Nanjing San and Pharmaceuticals' Class 1 new drugs "and Lebwe tablets" are to be included in the priority review

And Lebwe tablets (research and development code: SH229) is Nanjing Saint and independent research and development of a class 1 anti-HCV new drug, but also the first domestic independent research and development of NS5B inhibitors, liver targeting ability, high antiviral activity.
clinical results showed that SH229 was 2-3 times more active in in-body antiviral activity against gene 1-6 HCV than sophosphobubwe.
August 2020, Phase II Clinical (CTR20182539) for the treatment of HCV infection in Chinese patients with Lebwe was presented at the Annual Meeting of the European Society of Hepatology (EASL) and the Digital World Hepatology Conference.
this clinic is a phase II clinical development label, with Chinese patients with HCV infection randomly divided into 3 queues at a scale of 1:1:1, receiving treatment at 12 weeks 1 day 1 time 60 mg Daratawe joint SH229 400 mg (queue A), 600 mg (queue B) or 800 mg (queue C).
factors include the HCV genotype and cirrhosis.
end point of this study was the virus sustained response rate (SVR12) 12 weeks after treatment.
the study included 124 patients with HCV infection, including 64 cases of type 1 HCV, 31 cases of type 2 HCV, 14 cases of type 3 HCV and 15 cases In patients with type 6 HCV infection, 8.9% had baseline cirrhosis, 6.5% had failed front-line interferon therapy, and 88.7% had IL28B CC allegiance genes.
all patients had a mid-baseline HCV RNA level of 6.3 log10 IU/mL, of which 50.8% had a baseline HCV RNA level of ≥200000 IU/mL.
of the 124 patients assessed by SVR12, SVR12 was 100% for patients treated with type 1/2 HCV infection, and better treatment was achieved for patients with type 3/6 HCV infection, with SVR12 for patients with type 6 HCV infection reaching 93.3%.
safety, all subjects were well-to-do and did not treat the relevant SAE or AE suspension events.
concluded that SH229 combined with Darattawe's 1-day, 1-day, full-oral treatment programme showed encouraging therapeutic results and good tolerance in patients with pangene HCV infection in China.
。