On November 14, 2024, Shanxi Naan Biotechnology Co., Ltd. announced that its proprietary ADC T320 received clinical trial access from the Therapeutic Goods Administration (TGA) of Australia. As the CDMO partner for the T320 program, MabPlex congratulates Shanxi Naan on this exciting achievement.
MabPlex provided one-stop service for the T320 project from RCB to IND filing, including development for the antibody intermediate, conjugation, and analytical methods. MabPlex also executed cGMP production and stability in support of this program. Coordinating seamlessly with the Client, MabPlex completed delivery of toxicology samples in only 6 months.
T320 is the 23rd ADC program carried from sequence to IND by the MabPlex team, and has demonstrated significant tumor inhibition in preclinical studies, targeting a variety of solid tumors including cervical, lung, and pancreatic cancers. In animal model trials of pancreatic cancer, T320 demonstrated a tumor inhibition rate of more than 80%. T320 received Orphan Drug Designation from the FDA for the treatment of pancreatic cancer on May 30 this year and will be submitted for IND with the Center for officially submitted the IND application to the Center for Drug Evaluation (CDE) of the NMPA, and the FDA.
Dr. Qu Zhican, Chair of Shanxi Naan Biotech, said: “Thank you to the MabPlex team for their support and dedication to this project! MabPlex’s efficient, thorough, and compliant services were instrumental to this successful filing with the TGA. We are striving to advance the T320 clinical program, and hope to benefit more cancer patients as soon as possible.”
Dr. Xinfang Li, CEO of MabPlex, said, “We are very honored to provide comprehensive, one-stop CDMO services for Shanxi Naan and the T320 program, facilitating the development of novel oncology drugs. With a professional R&D, production, and quality management team, MabPlex is committed to providing high-quality, customized CDMO services for global biopharmaceutical companies. We wish the T320 program success in the clinic, to address the treatment of some of the most aggressive cancers.”
In response to the call for economic transformation of China and Shanxi Province, Shanxi Naan Biotech has launched a national high-tech enterprise integrating product research and development, technology output, production, and sales with independent IP biotechnology and start-up capital. At present, a number of new biological drugs with significant clinical value have been created for a variety of solid tumors and other diseases.
MabPlex is a CDMO company focused on providing professional, customized, and integrated CDMO services for antibodies, antibody drug conjugates, recombinant proteins, and other biologic drugs. MabPlex is one of the few organizations in the world that can provide comprehensive services across the clinical production of antibody drug conjugates. At present, over one hundred submissions across a wide variety of large-molecule biologics have been successfully completed. With 10+ years of focus on antibody-drug conjugates, a mature technology platform, and an average of 20+ years across CMC team leadership, MabPlex has collaborated with biopharmaceutical companies in China, the United States, Europe, Korea, India, Australia, et al.
