Frost & Sullivan: iRegene Therapeutics Honored as '2025 Forbes China Leading Enterprises in Industry Development'
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.
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Company Name: Frost & Sullivan
Contact Person: Qian Li
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Country: China
Website: http://www.frostchina.com
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