Domestic AI Biotech's Cell Therapy for 'Incurable Disease' Receives FDA Approval for Overseas Clinical Trials

Jun 24, 2024 18:11 CST Updated 18:11

iRegene Therapeutics

Cell Therapy Product Developer

On June 20, the U.S. Food and Drug Administration (FDA) officially approvediRegeneParkinson's PipelineNouvNeu001The IND Application.

As the world's first chemically induced, universal cell therapy product in the Parkinson's field to enter the clinical stage, iRegene's NouvNeu001 "combined Phase I-II clinical" study was approved by the National Medical Products Administration (NMPA) in August 2023 and has achieved positive safety and efficacy data in Phase I clinical trials.

This time, it was approved by the FDA to carry out clinical research,Means that the company has achieved "dual filing and dual approval" of IND for its Parkinson's pipeline in both China and the US.。

In response, Dr. Cai Meng, CMO of iRegene, stated that after obtaining the FDA special exemption, the NouvNeu001 IND has been further approved by the FDA, demonstrating the FDA's high recognition of iRegene's pioneering chemical induction platform and its innovative products. This also clears policy barriers for the company’s subsequent internationalization pathway, allowing universal cell therapy products produced in China to be directly exported for clinical trials.

Public information shows that iRegene isThe World's First Biotech to Apply "AI + Chemical Induction" in the Specific Functional Modification of Cells. This platform has the advantages of being more efficient, safer, lower-cost, and more suitable for large-scale industrial production in terms of cell function modification.

Based on this unique platform, iRegene has established a rich pipeline of universal iPSC (induced pluripotent stem cell) products, developing universal cell therapies for currently "incurable" diseases such as Parkinson's disease and other neurodegenerative disorders, as well as blindness, offering the potential for a cure.

Parkinson's disease is a common neurodegenerative disorder of the nervous system, characterized clinically by resting tremor, muscle rigidity, bradykinesia, and postural balance impairment.There is no completely curative therapy yet., known as a chronic "incurable disease." According to statistics,Global Parkinson's Disease Drug Market Size Reached 38.2 Billion Yuan in 2023, which is expected to reach 61.2 billion yuan by 2030.

But with the support of cutting-edge technology, iRegene is bringing a whole new possibility of reversing the progression of this disease.

At the beginning of 2024, NouvNeu001 successfully initiated clinical trials at Beijing Hospital and Zhongnan Hospital of Wuhan University. Currently, this clinical project has entered an accelerated phase. Based on the results of multiple cases independently completed at multiple centers, after using NouvNeu001 for treatment, not only was there a rapid and significant improvement in MDS-UPDRS scores, but patients' quality of life also greatly improved; moreover, it demonstrated good safety with no related adverse reactions. The NouvNeu001 project is about to enter the dose expansion phase.

Beyond neurodegenerative diseases, iRegene continues to explore other "incurable" disease areas. In March this year, the company made a breakthrough with its ophthalmic product.NouvSight001has been granted by the U.S. FDAOrphan DrugRecognition。

According to Dr. Wei Jun, CEO of iRegene, in the innovative therapy field of iPSC, iRegene has maintained a high level of rigor while balancing the progress of research and development. The project advancement plans previously formulated by the company were precisely scheduled down to the "week," which laid an essential foundation for the company to continuously push its core pipelines into clinical trials on schedule.

iRegene, established in 2017 and located in Wuhan Optics Valley Biomedical Industry Base, is one of the biotech companies that pioneered the application of "AI + chemical induction" for specific functional modification of cells. Based on this, the company has built a rich pipeline of universal iPSC products.The company has successively obtained two rounds of financing exceeding 100 million yuan within half a year, with investors including Fortune Ventures, Jiuyou Capital, Changjiang Chuangxin Investment, etc.。

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