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China-US Dual Filing Success: Porton Advanced's End-to-End Bacterial Vector CDMO Solution Accelerates NMPA Approval of Salvectors' Innovative Oncolytic Bacteria Therapy
SUZHOU, China and CRANBURY, N.J., May 28, 2026 /PRNewswire/ -- Porton Advanced, a leading cell and gene therapy CDMO, recently announced its client Salvectors has received Investigational New Drug (IND) clearance for their proprietary and innovative oncolytic bacteria therapy, "YB1-X7 Injection," from the Center for Drug Evaluation of China's National Medical Products Administration (NMPA). YB1-X7 has now successfully obtained IND clearance in both the United States and China, marking the beginning of a new chapter in global clinical development.
As the exclusive CDMO partner for the project, Porton Advanced provided comprehensive bacteria CMC services, including strain construction, process development, GMP production, quality studies, release testing, and regulatory submission support. Utilizing integrated production process, Porton Advanced ensured the stability, activity, and safety of the samples. Leveraging its robust testing capabilities, Porton Advanced facilitated thorough purity testing and quality control for the product. Additionally, an innovative purification method was employed to effectively remove process-related impurities while maintaining high product recovery rates and strain viability.
Porton Advanced has extensive experience in bacterial therapeutics, including Gram-negative and Gram-positive bacteria, as well as aerobic and anaerobic bacteria. Our integrated CDMO offerings range from microbial banking, aseptic filling to finishing of injectables. Porton Advanced also provides a full-service IIT and IND platform in collaboration with leading CRO partners, enabling global clients to accelerate the translation of research into clinical use.
About Salvectors
Shaoxing Salvectors Biotechnology Ltd. is a biotechnology company committed to developing new drugs for solid tumors using its drug delivery platform based on the YB1-v3.0 Salmonella bacteria as a carrier.
About Porton Advanced
Porton Advanced Solutions is a subsidiary of the leading CDMO, Porton Pharma Solutions. Porton Advanced has dual-headquarters in Cranbury, New Jersey, and Suzhou, China, providing end-to-end CDMO solutions for ATMPs including plasmids, viral vectors, cell therapy and nucleic acid therapies. We offer services from cell banking, process, and analytical method development, cGMP production to fill & finish, covering different stages of drug development from early research, IITs, Investigational New Drug (IND) applications, clinical trials, New Drug Applications (NDA), to commercialization. Our state-of-the-art, GMP-compliant facilities span an impressive 215,000 sq ft, equipped with 10 viral vector production lines, 12 cell therapy production suites and a multitude of clean rooms.
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