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Yahoo
24-06-2025
- Health
- Yahoo
Technological Advancements in Precision Delivery Drive Growth, High Costs Challenging Accessibility
The gene and cell therapies market targeting central nervous system (CNS) disorders is rapidly advancing, driven by increasing incidences of conditions like Parkinson's, Alzheimer's, and multiple sclerosis. With current treatments often ineffective, there's a pressing demand for innovative solutions. Technological advancements such as CRISPR and stem cell therapy are propelling market growth by offering precise, effective treatments. However, high development and manufacturing costs pose challenges. Industry leaders like Novartis are investing heavily in R&D. As the market evolves, there's a focus on personalized medicine and expansion in emerging markets. This growth promises improved patient outcomes and quality of life. Dublin, June 24, 2025 (GLOBE NEWSWIRE) -- The "Gene and Cell Therapies Targeting CNS Disorders Market - A Global and Regional Analysis: Focus on Drug and Region - Analysis and Forecast, 2025-2035" report has been added to offering. Global gene and cell therapies targeting central nervous system (CNS) disorders a market is on track for continued growth, driven by the aging population, and the development of more effective and comfortable solutions. The ongoing advancements in product technology and the expansion of care options will continue to shape the market's future. As demand for gene and cell therapies targeting central nervous system (CNS) disorders therapies rises, both global and regional players will play a key role in meeting the needs of individuals and healthcare systems alike, improving quality of life for people living with gene and cell therapies targeting central nervous system (CNS) disorders are rapidly advancing, offering potential treatments for conditions such as Parkinson's, Alzheimer's, Huntington's disease, and spinal cord injuries. Increasing incidences of CNS disorders one of the major driving factors of this market. The increasing number of patients with neurological disorders such as Alzheimer's, Parkinson's, and multiple sclerosis is creating an urgent need for innovative treatments. This drives demand for gene and cell therapies, as current treatments are often ineffective or only offer temporary of the significant drivers of the global gene and cell therapies targeting central nervous system (CNS) disorders market is the technological advancements in treatment delivery. The technological innovations in drug delivery systems, such as CRISPR and gene editing, stem cell therapy and AAV vectors for gene delivery. Furthermore, improved precision in treatment technologies such as CRISPR-Cas9 allow for precise editing of genes involved in neurological diseases. This level of precision offers hope for conditions that have a genetic root, such as Huntington's disease or spinal muscular atrophy have contributed to the market's the growth trajectory, several challenges continue to impact the global gene and cell therapies targeting central nervous system (CNS) disorders market. One of the primary challenges is high development and manufacturing costs. The developing and manufacturing gene and cell therapies, especially those targeting CNS disorders, is extremely production of viral vectors for gene delivery and the preparation of cell-based therapies are both costly and complex processes. The high costs of developing these therapies can limit accessibility and affordability for patients. Additionally, these high costs can result in delayed market entry and restrictions on patient access, particularly in low- and middle-income players in the global gene and cell therapies targeting central nervous system (CNS) disorders market, such as Novartis, and BrainStorm Cell Therapeutics are continuously innovating to improve the effectiveness and comfort of gene and cell therapies targeting central nervous system (CNS) disorders. These companies are investing heavily in research and development to introduce new, technologically advanced therapies into the market. With a strong emphasis on user-friendly and environmentally sustainable products, these companies are shaping the future of gene and cell therapies targeting central nervous system (CNS) disorders while enhancing their market positions competitive landscape of the global gene and cell therapies targeting central nervous system (CNS) disorders market is diverse, with numerous players across different regions offering a wide range of products. Regional players and local manufacturers are expected to play an important role in the market's growth, especially as demand increases in emerging markets such as Asia-Pacific. As consumer preferences shift towards more discreet, comfortable, and affordable solutions, the gene and cell therapies targeting central nervous system (CNS) disorders market will continue to evolve, fostering new opportunities for both established and emerging companies. As the gene and cell therapies targeting central nervous system (CNS) disorders market evolves, emerging trends such expansion of cell-based therapies and focuses on personalized or precision medicine. This trend allows treatments to be more specific and effective for individual patients, reducing side effects and improving patient outcomes. Companies Featured Novartis AG BrainStorm Cell Therapeutics Neuroplast Rapa Therapeutics Longeveron Key Topics Covered: Executive Summary1. Global Gene and Cell Therapies Targeting CNS Disorders Market: Industry Outlook1.1 Overview1.2 Regulatory Landscape1.3 Global Gene and Cell Therapies Targeting CNS Disorders Market, Patent Landscape1.3.1 By Country1.3.2 By Year1.4 Global Gene and Cell Therapies Targeting CNS Disorders Market, Clinical Trials Landscape1.5 Key Trends1.6 Market Dynamics1.6.1 Overview1.6.1.1 Impact Analysis1.6.2 Market Drivers1.6.3 Market Restraints1.6.4 Market Opportunities2. Global Gene and Cell Therapies Targeting CNS Disorders Market, by Drugs, $Million, 2023-20352.1 Gene Therapy Drugs2.2 Cell Therapy Drugs3. Global Gene and Cell Therapies Targeting CNS Disorders, by Region, $Million, 2023-20353.1 North America3.1.1 Key Findings in North America3.1.2 Market Dynamics3.1.3 Market Sizing and Forecast3.1.3.1 North America Gene and Cell Therapies Targeting CNS Disorders Market, By Country3.1.3.1.1 U.S.3.1.3.1.2 Canada3.2 Europe3.2.1 Key Findings in Europe3.2.2 Market Dynamics3.2.3 Market Sizing and Forecast3.2.3.1 Europe Gene and Cell Therapies Targeting CNS Disorders Market, By Country3.2.3.1.1 Germany3.2.3.1.2 U.K.3.2.3.1.3 France3.2.3.1.4 Italy3.2.3.1.5 Spain3.2.3.1.6 Rest-of-Europe3.3 Asia-Pacific3.3.1 Key Findings in Asia-Pacific3.3.2 Market Dynamics3.3.3 Market Sizing and Forecast3.3.3.1 Asia-Pacific Gene and Cell Therapies Targeting CNS Disorders Market, By Country3.3.3.1.1 Japan3.3.3.1.2 China3.3.3.1.3 India3.3.3.1.4 Rest-of-Asia-Pacific3.4 Rest-of-the-World3.4.1 Key Findings in Rest-of-the-World3.4.2 Market Dynamics3.4.3 Market Sizing and Forecast4. Global Gene and Cell Therapies Targeting CNS Disorders Market: Competitive Landscape and Company Profiles4.1 Competitive Landscape4.1.1 New Offerings4.1.2 Mergers and Acquisitions4.1.3 Partnerships, Alliances, and Business Expansion4.1.4 Funding Activities4.1.5 Regulatory Approvals4.2 Company Profiles4.2.1 Overview4.2.2 Product Portfolio4.2.3 Target Customers4.2.4 Key Professionals4.2.5 Analyst View5. Research MethodologyFor more information about this report visit About is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. CONTACT: CONTACT: Laura Wood,Senior Press Manager press@ For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900Sign in to access your portfolio
Associated Press
16-06-2025
- Business
- Associated Press
uBriGene Launches Clinical iPSC Banks to Accelerate Regenerative Medicine and Cell Therapy Development
ROCKVILLE, MD / ACCESS Newswire / June 16, 2025 / uBriGene Biosciences, a leading cell and gene therapy CDMO, is proud to announce the launch of its fully characterized, ready-to-use induced pluripotent stem cell (iPSC) banks. Developed using uBriGene's proprietary RNA-LNP reprogramming technology, these iPSC banks are now available to support research, translational development, and clinical applications reprogramming diagram uBriGene's iPSC seed banks and master cell banks (MCBs) are generated in GMP-compliant cleanrooms using healthy donor fibroblasts sourced from the USA in full compliance with FDA regulations. Reprogrammed with a non-integrating mRNA-LNP kit, the iPSCs are free of genomic footprint and residual RNA. Each bank undergoes rigorous quality control testing to confirm identity, genomic stability, sterility, the absence of adventitious viruses, and strong expression of stemness and pluripotency markers. Early-passage seed banks (P2-P5) and clonally derived MCBs are cryopreserved and released for use in a wide range of regenerative and allogeneic cell therapy programs. 'With our iPSC banks, clients can save 1-2 years and the uncertainty associated with donor cell sourcing and reprogramming,' said Dr. Xiulian Sun, CTO and Founder at uBriGene. 'These banks are designed to accelerate preclinical and clinical workflows with regulatory confidence.' uBriGene's iPSC banks are now available in both research-use only (RUO) and GMP-compliant formats. Gene editing services are also available upon request to customize cell lines for disease modeling or therapeutic development. To learn more about uBriGene's iPSC bank offerings, visit: About uBriGene Founded in 2015, uBriGene Biosciences is a leading Contract Development and Manufacturing Organization for advanced therapeutic medicinal products (ATMPs). The company provides integrated CDMO and CRO solutions, encompassing services for cell therapy products, viral vectors, and RNA-related products, with in-house QC testing and regulatory IND filing. Our GMP-validated Maryland facility offers one-stop CDMO services from process development to manufacturing, driving global advancements in ATMPs. Contact InformationMingjuan Liu Director of Marketing 800 663 2528 SOURCE: UBRIGENE BIOSCIENCES INC press release
Globe and Mail
09-06-2025
- Business
- Globe and Mail
Frost & Sullivan: iRegene Therapeutics Honored as "2025 Forbes China Leading Enterprises in Industry Development"
Shanghai, China--(Newsfile Corp. - June 8, 2025) - Recently, The "2025 Frost & Sullivan China Entrepreneurs Annual Conference and Forbes China Pioneer Innovators in Industry Development Selection Gala Evening of Honor," jointly organized by Frost & Sullivan and Forbes China, was successfully held at Regent Shanghai on The Bund. Amid the global trend of industrial innovation, the results of the "2025 Pioneer Innovators in Industry Development" selection jointly initiated by Forbes China and Frost & Sullivan were officially announced. iRegene Therapeutics was honored as one of Forbes China's 2025 Leading Enterprises in Industry Development. iRegene is pioneering the future of regenerative medicine with its AI-powered, chemically induced cell therapy platform. By combining cutting-edge technology, a robust R&D ecosystem, and a globally experienced leadership team, iRegene is redefining allogeneic therapies to make them safer, more effective, and broadly accessible. This recognition highlights iRegene's continued leadership in innovation and its commitment to transforming patient care through next-generation regenerative therapies. iRegene Therapeutics Honored as 2025 Forbes China Leading Enterprises in Industry Development Aroop Zutshi, Global Managing Partner and Executive Board Director of Frost & Sullivan, and Junyi Guo, General Manager of Business Operations at Forbes China, jointly presented the 2025 Forbes China Leading Enterprises in Industry Development award. Dr. Jun Wei, Chairman of iRegene Therapeutics, was invited to attend the gala. AI-Driven Chemical-Induced Cell Therapy: Reshaping the Future of Accessible Cell Therapy Since its establishment in 2017, iRegene Therapeutics has remained committed to addressing unmet clinical needs through the development of next-generation cell therapies. With a focus on chemically induced, universal cell therapy products, iRegene aims to deliver transformative treatments for patients with currently incurable diseases. iRegene Therapeutics has a proprietary, AI-based platform for screening chemical compounds to modify specific cellular functions. The platform leverages induced pluripotent stem cells (iPSCs) to enhance treatment potential. By combining compounds to form a chemically induced culture medium, the "AI+Chem" platform can efficiently and precisely reprogram or optimize a cell's fate and function, thereby enhancing the clinical capabilities of cell therapies. With a focus on the chemical induction system, iRegene has developed a comprehensive research and development (R&D) ecosystem and an international patent system that spans the industry. This ecosystem combines the discovery of 'cell fate determinants', the screening of chemical inducers and the validation of cellular function. The system does not use viral vector construction or transgenic methods; the straightforward CMC procedure is cost-efficient. Furthermore, cell transformation and functional optimization are entirely driven by the cells' natural genetic makeup. Transformation is synchronous under chemically enhanced regulation, eliminating the risk of genetic modification. iRegene's pioneering platform has been proven through the positive outcomes of the Phase I clinical trial. In addition, iRegene's executive team has an international perspective, with all members having successful overseas experience in their specialized fields. CEO Dr Wei Jun is a leading expert in regenerative medicine and the induced pluripotent stem cell (iPSC) technology, bringing strategic leadership to the company. Chief Medical Officer Dr Cai Meng has extensive experience taking innovative therapies from discovery through clinical development, while Chief Quality Officer Ren Xiang is a senior regulatory expert who provides solid support from IND approval to NDA clearance in China, the US, and other countries. Executive Vice President Emmanuel Montet, formerly Vice President of the Asia-Pacific region at Ipsen, now leads iRegene's global business development and international strategy. To accelerate global clinical translation and commercialization, iRegene places great emphasis on the philosophy of 'cooperation and mutual benefit'. At the end of 2021, iRegene entered a long-term collaboration with Danaher Corporation to co-develop next-generation platforms for clinical application. Under this partnership, Danaher will play an active role in developing multi-directional platforms for future iRegene Therapeutics projects. This will involve supplying advanced detection instruments and technical resources relating to life sciences research, the development of effective compounds and screening, multi-omics cell mechanism research, and multi-substance screening. Danaher will help iRegene Therapeutics to enhance the efficiency of platform construction and its ability to deliver practical solutions. Danaher will also support iRegene Therapeutics in developing distinctive, innovative drug pipelines and establishing a research and production base. This strategic cooperation has recently been elevated to the iRegene - Danaher Joint Innovation Center, which is the world's first "Joint Innovation Center for Chemically Induced Therapies and Microphysiology Systems". The center will focus on integrating artificial intelligence (AI)-driven chemically induced cell therapy R&D with microphysiology systems technology. It is committed to accelerating the clinical translation and application of innovative therapies, and providing patients globally with more precise and effective treatment solutions for diseases. Danaher will fully support iRegene Therapeutics' future planning and development, aiming to jointly advance innovative development in China's life sciences research. iRegene's breakthrough technology platform, strategic advantages and dedicated team have secured continuous support from several leading venture capital firms, with cumulative financing reaching nearly 400 million RMB (55.5 million USD). The company is advancing multiple programs through clinical development, targeting a win-win situation for its products and the capital markets alike, while providing patients around the world with next-generation chemically induced cell therapies that can genuinely reverse disease progression. About iRegene Therapeutics iRegene Therapeutics is a biotechnology company committed to becoming a global leader in universal chemical-induced cell therapy. As one of the first companies to harness AI and + chemical induction for the specific functional modification of cells, iRegene offers a safer, more scalable, and cost-effective alternative to traditional gene or cell therapies. Its pipeline targets diseases with high unmet need, including neurodegenerative disorders such as Parkinson's disease and blindness. Through pioneering science, strategic global partnerships, and a visionary leadership team, iRegene is reshaping the future of regenerative medicine - making advanced therapies accessible to patients worldwide. In August 2023, the NMPA approved the commencement of Phase I clinical trials for iRegene's first product: 'Human Dopaminergic Precursor Cell, NouvNeu001'. This product was developed using the 'AI+ Chem' platform. This made it the world's first chemically induced pluripotent stem cell (iPSC)-derived therapy to enter clinical trials. In June 2024, it was approved by the U.S. FDA for overseas clinical trials. Even more groundbreakingly, in March 2024, iRegene's 'Chemical Induction Platform' became the first system ever to be granted exemption by the FDA. The company's second product, NouvNeu003, which is intended for the treatment of early-onset Parkinson's disease, received NMPA approval in December 2023 and entered Phase I clinical trials. Both NouvNeu001 and NouvNeu003 have now completed Phase I trials. The Phase I results demonstrate good safety, tolerability, and encouraging efficacy in improving motor and non-motor symptoms. The Phase II trial for NouvNeu001 began in April 2025. In parallel, iRegene's first-in-class ophthalmic therapy, was granted Orphan Drug Designation (ODD) by the U.S. FDA in March 2024.
Associated Press
09-06-2025
- Business
- Associated Press
Frost & Sullivan: iRegene Therapeutics Honored as '2025 Forbes China Leading Enterprises in Industry Development'
Recently, The '2025 Frost & Sullivan China Entrepreneurs Annual Conference and Forbes China Pioneer Innovators in Industry Development Selection Gala Evening of Honor,' jointly organized by Frost & Sullivan and Forbes China, was successfully held at Regent Shanghai on The Bund. Amid the global trend of industrial innovation, the results of the '2025 Pioneer Innovators in Industry Development' selection jointly initiated by Forbes China and Frost & Sullivan were officially announced. iRegene Therapeutics was honored as one of Forbes China's 2025 Leading Enterprises in Industry Development. iRegene is pioneering the future of regenerative medicine with its AI-powered, chemically induced cell therapy platform. By combining cutting-edge technology, a robust R&D ecosystem, and a globally experienced leadership team, iRegene is redefining allogeneic therapies to make them safer, more effective, and broadly accessible. This recognition highlights iRegene's continued leadership in innovation and its commitment to transforming patient care through next-generation regenerative therapies. iRegene Therapeutics Honored as [2025 Forbes China Leading Enterprises in Industry Development] Aroop Zutshi, Global Managing Partner and Executive Board Director of Frost & Sullivan, and Junyi Guo, General Manager of Business Operations at Forbes China, jointly presented the 2025 Forbes China Leading Enterprises in Industry Development award. Dr. Jun Wei, Chairman of iRegene Therapeutics, was invited to attend the gala. AI-Driven Chemical-Induced Cell Therapy: Reshaping the Future of Accessible Cell Therapy Since its establishment in 2017, iRegene Therapeutics has remained committed to addressing unmet clinical needs through the development of next-generation cell therapies. With a focus on chemically induced, universal cell therapy products, iRegene aims to deliver transformative treatments for patients with currently incurable diseases. iRegene Therapeutics has a proprietary, AI-based platform for screening chemical compounds to modify specific cellular functions. The platform leverages induced pluripotent stem cells (iPSCs) to enhance treatment potential. By combining compounds to form a chemically induced culture medium, the 'AI+Chem' platform can efficiently and precisely reprogram or optimize a cell's fate and function, thereby enhancing the clinical capabilities of cell therapies. With a focus on the chemical induction system, iRegene has developed a comprehensive research and development (R&D) ecosystem and an international patent system that spans the industry. This ecosystem combines the discovery of 'cell fate determinants', the screening of chemical inducers and the validation of cellular function. The system does not use viral vector construction or transgenic methods; the straightforward CMC procedure is cost-efficient. Furthermore, cell transformation and functional optimization are entirely driven by the cells' natural genetic makeup. Transformation is synchronous under chemically enhanced regulation, eliminating the risk of genetic modification. iRegene's pioneering platform has been proven through the positive outcomes of the Phase I clinical trial. In addition, iRegene's executive team has an international perspective, with all members having successful overseas experience in their specialized fields. CEO Dr Wei Jun is a leading expert in regenerative medicine and the induced pluripotent stem cell (iPSC) technology, brings strategic leadership to the company. Chief Medical Officer Dr Cai Meng has extensive experience taking innovative therapies from discovery through clinical development, while Chief Quality Officer Ren Xiang is a senior regulatory expert who provides solid support from IND approval to NDA clearance in China, the US, and other countries. Executive Vice President Emmanuel Montet, formerly Vice President of the Asia-Pacific region at Ipsen, now leads iRegene's global business development and international strategy. To accelerate global clinical translation and commercialization, iRegene places great emphasis on the philosophy of 'cooperation and mutual benefit'. At the end of 2021, iRegene entered a long-term collaboration with Danaher Corporation to co-develop next-generation platforms for clinical application. Under this partnership, Danaher will play an active role in developing multi-directional platforms for future iRegene Therapeutics projects. This will involve supplying advanced detection instruments and technical resources relating to life sciences research, the development of effective compounds and screening, multi-omics cell mechanism research, and multi-substance screening. Danaher will help iRegene Therapeutics to enhance the efficiency of platform construction and its ability to deliver practical solutions. Danaher will also support iRegene Therapeutics in developing distinctive, innovative drug pipelines and establishing a research and production base. This strategic cooperation has recently been elevated to the iRegene – Danaher Joint Innovation Center, which is the world's first 'Joint Innovation Center for Chemically Induced Therapies and Microphysiology Systems'. The center will focus on integrating artificial intelligence (AI)-driven chemically induced cell therapy R&D with microphysiology systems technology. It is committed to accelerating the clinical translation and application of innovative therapies, and providing patients globally with more precise and effective treatment solutions for diseases. Danaher will fully support iRegene Therapeutics' future planning and development, aiming to jointly advance innovative development in China's life sciences research. iRegene's breakthrough technology platform, strategic advantages and dedicated team have secured continuous support from several leading venture capital firms, with cumulative financing reaching nearly 400 million RMB (55.5 million USD). The company is advancing multiple programs through clinical development, targeting a win-win situation for its products and the capital markets alike, while providing patients around the world with next-generation chemically induced cell therapies that can genuinely reverse disease progression. About iRegene Therapeutics iRegene Therapeutics is a biotechnology company committed to becoming a global leader in universal chemical-induced cell therapy. As one of the first companies to harness AI and + chemical induction for the specific functional modification of cells, iRegene offers a safer, more scalable, and cost-effective alternative to traditional gene or cell therapies. Its pipeline targets diseases with high unmet need, including neurodegenerative disorders such as Parkinson's disease and blindness. Through pioneering science, strategic global partnerships, and a visionary leadership team, iRegene is reshaping the future of regenerative medicine — making advanced therapies accessible to patients worldwide. In August 2023, the NMPA approved the commencement of Phase I clinical trials for iRegene's first product: 'Human Dopaminergic Precursor Cell, NouvNeu001'. This product was developed using the 'AI+ Chem' platform. This made it the world's first chemically induced pluripotent stem cell (iPSC)-derived therapy to enter clinical trials. In June 2024, it was approved by the U.S. FDA for overseas clinical trials. Even more groundbreakingly, in March 2024, iRegene's 'Chemical Induction Platform' became the first system ever to be granted exemption by the FDA. The company's second product, NouvNeu003, which is intended for the treatment of early-onset Parkinson's disease, received NMPA approval in December 2023 and entered Phase I clinical trials. Both NouvNeu001 and NouvNeu003 have now completed Phase I trials. The Phase I results demonstrate good safety, tolerability, and encouraging efficacy in improving motor and non-motor symptoms. The Phase II trial for NouvNeu001 began in April 2025. In parallel, iRegene's first-in-class ophthalmic therapy, was granted Orphan Drug Designation (ODD) by the U.S. FDA in March 2024. Media Contact Company Name: Frost & Sullivan Contact Person: Qian Li Email: Send Email Country: China Website:
Yahoo
09-06-2025
- Business
- Yahoo
Frost & Sullivan: iRegene Therapeutics Honored as "2025 Forbes China Leading Enterprises in Industry Development"
Shanghai, China--(Newsfile Corp. - June 8, 2025) - Recently, The "2025 Frost & Sullivan China Entrepreneurs Annual Conference and Forbes China Pioneer Innovators in Industry Development Selection Gala Evening of Honor," jointly organized by Frost & Sullivan and Forbes China, was successfully held at Regent Shanghai on The Bund. Amid the global trend of industrial innovation, the results of the "2025 Pioneer Innovators in Industry Development" selection jointly initiated by Forbes China and Frost & Sullivan were officially announced. iRegene Therapeutics was honored as one of Forbes China's 2025 Leading Enterprises in Industry Development. iRegene is pioneering the future of regenerative medicine with its AI-powered, chemically induced cell therapy platform. By combining cutting-edge technology, a robust R&D ecosystem, and a globally experienced leadership team, iRegene is redefining allogeneic therapies to make them safer, more effective, and broadly accessible. This recognition highlights iRegene's continued leadership in innovation and its commitment to transforming patient care through next-generation regenerative therapies. iRegene Therapeutics Honored as 2025 Forbes China Leading Enterprises in Industry Development Aroop Zutshi, Global Managing Partner and Executive Board Director of Frost & Sullivan, and Junyi Guo, General Manager of Business Operations at Forbes China, jointly presented the 2025 Forbes China Leading Enterprises in Industry Development award. Dr. Jun Wei, Chairman of iRegene Therapeutics, was invited to attend the gala. AI-Driven Chemical-Induced Cell Therapy: Reshaping the Future of Accessible Cell Therapy Since its establishment in 2017, iRegene Therapeutics has remained committed to addressing unmet clinical needs through the development of next-generation cell therapies. With a focus on chemically induced, universal cell therapy products, iRegene aims to deliver transformative treatments for patients with currently incurable diseases. iRegene Therapeutics has a proprietary, AI-based platform for screening chemical compounds to modify specific cellular functions. The platform leverages induced pluripotent stem cells (iPSCs) to enhance treatment potential. By combining compounds to form a chemically induced culture medium, the "AI+Chem" platform can efficiently and precisely reprogram or optimize a cell's fate and function, thereby enhancing the clinical capabilities of cell therapies. With a focus on the chemical induction system, iRegene has developed a comprehensive research and development (R&D) ecosystem and an international patent system that spans the industry. This ecosystem combines the discovery of 'cell fate determinants', the screening of chemical inducers and the validation of cellular function. The system does not use viral vector construction or transgenic methods; the straightforward CMC procedure is cost-efficient. Furthermore, cell transformation and functional optimization are entirely driven by the cells' natural genetic makeup. Transformation is synchronous under chemically enhanced regulation, eliminating the risk of genetic modification. iRegene's pioneering platform has been proven through the positive outcomes of the Phase I clinical trial. In addition, iRegene's executive team has an international perspective, with all members having successful overseas experience in their specialized fields. CEO Dr Wei Jun is a leading expert in regenerative medicine and the induced pluripotent stem cell (iPSC) technology, bringing strategic leadership to the company. Chief Medical Officer Dr Cai Meng has extensive experience taking innovative therapies from discovery through clinical development, while Chief Quality Officer Ren Xiang is a senior regulatory expert who provides solid support from IND approval to NDA clearance in China, the US, and other countries. Executive Vice President Emmanuel Montet, formerly Vice President of the Asia-Pacific region at Ipsen, now leads iRegene's global business development and international strategy. To accelerate global clinical translation and commercialization, iRegene places great emphasis on the philosophy of 'cooperation and mutual benefit'. At the end of 2021, iRegene entered a long-term collaboration with Danaher Corporation to co-develop next-generation platforms for clinical application. Under this partnership, Danaher will play an active role in developing multi-directional platforms for future iRegene Therapeutics projects. This will involve supplying advanced detection instruments and technical resources relating to life sciences research, the development of effective compounds and screening, multi-omics cell mechanism research, and multi-substance screening. Danaher will help iRegene Therapeutics to enhance the efficiency of platform construction and its ability to deliver practical solutions. Danaher will also support iRegene Therapeutics in developing distinctive, innovative drug pipelines and establishing a research and production base. This strategic cooperation has recently been elevated to the iRegene - Danaher Joint Innovation Center, which is the world's first "Joint Innovation Center for Chemically Induced Therapies and Microphysiology Systems". The center will focus on integrating artificial intelligence (AI)-driven chemically induced cell therapy R&D with microphysiology systems technology. It is committed to accelerating the clinical translation and application of innovative therapies, and providing patients globally with more precise and effective treatment solutions for diseases. Danaher will fully support iRegene Therapeutics' future planning and development, aiming to jointly advance innovative development in China's life sciences research. iRegene's breakthrough technology platform, strategic advantages and dedicated team have secured continuous support from several leading venture capital firms, with cumulative financing reaching nearly 400 million RMB (55.5 million USD). The company is advancing multiple programs through clinical development, targeting a win-win situation for its products and the capital markets alike, while providing patients around the world with next-generation chemically induced cell therapies that can genuinely reverse disease progression. About iRegene Therapeutics iRegene Therapeutics is a biotechnology company committed to becoming a global leader in universal chemical-induced cell therapy. As one of the first companies to harness AI and + chemical induction for the specific functional modification of cells, iRegene offers a safer, more scalable, and cost-effective alternative to traditional gene or cell therapies. Its pipeline targets diseases with high unmet need, including neurodegenerative disorders such as Parkinson's disease and blindness. Through pioneering science, strategic global partnerships, and a visionary leadership team, iRegene is reshaping the future of regenerative medicine - making advanced therapies accessible to patients worldwide. In August 2023, the NMPA approved the commencement of Phase I clinical trials for iRegene's first product: 'Human Dopaminergic Precursor Cell, NouvNeu001'. This product was developed using the 'AI+ Chem' platform. This made it the world's first chemically induced pluripotent stem cell (iPSC)-derived therapy to enter clinical trials. In June 2024, it was approved by the U.S. FDA for overseas clinical trials. Even more groundbreakingly, in March 2024, iRegene's 'Chemical Induction Platform' became the first system ever to be granted exemption by the FDA. The company's second product, NouvNeu003, which is intended for the treatment of early-onset Parkinson's disease, received NMPA approval in December 2023 and entered Phase I clinical trials. Both NouvNeu001 and NouvNeu003 have now completed Phase I trials. The Phase I results demonstrate good safety, tolerability, and encouraging efficacy in improving motor and non-motor symptoms. The Phase II trial for NouvNeu001 began in April 2025. In parallel, iRegene's first-in-class ophthalmic therapy, was granted Orphan Drug Designation (ODD) by the U.S. FDA in March 2024. Media Contact Company Name: Frost & SullivanWebsite: PR@ To view the source version of this press release, please visit Sign in to access your portfolio
