Sino Biopharmaceutical Strengthens Hepatology Portfolio with Exclusive Partnership with GSK for Bepirovirsen, a First-in-Class Small Nucleic Acid Therapy for Chronic Hepatitis B

(Source: A Large Pine Tree)

Event:On May 11, 2026, Sino Biopharm announced an exclusive strategic collaboration with GSK to accelerate the launch of the FIC drug Bepirovirsen in China. According to the agreement terms, CHIATAI TIANQING will be responsible for the commercialization of Bepirovirsen in mainland China (fully accounted as revenue), while GSK will continue as the Marketing Authorization Holder (MAH). In early 2026, Bepirovirsen had submitted its marketing application to the CDE and was included in the priority review list, with the potential to become the first drug to achieve functional cure for chronic hepatitis B, bringing a revolutionary breakthrough to the field of hepatitis B treatment in China.

Large Number of Hepatitis B Patients in China, Bepirovirsen Shows Excellent Data

Hepatitis B is a liver infection caused by a virus that can lead to acute or chronic liver disease. It is estimated that there are approximately 75 million hepatitis B virus carriers in China, with over 450,000 hepatitis B-related deaths annually. In China, about 84.4% of liver cancer cases are associated with chronic hepatitis B infection.

Bepirovirsen is a first-in-class ASO with a triple mechanism for the treatment of chronic hepatitis B (CHB) in adults. It was included in the CDE's breakthrough therapy program in August 2021 and in the priority review and approval process in April 2026.

On January 7, 2026, GSK announced positive results from two Phase III studies (B-Well 1 and B-Well 2) of Bepirovirsen for the treatment of chronic hepatitis B. This drug is the first small nucleic acid drug in the chronic hepatitis B field to complete Phase III studies. GSK believes that Bepirovirsen has the potential to become the first drug to achieve functional cure for chronic hepatitis B.

The primary endpoint of the B-Well 1 and B-Well 2 studies was the proportion of patients with baseline HBsAg levels not exceeding 3000 IU/ml achieving functional cure, while the key secondary endpoint was the proportion of patients with baseline HBsAg levels not exceeding 1000 IU/ml achieving functional cure. The results showed that both studies met their primary endpoints, with the proportion of patients in the Bepirovirsen group achieving functional cure significantly higher than in the placebo group. Additionally, the studies achieved all endpoints, with Bepirovirsen showing even more pronounced effects in patients with baseline HBsAg levels not exceeding 1000 IU/ml.

The company is a leader in the field of liver disease in China, and the cooperation is expected to further enhance the company's pipeline strength.

Sino Biopharm is one of the earliest pharmaceutical companies in China to focus on the liver disease field, and has taken the lead in building a comprehensive product portfolio covering the entire lifecycle of liver disease. A series of liver disease medications represented by Tianqing Ganmei® and Runzhong® have played an important role in promoting the understanding and knowledge dissemination of hepatitis B diagnosis and treatment in China. Currently, the group is focusing on directions such as metabolic associated steatohepatitis (MASH), curative therapies for hepatitis B, cirrhosis, and acute liver injury. Multiple innovative pipelines have entered clinical stages: Lanifibranor (pan-PPAR agonist) is undergoing Phase III clinical trials globally, TQ-A3334 (TLR-7 agonist) and TQA3605 (HBV core protein allosteric modulator) are both in Phase II clinical trials, and Kylo-0603 (THR-β agonist) is in Phase I clinical trials. In the future, Sino Biopharm will continue to deepen its expertise in the liver disease field, develop more cutting-edge innovative therapies, and commit itself to addressing unmet global clinical needs.

Risk Warning

Product sales below expectations, centralized procurement risks, policy risks, innovative drug clinical trial risks

Securities Research Report: "TF SecuritiesSino Biopharm: Introduction of GSK's Hepatitis B Small Nucleic Acid New Drug Strengthens Capabilities in Liver Disease Field》

Release Date for External Publication: May 13, 2026

Report Issuing Institution: TF Securities Co., Ltd.

Analysts of this report:

Yang Song SAC Professional Certificate No.: S1110521020001

Liu Yibo SAC Practice Certificate No.: S1110525080001