On Feb. 11, China National Medical Products Administration (NMPA) conditionally granted the emergency approval to Pfizer's co-packaged nirmatrelvir tablets and ritonavir tablets (Paxlovid).1
As an oral small-molecule drug, Paxlovid was approved for treating adult patients with mild-to-moderate COVID-19 with the risk of developing into severe conditions. Pfizer is required to continue research on the drug and submit the research results in time.
The drug received China NMPA's approval in less than two months after the U.S. Food & Drug Administration (FDA)'s emergency use authorization in December last year. NMPA's fast approval shows the authority is paying particular heed to COVID-19 drugs.
Apart from Paxlovid, another approved COVID-19 drug in China is Brii Bioscience's Amubarvimab/Romlusevimab Combination, a neutralizing antibody combination therapy developed in China.2
China Encourages Development of COVID-19 Drugs
NMPA has established a panel for emergency approval of COVID-19 drugs to deal with relevant applications immediately.3 Since COVID-19 is a major infectious disease threating the public health, drugs for treating the disease are highly possible to get admitted into programs for expediting marketing authorization.
The drug regulator has also drafted several guidelines for COVID-19 therapy, covering stages of non-clinical pharmacodynamics studies, clinical research on chemistry, manufacturing, and controls (CMC), as well as clinical trials.
Guidelines for COVID-19 Drugs | |||
Guideline | Status | Release | |
1 | Guidelines for COVID-19 Neutralizing Antibody Drug's CMC Research and Technical Documents for Applying for Clinical Trials (Trial) | In effect | Sept. 9, 2020 |
2 | Technical Guidelines for the Clinical Trials for Therapeutic or Prophylactic New Drugs Against COVID-19 (Trial) | Consultation Draft | Sept. 3, 2021 |
3 | Technical Guidelines for Non-clinical Pharmacodynamic Research and Evaluation of Chemical Drugs Against COVID-19 (Trial) | In effect | Dec. 7, 2021 |
4 | Technical Guidelines for Non-clinical Pharmacodynamic Research and Evaluation of Anti-inflammatory Drugs for COVID-19 Pneumonia (Trial) | In effect | Dec. 7, 2021 |
5 | Technical Guidelines for Non-clinical Research on Neutralizing Antibody Drugs Against COVID-19 (Trial) | In effect | Dec. 7, 2021 |
6 | Technical Guidelines for Clinical Trials of New Drugs for COVID-19 Pneumonia | In effect | Feb. 17, 2022 |
Chinese Pharmaceutical Companies Are Developing COVID-19 Therapies
COVID-19 has wreaked havoc on public health and economic development globally. With new variants, COVID-19 may bring more threat to humans. Under this circumstances, Chinese pharmaceutical companies are developing COVID-19 medicines as part of the global efforts to fight against the disease.
COVID-19 Drugs Being Developed by Chinese Companies | |||
Type | Drug | Company/Institute | Stage |
Nonsteroidal antiandrogen | Proxalutamide | Kintor Pharma | Phase III clinical trial |
Dual-target inhibitor | Azvudine | Genuine Biotech | Phase III clinical trial |
Antiviral | Avigan | Zhejiang Hisun Pharmaceutical | Phase II/III clinical trial |
Antiviral | SIM0417 | Jiangsu Simcere Pharmaceutical | Pre-clinical |
Antiviral | Vv116 | Shanghai Junshi Biosciences | Pre-clinical |
Enzyme inhibitor | 3CL protease inhibitor | Guangsheng Zhonglin Biotechnology and WuXi AppTec | Pre-clinical |
Enzyme inhibitor | RNA-dependent RNA polymerase (RdRp) inhibitor/3C-like protease (3CL) pro inhibitor ASC11 | Ascletis Pharma | Pre-clinical |
Enzyme inhibitor | RAY003/RAY004 | Raynovent | Pre-clinical |
Enzyme inhibitor | RdRp inhibitor SHEN26 | Kexing Biopharm; Shenzhen Antaiwei Biomedicine | Pre-clinical5 |
Enzyme inhibitor | 3CL protease inhibitor EDDC-2214 | Everest Medicines; Experimental Drug Development Center (EDDC) of Singapore | Pre-clinical6 |
Besides, five Chinese pharma companies became manufacturers of COVID-19 drugs in January this year, namely Fosun Pharma, BrightGene Bio-Medical Technology, Zhejiang Langhua Pharmaceutical, Longzeal Pharmaceutical, and Shanghai Desano Pharmaceuticals. The five companies received the authorization to manufacture MSD's COVID-19 antiviral medication molnupiravir.7
In general, on the one hand, China authorities support the development of COVID-19 medications. On the other hand, quite a few Chinese drug makers are pouring efforts in developing and producing them.
