Ruijian Medicine Launches New Chengdu Headquarters and Deepens Collaboration with Danaher to Accelerate Clinical Translation of Novel Cell Therapies

On May 28, iRegene's new headquarters in Chengdu officially began operations. The new location is in Chengdu Tianfu International Bio City and has been developed into iRegene's cell therapy drug research, development, and production base.

 Figure: Ribbon Cutting

In recent years, Chengdu's biopharmaceutical industry has maintained rapid development. Based on comprehensive industrial support policies, a complete upstream and downstream industrial chain, supply chain network, and innovation ecosystem have been formed. Chengdu High-tech Zone also firmly ranks among the "first tier" of China's biopharmaceutical industrial parks.

"Chengdu has given us ample space and necessary conditions to focus on refining our products. The new headquarters will further accelerate the industrialization and commercialization of the company's pipeline, laying a solid foundation for iRegene's future strategic development," said Dr. Wei Jun, founder and CEO of iRegene.

In addition, at the opening ceremony of iRegene's new headquarters in Chengdu on the same day, the "iRegene-Danaher Joint Innovation Center" was officially inaugurated. As the world’s first "Joint Innovation Center for Chemical Induction Therapy and Microphysiological Systems," the center will focus on the deep integration of AI-driven chemical induction cell therapy research and development with microphysiological system technology, accelerating the clinical translation and application of innovative therapies to provide global patients with more precise and efficient disease treatment solutions.

Figure: Danaher-iRegene Joint Innovation Center Signing

Currently, iRegene's core product for Parkinson's disease treatment, NouvNeu001, received approval from the National Medical Products Administration (NMPA) in August 2023 to commence combined Phase I-II clinical research. It has become the world’s first chemically induced, off-the-shelf cell therapy to enter clinical trials in the Parkinson's field. In June 2024, NouvNeu001 also gained clinical approval from the U.S. FDA, achieving dual IND approvals in both China and the United States. Presently, the 12-month data from Phase I clinical trials indicate that the product demonstrates excellent performance in both safety and efficacy metrics and has now advanced to Phase II clinical trials.

In addition, the company's second Parkinson's treatment product, NouvNeu003, was approved by China's NMPA to enter clinical trials in December 2023, and has currently completed dosing for all subjects in Phase I clinical trials. The ophthalmology product NouvSight001 received Orphan Drug Designation (ODD) from the U.S. FDA in March 2024. Meanwhile, iRegene's "Chemical Induction Platform" became the world’s first R&D system to receive special exemption qualifications from the U.S. FDA in March 2024.

Multiple advancements combined have enabled iRegene to become the leading enterprise in the international pluripotent stem cell field, gaining the most regulatory approvals, achieving the fastest pipeline progress, and treating the largest number of patients, drawing significant attention from numerous institutions. Just this past April, iRegene completed a nearly 100-million-yuan B+ round of financing. Combined with the over 100-million-yuan B round of financing completed in October of last year, the company has cumulatively raised over 200 million yuan in less than half a year, setting a new high for financing in China's iPSC sector.

"The 'AI + Chemical Induction' platform of iRegene will accelerate technological breakthroughs in the field of cell therapy, highly aligning with the key development track of cell and gene therapy in BioCity." A relevant official from Chengdu Tianfu International BioCity stated.

The official launch of the new Chengdu headquarters also represents a further enhancement in iRegene's industrialization and commercialization capabilities. Dr. Wei Jun stated that iRegene has already achieved an annual production capacity of 360,000 doses for the NouvNeu001 Parkinson's pipeline. After the Chengdu production base becomes operational, the capacity will be further expanded. "We will leverage our strengths to strengthen cooperation with upstream and downstream sectors of Chengdu's biopharmaceutical industry, establishing iRegene as a globally leading cell therapy biotechnology company based in China with a vision for the world."

"The settlement of iRegene has injected new vitality and innovative momentum into the biocity. After more than eight years of development, the biocity now boasts complete industrial support, an excellent policy environment, and abundant talent resources, providing fertile ground full of opportunities and hope for the growth of iRegene," said Zheng Yubo, General Manager of Guosheng Capital.

iRegene's new headquarters in Chengdu not only meets the company's needs for industrialization and commercial development, but also the "Danaher-iRegene Joint Innovation Center," established in collaboration with global life science giant Danaher, will begin operations at the new location.

As early as 2022, iRegene and Danaher launched their collaboration by establishing the "iRegene-Danaher China Life Sciences Joint Laboratory" to advance the research and clinical application of globally innovative AI platform-based chemically induced cell therapies. The establishment of this joint innovation center marks a further upgrade in their partnership, creating the world’s first "Joint Innovation Center for Chemically Induced Therapies and Microphysiological Systems."

According to the plan, the Joint Innovation Center will rely on iRegene's globally pioneering "AI + Chemical Induction" platform, the original technological advantages of Microphysiological Systems (MPS), and Danaher's support in high-end equipment, automation solutions, and global industrial resources, to build a full-chain R&D platform from target discovery to preclinical validation.

"Microphysiological systems are core tools for the next generation of drug development. The deep collaboration with iRegene not only bridges the technical gap between cell therapy and true human models but also redefines the industry standards for precision medicine," said Hu Xiangyu, President of Danaher's Life Sciences Platform.

Specifically, the two parties will build physiological models such as organoids and organ chips based on "AI + chemical induction technology" to simulate the pathological microenvironment of the human body. The ultimate goal is to form a "chemical induction + microphysiological system" model to accelerate the efficacy and safety evaluation of cell therapies, thereby improving the efficiency of drug development and reducing the cost of new drug research. At the same time, by integrating equipment resources from Danaher, they will further promote the intelligence and scalability of cell therapy processes.

Dr. Wei Jun, CEO of iRegene, stated: "This upgraded cooperation will leverage the high-fidelity modeling advantages of organoid technology to drive chemical-induced cell therapy from foundational technological breakthroughs towards comprehensive systematic innovation. Danaher's global resources and cutting-edge equipment will help us overcome treatment bottlenecks for complex diseases, turning more 'incurable' conditions into history."