YueSai Bio's GMP Manufacturing Facility Officially Launched, Advancing Innovative Stem Cell Therapies for Parkinson’s Disease
Parkinson’s disease is the second most common neurodegenerative disorder worldwide. Its primary cause is the degeneration of dopaminergic neurons in the substantia nigra of the midbrain, leading to insufficient dopamine secretion in the striatum and subsequently resulting in motor impairments such as tremor, bradykinesia, and gait abnormalities.Currently, China has approximately 4 million patients with Parkinson’s disease, with a prevalence rate of about 1.7% among individuals aged 65 and older, posing a significant challenge to the country’s increasingly aging society.Traditional pharmacotherapy centered on levodopa can only alleviate symptoms and is associated with severe adverse drug reactions in the later stages. According to the “2022 Report on Disease Diagnosis, Treatment, and Quality of Life of Parkinson’s Disease Patients in China,”83% of patients are highly anticipating the emergence of “new drugs and new therapies.”
Against this backdrop, Shanghai Yuesai Biotechnology Co., Ltd., which has mastered multiple core technologies in the field of cell therapy for neurological disorders, is accelerating the development and clinical translation of cell-based therapies for Parkinson’s disease based on clinical needs.2On April 8, 2023, the GMP-grade production base of Yuesai Bio, located in the Waigaoqiao Free Trade Zone No. 1 Life Science and Technology Industrial Park in Shanghai, was officially completed.Academician of the Chinese Academy of Sciences Pei Gang, Director of the Shanghai Biomedical Industry Promotion Center Liu Houjia, Deputy Director of the Center for Excellence in Brain Science and Intelligence Technology of the Chinese Academy of Sciences Wang Zuoren, CEO of Xingbei Group Wu Haixia, Managing Director of Taifu Capital Cheng Wei, Vice President of Sherpa Investments Song Zhichaoattended the on-site ceremony and cut the ribbon for the relocation to the new premises and the completion of the GMP-compliant manufacturing facility, marking a complete success for the opening ceremony.
▲ Ribbon-Cutting Ceremony for Yuesai Biologics' New Office Relocation and GMP Facility Completion
At the opening ceremony,Yuesai Bio Founder Chen YuejunFirst, we extend our gratitude to Mr. Pu and Director Du Jiulin for their support in building the R&D team since 2016. As a researcher, Dr. Chen Yuejun deeply understands that only by translating scientific achievements into practical applications can we truly benefit the public; this is the fundamental driving force behind the establishment of Yuesai Biotechnology. In the future, Yuesai Biotechnology will actively implement the national strategic direction of “prioritizing people’s lives and health” as outlined in the 19th National Congress of the Communist Party of China. We will align with the latest Good Manufacturing Practice (GMP) Guidelines for Cell Therapy Products issued by the National Medical Products Administration (NMPA), strictly adhere to GMP standards in production management, and manufacture high-standard cell therapy products within the industry. This will ensure the smooth progress of current Investigator-Initiated Trials (IITs) and future Phase I/II clinical trials.
▲ Chen Yuejun, Founder of Yuesai Biotech
Academician of the Chinese Academy of Sciences, Pei GangHe stated that with the development of China’s pharmaceutical industry, cell and gene therapy (CGT) has become a significant milestone in history, and Yuesai occupies a pivotal position at this critical juncture. Academician Pei Gang also affirmed Dr. Chen Yuejun’s original aspiration and practical efforts in advancing the clinical translation of stem cells, expressing strong optimism about Yuesai’s future prospects in the stem cell field. Finally, Academician Pei Gang noted that the rapid development of China’s biopharmaceutical sector over the past 10 to 20 years has benefited not only from national policies but also from the overseas practical experience brought by returning top-tier talents and the rational allocation of domestic capital toward service innovation.
▲ Academician of the Chinese Academy of Sciences, Pei Gang
Liu Houjia, Director of the Shanghai Biopharmaceutical Industry Promotion CenterIt was noted that cell and gene therapy is a key area of focus for Shanghai’s innovative pharmaceutical industry. The two previously approved immune cell therapies both originated in Shanghai, and there is hope that stem cell therapies will emerge from Yuesai. Although the approval of stem cell drugs appears more challenging due to factors such as manufacturing standards and first-generation innovation, patient demand continues to grow from a societal perspective. Local governments will spare no effort in promoting the translation of scientific and technological achievements in cell and gene therapy into clinical applications.
▲ Liu Houjia, Director of the Shanghai Biomedical Industry Promotion Center
Deputy Director of the Center for Excellence in Brain Science and Intelligence Technology, Chinese Academy of Sciences, Wang ZuorenIt emphasized General Secretary Xi Jinping’s adherence to the “Four Orientations”: “orienting toward the frontiers of global science and technology, toward the main battlefield of economic development, toward major national needs, and toward the life and health of the people.” It praised Dr. Chen Yuejun for consistently prioritizing both basic research and clinical translation, thereby charting a new path for the institute in translating research outcomes. This path leads from source innovation to domestically produced technologies, safeguarding the life and health of the people.
▲ Wang Zuoren, Deputy Director of the Center for Excellence in Brain Science and Intelligence Technology, Chinese Academy of Sciences
Cheng Wei, Managing Director of Taifu CapitalFirst, it is worth acknowledging that Yuesai’s rapid development over the past two years has delivered a highly satisfactory performance. In particular, the construction of its GMP-compliant manufacturing facility demonstrates the Yuesai team’s strong capability in industrial translation and commercialization. Meanwhile, as an investor, Cheng Wei is very optimistic about Yuesai’s growth potential. Through her collaboration with Yuesai, she has deeply experienced the “joy” of being an angel investor: while focusing on the company’s development, she also finds fulfillment in meeting patient needs through ongoing communication with clinical institutions.
▲ Cheng Wei, Managing Director at Taifu Capital
Wu Haixia, CEO of Xingbei Group, specifically highlighted the birthplace of Yuesai Biologics—the Free Trade Zone No. 1 Life Science Park. As a high-tech industrial ecosystem brimming with vitality and an innovative atmosphere, Free Trade Zone No. 1 provides numerous enterprises with superior platforms and resources, enabling them to fully leverage their strengths and grow together with other companies.
▲ Wu Haixia, CEO of Xingbei Group
The newly inaugurated integrated R&D and GMP manufacturing center covers an area of approximately 2,800 square meters and includes comprehensive production, quality control, and warehousing facilities. Its designed capacity supports the concurrent development of four drug pipelines.Under an advanced control system, the cleanliness level in the production area reaches Grade B, fully meeting the environmental requirements for GMP manufacturing of cell therapy products. The quality control (QC) area is equipped with a comprehensive suite of advanced instruments for process development and quality control research of cell-based products, aiming to establish corporate QC standards that exceed industry requirements. Yuesai Biologics has established a robust quality management system aligned with the latest “Guidelines for Good Manufacturing Practice of Cell Therapy Products (Trial)” issued by the National Medical Products Administration (NMPA). Building on this foundation, the team will carry out chemistry, manufacturing, and controls (CMC) research and development, with the goal of advancing its products into clinical trials as early as possible.
▲ Tour of Yuesai Biotech’s GMP Production Workshop
Yuesai Biologics boasts a professional CMC team with extensive experience in stem cell R&D and GMP-compliant cell therapy manufacturing, safeguarding production compliance and product safety.The completion and inauguration of the R&D and Production Center empower Yuesai Bio to further advance technological R&D and clinical translation, accelerating pipeline progress. Currently, Yuesai Bio has established three core technology platforms centered on neural differentiation of human pluripotent stem cells, all with independent intellectual property rights:Lineage tracing technology, GMP-grade gene editing technology, and GMP-grade stem cell neural differentiation technology.
Chen Yuejun, Founder of Yuesai BiotechSenior Researcher at the Center for Excellence in Brain Science and Intelligence Technology, Chinese Academy of Sciences, has long been engaged in research on neural differentiation and neural regeneration, achieving a series of internationally recognized research outcomes:Established a novel technology for the efficient directed differentiation of human pluripotent stem cells into midbrain substantia nigra dopaminergic neurons; developed a novel technique, SISBAR, capable of high-throughput lineage tracing across differentiation stages.A clear description of the differentiation pathways of target and non-target cells in donor cell-derived medicinal products provides critical foundational technical support for achieving comprehensive quality control throughout the differentiation process; surface marker molecules capable of specifically characterizing dopaminergic neural precursor cells have been discovered and identified.
The research team leveraged these marker molecules to develop a novel strategy for preparing donor cell-based therapeutics with highly enriched target cells, thereby enabling safer and more effective cellular therapy outcomes for Parkinson’s disease following transplantation; the research teamEstablished a Remote Regulation Technology for Transplanted Cell Viability, elucidating the mechanisms underlying the integration and function of transplanted neural cells within disease-affected brain circuits. These studies have been published in top-tier international journals in stem cell research and have received high acclaim from peer reviewers worldwide.Based on this research, the team has filed multiple domestic and international invention patents.
▲ The high-throughput, full-lineage tracing technology SISBAR across differentiation stages is used to stably produce high-purity donor cells for transplantation, enhancing post-transplant therapeutic outcomes (Image source: Yuesai Bio)
Supported by three core technology platforms and integrated with a comprehensive in vitro/in vivo stem cell research system encompassing in vitro cell differentiation, mouse models, and macaque models, Yuesai Biotech relies on standardized R&D and GMP-compliant production facilities to dedicate itself to the manufacturing of donor cell therapies with high purity, stringent standards, and advanced maturity, thereby laying the foundation for stable, efficient, and safe clinical cell therapy outcomes.Yuesai Bio has currently established its presence in four major disease areas: Parkinson’s disease, retinal diseases, spinal cord injury, and cancer., aiming to achieve the corporate vision of “Stem Cell Technology Creating a Healthy Future for Humanity.”
To put this vision into practice,Yuesai Bio and Ruijin Hospital Launch Research Project on Autologous Stem Cell Therapy for Parkinson’s DiseaseBy deeply integrating basic research with clinical studies, we not only ensure a continuous source of innovation in the discipline of brain and intelligence sciences but also leverage medical resources to benefit patients, thereby advancing the development of China’s cellular therapy sector for Parkinson’s disease and propelling China’s stem cell therapies for Parkinson’s disease to the global forefront. The completion and commissioning of Yuesai Bio’s 2,800-square-meter standardized R&D and GMP-compliant production facility will provide robust hardware support for the smooth implementation of this project.
▲ YueSai Bio and Ruijin Hospital Launch Collaborative Project on Autologous Stem Cell Therapy for Parkinson’s Disease (Image source: YueSai Bio)
The tireless efforts of the research team align with the booming development trend in China’s life sciences sector. At the Fifth Plenary Session of the 19th Central Committee of the Communist Party of China, a clear new direction for scientific and technological innovation was proposed: “oriented toward safeguarding people’s lives and health.” Yuesai Biologics actively implements this national strategic directive by strengthening collaborative linkages among industry, academia, research, and clinical application, transforming its accumulated scientific and technological innovations into industrial advantages, promoting the formation of new models in regenerative medicine therapy, and benefiting a broad patient population.
Yuesai Biologics prioritizes original and pioneering basic research, tackles key core technologies, and continuously applies for and builds a portfolio of core patents. The company is dedicated to developing novel stem cell drugs with independent intellectual property rights and international competitiveness, aiming to translate scientific achievements into clinically viable and patient-accessible therapies. In doing so, Yuesai Biologics fulfills its mission to alleviate patient suffering and promote human health and well-being.
With the successful conclusion of the standardization R&D initiative and the opening ceremony of the GMP-compliant production facility, Yuesai Biologics has demonstrated its corporate image as an industry leader characterized by cutting-edge technology, robust scientific research capabilities, and strong translational capacity. The company is committed to addressing genuine clinical needs, pursuing excellence through bold innovation and decisive action, while embodying a corporate mission dedicated to helping humanity achieve healthier lives. Through the sustained efforts of researchers committed to advancing independent innovation and industrialization in cellular therapies for Parkinson’s disease, the therapeutic potential of stem cell treatments will be fully realized, bringing us closer to the dawn of a cure for Parkinson’s disease.
References:
1. “2022 Annual Report on Disease Diagnosis, Treatment, and Quality of Life for Parkinson’s Disease Patients in China”
2. Yue Sai Bio Official Website