February 2, 2026
Source: drugdu
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On January 29, 2026, PotentiaBiotech supported CSPC Group in obtaining implied approval for clinical trials from the National Medical Products Administration (NMPA) for its independently developed SYS6055 Injection, with the application acceptance number: CXSL2500947. This marks China’s first in vivo CAR-T therapy to receive clinical trial approval, indicated for relapsed/refractory aggressive B-cell lymphoma. PotentiaBiotech extends its warm congratulations on this milestone achievement!
Picture 1: From the Wechat Public Account “PotentiaBiotech”
About CSPC Group
CSPC Holding Group Co., Ltd. was established in 1997. Guided by its long-standing philosophy of "Developing Quality Medicines for China and Benefiting People Worldwide", the company has sustained double-digit growth in its core operating indicators for many years through innovation-driven development. It has now grown into an international innovation-oriented enterprise with 28,000 employees. Its listed subsidiary on the Hong Kong Stock Exchange (01093.HK) is a constituent stock of the Hang Seng Index, and ranks 19th globally in the ranking of pharmaceutical companies by R&D pipeline scale, standing as a representative Chinese pharmaceutical enterprise that serves patients worldwide.
About PotentiaBiotech
Suzhou PotentiaBiotech Pharmaceutical Co., Ltd. was founded in December 2018. Headquartered in Suzhou and backed by its listed parent company Porton Group (Stock Code: 300363), PotentiaBiotech provides global customers with one-stop, full-lifecycle service solutions for gene and cell therapy products, spanning from preclinical research to marketing authorization.
PotentiaBiotech has established CRO and CDMO platforms covering plasmids, viral vectors, cell therapies, gene therapies, nucleic acid therapeutics and other modalities. It owns R&D and manufacturing facilities with a total area of over 20,000 m² (215,278 sq ft), 10 viral vector production lines, 12 GMP-compliant cell therapy production lines (including 2 commercial manufacturing suites), as well as hundreds of cleanrooms. To date, PotentiaBiotech has supported customers in obtaining 24 clinical approvals worldwide, covering jurisdictions including China, the United States, and New Zealand. It has 11 projects in Phase I/II clinical trials and commercial process change stages, and has successfully supported the transfer of multiple overseas projects to China.
The localization rate of raw materials for PotentiaBiotech’s viral platform processes exceeds 96%, which effectively reduces costs while ensuring supply chain security. To date, PotentiaBiotech has delivered multiple batches of in vivo CAR-T products to global customers, with viral final product titers reaching 1E+9 TU/mL and batch yields reaching the 1E+12 TU level. Leveraging its end-to-end CDMO platform, PotentiaBiotech provides partners with full-process services ranging from plasmid construction and lentivirus production to CAR-T cell manufacturing, covering both ex vivo CAR-T and in vivo CAR-T therapies. It supports the development and manufacturing of a diverse range of CGT products, including gene-edited products, viral vectors, and cellular products.
We are committed to a customer-centric approach, delivering exceptional global, end-to-end CDMO services to bring high-quality medicines to patients sooner.
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