CDE Accepts IND Application for TQA3038, a Novel Class 1 siRNA Drug Targeting Hepatitis B Virus by CSPC

On July 26, the Class 1 new drug TQA3038 (siRNA) injection, independently developed by Zhengda Tianqing, submitted a clinical trial application to the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) and was accepted.

It is reported that TQA3038 Injection, independently developed by Chia Tai Tianqing, is a small interfering RNA (siRNA) drug targeting the hepatitis B virus (HBV), indicated for chronic hepatitis B. TQA3038 is a GalNAc-conjugated siRNA drug that accumulates in the liver. By forming the RISC complex with proteins such as Ago2 within cells, it effectively degrades targeted RNA and inhibits the translation of related proteins, thereby blocking the replication of the hepatitis B virus. This drug is expected to significantly improve the functional cure rate of patients in clinical practice.

TQA3038 adopts a nucleic acid sequence with independent intellectual property rights, and exhibits stronger antiviral activity both in vitro and in vivo compared to the siRNA with the fastest current clinical progress. Non-clinical study results show that TQA3038 can significantly inhibit infection markers in AAV-HBV model mice; it demonstrated good safety and tolerability in rat and cynomolgus monkey toxicology tests, with a wide safety margin. The approval of TQA3038 injection for hepatitis B clinical trials will further expand the innovative drug pipeline of Chia Tai Tianqing in the field of liver diseases, and is expected to become a cornerstone for achieving functional cure of hepatitis B, bringing new treatment options to a wide range of patients.

Editor: Cotton Tree

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