On September 15, the CDE official website announced that Hengrui Medicine's new generation of liver-targeted hepatitis B virus siRNA drug HRS-5635 injection is planned to be included in the breakthrough therapy variety for the treatment of chronic hepatitis B.

Chronic hepatitis B (CHB) is a chronic inflammatory liver disease caused by persistent infection with the hepatitis B virus (HBV). According to the World Health Organization, 254 million people worldwide were living with chronic HBV infection in 2022, with approximately 1.2 million new infections. In China, a major country with a high incidence of CHB, epidemiological data from 2020 estimated that there were approximately 75 million HBV carriers, of whom approximately 30 million were infected but unaware. Of those diagnosed, 17 million required antiviral treatment, but only 3 million received it.

In addition, HBV infection significantly increases the risk of developing cirrhosis and liver cancer. The proportion of cirrhosis and liver cancer caused by HBV in Chinese patients is as high as 77% and 84%, respectively.

Functional cure, as the ideal treatment goal for chronic hepatitis B, aims to eliminate hepatitis B surface antigen (HBsAg) after a limited course of treatment, thereby significantly reducing the incidence of end-stage liver disease.

However, existing treatments have limited efficacy in clearing HBsAg, and there is an urgent need to develop more effective products or treatment options to further improve the functional cure rate of CHB patients.

RNA interference (siRNA) is a promising clinical cure for hepatitis B. Compared to other drugs, siRNAs are highly targeted and can degrade HBV transcripts. They can inhibit HBV antigen expression, block viral replication, alleviate immune tolerance, and suppress HBsAg from integrated HBV-DNA and cccDNA.

Although there is currently no siRNA therapy for the treatment of chronic hepatitis B in the world, there are more than 20 candidate drugs under development, and many pipelines have entered the Phase II clinical stage.

Hengrui Medicine's HRS-5635 is a next-generation liver-targeted siRNA drug targeting hepatitis B virus (HBV). Clinical studies for HRS-5635 in chronic hepatitis B have advanced to Phase II. Its inclusion in the Breakthrough Therapy Designation by the CDE is expected to accelerate its market launch. Furthermore, a clinical trial of HRS-5635 in combination with pegylated interferon α (Peg-IFNα) for the treatment of chronic hepatitis B was approved in April of this year, potentially providing more treatment options for patients with chronic hepatitis B.

On the same day, Xingyao Kunze's HT-101 was also publicly announced by the CDE for Breakthrough Therapy Designation, intended for use in combination with HT-102 injection (an anti-HBV monoclonal antibody) for the treatment of chronic hepatitis B virus infection. Earlier in July of this year, this product was already designated a Breakthrough Therapy for chronic hepatitis B virus infection as a single agent. The combination of HT-101 and HT-102 is expected to further achieve clinical cure goals.

Bowang Pharmaceutical's BW-20507 was also included in the breakthrough therapy designation by the CDE in June this year, with the proposed indication being chronic hepatitis B virus infection.

Conclusion: The CDE has recently designated several siRNA drugs for the treatment of chronic hepatitis B as breakthrough therapies, demonstrating its recognition and anticipation for the promising potential of this technology. Although no relevant products have yet been officially launched, their future development remains promising, potentially bringing new therapeutic hope to hepatitis B patients.

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