Ruijian Pharmaceuticals Announces Successful Launch of Phase II Clinical Trial for NouvNeu001, the World’s First Off-the-Shelf iPSC-Derived Cell Therapy for Moderate-to-Severe Parkinson’s Disease

Recently,News from the Field of Innovative Parkinson's Drugs AgainExciting news——iRegene Pharmaceutical Technology Co., Ltd. (iRegene)Successfully Convened by the Company's Independently DevelopedNouvNeu001InjectionFor the treatment of moderate to severe Parkinson's diseaseI/IIPeriodClinical TrialResearcher Society, and successfully launched the new drugIIClinical Phase Initiation Meeting.

This is alsoiRegeneFirst to Achieve a Universal Type in Parkinson's Field Entering Clinical Stage GloballyiPSCDerivativeAnother milestone event announced after cell therapy products.Centered on Parkinson's disease, an "irreversible condition," the universal cell therapy developed by iRegene has significantly outpaced similar competing products in terms of clinical progress and scale.

With the acceleration of population aging, the incidence of Parkinson's disease continues to rise. Data from the World Health Organization shows that in the past 25 The global incidence of Parkinson's disease has doubled by mid-year.2019 In 2023, there were over 850 10,000 people suffer from Parkinson's disease，Central nervous system diseases, including Parkinson's diseaseHas becomeThe Leading Cause of Disability Worldwide.

Although the issue of Parkinson's disease is becoming increasingly severe with the aggravation of aging,On the marketStill noAny effective drug can reverseTheThe Degeneration Process of Neurons in the Brain of Patients. In the face of this clinical reality dilemma,iRegene as a globaliPSCLeader in the field of Parkinson's cell therapy,In2023Year8Month Unveils Its Parkinson'sFirst CreationNew DrugNouvNeu001Clinical work, this is alsoThe World's First Universal Type in the Parkinson's Field to Enter Clinical StageiPSCDerived Cell Therapy Products。

Currently,NouvNeu001Has achieved "dual submission and dual approval" in clinical trials in China and the United States,iRegeneBased on this achievementFor the world's first completion in both China and the U.S.INDiRegene: The Parkinson's Cell Drug Development Enterprise with Dual ApprovalsiRegene is indisputably the global leader in the research and development progress, clinical trial scale, and regulatory recognition of cell replacement therapies for Parkinson's disease.

This timeiRegeneSuccessfully Held in WuhanNouvNeu001InjectionFor the treatment of moderate to severe Parkinson's diseaseI/IIPeriodClinical TrialResearcher SocietyAndIIPeriodThe launch meeting marks a breakthrough for the new drug and another significant advancement in the field of Parkinson's treatment.

According to the company, theIIPhase ResearchBrings together a top team of experts in the field of Parkinson's disease treatment in China, including Professor Chen Haibo from Beijing Hospital.Team、, Professor Hui-Fang Shang from West China Hospital of Sichuan UniversityTeam, Professor Xiong Nanxiang from Zhongnan Hospital of Wuhan UniversityTeam、Niu Chaoshi from the First Affiliated Hospital of University of Science and Technology of ChinaProfessorTeamAndHuazhong University of Science and Technology AffiliatedPeking Union Medical College HospitalXiong NianProfessorTeamiRegeneCEODr. Jun Wei,CMODr. Cai Meng and the core R&D team, as well asCRO、SMORepresentatives from partner organizations attended the meeting. All parties presentReviewed togetherIPhase clinical trials, andAs forIIIn-depth discussions were held on topics such as the clinical research protocol and key evaluation indicators, providingNouvNeu001InjectionFor the treatment of moderate to severe Parkinson's diseaseIIPeriodClinical Trialand Confirmatory Clinicalhas laid a solid foundation for the smooth progress.

At the beginning of the conference, "NouvNeu001InjectionFor the treatment of moderate to severe Parkinson's diseaseI/IIPeriodClinical Trial" The principal investigator of the clinical trial, Professor Chen Haibo from Beijing Hospital, delivered the opening speech. Subsequently, iRegeneCEODr. Jun Wei reported the product development process and preclinical data to the experts present; Professor Haibo Chen further...IA review of the clinical trials was conducted, summarizingNouvNeu001InjectionFor the treatment of moderate to severe Parkinson's diseaseIPhase clinical trial, which is a single-arm, multi-center, open-label clinical trial, commented by Professor Chen Haibo onISystematic Review and Analysis of the Primary Safety and Tolerability Endpoints in Clinical Trials, and RevealedNouvNeu001In clinicalISignificant trends in efficacy improvement were observed during the trial period. After receiving the transplantation, the subjects showed significant improvement trends both in behavioral and non-behavioral aspects. Professor Xiong Nanxiang from Zhongnan Hospital of Wuhan University introducedNouvNeu001InjectionFor the treatment of moderate to severe Parkinson's diseaseISummary of Exploratory Work and Experience in Neurosurgery During Clinical Trials, Dr. Wang Qiao from Beijing Hospital Discusses Surgical Drug Delivery and Postoperative Reconstruction；Dr. Ma Xinxin from Beijing Hospital shared the key evaluation indicators of the study. Finally, all participating teams conducted a systematic discussion on aspects such as clinical trial strategies, evaluation indicators, and delivery optimization strategies.West China Hospital of Sichuan UniversityProfessor Shang Huifang, Niu Chaoshi from the First Affiliated Hospital of University of Science and Technology of ChinaProfessorExperts such asIIThe Phase Clinical Trial: Multiple Constructive Opinions and Suggestions. Open and Practical Discussion by Attending ExpertsForNouvNeu001InjectionFor the treatment of moderate to severe Parkinson's diseaseIIPeriodClinical Trialand Confirmatory Clinicalhas laid a solid foundation for the smooth progress.

Public information shows,NouvNeu001Injection Solution2023Year8Month Obtained in ChinaNMPAApproved to enter the clinical stage, becoming the world's first chemically inducediPSCDerived therapeutic products, and2024Year6Month Obtained in the United StatesFDAApproval to Conduct Overseas Clinical Research Achieved in Both China and the USIND"Dual Filing and Dual Approval"。

AsThe world's first to obtainFDA"Special Exemption"QualifiedBiotechiRegene ranks first globally in the research and development progress, clinical trial scale, and regulatory recognition of cell replacement therapy for Parkinson's disease.. Currently, the research hasSuccessfully ConcludedIPhase ClinicalExperiment, Data shows that it has good safety and tolerability, and successfully achieves the main objectives of the study,The secondary indicator efficacy data has demonstrated a significant market advantage. ISuccessful Completion of Phase Clinical TrialsFor SubsequentConfirmatoryClinicalImplementation of the ExperimentProvidedSolid Foundation。iRegeneNouvNeu001Also becomes the world's first to enter clinicalIIPeriodiPSCDerived Generalized Parkinson's Cell Therapy Product.

It is reported that iRegene will continue to focus on the development of innovative cell therapy products, helping to address the global challenge of Parkinson's disease treatment and bringing more hope of recovery to patients.NouvNeu001Injection as a potential"Reverse the course of the disease"'s innovative therapy has the potential to bring a fundamental treatment breakthrough for Parkinson's disease patients.

iRegeneCMODr. Cai Meng said: "This keyIIThe initiation of the clinical trial phase is iRegene's commitment to practice."Providing Universal Therapy for Patients"An important milestone in the mission. We believe that, with the dual assurance of the expert team's extensive clinical experience and iRegene's robust production processes and quality systems,NouvNeu001The clinical trial of the injection will be carried out steadily, benefiting a large number of patients as soon as possible."

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