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.
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.
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.
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 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. 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 |
Reprinted from: ChemLinked
Reference Links
- Breaking: Immediate Effect of China’s Vaccine Manufacture & Distribution Rules
- China Approves Pfizer’s Paxlovid, Encouraging COVID-19 Drug Development
- China Approves Eleven COVID-19 Antigen Self-test Kits
- Introduction to China’s COVID-19 Vaccines
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