China-based Shenzhen Chipscreen Biosciences Co., Ltd. (SHA: 688321) announced that the National Medical Products Administration (NMPA) has granted clearance to conduct a study of its investigational drug CS12088 in adult patients with chronic hepatitis B.

Drug Mechanism and Preclinical Data
CS12088 is an HBV nucleocapsid assembly regulator that interferes with the assembly of the HBV nucleocapsid. It blocks the packaging of pre-viral RNA into the nucleocapsid, thereby inhibiting the replication of HBV DNA and suppressing the production of mature viral particles. Preclinical data have demonstrated that CS12088 has significant antiviral activity, liver-targeting characteristics, and good safety and tolerability.

Potential Advantages
CS12088 has shown the ability to maintain antiviral activity against different genotypes of HBV, which could potentially overcome clinical nucleoside analogue resistance and maintain high antiviral activity against resistance caused by core protein mutations. Additionally, CS12088 has a significant inhibitory effect on HBeAg and HBsAg levels, with direct antiviral activity and the potential for HBsAg seroreversion.-Fineline Info & Tech