China Approves First Domestic Oral Drug for COVID-19

by Grace Wang Jul 28, 2022

On July 25, China National Medical Products Administration (NMPA) granted conditional approval to Chinese domestic company Genuine Biotech's Azvudine Tablets for treating COVID-19 pneumonia.1

Azvudine's Indication

Azvudine was approved for treating HIV-1-infected adult patients in July 2021. Now the drug has a new indication for treating adult patients with the normal type of COVID-19 pneumonia.

In China, COVID-19 pneumonia conditions are divided into four types clinically: mild, normal, severe, and critical. The normal type means that patients have a fever and/or respiratory symptoms that are related to COVID-19 pneumonia and presented in medical imaging. The patients have a normal or reduced total amount of white blood cells, including a normal or reduced amount of lymphocytes.2

Azvudine's Clinical Trial Result

From phase II to phase III clinical trials, patients turn COVID-19-negative in 3-4 days after taking Azvudine at a daily amount of 5mg.3

According to the phase III clinical trial result, Azvudine has the following functions and characteristics.

Ÿ   Improving symptoms: Azvudine can improve the rate of moderate COVID-19 pneumonia patients whose symptoms get improved and shorten the time for improvement. On the 7th day after the first dose, the rate of improved subjects taking Azvudine is 40.43%, much higher than 10.87% (p < 0.001) in subjects taking the placebo.4 The median time for patients to improve symptoms in the Azvudine group has a significant statistical difference from that in the placebo group (p < 0.001).

Ÿ   Inhibiting virus: Azvudine can inhibit SARS-CoV-2 activities with viral clearance time of about 5 days.

Ÿ   Safety: In general, Azvudine is well tolerated by subjects. The drug shows no increase of risks for subjects and no statistical difference in adverse events compared to placebos.

COVID-19 Drugs in China

Apart from Azvudine, other NMPA-approved COVID-19 drugs are Pfizer's Paxlovid (nirmatrelvir tablets and ritonavir tablets) and Brii Bioscience's Amubarvimab/Omlusevimab Combination Therapy (Injection).

As shown in the table below, multiple Chinese companies are developing COVID-19 therapies. More COVID-19 drugs are expected to be approved as China is still fighting against the epidemic.

COVID-19 Drugs Being Developed by Chinese Companies


Drug name or code

Company

Target

Stage

1

VV116

Junshi Biosciences and Suzhou Wangshanwangshui

RNA-dependent RNA polymerase (RdRp)

Phase III clinical trial

2

Proxalutamide

Kintor Pharma

Androgen receptor

Phase III clinical trial

3

HC-1119

Hinova Pharma

Androgen receptor

Phase III clinical trial

4

SHEN26

Kexing Biopharm

RdRp

Phase II clinical trial

5

SIM0417

Jiangsu Simcere Pharmaceutical

3CL protease

Phase I clinical trial

6

FB2001

Frontier Biotechnologies

3CL protease

Phase I clinical trial

7

RAY003

Raynovent

3CL protease

Phase I clinical trial

8

EG-009A

Evergreen Therapeutics

ENac, FKBP5, GILZ

Phase I clinical trial

9

VV993

Junshi Biosciences and Suzhou Wangshanwangshui

3CL protease

Pre-IND

10

ASC11

Ascletis Pharma

3CL protease

Pre-IND

11

ASC10

Ascletis Pharma

RdRp

Pre-IND

12

GST-HG171

Fujian Cosunter Pharma

3CL protease

Pre-IND

13

EDDC-2214

Everest Medicines

3CL protease

Pre-IND

14

Jaktinib Hydrochloride

Zelgen Biopharmaceuticals

Janus kinase (JAK)

Pre-IND

15

-

Boji Medical

3CL protease

Pre-IND

16

-

Panlong Pharmaceutical

3CL protease

Pre-IND

17

-

Guangsheng Zhonglin Biotechnology and WuXi AppTec

3CL protease

Pre-IND

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Grace Wang
ChemLinked Regulatory Analyst / Editor
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