Hepatitis B Drug HT-101 (siRNA) Receives FDA Clinical Approval

On February 2, 2024, Suzhou Starlight Kunze Biopharmaceutical Co., Ltd. (hereinafter referred to as "Starlight Kunze") announced that its hepatitis B drug candidate HT-101 (siRNA) has received approval from the U.S. FDA to proceed directly to Phase Ib clinical trials for chronic hepatitis B virus infection.

HT-101 injection is the first domestically developed anti-hepatitis B siRNA product to enter the clinical phase. It has completed all studies in healthy volunteers and all dosing in Phase Ib clinical trials for patients with chronic hepatitis B in China. Preliminary research data indicate that HT-101 demonstrates good safety and tolerability in both healthy individuals and patients with chronic hepatitis B, and it significantly reduces hepatitis B surface antigen (HBsAg) in chronic hepatitis B patients, with a reduction of more than 2 logs in the medium to high dose groups and no significant rebound.

During the Phase Ib clinical interim investigator meeting, renowned experts such as Professor Jia Jidong, Director of the Liver Disease Research Center at Beijing Friendship Hospital, and Professor Niu Junqi from the First Hospital of Jilin University, highly praised the efficacy of this drug candidate.

Currently, the development progress of HT-101 is in the "first tier" compared to global peers in clinical development, with the potential to become a "best in class" product. With this FDA clinical approval, Starlight Kunze will initiate overseas clinical development for this product.