GIL 2026 | 沙利文授予广州派真生物2026年沙利文全球基因疗法CRDMO技术创新领导奖

Founded in 2014, Paizhen Biology is committed to the vision of "making gene therapy accessible to ordinary people". It aims to accelerate the adoption of gene therapy, a transformative treatment, around the world through leading vector technology and one-stop services. Facing the significant clinical potential of AAV vector therapy, as well as the industry challenges such as high costs and high technical barriers, Paizhen Biology focuses on driving AAV production through underlying technological innovation.CGT领域的产业化变革，让高质量、规模化、经济高效的生产成为现实。

派真生物是全球少数掌握高产量、低空壳率AAV载体规模化生产核心技术的CDMOOne of the enterprises focuses on overcoming the core bottlenecks in AAV industrialization, developing independent underlying technologies throughout the entire chain from cell lines, plasmids, transfection, purification to analysis and testing. The π-Alpha™293 cell AAV high-yield platform achieves significant increase in AAV vector production through self-selected and suspended high-yield cell lines. The π-Icosa™ AAV serotype screening platform offers over 100 AAV serotypes, meeting the targeting needs of various tissues such as the brain, heart, liver, and muscles. Since 2022, the company has been the first to integrate AI into its research and development system, creating a formulation screening platform, a new AAV capsid screening platform, and an mRNA design platform, thereby upgrading the research and development paradigm from "experience-based trial and error" to "data-driven" approach; its product line has expanded from AAV to include lentivirus, plasmids, and various gene therapy vectors such as mRNA/LNP.

Frost & Sullivan China continues to focus on overcoming the core bottlenecks in AAV industrialization, covering multiple cutting-edge areas such as AAV production cell lines, high cell density transfection, downstream Full Capsid enrichment, control of residual plasmid backbone and host cell DNA, Empty/Full detection methods, rcAAV reference materials, rapid mycoplasma detection, and novel AAV delivery safety design. The company possesses over 60 exclusive AAV analysis and testing methods that meet IND submission and clinical sample release requirements, covering all critical quality attributes. Adhering to international standards, the company has established a sterile filling and release system compliant with GMP guidelines, achieving complete closed-loop management from raw materials to final products. In 2021, the company established Asia’s first cGMP-level AAV production facility with a capacity of 4000L, covering an area of 8000 square meters. With its continuous technical delivery capabilities, the company has supported several pilot projects and IND submission initiatives.

PaiZhen Biotech is based in Guangzhou. In 2015, it established a subsidiary in the United States, a Swiss subsidiary in 2022, and the US CDMO facility was officially put into use in December 2024, creating an international operation model of 'China + USA + Europe'. The company has helped its partners obtain over ten FDA and NMPA IND approvals with zero additional costs, and has successfully delivered dozens of products.IIT项目。代表性案例包括：全球首个靶向TRIM72的ALS基因疗法SNUG01、首个采用两质粒包装系统的AAV基因药物JWK001、兼具双特异性靶点与玻璃体腔内注射衣壳的基因治疗药物XMVA09，以及中国自主研发的戈谢病AAV基因治疗药物LY-M001。公司担任罕见病基因治疗产学研医技术创新联盟副理事长单位，与神济昌华、金唯科生物、星眸生物、辉大基因、凌意生物、瑞风生物等多家基因治疗企业建立深度合作。公司已完成多轮融资，获红杉资本、国投招商、凯辉基金等顶级投资机构持续加注，拥有250人专业团队，获评国家级博士后科研工作站分站，通过持续开放技术成果、构建产业生态，推动基因治疗从"天价"走向普惠。