Chuangjing Update | iRegene Therapeutics' Parkinson's Disease Cell Therapy Product Completes China Phase II Enrollment and Dosing Plan, Competing Internationally Through Core Platform Strength

Chuangjing Capital focuses on investment management in the healthcare industry. With high-quality industry resources and rich investment experience, it discovers outstanding entrepreneurs in the industry and provides multi-dimensional professional support. It has formed a complete cycle of project discovery, project investment, industry empowerment, and investment exit to support the development of the healthcare industry.

Its management team comes from leading investment institutions and industry-leading companies such as Hillhouse Capital, China National Pharmaceutical Group, and BGI. At present, it has jointly launched several funds with listed company Hotgen Biotech (688068), molecular diagnostics leader Bioperfectus Technologies, and other partners.

Recently, iRegene Therapeutics Co., Ltd., a portfolio company of Chuangjing Capital, announced that its Parkinson's disease cell therapy product NouvNeu001 has completed dosing for all enrolled patients in its China Phase II clinical trial.

This is another major development milestone for this pipeline after the first patient was dosed in its U.S. Phase II clinical trial on February 11, 2026. NouvNeu001 is also the only cell therapy product in the iPSC field so far to receive both FDA Fast Track Designation (FTD) and Regenerative Medicine Advanced Therapy (RMAT) designation, further strengthening the company's leading position in regenerative medicine in both China and the United States.

At the same time, NouvNeu004, a new product developed based on iRegene Therapeutics' AI + chemical induction platform and targeting multiple system atrophy-parkinsonian type (MSA-P), has received full-cycle Phase I-III clinical approval in China and Phase I clinical approval in the United States. It has also completed dosing of the first patient in China.

Regarding the important milestone of completing dosing for all patients in the China Phase II clinical trial of NouvNeu001, Wei Jun, CEO of iRegene Therapeutics, said that this shows the company is moving from an innovative company with leading projects toward a platform-based cell therapy company with continuous output capabilities.

The Value of Cell Therapy for Parkinson's Disease Is Not Symptom Improvement, but Functional Reconstruction

Current mainstream treatments for Parkinson's disease still mainly include levodopa, dopamine receptor agonists, and deep brain stimulation. These treatments can improve symptoms to some extent, but overall, they remain symptomatic management. They are still unable to fundamentally restore the degenerated dopaminergic neural pathways.

For this reason, cell replacement therapy has always been considered one of the most promising approaches for achieving functional repair. The logic of NouvNeu001 is to direct iPSCs to differentiate into function-enhanced dopaminergic neural precursor cells, and then transplant them into specific brain sites to repair the disease from the level of lesion physiology and neural circuits.

AI + Chemical Induction Is Not Just a Technical Label, but iRegene's Core Platform Asset

If NouvNeu001 represents iRegene Therapeutics' clinical breakthrough in Parkinson's disease, then what deserves even more industry attention is that its AI + chemical induction platform is being continuously validated by a second and third project.

For a biotech company, the real value of a platform is never only whether the concept is advanced. It lies in whether the platform can continuously produce candidate products that enter clinical development and have global competitiveness.

The differentiated strength of iRegene's AI + chemical induction platform is that it integrates AI-driven omics analysis, developmental regulation network modeling, and chemical induction-based cell function control into one development framework.

Its significance is not only finding a candidate molecule more efficiently or making a type of cell more quickly. More importantly, it aims to build a reproducible methodology: using AI to identify key regulatory nodes, and then using chemical induction to precisely reshape cell fate and function. This can improve the controllability, consistency, and industrial feasibility of cell therapy product development.

This is especially important in the cell therapy industry. The real limits to industry scale-up are often not the scientific hypothesis itself, but complex processes, large batch-to-batch differences, high costs, difficulty in scale-up, and weak cross-indication reuse capability.

If a platform can both improve candidate development efficiency and strengthen the standardization of differentiation processes and product manufacturing, it improves not only the success probability of a single project, but also the company's overall asset generation efficiency and industrialization potential.

From this perspective, the continuous progress of NouvNeu001, NouvSight001, and NouvNeu004 means that iRegene's AI + chemical induction system is moving from an underlying tool supporting one project toward a platform engine that continuously generates cell therapy assets. This is also why the market's view of iRegene is shifting from whether it has a leading pipeline to whether it can become a platform-based cell therapy company.

iRegene Has Built a Reproducible Industrialization Framework with International Competitiveness

From the perspective of international competition, neurodegenerative diseases have always been one of the areas with the highest technical barriers and greatest clinical development difficulty in innovative drugs. iPSC-derived neural cell therapy is an even higher-barrier track within this field.

In the past, Chinese companies' advantages in global innovative drug competition were more concentrated in mature fields such as oncology and autoimmune diseases. Today, iRegene's ability to advance NouvNeu001 into mid-stage clinical development in both China and the United States, complete successful enrollment and dosing of all China Phase II subjects in less than 10 months, and further achieve clinical approvals for NouvNeu004 in both China and the United States shows that iRegene Therapeutics has entered a true global race in this frontier field.

The significance of NouvNeu001 completing dosing for all enrolled patients in China Phase II is no longer just that one project is moving forward. It is also an important point showing that iRegene's AI + chemical induction platform has entered the clinical value validation stage.

As NouvNeu001 advances through Phase II clinical development in Parkinson's disease in both China and the United States, and as NouvNeu004 completes approvals in China and the United States and starts clinical development for MSA, iRegene is gradually proving that it is no longer only an innovative company with leading projects. It is becoming an international innovative company with platform-based output capabilities, and may become a representative example of a Chinese platform-based cell therapy company entering global frontier competition.

Non-Inducement Statement

This press release contains forward-looking statements, which are mainly based on the current views, expectations, estimates, and predictions of the company's management. Words such as "hope," "expect," "believe," "may," "design," "effect," "evaluate," "forecast," "goal," "plan," "purpose," "will," "intend," and similar expressions related to the company are intended to indicate forward-looking statements.

Forward-looking statements are affected by risks and uncertainties. Many of these risks are difficult to predict and are usually beyond the company's control. As a result, actual results may differ from those described in the forward-looking statements. The company has no obligation to publicly update or revise any forward-looking statements.