UniXell Biotechnology Secures FDA IND Clearance for UX-DA003, Achieving China-U.S. Dual Breakthrough in iPSC Parkinson's Therapy

SHANGHAI, June 23, 2026 /PRNewswire/ -- UniXell Biotechnology Co., Ltd. ("UniXell") has secured Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) for UX-DA003, its allogeneic induced pluripotent stem cell (iPSC)-derived therapy for Parkinson's disease. Paired with the prior IND approval from China's National Medical Products Administration (NMPA) on June 3, 2026, the candidate will undergo clinical development in both China and the United States concurrently, marking a landmark dual-country breakthrough for the company's neurodegenerative disease pipeline. This milestone solidifies UniXell's unique dual-pathway clinical strategy covering personalized autologous and scalable off-the-shelf allogeneic iPSC therapeutics.

UX-DA003 is an allogeneic iPSC-derived midbrain dopaminergic progenitor cell therapy, built upon UniXell's independently developed core technologies - the proprietary SISBAR lineage tracing platform and high-precision directed differentiation system. Supported by the company's  clinical grade, GMP compliant iPSC seed cell bank with verified genetic stability and consistent differentiation capacity, the candidate fully meets dual regulatory requirements in China and the U.S., laying a solid foundation for standardized global clinical translation.

Comprehensive preclinical data demonstrates that UX-DA003 delivers industry-leading therapeutic efficacy, along with notable advantages in safety and manufacturability:

• Ultra-high purity: the proportion of functional dopaminergic neurons reaches 50–60% in graft, which represents a substantial improvement compared with the industry average of merely 2–15%.
• Lower dose therapy with enhanced therapeutic potential: Optimized cell purity reduces the required clinical dosage by 50–80% versus conventional cell therapy regimens.
• Excellent long-term safety: The proliferating rate of cells is only 0.23% at six months post-transplantation, lower than the reported range of 0.5–11%, which effectively reduces long-term safety risks.

These enable UX-DA003 to deliver superior safety, reduced off-target effects, and enhanced manufacturability, unlocking the large-scale, standardized clinical application of allogeneic iPSC therapy for Parkinson's disease.

With the latest FDA clearance, UniXell has achieved four major regulatory milestones in China and the U.S. within three months, covering core pipeline programs for Parkinson's disease and drug-resistant epilepsy. The company's differentiated Parkinson's therapy portfolio integrates two complementary technical routes to meet diverse clinical demands:

• UX-DA001 (Autologous iPSC Therapy): Currently in a Phase I clinical trial at Ruijin Hospital (Shanghai). Developed from patients' own cells, this therapy effectively avoids immune rejection. The first enrolled patient has completed one year of follow-up, and preliminary clinical outcomes have confirmed a favorable safety profile. This therapy represents a precise personalized treatment solution.
• UX-DA003 (Allogeneic iPSC Therapy): A standardized off-the-shelf cell product based on universal GMP-grade iPSC seed cell banks. It features scalable production, low cost, and wide accessibility, making it suitable for large-scale clinical promotion and delivering widespread benefits to patients.

Lanlin Wu, Chief Executive Officer of UniXell Biotechnology, shared her insights on this milestone: "Autologous and allogeneic iPSC therapies target distinct clinical scenarios for Parkinson's disease. Our dual-pathway strategy not only provides flexible, individualized treatment options for patients but also accelerates the scalable industrialization of iPSC regenerative medicine. The FDA IND clearance of UX-DA003 is a critical step in our global clinical layout. We will continue to advance parallel clinical development in China and the U.S., and push forward the global commercialization of innovative iPSC-based therapies for neurodegenerative diseases."

UniXell stated that UX-DA003's regulatory filings submitted across the two jurisdictions leverage a unified iPSC seed cell platform alongside standardized manufacturing processes, enabling harmonized regulatory compliance and production strategies for both China and the United States. This arrangement will strongly underpin the global rollout of the company's allogeneic cell therapy pipeline.

About UniXell Biotechnology

UniXell Biotechnology Co., Ltd. is a leading innovative biotech company focusing on the research and clinical transformation of iPSC-based regenerative therapies. Centering on major neurological diseases including Parkinson's disease and drug-resistant epilepsy, the company builds dual technical systems of autologous personalized therapy and allogeneic standardized therapy, committed to developing safe, efficient and accessible next-generation cell therapies for global patients.

SOURCE Unixell Biotech