Milestone Event -- SalMet-Vec®, an oncolytic bacteria drug developed by Sinogen Pharmaceutical approved by China NMPA to officially enter clinical trials
On September 6, 2023, Guangzhou Sinogen Pharmaceutical Co., Ltd. (referred to as Sinogen Pharmaceutical) announced that the oncolytic bacteria drug for the treatment of advanced solid tumors -- SalMet-Vec® (SGN1 injection) which is independently developed by the company has passed the review of Investigational New Drug Application (IND) by China National Medical Products Administration (NMPA), and has been approved to officially enter two clinical trials of intravenous administration and intratumoral administration in Chinese Mainland.
Dr. Allan Zijian Zhao, Chairman and CEO of Sinogen Pharmaceutical, said, "The oncolytic bacteria drug SalMet-Vec® (SGN1 injection) developed by Sinogen Pharmaceuticals has been officially approved by the Center for Drug Evaluation (CDE) to enter two clinical trials, which is a significant milestone in the company's development. On the one hand, this is CDE's recognition of Sinogen Pharmaceutical's preliminary work, and on the other hand, it also puts forward corresponding requirements for our future clinical trials. Sinogen Pharmaceutical will take this opportunity to rapidly deploy and accelerate the progress of global multicenter clinical trials (MRCT) on malignant tumor indications that currently lack effective treatment methods.”
About Oncolytic Bacteria Product SalMet-Vec®
Oncolytic bacteria product SalMet-Vec® is a first-in-class genetic engineering biological product that can accurately target and rapidly dissolve tumors. SalMet-Vec® carries specific methionine hydrolase through attenuated Salmonella carrier, depriving the necessary amino acids required for tumor growth, thus killing tumor and preventing tumor proliferation. It is an efficient and tumor-targeting product for broad-spectrum solid tumors. Sinogen Pharmaceutical owns the complete global intellectual property rights of SalMet-Vec®, and it has more than 50 invention patents worldwide and has been authorized for 22.
Up to now, Sinogen Pharmaceutical has successfully obtained the Investigational New Drug Application (IND) permission from China NMPA, US FDA and Taiwan TFDA, and it is conducting phase I/IIa registered clinical trials of intravenous administration and intratumoral administration of SalMet-Vec® in multiple clinical trial centers in the US and Taiwan, China. The clinical trials recruited patients with liver cancer, osteosarcoma, lung cancer, head and neck cancer, prostate cancer, breast cancer, melanoma and other advanced malignant solid tumors. In order to accelerate its progress and review process in the United States, the FDA has granted three Orphan Drug Designations to the oncolytic bacteria drug SalMet-Vec®.
About Sinogen Pharmaceutical
Sinogen Pharmaceuticals is a biopharmaceutical company jointly founded by four national high-level talents and experts, dedicated to the development of innovative biological anti-tumor drugs to meet the global demand for malignant tumor treatment market. Through the joint efforts of dozens of scientific researchers, Sinogen Pharmaceutical has gradually established the world's first rapid broad-spectrum oncolytic bacteria technology platform and completed preclinical research, CMC production process development, and the construction of large-scale production facilities that comply with GMP standards on its core oncolytic bacteria product SalMet-Vec®.
