China's First Chronic Hepatitis B Drug T101 Approved to Enter Clinical Trials Successfully Completes the first subject Administration of Phase II

China's First Chronic Hepatitis B Drug T101 Approved to Enter Clinical Trials Successfully Completes the first subject Administration of Phase II

Recently, in Beijing Youan Hospital, Capital Medical University, Transgene Tasly (Tianjin) Biopharmaceutical Co., Ltd. (hereinafter referred to as Transgene Tasly), a wholly-owned subsidiary of Tasly Biopharmaceuticals Co., Ltd. (hereinafter referred to as “Tasly Biopharma”), has successfully completed administration of T101 (a novel immunotherapeutic vaccine for chronic hepatitis B) developed by it to the first subject in the Phase II clinical trial. The administration process went smoothly, and by far, the subject has no adverse reactions.

Basic Information of T101

T101 is a therapeutic vaccine targeted to treat chronic hepatitis B. Unlike antiviral therapy that inhibits HBV replication through antiviral drugs, T101 induces the patient’s own HBV-specific cytotoxic T lymphocytes (“CTL”) to inhibit and kill HBV or induce the apoptosis of liver cells infected by HBV, so as to control the patient’s condition continuously and achieve the purpose of functional cure of chronic hepatitis B.

T101 is the first immunotherapeutic product using virus as the vector for chronic hepatitis B that has initiated clinical trials in China. The results of the Phase I clinical trial showed that T101 can break the immune tolerance of patients with chronic hepatitis B and stimulate HBV-specific T cell immune response. Its single and multiple injections have good resistance in patients with chronic hepatitis B, and did not cause any SAE.

T101 was initially developed by French Transgene. Tasly Biopharma has the exclusive commercialization right of T101 in China. Its subsidiary, Transgene Tasly has the exclusive right to develop this product in China. Tasly Biopharma and Transgene Tasly will actively promote the clinical development and marketing progress of this product.

T101’s Clinical Development Progress

Transgene Tasly submitted the IND filing for T101 in January 2016

Transgene Tasly obtained the IND approval for T101 in June 2017

On July 12, 2019, T101 completed the phase I clinical study and reached the main research endpoint. The prinpical investigator of the phase I clinical study was Professor Niu Junqi from The First Bethune Hospital of Jilin University.

On December 10, 2019, the first subject administration of T101 Phase II clinical trial was completed in Beijing Youan Hospital, Capital Medical University. The process went smoothly, and the subject had no adverse reactions during the drug administration.

Currently, in the multi-center, randomized and open-label phase II clinical trial of T101 developed in China, the study leader site is Beijing Youan Hospital, Capital Medical University, with the participating sites including Beijing Ditan Hospital, Capital Medical University and the Fifth Medical Center of Chinese PLA General Hospital. The Principal investigator was Professor Chen Xinyue from Beijing Youan Hospital, Capital Medical University. The main study purpose is to evaluate the safety, efficacy and immunogenicity of T101 combined with nucleotide analogue in the treatment of patients with chronic hepatitis B, to explore the best-in-class dosing regimen, and providing a design basis for the phase III plan.

T101’s Future Market Prospects

In China, hepatitis B is the most harmful infectious disease with the largest number. According to a report from Frost & Sullivan, the number of patients infected with HBV in China was 79.5 million in 2014, and 73.9 million in 2018, and it is expected to be 68.1 million in 2023. T101 has a huge market space in the future.