Gelonghui, April 25 | China Biopharmaceutical (01177.HK) announced that the Group's self-developed Class 1 innovative drug “TQA3038 (siRNA)” has recently successfully completed phase I clinical research.
TQA3038 injection is a small interfering RNA (siRNA) drug independently developed by the Group to target hepatitis B virus (HBV). The indication is chronic hepatitis B. As an N-acetylgalactosamine (GalNAc) -conjugated siRNA drug, TQA3038 can be concentrated in the liver, effectively degrades targeted RNA, inhibits translation of related proteins, thereby blocking the replication of hepatitis B virus, and is expected to significantly improve the functional cure rate of patients clinically. TQA3038 uses a nucleic acid sequence with independent intellectual property rights. Compared with siRNA, which currently has the fastest clinical progress, it has stronger antiviral activity in vitro and in vivo.
The “Randomized, Double-blind, Placebo-Controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of TQA3038 in Healthy Adult Subjects” initiated by the Group has recently been successfully completed. This study was the first human clinical trial of TQA3038. The drug-related adverse events in the study were all grade 1-2, and no serious adverse events occurred.
The study results showed that TQA3038 has good safety and tolerability, and is similar to the safety of other siRNA drugs under development; its pharmacokinetic characteristics are consistent with its non-clinical pharmacokinetic characteristics, and are also similar to the human pharmacokinetic characteristics reported by other similar siRNA drugs under development. The Group will soon commence follow-up clinical research on TQA3038 injection in patients with chronic hepatitis B.