Chinese Innovators Shine at AASLD 2025: AusperBio, Xingyao Kunge, and HuaHui Anjian Advance Hepatitis Therapies Toward Functional Cure

▎Armstrong

From November 7 to 11, 2025, the 76th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) will be held in Washington. Among the 39 latest breakthrough (late-breaking) studies, six are from innovative drugs developed in China. Although the number is not large, most represent cutting-edge and pioneering significant advancements. These six breakthrough studies include: Phase 2b registrational clinical data (5007) of Huahui Health's world-first PreS1 antibody for treating hepatitis D; Phase 2 clinical data (5010) of Fujian Cosunter Pharmaceutical Co., Ltd.'s small molecule HBsAg inhibitor GST-HG131 for treating hepatitis B; Phase 1b/2a clinical data (5013) of Suzhou Hepa Thera Biotech Co., Ltd.'s hepatitis B siRNA therapy HT-101 combined with HBsAg neutralizing antibody HT-102 for treating hepatitis B; 48-week Phase 2 clinical data (5022) of AusperBio's hepatitis B ASO therapy AHB-137 for treating hepatitis B; First-in-human trial data (5029) of Shanghai Jinwei Biotechnology Co., Ltd.'s lentiviral vector-based hepatitis B vaccine J-51; Updated latest data from Brii Biosciences' ENSURE Phase 2 clinical trial (5036).

AusperBio: AHB-137 Week 24 Post-Treatment Data Released, Establishing a Cornerstone for Functional Cure

At last year's AASLD meeting, AusperBio reported that 24 weeks of AHB-137 treatment achieved the highest historical HBsAg seroclearance rate for monotherapy. At this year’s AASLD meeting, AusperBio announcedAHB-137 Week 24 Post-Treatment Data. Strong and sustained antiviral response was demonstrated 24 weeks after the end of treatment (i.e., at Week 48), including complete response (HBsAg<0.05 IU/mL and HBV DNA

Hepa Thera: HT-101+HT-102 Combined Therapy Significantly Improves HBsAg Clearance Rate

Hepa Thera reported the Phase 1b/2a clinical data of HT-101 (siRNA) + HT-102 (HBsAg antibody) combination therapy for chronic hepatitis B, with a total of 56 subjects enrolled.

After 24 weeks of treatment, the total HBsAg seroclearance rate in the combination therapy group increased to 22/28 (79%) (data for Group E at 20 weeks). In Group E, 90% of patients achieved HBsAg clearance by Week 20, with 2/10 (20%) participants achieving HBsAg clearance as early as Week 4.

As the data shows, HT-101 monotherapy can rapidly reduce HBsAg but does not clear it thoroughly, and the reduction of HBsAg by HT-101 alone is limited. The combination of the two drugs can achieve the goal of faster and more complete HBsAg clearance. Further attention needs to be paid to the rebound situation after discontinuation to obtain the final functional cure data.

Huahui Health: World's First PreS1 Antibody Brings Breakthrough Efficacy to Hepatitis D Treatment

Huahui Health's HH-003 is the world's first PreS1 antibody, currently in the regulatory review stage for the treatment of hepatitis D. It has already obtained approval in China.、Dual Breakthrough Therapy Designation in the U.S. The 2b-phase pivotal registrational clinical data was disclosed at this AASLD conference, showing excellent efficacy of HH-003 in composite endpoint response rate, virological suppression, ALT normalization, and improvement in liver stiffness.

• At 24 weeks of treatment, the composite response rates of the two dose groups of Libevetamab were significantly higher than that of the control group; 35.0% (14/40) of the 20mg/kg group and 32.4% (11/34) of the 10mg/kg group reached the primary endpoint, compared to only 5.0% (1/20) in the control group.
• At 48 weeks of treatment,LibevetumabThe composite response rates of the two dose groups further increased, with the 20mg/kg group and the 10mg/kg group rising to 42.5% and 44.1%, respectively, while the control group remained at 5.0%.

Summary

China's innovative drugs have transitioned from following to leading, particularly evident in the field of liver diseases. Multiple foreign companies have long been established in the area of small nucleic acids for hepatitis B, and several siRNA therapies have shown treatment efficacy, but they remain far from the goal of functional cure. Brii Biosciences has achieved a higher HBsAg seroclearance rate through siRNA + therapeutic vaccines, while Hepa Thera has done so through siRNA + neutralizing antibodies. GSK’s ASO therapy has advanced to phase III clinical trials, but its HBsAg seroclearance rate remains low. AusperBio's AHB-137 has demonstrated a significantly improved HBsAg seroclearance rate, which still shows notable advantages 24 weeks after discontinuation, further solidifying its position as a cornerstone drug in hepatitis B treatment. Huahui Health’s HH-003, the world’s first drug with a new target and mechanism, has brought breakthrough efficacy to hepatitis D patients and is nearing commercialization.