Xingyao Kunze's Combination Therapy for Hepatitis B Receives NMPA Breakthrough Therapy Designation

On September 23, Hepa Thera announced that its self-developed HT-101 injection combined with HT-102 injection has been officially included in the breakthrough therapy category by the China National Medical Products Administration (NMPA).The proposed indication is for the treatment of chronic hepatitis B virus infection.。

HT-101 is an innovative GalNAc-conjugated siRNA drug that achieves anti-HBV effects by specifically targeting the liver to silence HBV mRNA, blocking the synthesis of multiple viral proteins. HT-102 is a fully human monoclonal antibody against HBsAg, which can prevent HBV reinfection, clear subviral particles containing HBsAg from circulation in the body, and reduce subviral particle-mediated immunosuppression. The combination of HT-101 injection and HT-102 injection theoretically...Simultaneously targeting HBsAg in peripheral blood and multiple HBV viral proteins within the liver, the mechanisms are complementary with a potential synergistic effect.。

According toHepa Thera's press release introduced that this Breakthrough Therapy DesignationThe designation is based on the significant antiviral activity and favorable safety profile demonstrated in early clinical trials. The Phase 1b clinical trial of HT-101 showed a sustained decline in HBsAg levels across all dose groups after two administrations, with some patients in the high-dose group achieving HBsAg clearance. Preliminary data from the Phase 2 trial further indicates that HT-101, in combination...HT-102It is significantly superior to similar products in both onset time and HBsAg clearance rate.

References:
[1]Hepa Thera's HT-101 Injection Combined with HT-102 Injection Granted Breakthrough Therapy Designation by the National Medical Products Administration. From https://mp.weixin.qq.com/s/qzjNgjim6O1JePky6x0LWA

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