GSK Licenses First-in-Class Hepatitis B Drug Bepirovirsen to China's Tianda Tianqing for Accelerated Launch

On May 11, Sino Biopharmaceutical Co., Ltd. officially announced that its core enterpriseCHIATAI TIANQING and GSK（GSK）Reach an Exclusive Strategic Cooperation, will accelerate the launch process of the first-in-class (FIC) new drug Bepirovirsen in China. Earlier this year, Bepirovirsen submitted an application for market approval to the CDE and was included in the priority review list.Expected to become the first drug to achieve functional cure for chronic hepatitis B。

Hepatitis B is a liver infection caused by a virus that can lead to acute or chronic liver disease. Chronic hepatitis B refers to the inability of the immune system to clear the virus, resulting in long-term infection. Many patients typically require lifelong antiviral treatment to suppress the virus, making functional cure a key goal in the management of this disease.

Bepirovirsen is a first-in-class antisense oligonucleotide (ASO) with a triple mechanism for the treatment of chronic hepatitis B (CHB) in adults. It was included in the breakthrough therapy designation program by China's CDE in August 2021 and in the priority review and approval process in April 2026. Bepirovirsen demonstrated statistically significant and clinically meaningful functional cure rates in the Phase III clinical studies B-Well 1 and B-Well 2, supporting the submission of the marketing application.

According to the terms of the agreement,CHIATAI TIANQING will be responsible for the import, distribution, hospital access, as well as promotional and non-promotional activities of Bepirovirsen in mainland China.All sales revenue generated by this product will be recognized as CHIATAI TIANQING's operating income. GSK will continue to act as the Marketing Authorization Holder (MAH), responsible for regulatory affairs, quality control, pharmacovigilance, and global medical strategy.

Both parties will also have the opportunity to further explore cooperation regarding some of Sino Biopharmaceutical Co., Ltd.'s R&D pipeline assets that are currently seeking collaboration opportunities outside the Chinese market. This collaboration will support the establishment of a long-term partnership between the two sides and provide a solid foundation for future expansion into innovative asset cooperation.

Globally, multiple hepatitis B clinical cure antisense oligonucleotide (ASO) and small interfering RNA (siRNA) candidate drugs are currently undergoing clinical research.

In addition to bepirovirsen, GSK has several small nucleic acid therapies for hepatitis B in development, such as GSK5637608 (formerly known as JNJ-3989 (ARO-HBV)), which is currently undergoing Phase II clinical trials. Xalnesiran, an siRNA drug developed by Roche and Dicerna, targets conserved regions of the hepatitis B virus (HBV) genome to silence multiple HBV transcripts and may be effective for patients with chronic HBV infection, either in combination with or without immunomodulators.

Significant progress has also been made in the development of small nucleic acid drugs in China. Drugs currently under development include BRII-835 (Elebsiran), a hepatitis B siRNA candidate drug from Brii Biosciences, and ASC22 (Envafolimab) from Ascletis Pharma.Xingyao Kunze's HBV siRNA candidate drug HT-101, and CHIATAI TIANQING's HBV siRNA candidate drug TQA-3038.

Reference: Dingxiangyuan Insight Database

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