China’s NMPA conditionally approves two oral drugs for Covid-19

The National Medical Products Administration (NMPA) of China has granted conditional approval for two domestically developed oral drugs to treat Covid-19.

Simcere Pharmaceutical Group and Shanghai Junshi Biosciences’ subsidiary have submitted the applications for the two drugs Xiannuoxin (SIM0417) and VV116, respectively.

The anti-SARS-CoV-2 drug candidate Xiannuoxin has been co-developed by Simcere Group, along with Shanghai Institute of Materia Medica (SIMM) and Wuhan Institute of Virology (WIV), Chinese Academy of Sciences (CAS).

It is a combination of a small molecule anti-SARS-CoV-2 drug candidate and Ritonavir.

The drug targets 3C-like protease that is said to be essential for replication of the SARS-CoV-2 virus.

It showed broad spectrum antiviral activity and highly potent in pre-clinical trials.

The NMPA granted two clinical trial approvals for Xiannuoxin last year to treat mild to moderate Covid-19 and post-exposure prophylaxis for close contacts of people tested Covid-19 positive.

The two oral small-molecule drugs Xiannuoxin and VV116 have been developed to treat mild to moderate Covid-19 adult patients.

The regulatory agency stated that patients should strictly use the two drugs as guided by doctors.

In December last year, Simcere Pharmaceutical completed participant enrolment in Phase II/III clinical trial of Xiannuoxin.

The placebo-controlled, randomised, multi-centered, double-blind clinical study was designed for assessing the safety and efficacy of the drug in symptomatic mild to moderate Covid-19 adult participants.

A total of 1,208 participants were enrolled in the trial.

Time taken until recovery from the disease symptoms as well as the reduction of viral load are the clinical endpoints of the trial.