In a momentous milestone that redefines the frontier of the global cell and gene therapy (CGT) landscape, the Investigational New Drug (IND) clearance of STX11101 Injection has been officially granted by China's Centre for Drug Evaluation (CDE). Developed by Shanghai Stexo Biotechnology Co., Ltd. for the treatment of acute liver failure, STX11101 is the first-ever exosome-based therapeutic in China to receive IND clearance. This landmark milestone marks a monumental shift in translating extracellular vesicle (EV) research into regulated clinical development and industrial-scale manufacturing. Beyond being a regulatory first, the approval demonstrates that exosome therapeutics have entered a new stage of development—where scalable manufacturing, quality control and CMC can support clinical translation under an established regulatory pathway.

For CytoNiche Biotech, this milestone represents another landmark achievement in advancing MSC-derived therapies. Having previously supported the manufacturing behind China's first approved stem cell therapy (Amimestrocel Injection), CytoNiche has now enabled another national first through its 3D FloTrix™ platform, reinforcing its position as a trusted technology partner for the industrialisation and CMC development of MSCs and their derivatives, from living cell therapies to exosome-based therapeutics.

Breaking the Bottleneck: The Era of Exosome Therapeutics Begins

While MSC-derived exosomes have long been recognised for their powerful anti-inflammatory, regenerative, and low-immunogenicity properties, transitioning them from a laboratory curiosity to a clinical-grade pharmaceutical has historically been halted by a major industrial bottleneck: manufacturing consistency and scalable CMC compliance.

Exosomes are incredibly complex nano-sized vesicles. Traditional two-dimensional (2D) culture methods suffer from significant batch-to-batch variability, low yields, and high labour costs, making standard pharmaceutical-grade scale-up nearly impossible.

The clinical clearance of STX11101 successfully shatters this barrier, demonstrating that high-quality, reproducible exosome therapeutics can be achieved at a commercial scale under a standardised, closed, and fully regulated CMC framework.

From Stem Cells to Exosomes: CytoNiche as the Backbone of Regenerative Medicine

CytoNiche’s pivotal contribution to this milestone builds directly upon its distinguished track record in advancing MSC-based modalities. The company previously supported the manufacturing infrastructure behind China's inaugural approved stem cell therapy, providing the core 3D manufacturing technology that enabled its successful commercialisation.

By enabling both China's first approved stem cell therapy and the nation's first exosome therapeutic to secure IND clearance, CytoNiche has demonstrated the profound versatility of its 3D FloTrix™ platform across the entire spectrum of MSCs and MSC-derived products. Together, these dual structural achievements highlight the company's pioneering role in steering scalable manufacturing and CMC strategies for next-generation regenerative medicine—solidifying its position as an indispensable ally and the ultimate technological backbone for advanced therapy enterprises.

Scale Up and Pure Quality: The 3D FloTrix™ Advantage

The manufacturing workflow for STX11101 was established using CytoNiche’s signature 3D FloTrix™ Cell Intelligent Manufacturing Platform. Rather than growing cells flat on plastic, the platform creates a biomimetic three-dimensional microenvironment using its proprietary dissolvable microcarriers. This allows MSCs to expand naturally in suspension, mimicking their native in vivo environment, which drastically optimises cell health and consistency.

To support the specific demands of Stexo’s exosome pipeline, CytoNiche deployed an integrated, closed-loop solution that manages the entire lifecycle of downstream secretome processing:

• Biomimetic 3D Cell Expansion: Utilises an advanced three-dimensional microenvironment to ensure stable, high-density MSC expansion, laying the foundation for the consistent secretion of premium-quality exosomes.
• Continuous Perfusion Harvesting: Implements an efficient, non-disruptive collection workflow via a closed, perfusion-based culture process to maximise yield without compromising cell viability.
• Automated Downstream Processing: Deploys the 3D FloTrix™ vivaSPIN-SU and 3D FloTrix™ vivaEXO systems to achieve rapid concentration and high-purity isolation, significantly reducing manual intervention and contamination risks.
• CMC-Oriented Manufacturing: Guarantees rigorous process consistency and robust product quality control, delivering a fully scalable production blueprint tailored to the strict demands of clinical development and IND programmes.

A Solid Foundation for Advanced Therapy Enterprises

The clearance of STX11101 aligns with China's rapidly evolving regulatory framework, which has introduced explicit new guidance for cell-derived secretomes and advanced therapeutics. By meeting these rigorous standards, CytoNiche has built a fully transparent, repeatable, and cost-effective blueprint for IND applications.

For advanced therapy medicinal product (ATMP) enterprises worldwide, CytoNiche has transitioned from a component supplier to a comprehensive industrial ally. By de-risking the most challenging engineering phases of cell and derivative therapeutics, CytoNiche stands as the solid backbone of regenerative medicine—accelerating the journey from lab bench discoveries into accessible, life-saving clinical realities.

About Shanghai Stexo Biotechnology Co., Ltd.

Shanghai Stexo Biotechnology Co., Ltd. is dedicated to the research, development and commercialisation of stem cell-derived extracellular vesicle (EV)/exosome therapeutics. The company has established a proprietary platform for genetically engineered stem cell-derived exosomes and is supported by a robust R&D system, a quality management framework, and a strong intellectual property portfolio.

With cGMP-compliant manufacturing and quality control capabilities for large-scale exosome production, Stexo is advancing a pipeline of innovative exosome therapeutics targeting acute liver failure, stroke, lung injury, neurodegenerative diseases and autoimmune disorders, with the aim of addressing significant unmet medical needs.

About CytoNiche Biotech

CytoNiche™ is advancing the cell and gene therapy (CGT) industry through its scalable 3D FloTrix™ platform, providing end-to-end solutions for industrial-scale cell manufacturing. Its portfolio includes GMP-grade dissolvable microcarriers, serum-free media for mesenchymal stromal/stem cells (MSCs), and GMP-compliant equipment and consumables that support the complete manufacturing workflow.

Supported by FDA Master Files and adopted across multiple clinical programmes and a commercialised cell therapy product, CytoNiche's technologies enable scalable manufacturing for MSCs, exosomes and next-generation cell therapies. Guided by its vision of leading a new era of cell industrialisation and its mission of advancing global access to cell technologies through disruptive and scalable manufacturing innovations, CytoNiche is committed to accelerating the development and commercialisation of advanced cell therapies worldwide.