Qilu Pharmaceutical Submits Clinical Trial Application in China for Hepatitis B RNAi Therapy AB-729 Injection

Today (May 10), the CDE website announced that Arbutus Biopharma and Qilu Pharmaceutical Co., Ltd. jointly submitted a clinical trial application for AB-729 injection, which has been accepted. Public information shows that AB-729 is an RNAi drug developed by Arbutus for the treatment or prevention of hepatitis B, and Qilu Pharmaceutical holds the rights in China.

Chronic hepatitis B is a potentially life-threatening liver infection caused by the chronic hepatitis B virus (HBV), which can lead to cirrhosis and liver cancer. The difficulty in curing chronic hepatitis B lies not only in the replication of HBV within the body but also in the large amount of viral proteins that suppress the human immune response, preventing immune cells from controlling viral replication. Therefore, reducing the expression of viral proteins is necessary to reinvigorate the function of immune cells.

RNA Interference (RNAi) is a mechanism present in living cells that suppresses the expression of specific genes, thereby affecting the production of specific proteins. AB-729 is an RNAi drug targeting hepatocytes, utilizing a novel covalently conjugated N-acetylgalactosamine (GalNAc) delivery technology developed by Arbutus Biopharma, and can be administered via subcutaneous injection. In preclinical models, AB-729 has been shown to inhibit HBV viral replication, reduce all viral RNA transcripts, and lower all HBV antigens, including hepatitis B surface antigen (HBsAg), demonstrating pan-genotypic activity across all HBV genotypes.

In December 2021, Qilu Pharmaceutical Co., Ltd. entered into an exclusive licensing agreement and strategic collaboration with Arbutus Biopharma Corp. for the development and commercialization of the candidate drug in Greater China (including mainland China, Hong Kong, Macao, and Taiwan regions). This collaboration includes upfront and milestone payments of up to 285 million US dollars.