA为其授予了“突破性疗法”认定，开启加速审评通道。 在国际竞争中，相关公司通过临床试验和合作不断追赶，显示出这个领域的激烈竞争与合作潜力，不少国家也在积极布局，以期共享中国在该领域的科研成果。 药物的研发除了带来新希望，也引发人们对未来的关于药物可及性和经济负担的关注。 根据药物经济学模型，全面疗程的费用预计在8到12万元左右，但与此同时，贺普拉肽已被列入国家医保谈判的预备名单，有望实现超50%的报销比例，减轻患者负担。 伴随生产企业规划和智能化生产线的建设，药物可及性逐步提高，从而降低治疗成本，让更多患者受益。 与此同时，乙肝的预防措施也在持续革新。 我国新生儿乙肝疫苗接种率已稳定在98%以上，保证了新生代的免疫保护。2024年版的《慢性乙型肝炎防治指南》追加了对30岁以上人群的抗体筛查建议，以期及早发现感染者，干预治疗。 新上市的20μg提升剂量疫苗，其保证保护效价已达99.2%，提供更持久、更强的免疫屏障。 国际合作与竞争亦日益激烈。 比如，美国Assembly Biosciences公司二期临床数据表现不佳，清除率仅为12%，而欧洲则已开始推动中欧数据互认，日本武田制药也在与研发团队进行技术合作，试图在全球争夺药物市场和科研话语权。 这样的格局，意味着未来的乙肝药物将不再是单纯的“竞赛”，而是一个多方合作、优势互补的国际生态。 在预防方面，除了疫苗的持续优化外，科技的进步也为未来提供了更多可能。 例如，基因编辑技术在疫苗和治疗药物上的应用，将有望带来更安全、有效的预防方案。 结合我国广泛的疫苗接种基础和优化的筛查策略，未来或许可以实现“早筛早治、全方位覆盖”的乙肝控制目标，大幅降低发病率、改善患者生活质量。 总结来看，乙肝的科研进展正处于黄金期，从“难以根除”的瓶颈逐渐向“可望根除”的未来转变。 新药的突破，预防策略的升级，以及国际合作的深入，都预示着一个更有希望的时代即将到来。 未来的挑战在于如何将科研转化为更广泛的临床应用，让每一位感染者都能享受到科技带来的福祉。 这不仅是医学的胜利，更是公共健康、人类福祉的共同目标。 我们应当紧跟这些新动态，积极推动政策、普及知识，让乙肝不再是无法逾越的阴影，而是逐步走向终结的历史篇章。