Guangzhou Sinogen Pharmaceutical announced that the FDA has granted Orphan Drug Designation(ODD) to oncolytic bacteria product SalMet-Vec® again.
On December 14, 2022 US time, the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to oncolytic bacteria drug SalMet-Vec ®, the core product of Sinogen Pharmaceutical, for the treatment of hepatocellular carcinoma(HCC). This is the second time that SalMet-Vec® has been granted ODD after receiving ODD for the treatment of osteosarcoma last month.
Liver cancer is one of the most common and high mortality cancers in the world. Hepatocellular carcinoma (HCC) is the most common type of primary liver cancer, which is characterized by insidious onset, easy metastasis and recurrence, and poor prognosis. In China, the incidence rate and mortality of liver cancer are also among the top among malignant tumors. In 2020, China has had 410,038 new cases of liver cancer, accounting for 9% of all new cancer cases. Moreover, most of the patients with liver cancer were in the middle and late stage when they were diagnosed, and the treatment methods such as surgery could not effectively control the disease progression, so the overall five-year survival rate of liver cancer was only 12.5%. Therefore, finding more effective treatment methods to improve the survival rate of patients with liver cancer, especially those with advanced liver cancer, is one of the tough problems to be solved urgently.
About Orphan Disease
Orphan disease is a rare disease. The FDA's Office of Orphan Products Development grants orphan status to drugs intended for the safe and effective treatment, diagnosis or prevention of rare diseases or conditions affecting fewer than 200,000 people in the United States. ODD is designed to provide drug developers with various benefits to support the development of novel drugs, including market exclusivity for seven years upon FDA approval, eligibility for a 25% federal tax credits for qualified clinical trials, waiver of marketing registration application fees, reduced annual product fees, clinical protocol assistance and qualification for expedited development programs.
About Oncolytic Bacteria Product SGN1About 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 20.
At present, Sinogen Pharmaceutical has successfully obtained the new drug clinical trial application (IND) license from the US FDA and Taiwan TFDA, and has successively started the clinical trial of intravenous administration and intratumoral administration of oncolytic
