14 March 2022 | News
NMPA clears IND for First T-Cell Receptor (TCR) T Cell Therapy to treat Hepatitis B virus (HBV) associated hepatocellular carcinoma (HCC)
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Singapore-based SCG Cell Therapy Pte Ltd, a leading biotechnology company, announced that the China National Medical Products Administration (NMPA) has cleared its Investigational New Drug (IND) application for SCG101, the company's first T-cell receptor T-cell therapy targeted hepatitis B viral antigens. SCG101 is the first TCR-T cell therapy approved by the NMPA for the treatment of hepatocellular carcinoma.
"NMPA's clearance of our IND application for SCG101 is an important milestone for our cell therapy program as it marks the first TCR-T product candidate to advance from our pipeline of therapies geared to treat unmet needs in major cancer indications" said Frank Wang Shuli, Chief Executive Officer of SCG Cell Therapy.
SCG101 is an autologous TCR-T cell therapy targeting specific hepatitis B virus (HBV) epitopes. During HBV infection, integration of HBV DNA into the genome of hepatocytes occurs commonly, which causes damages to the integrated hepatocyte genome and leads to the occurrence of HCC. SCG101 can redirect T cells to target HBV epitopes expressed on the cell surface and become a new therapeutic strategy for HBV-associated HCC.
Hepatitis B virus (HBV) infection is the major cause of hepatocellular carcinoma (HCC) in more than 80% of the Asian population.
About 120 million people in China have hepatitis B, or one in twelve people carries the hepatitis B virus (HBV). Hepatocellular carcinoma caused by viral hepatitis B (HBV) infection accounts for 83.77% of the estimated 466,000 new cases of liver cancer in China each year.