YolTech Therapeutics Announces GMP Manufacturing Facility Expansion to Support Gene Editing Therapy Commercial Manufacturing

Shanghai, China - March 21, 2025—YolTech Therapeutics, a clinical-stage in vivo gene editing company committed to pioneering the next generation of precision genetic medicines, announced plans to significantly expand its Good Manufacturing Practices(GMP)-compliant facility in Nanjing, Jiangsu Province. The facility will grow to approximately 54,000 square feet, providing YolTech the capacity to support the manufacturing of key components for its CRISPR-based investigational therapies upon regulatory approvals.

The expansion underscores YolTech’s commitment to advancing its robust pipeline of gene-editing therapies, including its lead program, YOLT-201, an investigational in vivo CRISPR-Cas9-based gene-editing therapy for patients with transthyretin amyloid cardiomyopathy (ATTR-CM). Early data from an investigator-initiated trial (IIT) demonstrate that YOLT-201 has shown promising efficacy in modifying disease progression. The trial has successfully completed the Phase 1/2a dose-escalation phase, with patient enrollment for the dose-expansion cohort currently ongoing. The pivotal study is on track for completion by the end of next year, based on the current trial progress. In addition to YOLT-201, YolTech has initiated clinical trials for several other promising candidates targeting metabolic disorders and rare genetic diseases, including YOLT-101, YOLT-203, and YOLT-204.

“As we continue to advance a robust pipeline of next-generation gene-editing therapies, scalable and reliable manufacturing is crucial to delivering transformative treatments to patients worldwide,” said Dr. Yuxuan Wu, Founder and Chief Executive Officer of YolTech Therapeutics. “This new facility is a strategic investment in our future, enabling us to meet the growing demand for high-quality manufacturing as we progress toward late-stage clinical trials and, ultimately, commercialization.”

YolTech's Nanjing manufacturing facility is compliant with GMP standards and provides comprehensive end-to-end production capabilities for YolTech's gene-editing therapeutics. This integrated platform encompasses mRNA synthesis, LNP formulation & encapsulation, through to aseptic fill-finish processes, ensuring seamless manufacturing from drug substance to final dosage form.

About YolTech

YolTech Therapeutics is a clinical-stage in vivo gene editing company committed to pioneering the next generation of precision genetic medicines. Our approach combines innovative gene editing technologies with an advanced lipid nanoparticle (LNP) delivery system, creating a versatile platform designed to address a wide range of serious diseases. Central to our mission is the development of internal capabilities, including end-to-end manufacturing, to ensure the highest standards of quality and scalability. Our lead candidate, targeting ATTR, marks a significant milestone as China's first LNP-mediated in vivo gene editing therapy to enter clinical development. With promising early clinical outcomes, YolTech is also advancing therapies for familial hypercholesterolemia (FH) and primary hyperoxaluria type 1 (PH1). As a company dedicated to transforming the treatment landscape, YolTech continues to push the boundaries of what is possible in gene editing.

For more information, please visit: www.yoltx.com