Global First iPSC Therapy for Parkinson’s Priced at ¥2.38M; Progress Updates from Seven Chinese Biotechs
Nuwacell
Cell Therapy Product Developer
iRegene Therapeutics
Cell Therapy Product Developer
May 16, 2026
eMedClub News
Recently, Japan's Central Social Insurance Medical Council approved the inclusion of Amchepry, jointly developed by Sumitomo Pharma and Racthera, into the national health insurance.The price per person is 55,306,737 yen.(Approximately RMB 2.38 million), it is expected to be officially put into clinical treatment as early as this fall. This also marksThe World's First iPSC Regenerative Medicine Drug Officially Enters Commercialization Phase。
Amchepry restores dopaminergic nerve function by inducing the differentiation of iPSCs into dopamine neural precursor cells, which are then transplanted into the patient's brain. The drug was approved for marketing on the condition that its long-term efficacy must be further validated through real-world clinical applications within 7 years after approval, after which it can be converted to unconditional approval.
Japan has a "High-Cost Medical Care System".If medical expenses exceed the individual's burden ceiling, an application can be made to reimburse the costs exceeding the limit.. This system will reduce the financial burden on individual patients using Amchepry, globallyThe First to Achieve Medical Insurance AccessThe inclusion of Amchepry, an iPSC-based regenerative medicine drug, in health insurance not only brings a revolutionary breakthrough in Parkinson's disease treatment but also marks a significant milestone for the global regenerative medicine industry.
Progress Made by Multiple Companies in Parkinson's Disease
Parkinson's disease is a popular indication in the iPSC drug development field. Given its urgent clinical needs and the significant limitations of existing treatments, it has become a key research and development direction and core breakthrough in the global regenerative medicine field.Currently, the global Parkinson's iPSC therapy has formed a tiered development pattern advancing through clinical phases I/II/III., mainly focusing on"Cell Replacement Repair of Dopaminergic Neurons"The strategy. As an important birthplace of global innovative drug research and development in China, many companies have already made arrangements.(The following ranking is in no particular order)。
Zhongsheng Traceability
Anhui Zhongsheng Traceability Biotechnology Co., Ltd.'s NCR201 Injection is an iPSC-derived dopaminergic neural progenitor cell product.（iDAP）Treatment Product. In December last year, the "NCR201 Phase II Clinical Research Project Kick-off Meeting" was successfully held, marking this pipelineOfficially Moving into the Critical Phase of Efficacy Confirmation, the overall progress is among the top in China.
Disclosed Phase I clinical data shows that NCR201 has demonstrated good safety, tolerability, and preliminary efficacy trends in patients with mid-to-late stage Parkinson's disease. After transplantation, improvements in "off periods" were observed in multiple patients, significant increases in dopamine function PET-CT signals were noted, and oral dopamine dosages decreased.
Notably, a 37-year-old female patient who has been battling early-onset Parkinson's disease for over a decade showed improvement after receiving NCR201 treatment.Achieved "Functional Cure" in 3 Months, alsoFor the First Time GloballyReported Cases of Functional Cure.
iRegene
iRegene's self-developed NouvNeu001 injection is the world's first iPSC-derived universal dopaminergic progenitor cell therapy product to enter the clinical stage. In March this year, iRegene announced that the pipelineCompleted dosing of all enrolled patients in Phase II clinical trial in China, while in February, the first patient dosing in the U.S. Phase II clinical trial has been completed.
It is worth mentioning that iRegene has carried out a "full range" layout in the Parkinson's field and has also developedThe World's FirstNouvNeu003, an iPSC-derived universal cell therapy for early-onset Parkinson's disease, has entered the registered clinical stage; targeting multiple system atrophy-Parkinsonian type.（MSA-P）NouvNeu004 has also obtained clinical approval for the entire cycle of Phase I-III trials in China.
Shize Bio
XS411 Cell Injection, developed by Shize Bio, is its independently researched and developed clinicalGMP-Grade Allogeneic Universal "Off-the-Shelf" iPSC-Derived Dopaminergic Neural Progenitor Cell New DrugIn the enrolled multiple cases of moderate to severe Parkinson's disease patients, after receiving cell transplantation treatment, there was a significant improvement trend in various efficacy indicators such as UPDRS motor score and on-off period duration. The average "on" time of patients was extended by several hours, and multiple indicators showed significant improvement, further confirming the efficacy and safety of this pipeline.
Shize Bio has obtained9 ItemsClinical trial approval in both China and the U.S., with the project targeting primary Parkinson's disease having advanced to Phase II.(Phase II Clinical Trial in China and Phase I Clinical Trial in the United States)Projects targeting early-onset Parkinson's disease and Parkinsonian-type multiple system atrophy have both advanced to the China registration clinical Phase I+II.
YueSai Bio
Leapcell Bio UX-DA001 is aThe World's FirstAt the same time inApproved in China and the USiPSC-derived Parkinson’s disease autologous cell therapy drugs entering clinical stages can be injected into brain lesion areas through minimally invasive methods, with the aim of replacing lost neurons and restoring dopamine function in the brain.
At the International Parkinson and Movement Disorder Society Annual Meeting in October 2025, YueSai Biotech announced the 6-month follow-up data of the first Parkinson's disease patient: the patient overall tolerated well, with significant improvement in motor function. The MDS-UPDRS-III score improved by 21 points during "off" periods and by 9 points during "on" periods.Improvement ratios all exceed 45%In addition, 18F-FP-CIT PET imaging showed sustained enhancement of dopamine transporter signals in the bilateral putamen transplantation areas, providing objective evidence of cell survival and functional integration.
Huixin Medical Valley
Huixin Medical Valley globallyFirst CreationDirect Reprogramming of Somatic Cells into Induced Neural Stem Cells（iNSC）The industrialization path is proceeding hand in hand with Xuanwu Hospital of Capital Medical University on iNSC-derived dopaminergic neuron precursors.（iNSC-DAP）Exploratory Clinical Study for Parkinson's Treatment.
Ruizhen Regenerative Medicine
The Dopamine Precursor Cell Differentiation and Preparation Technology Independently Developed by Ruizhen Regenerative MedicineInvention Patent Has Been Authorized, as the first company in China to obtain relevant patent authorization. The company has independently developed an iPSC-derived cell therapy pipeline for Parkinson's disease, iDA-001, and is planning to pursue both IND application and IIT projects simultaneously.
iKai Biotech
As an innovative biotechnology company focused on the translation of iPSC technology, iRegene has established a systematic R&D pathway for iPSC-based cell therapies, covering innovative areas such as neurological diseases like Parkinson's disease and epilepsy, and is accelerating the development of multiple products based on an AI-driven R&D system.Allogeneic Universal iPSC-Derived Cell New DrugEnter the clinical stage.
In October 2025, the iPSC-derived dopaminergic progenitor cell drug independently developed by iKai Bioscience achieved significant progress in clinical trials conducted at the Second Affiliated Hospital of Zhejiang University. The core motor symptoms of the first Parkinson's disease patient treated improved significantly at the six-month postoperative follow-up, with good safety and no side effects.
Editor-in-Chief | Xun
Proofread by Xun
References:
1.https://tchina.kyodonews.net/articles/-/8190
2.Official Website of the Company
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