#Singapore #SCG101 #SCG Cell Therapy #Hepatitis B

SCG Cell Therapy Announces Groundbreaking Approval in China

SCG Cell Therapy Pte Ltd, a pioneering biotechnology firm, has made headlines with its recent announcement that the China National Medical Products Administration (NMPA) has cleared its Investigational New Drug (IND) application for SCG101V. This marks a notable milestone as SCG101V becomes the first investigational cell therapy approved to enter a Phase 1/2 clinical trial specifically for chronic hepatitis B virus (HBV) infection.

SCG101V is a transformative therapy designed to cure chronic hepatitis B by targeting and eliminating the notorious HBV covalently closed circular DNA (cccDNA) and HBV-DNA integration that resides within the infected liver cells. These infected hepatocytes are responsible for sustaining the long-term infection and producing antigens that current antiviral treatments fail to eradicate. Professor Ulrike Protzer, the Scientific Founder of SCG and Director of the Institute of Virology at the Technical University of Munich, emphasized the innovation behind SCG101, highlighting its ability to mimic the immune response seen in individuals who spontaneously clear HBV infections.

The Phase 1 clinical trial involving SCG101 has shown promising results, demonstrating a commendable safety profile while maintaining the clearance of hepatitis B surface antigen (HBsAg) for patients suffering from HBV-related hepatocellular carcinoma (HCC). Remarkably, among participants who had previously received multiple treatments, 94% had undergone nucleoside analogue antiviral therapy, and 72% presented with liver cirrhosis. Post-administration of SCG101, patients reported a swift decrease in HBsAg levels, with 94% experiencing a 1.0–4.6 log₁₀ reduction within 28 days, sustaining HBsAg levels below 100 IU/mL for up to a year. Furthermore, 23% managed to achieve complete loss of HBsAg, a significant milestone indicating a potential cure.

Professor Niu Jinqi from The First Hospital of Jilin University remarked on SCG101's potential, stating that it has shown significant breakthroughs in managing HBV-related liver cancer and offers exciting prospects for millions battling chronic hepatitis B. The new IND approval marks a pioneering advancement toward a functional cure for this widespread viral infection. Chronic HBV infection affects approximately 300 million individuals worldwide, escalating the risk of liver cirrhosis and cancer, leading to over 820,000 fatalities annually.

Christy Ma, the Chief Executive Officer of SCG Cell Therapy, expressed pride in this IND clearance, emphasizing its significance not only for SCG but for the healthcare sector's approach to hepatitis B treatment. With indications covering HBV-related cancers and chronic hepatitis B, SCG101 is positioned as the first cell therapy product to gain regulatory approval for Phase 1/2 clinical trials, solidifying SCG's leading role in the quest for a long-term functional cure. SCG is now on track to commence pivotal studies following the successful completion of its Phase 1 study in patients with HBV-HCC.

About SCG101

SCG101 is an innovative autologous T cell receptor (TCR) therapy aimed at specifically targeting the hepatitis B surface antigen. Utilizing SCG’s proprietary GianTCR™ screening platform, SCG101 demonstrates the targeted immune-mediated clearance of infected and malignant cells.

Understanding HBV

Hepatitis B is a serious liver infection induced by the hepatitis B virus, often leading to chronic infections that significantly raise the risk of cirrhosis and liver cancer. This infection remains a major health challenge worldwide, with 300 million people affected and over a million deaths occurring annually, despite existing vaccines and treatments.

About SCG Cell Therapy

SCG Cell Therapy is at the forefront of biotechnology, focusing on revolutionary immunotherapies for infectious diseases and associated cancers. With its headquarters in Singapore, SCG is expanding its operations across China and Germany, leveraging regional capabilities to drive innovation from drug research to commercial development.