Global Expansion Milestone: Yuesai Bio's UX-DA003 Receives FDA IND Clearance

June 19, 2026Stem Cell Therapeutic Drug R&D Enterprise “UniXell”Announced that UX-DA003 (allogeneic iPSC-derived midbrain dopaminergic neural precursor cell injection) has officially received the Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA). This follows the product’s approval on June 3, 2026NMPA Clinical Trial Implicit ApprovalAnother Key Milestone Achieved by UniXell in Its Internationalization Journey Following Licensing Approval. With this, UniXell’s dual-path strategy of “autologous + allogeneic” approaches has achieved full regulatory alignment in both China and the United States in the field of Parkinson’s disease (PD), marking the formal entry of China’s original cell therapies into the global pharmaceutical market.

The successful approval of UX-DA003,Core reliance on UniXell’s independently developed high-throughput lineage tracing technology (SISBAR) platform and efficient directed differentiation technology platformSupported by these two major technology platforms, the drug purity of UX-DA003 is significantly higher than that of international counterparts. The yield of functional cells—dopaminergic neurons—post-transplantation has increased from the international average of 2–15% to 50–60% (all data reported herein are published, internationally peer-reviewed, and publicly available data). Furthermore, UniXell has established the most scientific and precise quality control system for Parkinson’s disease (PD) cell therapy products in the industry. The high purity of UX-DA003 allows its dosage to be only 1/5 to 1/2 of the international average, thereby minimizing compression of surrounding brain tissue caused by cell transplantation and ensuring a higher safety profile. With fewer impurity cells, UX-DA003 demonstrates a proliferating cell ratio of merely 0.23% at six months post-transplantation (compared to the international range of 0.5–11%). This substantially mitigates potential side effects caused by the release of other neurotransmitters from off-target cells, as well as long-term tumorigenicity and safety risks associated with excessive proliferation of off-target cells.

UX-DA003 utilizes iPSC seed cells independently developed by UniXell Biotechnology.. UniXell has constructed, through its established GMP-grade iPSCs construction platform,iPSC Seed Cell Bank with Clear Genetic Background, Excellent Differentiation Potential, and Compliance with Chinese and U.S. Standards for Global Commercial Drug Filing, and has passed the rigorous quality testing and certification by the National Institutes for Food and Drug Control (NIFDC) of China and the U.S. FDA.

UX-DA003 is precisely built upon UniXell’s core technology platform, achievingthe "fast-track dual submission and dual approval" pace, with implicit approval from the NMPA in China on June 3 and FDA IND clearance secured just half a month later on June 19—For the same product and the same master cell bank, synchronized regulatory alignment between China and the United States not only validates the platform’s bilateral compliance but also establishes a model for replicating parallel “domestic–overseas” submission pathways across the company’s future allogeneic cell therapy pipelines.

With the FDA approval of UX-DA003,UniXell has become one of the few companies worldwide to simultaneously master both autologous and allogeneic iPSC cell therapy technologies for Parkinson’s disease., a differentiated product portfolio has been developed for different patient groups:

• Autologous Pathway (UX-DA001): Prepared using the patient’s own cells, completely avoiding the risk of immune rejection. Currently, this product is undergoing Phase I clinical trials at Ruijin Hospital in Shanghai.The first patient has completed one year of treatment; clinical data demonstrate a favorable safety profile and significant efficacy, with the patient having regained the ability to live independently.. In June 2025, the product was granted Fast Track designation by the U.S. FDA.

• Allogeneic Pathway (UX-DA003): Leveraging a universal iPSC seed cell bank, scalable production can be achieved. Preclinical studies have demonstrated that UX-DA003 significantly improves motor deficits in animal models of Parkinson's disease and precisely integrates into host brain circuits to form functional connections, offering new hope for patients in urgent need of treatment.

  
  

The approval of UX-DA003 not only enhances the portfolio in the field of Parkinson’s disease,This further announces the completion of UniXell’s comprehensive strategic layout across both the Parkinson’s disease and refractory epilepsy tracks in China and the United States.Within three months, UniXell consecutively obtained four regulatory approvals in China and the United States for its off-the-shelf cell therapies targeting epilepsy and Parkinson’s disease. This achievement not only underscores the efficiency and stability of the UniXell team but also marks the company’s steady evolution from an explorer in a single disease area to a leader in innovative therapies covering multiple neurological disorders.

Wu Lanlin, CEO of UniXell“It is stated that autologous and allogeneic therapies each have their respective applicable scenarios and unique advantages. Leveraging its ‘dual-path’ development strategy, UniXell is able to more precisely serve patient populations with diverse needs. The FDA approval of UX-DA003 marks a significant step in the company’s globalization strategy. We will accelerate clinical development to enhance global access to healthcare while achieving sustainable industry growth.”