Domestic Hepatitis B Drug Development Gains Momentum as Hengrui Medicine, Fosun Pharma and Others Advance Innovative Therapies

　　【Pharmaceutical Network Industry Dynamics】Chronic hepatitis B is a chronic inflammatory liver disease caused by persistent infection with the hepatitis B virus (HBV), and it serves as a major cause of liver cirrhosis and primary hepatocellular carcinoma. Data indicates that in 2025, approximately 296 million individuals worldwide are chronically infected with HBV, with China accounting for 75 million, or roughly 25% of the global total, underscoring a substantial market demand for therapeutic drugs. Meanwhile, in recent years, significant clinical breakthroughs have continuously emerged in the hepatitis B field. As a country bearing a high disease burden, China has witnessed a flourishing landscape in the research and development of novel anti-HBV therapeutics. Recently, leading domestic and international pharmaceutical companies, including Hengrui Pharma, AusperBio, and GlaxoSmithKline, have successively announced new R&D breakthroughs, bringing renewed hope for a curative treatment of hepatitis B.
 

For example, on May 26, Hengrui Pharma registered a Phase III clinical trial for HRS-5635, a novel siRNA drug for hepatitis B, for the treatment of chronic hepatitis B infection. The Phase III trial plans to enroll 540 subjects with chronic hepatitis B. This study aims to evaluate the efficacy and safety of HRS-5635 injection in HBeAg-negative chronic hepatitis B patients who are virologically suppressed on nucleos(t)ide analog therapy. It is expected to be completed by June 2028.
 

According to available data, HRS-5635 injection is a next-generation liver-targeted siRNA drug against HBV independently developed by Hengrui Pharma. In September 2025, HRS-5635 was granted Breakthrough Therapy Designation by the CDE for the treatment of chronic hepatitis B. Phase II clinical trial results of HRS-5635 monotherapy for chronic hepatitis B indicate that HRS-5635 has the potential to improve the functional cure rate for chronic hepatitis B, while simultaneously demonstrating a favorable safety profile.
 

On May 27, AusperBio, a company focused on developing proprietary targeted-delivery small nucleic acid therapeutics, announced that it presented the final follow-up data from the Phase II clinical trial of its independently developed antisense oligonucleotide (ASO) drug AHB-137 in treatment-naïve chronic hepatitis B (CHB) patients in mainland China at the 2026 European Association for the Study of the Liver (EASL) Annual Meeting (AB-10-8008, NCT06829329).
 

The results demonstrated that AHB-137 exhibited potent and sustained antiviral activity in treatment-naïve chronic hepatitis B patients, achieving a 70% functional cure (FC) rate in the population with baseline HBsAg levels of 100–1000 IU/mL, while the overall safety profile was consistent with expectations.
 

AHB-137 is a novel unconjugated ASO drug developed by AusperBio based on its proprietary Med-Oligo™ antisense oligonucleotide technology platform. Featuring a triple mechanism of action, the drug has demonstrated positive results in both preclinical and clinical trials. The newly announced study findings further validate its therapeutic potential in treatment-naïve chronic hepatitis B patients, representing a broad chronic hepatitis B population.
 

Also on May 27, GlaxoSmithKline's (GSK) chronic hepatitis B therapeutic bepirovirsen injection (GSK836) once again submitted a marketing application to the National Medical Products Administration (NMPA), which has been accepted and is currently in the "under review" status. Bepirovirsen aims to achieve a functional cure for hepatitis B. Based on positive data from two Phase III clinical trials (B-Well 1/2), the functional cure rate when combined with standard of care is significantly higher than that of standard of care alone. The drug demonstrates superior efficacy in patients with baseline HBsAg ≤ 1000 IU/mL and exhibits a favorable safety profile. Marketing applications for this drug have also been filed in Japan, the European Union, the United States, and other regions.
 

In addition to breakthroughs in clinical drug R&D, Chinese pharmaceutical companies are also continuously deepening their strategic layout in the Hepatitis B (HBV) innovation sector. According to an announcement by Fosun Pharma on May 26, its controlling subsidiary, Fosun Pharmaceutical Industry, intends to invest a total of RMB 414 million to participate in the Series B financing round of Xingyao Kunze alongside other new investors, and to acquire a portion of the equity interests in Xingyao Kunze held by the company's associates, Suzhou Fund and Tianjin Fund. Public information indicates that Xingyao Kunze is primarily engaged in the research and development of innovative therapeutics for liver diseases. Its current key R&D pipeline includes the innovative siRNA drug HT-101 injection (hereinafter referred to as "HT-101"), the neutralizing antibody HT-102 injection (hereinafter referred to as "HT-102"), as well as the combination therapy of HT-101 and HT-102, among others.
 

Regarding R&D progress, HT-101 monotherapy, HT-102 monotherapy, and the combination of HT-101 and HT-102 for the treatment of chronic hepatitis B virus (HBV) infection are currently all undergoing Phase II clinical trials in China. HT-101 monotherapy and the combination of HT-101 and HT-102 have respectively been granted Breakthrough Therapy Designation by the National Medical Products Administration (NMPA).
 

Recently, multiple innovative drugs have successively achieved key milestones, bringing new hope to hepatitis B patients in China. With domestic and international pharmaceutical companies synergizing their efforts and technological advancements accelerating, more novel hepatitis B therapies are likely to emerge in the future. These developments hold the promise of gradually overcoming the clinical challenge of curing chronic hepatitis B, thereby supporting China in achieving its public health goals for hepatitis B prevention and control.
 

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