May 20, 2026– Porton Advanced proudly announces 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). The approval enables clinical studies in patients with advanced solid tumors in China, marking a significant achievement: YB1-X7 has now successfully obtained IND clearance in both the United States and China, opening a new chapter in global clinical development.
This milestone not only recognizes Salvectors’ proprietary synthetic biology platform but also validates the strong collaboration between our two teams. From the U.S. to China, Porton Advanced’s global, end-to-end CDMO platform has consistently provided a solid foundation for the China-US dual filing strategy of innovative drugs.
As the exclusive CDMO partner for the project, Porton Advanced provided comprehensive 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.
We have extensive experience in live bacterial therapeutics, including Gram-negative and Gram-positive bacteria, as well as aerobic and anaerobic bacteria. Salvectors' strong integration of synthetic biology technology platforms, along with its exceptional research and development and operational capabilities, played a key role in achieving this milestone. We believe YB1-X7 will achieve further positive clinical outcomes and bring meaningful innovation and change to the field of oncology.
Shaoxing Salvectors Biotechnology Ltd.(former name:Shanghai 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.
Founded in 2022 by Dr. Bin Yu, the company has obtsined IND approvals from the U.S. FDA for its first-in-class product, YB1-X7, and has launched IIT (Investigator-Initiated Trial) clinical trials for a variety of malignant solid tumors in China.
Porton Advanced Solutions is a subsidiary of the leading CDMO, Porton Pharma Solutions. Porton Advanced has headquarters in Cranbury, New Jersey, and two GMP sites in Suzhou, China, providing end-to-end CDMO solutions for ATMPs. 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, Investigator-initiated Clinical Trial Services (IITs), and Investigational New Drug (IND) applications to clinical trials, New Drug Applications (NDA), and commercialization.
Porton Advanced has developed specialized CRO and CDMO platforms focusing on plasmids, viral vectors (lentiviral vector, adenoviral vector, AAV, etc.), cell therapy CMC services including CAR-T, TCR-T, CAR-NK, HSC, exosome, etc., bacterial vector and nucleic acid therapies. Our state-of-the-art, GMP-compliant facilities span an impressive 215,000 sq ft, equipped with 10 viral vector GMP-compliant production lines, 12 cell therapy GMP-compliant production suites (2 for commercial products) and a multitude of cleanrooms. As of now, we have successfully supported our clients to secure 25 global IND approvals from NMPA, FDA, and Medsafe, with 12 ongoing Phase I/II ATMP projects. Additionally, Porton Advanced has supported the successful transition of several overseas clinical-stage pipelines into China.
Porton Advanced is committed to a customer-centric approach, offering excellent global, end-to-end CDMO services to our clients, enabling earlier access to good medicines
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