On December 5, China Biopharm announced that it is conducting a randomized, double-blind, placebo-controlled Phase I clinical trial to evaluate the safety, tolerability and pharmacokinetic profile of TQA3038, a small interfering RNA (siRNA) targeting the hepatitis B virus (HBV) developed independently by China Biopharm for the indication of chronic hepatitis B (CHB). TQA3038 is a small interfering RNA (siRNA) drug developed independently by China Biopharmaceuticals targeting HBV, with the indication of chronic hepatitis B. The first human clinical trial of TQA3038 has been completed with the enrollment of the first batch of subjects, and the dosing process went smoothly, and post-dosing observation has been completed.

Chronic hepatitis B is a serious public health problem worldwide, with approximately 290 million chronically infected patients worldwide. China is a high prevalence area of hepatitis B. It is estimated that there are about 86 million chronic HBV-infected patients, and a large number of patients still need treatment. Among patients with chronic hepatitis B who are not effectively treated, 15-40% are at risk of progression to cirrhosis, liver failure or even liver cancer. Current treatments include nucleoside analogs (NAs) and interferon, etc., but it is difficult to achieve a functional cure, and the development of effective therapies is urgently needed. The current consensus of domestic and international experts is to aim for a functional cure of HBV, defined as the sustained clearance of HBsAg and HBV DNA in serum after a limited course of treatment. And the reduction of HBsAg is the main challenge in the current clinical treatment.

TQA3038, as a GalNAc-conjugated siRNA drug, can be enriched in the liver to effectively degrade the targeted RNA and inhibit the translation of the relevant proteins, thus blocking the replication of hepatitis B virus, which is expected to significantly improve the functional cure rate of patients in the clinic.TQA3038 adopts nucleic acid sequence with independent intellectual property rights, which, compared with current siRNAs with the fastest progress in the clinic, possesses stronger antiviral activity in vitro and in vivo. The results of non-clinical studies show that TQA3038 can significantly inhibit the infection index of AAV-HBV model mice; it has demonstrated good safety and tolerability in rat and crab-eating monkey toxicology tests, with a large safety window.

The successful enrollment of the first batch of subjects marks the official opening of this clinical study, and TQA3038 injection is expected to become the cornerstone of realizing a functional cure for hepatitis B, bringing a brand-new therapeutic option for the majority of patients.

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