NMPA Clears IND for First T-Cell Receptor (TCR) T Cell Therapy to Treat Hepatitis B virus (HBV) associated hepatocellular carcinoma (HCC)

SINGAPORE,March 11,2022 -- Singapore-based SCG Cell Therapy Pte Ltd ("SCG"),a leading biotechnology company,today 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'sclearance 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.[1]

About SCG101

SCG101,an autologous T-cell receptor (TCR) T cell therapy targeting specific hepatitis B virus (HBV) epitopes,is a potential novel treatment for HBV-related hepatocellular carcinoma (HCC). HCC is the most common type of liver cancer. In Asia,HBV accounts for more than 80% of virus-associated HCC cases. HCC is typically diagnosed late in its course and is associated with the poor prognosis. Preliminary data indicates that SCG101 is a novel TCR-T therapy against HBV-related HCC. SCG101 currently being investigated in clinical trials.

About Liver Cancer

Hepatocellular carcinoma (HCC) is the most common form of primary liver cancer,which is the sixth most frequently diagnosed cancer worldwide. It is estimated there were more than 905,000 new cases of liver cancer and more than 830,100 deaths from the disease globally in 2020,making it one of the leading causes of cancer deaths around the world. Between 80-90% of all patients with HCC also have cirrhosis,which is primarily caused by infection with the hepatitis B or C viruses. Chronic liver diseases are associated with inflammation that,over time,results in immunosuppression and can lead to the development of HCC. Hepatocellular carcinoma,which is often diagnosed at an advanced stage,has a five-year survival rate of less than 15%.

About SCG Cell Therapy

SCG is a leading biotechnology company focusing on the development of novel immunotherapies in infections and its associated cancers. The company targets the most common cancer-causing infections: helicobacter pylori,human papillomavirus,and hepatitis B,and develops a broad and unique pipeline of T cell therapies,antibodies,and therapeutic vaccines against infections and to prevent and cure its associated cancers. Established and headquartered in Singapore,SCG combines regional advantages in Singapore,China and Germany,covering the entire value chain from innovative drug research and discovery,manufacturing,clinical development and commercialization. SCG collaborates with leading scientists and researchers to bring first-in-class and best-in-class medical products/technologies to enhance innovation in medical product development. For more information about SCG,please visit us at www.scgcell.com.

[1] http://t.10jqka.com.cn/pid_208168622.shtml