Sino Biopharmaceutical Limited (HKEX: 01177) has announced that its subsidiary, Chia Tai Tianqing Pharmaceutical Group Co., Ltd., has received approval from the National Medical Products Administration (NMPA) to conduct clinical trials for its Class 1 innovative drug, IM-101 injection ("PreS1 Recombinant Fusion Protein"). The drug is intended for the treatment of chronic hepatitis B (CHB).

IM-101 is a novel recombinant fusion protein targeting PreS1, with the potential to break immune tolerance and rebuild the specific immune response to the hepatitis B virus (HBV). PreS1 is a key component of the HBV large surface protein, mediating virus adsorption and invasion by binding to the sodium taurocholate co-transporting polypeptide (NTCP) receptor on hepatocytes.

IM-101 has the potential to induce multiple immune effects. At the humoral immunity level, PreS1-specific antibodies can directly neutralize virus particles, block their binding to the NTCP receptor, prevent viral entry into liver cells, and reduce HBV reinfection and the replenishment of intrahepatic viral replication templates. At the cellular immunity level, IM-101 can activate HBV-specific T-cell responses, clearing virus-infected hepatocytes through both cytotoxic and non-cytotoxic pathways, thereby reducing the viral reservoir. This provides a key therapeutic strategy for achieving a functional cure for CHB.

Chronic hepatitis B represents a major global public health challenge. There are approximately 290 million people worldwide living with chronic HBV infection, with about 75 million cases in China. Without timely and standardized antiviral treatment, CHB carries a high risk of progressing to cirrhosis, liver failure, and hepatocellular carcinoma.

Current CHB treatment primarily relies on two major drug classes: nucleos(t)ide analogues (NAs) and interferons. While NAs can effectively suppress HBV DNA replication, their hepatitis B surface antigen (HBsAg) clearance rate is only 0-3%, and the relapse rate after discontinuation is high, meaning most patients require long-term or even lifelong treatment. Interferons possess both direct antiviral and immunomodulatory effects; however, clinical responses show significant individual variation, with a monotherapy HBsAg seroclearance rate of only 3%-7% in the overall population.

Functional cure is defined as sustained serum HBsAg and HBV DNA levels below the lower limit of detection after a finite course of treatment. Its core lies in restoring the body's long-term immune control over HBV, thereby reducing the risk of end-stage liver diseases such as cirrhosis and liver cancer.

As a leader in China's liver disease field, the Group focuses on core areas including functional cure for hepatitis B, HBV suppression, and metabolic dysfunction-associated steatohepatitis (MASH). Several investigational innovative drugs have entered clinical stages: Lanifibranor (a pan-PPAR agonist) is in global Phase III trials; TQA3605 (an HBV core protein allosteric modulator) has received CDE approval to proceed to Phase III trials; and TQ-A3334 (a TLR-7 agonist) and Kylo-0603 (a THR-β agonist) are both in Phase II trials.

Furthermore, the Group has entered a strategic collaboration with GSK to accelerate the launch of bepirovirsen in China. The drug has already submitted a marketing application in China and has been included in the priority review and approval process, with the potential to become the world's first new drug approved for the functional cure of hepatitis B.

The approval for IM-101 further enriches the Group's pipeline in the field of active immunotherapy. The Group will continue to explore monotherapy and combination therapy strategies involving drugs with different mechanisms of action, aiming to provide diverse treatment options for a broader range of liver disease patients.