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Guangzhou, China — November 21, 2025 — The Greater Bay Area Workshop on Cell and Gene Therapy Development was successfully convened in Nansha, Guangzhou. The event was jointly hosted by SDM, Guangdong Medical Valley, and the Guangzhou Pharmaceutical Association, with strong support from the Greater Bay Area Life Science Industry Promotion Association and Cell Chain.
The Workshop gathered leading experts including Dr. Gao Jianchao, Research Fellow at Changping Laboratory and former Senior Reviewer at the Center for Drug Evaluation (CDE); Professor Miyachi Hikogo, Chief Expert of Chanyu Clinic; Lin Liulin, Vice Dean of the Marxism College at Guangzhou Party School; He Jiechang, Deputy Director of the Nansha District Health Bureau; Dr. Howard Yuwen, SVP Global Regulatory Affairs & CBO at SDM; Dr. Chen Yixiong, Co-founder & CSO of Lingyi Biotechnology; Xie Jiasheng, Executive President of Guangdong Medical Valley; Dr. Bao Yuanwu, General Manager of Early Clinical and Laboratory Services at SDM; Dr. Zhao Juanjuan, Head of the Cell and Gene Therapy Platform at SDM (Amador Hangzhou Laboratory); Dr. Wei Shihu, Vice General Manager of Early Clinical Medicine and Pharmacovigilance at SDM, and Zuo Peng, Vice General Manager of Early Clinical Operation, alongside other industry experts, entrepreneurs, and investors.
Dr. Gao Jianchao focused on key clinical development trends and technical requirements for CGT, including patient population selection, control group design, safety monitoring, and efficacy endpoints such as functional outcomes. Dr. Gao also introduced platforms established by Changping Laboratory, including investigator-initiated trials (IIT) and real-world data systems, to provide comprehensive technical guidance for CGT clinical research.
Dr. Howard Yuwen, SVP Global Regulatory Affairs & CBO at SDM, systematically outlined regulatory frameworks in the US, Europe, Japan, and China. Dr. Yuwen detailed classification standards for CGT products by authorities like the FDA and EMA, key accelerated approval pathways, and long-term follow-up requirements, emphasizing the importance of scientific trial design and safety monitoring withhighlight on the significant growth in global CGT trials and trending in autoimmune diseases as a new frontier for CGT applications.
AAV2.0-Based Gene Therapy: Development and Applications
Dr. Chen Yixiong, Co-founder & CSO of Lingyi Biotech, addressed the unmet clinical needs of rare disease patients globally, underscoring the advantages of AAV vectors, such as their high safety profile and low immunogenicity. Dr. Chen pointed out risks associated with AAV1.0, including potential overexpression, and explained how Lingyi’s AAV2.0 technology, via the CREATE™ system, enables controlled gene expression to balance efficacy and safety. The company’s LY-M001, the first gene therapy for Gaucher disease to receive IND approvals in both China and the US, along with FDA orphan drug designation, has shown promising clinical results, including rapid enzyme activity recovery and reduced hepatosplenomegaly, offering a potential one-time, lifelong treatment for rare diseases.
Fuchan Medicine’s Chronic Disease Regenerative Management System: International Practices in Cell Therapy and Integrative Medicine
Professor Miyachi Hikogo, Chief Expert of Chanyu (Guangzhou) Comprehensive Outpatient Department Co., Ltd., introduced Fuchan Medicine’s closed-loop cell therapy services, which began with an immune cell center and have since earned multiple certifications, including ISO9001. The system features standardized GMP laboratories and fully automated cell production lines. Its core technologies cover stem cells, immune cells, and exosome applications, offering precision treatments—such as intravenous and localized injections—for eight chronic conditions, including diabetes and arthritis.
Bioanalytical Strategies and Challenges in Cell Therapy
Dr. Zhao Juanjuan, Head of the CGT Platform at SDM (Amador Hangzhou Laboratory), provided an overview of cell therapy categories, mechanisms of action, and market trends, including the rise of allogeneic CAR-T and expansion into solid tumors. Dr. Zhao detailed key bioanalytical aspects such as pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and biomarker assays, alongside practical considerations like sample stability and reagent selection, offering technical support for cell therapy clinical studies.
Opportunities and Challenges in Collaborative Development of the Greater Bay Area CGT Industry
A roundtable discussion moderated by Mr. Xie Jiasheng, Executive President of Guangdong Medical Valley, featured insights from Dr. Gao Jianchao; Professor Miyachi Hikogo; He Jiechang, Deputy Director of the Nansha District Health Bureau; Dr. Wei Shihu of SDM; and Dr. Chen Yixiong of Lingyi Biotech. The panel delved into collaborative opportunities and challenges in the Bay Area CGT sector, offering expert perspectives on policy, technology translation, and clinical implementation.
SDM’s Integrated Support for CGT Innovation
As a clinical development pioneer with 20 years of experience, SDM provides end-to-end support for innovative therapies like CGT through its ecosystem. Its subsidiary Shanghai Shouyan focuses on translational science and early-phase clinical development, with expertise in cell and gene therapy, and has successfully delivered multiple groundbreaking cell therapy projects.
To further bolster CGT research, SDM’s Amador (Hangzhou) laboratory offers advanced technical capabilities and an experienced team. Core services include:
- Flow Cytometry: For immunophenotyping, receptor occupancy, and more.
- Functional Cell Assays: Including cytokine release syndrome risk assessment, neutralizing antibody detection, and ADCC/CDC analysis.
- Pharmacodynamic Biomarker Detection: Providing crucial insights into mechanisms of action.
The lab supports over 100 bioanalysis projects annually, delivering reliable data for PK and immunogenicity studies of cell-based therapies.
Moving forward, SDM remains committed to offering tailored global development strategies and looks forward to collaborating with industry partners to advance clinical trials worldwide.
KY-0301 is the world's first nano-dual-anti-ADC developed by Novatim based on its own innovative nano-dual-anti-ADC platform “TPEBEN”.
Beijing Shouyan Lab is certified by NGSP in the United States.
Provide diverse and better treatment options for patients worldwide.
At the intersection of the end of the year, we sincerely invite you to join us in focusing on the shining points of the year, and to look back together and cherish the bright moments that have illuminated our way forward in the past year.
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On the way to further explore and promote the professional development of medical clinical trials, SDM and Tonghua Dongbao jointly successfully held a nine-month "Diabetes Professional CRA Series course".
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KY-001 is an oral small-molecule inhibitor targeting the YAP/TAZ-TEAD interaction in the Hippo pathway with a proposed indication for advanced solid tumors driven by Hippo dysregulation.
Dr. Wang delivered a keynote presentation titled "The Power of Quantitative Pharmacology: Critical Insights from Landmark Clinical Development and Regulatory Cases," providing an in-depth analysis of the central role of quantitative pharmacology across the entire clinical development lifecycle of investigational drugs.
The seminar attracted representatives from nearly 30 pharmaceutical companies in the Sichuan-Chongqing region, injecting new momentum into the regional biopharmaceutical innovation ecosystem.
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Beijing, October 14, 2025 – SDM, a one-stop clinical development CRO, today announced that Dr. Weishihu has joined the company as Deputy General Manager of Medical and Pharmacovigilance for the Early Clinical Business Unit. He will be fully responsible for developing and managing the company's early clinical development medical strategies and pharmacovigilance systems.
SDM Bioservices, serving as Jing Medicine’s regulatory strategy partner, played a pivotal role in the successful FDA application process. Leveraging deep expertise in global regulatory affairs, SDM delivered comprehensive GAP analysis, technical document preparation, and submission management services. SDM also supported Jing Medicine’s IND application in China, establishing a robust foundation for the program’s global development strategy.
The High-Quality Development Seminar on the Greater Bay Area's Cell and Gene Industry concluded successfully on November 21st! Stem Pharm comprehensively demonstrated its integrated service capabilities and cutting-edge layout in the field of cell and gene therapy during the seminar. Multiple senior executives of Stem Pharm attended the event, joining hands with industry partners to explore the coordinated development of cell and gene therapy (CGT) in the Greater Bay Area.
As BaoPharm's strategic regulatory partner, SDM Bioservices' global registration team delivered comprehensive support for this project, including gap analysis, technical dossier compilation, and submission management services.
As a clinical development pioneer with twenty years of China-focused expertise, SDM Bioservices provides comprehensive clinical research solutions to pharmaceutical partners worldwide. Our integrated capabilities include proven regulatory submission experience across China, U.S. and EU markets, innovative early-phase development approaches, reliable bioanalytical services, and demonstrated expertise in managing large-scale clinical trials for therapeutic drugs, and specialized knowledge in vaccines and medical aesthetics.
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