China Approves First Domestic Oral Drug for COVID-19

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.

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