China Biopharmaceutical (01177): IM-101 injection “preS1 recombinant fusion protein” clinical trial application approved by NMPA

Zhitong Finance App News, China Biopharmaceutical (01177) announced that the IM-101 innovative drug IM-101 injection “preS1 recombinant fusion protein” developed by Zhengda Tianqing Pharmaceutical Group Co., Ltd. (Zhengda Tianqing), a subsidiary of the Group, has obtained clinical trial approval from the China National Drug Administration (NMPA) to treat chronic hepatitis B (CHB).

IM-101 is an innovative recombinant fusion protein targeting Pres1, which has the potential to disrupt immune tolerance and rebuild the immune response specific to chronic hepatitis B virus (HBV). Pres1 is an important component of HBV large surface protein. It mediates virus adsorption and invasion by binding to sodium taurine co-transport polypeptide (NTCP) receptors on the surface of hepatocytes. IM-101 has the potential to induce multiple immune effects: at the level of humoral immunity, preS1-specific antibodies can directly neutralize viral particles, block their binding to NTCP receptors, prevent the virus from entering hepatocytes, and reduce HBV reinfection and supplementation of hepatic viral replication templates; at the cellular immune level, IM-101 can activate HBV-specific T-cell responses, and eliminate viral reservoirs through the dual pathways of cellular killing and non-cellular killing to eliminate viral reservoirs.

CHB is a major public health issue facing the world. There are about 290 million people infected with chronic HBV in the world, of which there are about 75 million cases in China. If standardized antiviral treatment is not received in a timely manner, CHB has a higher risk of progression to cirrhosis, liver failure, and even hepatocellular carcinoma.

Currently, CHB treatment mainly relies on two main types of drugs: nucleogane (acid) analogues (NAs) and interferons. NAS can effectively inhibit HbV DNA replication, but its hepatitis B surface anti-bacterial (HBsAg) clearance rate is only 0-3%, and the recurrence rate is high after discontinuation of the drug. Most patients require long-term or even lifelong treatment. Interferons have both direct antiviral and immunomodulatory effects, yet there are significant individual differences in clinical response. The negative rate of HBsAg in the overall population with monotherapy is only 3%-7%. Functional cure means that serum HBsAg and HBV DNA continue to fall below the lower detection limit after discontinuation of a limited course of treatment. Its core is to restore the body's long-term immune control over HBV, thereby reducing the risk of terminal liver diseases such as cirrhosis and liver cancer.

As a leading company in the field of liver disease in China, the Group focuses on core fields such as functional treatment of hepatitis B, hepatitis B virus suppression, and steatohepatitis (MASH). Many new drugs under development have entered the clinical stage: ranilano (pan-PPAR agonist) is undergoing phase III clinical trials globally, and TQA3605 (HBV core protein modulator) has obtained CDE's approval to carry out phase III clinical trials. Both TQ-A3334 (TLR-7 agonist) and Kylo-0603 (THR-beta agonist) are in phase III clinical trials. Furthermore, the Group has reached a strategic cooperation with GSK to jointly accelerate the marketing process of Bepirovirsen in China. The drug has submitted a marketing application in China and has been included in the priority review and approval process. It is expected to become the world's first novel functional cure for hepatitis B approved for marketing. IM-101 further enriches the Group's pipeline layout in the field of active immunotherapy. The Group will continue to explore single drug and combination treatment strategies with different mechanisms to provide diversified treatment options for a wider range of patients with liver disease.