Chinese Health Authorities, Pharmaceutical Industry, and Healthcare Professionals Race against Time

Fighting Coronavirus Disease 2019 (COVID-19) Epidemic

Sophia Duan
PPC China
Photo courtesy of CDC/Alissa Eckert, Dan Higgins

he Coronavirus Disease 2019 (COVID-19) caused by the coronavirus SARS-CoV-2 (previously known as 2019-nCoV), first identified in Wuhan City in the Hubei Province of China, has led to more than 79,000 cumulative confirmed cases of human infections and at least 2,900 deaths in China (as of March 1, 2020). It has also spread quickly to more than 60 countries beyond China. In China, a series of powerful measures were taken to contain the spread of COVID-19, including the early identification and quarantining of infected patients. Chinese health authorities, pharmaceutical companies, and healthcare professionals are also responding quickly and working around the clock to accelerate the research and development of products for the identification, prevention, and treatment of COVID-19.

The National Medical Products Administration (NMPA) has been taking initiatives to speed up the approval and supervision of detection and control products for COVID-19. As of January 31, 2020, NMPA had approved seven nucleic acid reagent test kits for the new coronavirus in an expedited way to serve the need for fast identification. By March 01, NMPA had approved more than 245 registrations of relevant medical supplies for infection control in accordance with emergency approval procedures. NMPA has also promised to give “green lights” to, and to highly prioritize, enterprises which apply for clinical trials or market authorization for products to control COVID-19. Any company or institute can contact the Center for Drug Evaluation (CDE) anytime for applications of products relating to the treatment or prevention of COVID-19. It has been reported that clinical trials of five investigational products including favipiravir have been approved. Convalescent plasma therapy has also been introduced as a new therapeutic method. NMPA has been simultaneously strengthening its supervision and inspection procedures to ensure the quality and safety of relevant medicines and medical devices for COVID-19.

Several clinical studies have been or will soon be launched to investigate the efficacy and safety of products for the prevention and treatment of COVID-19. As of March 1, 2020, 295 clinical trials were retrieved on the Chinese clinical trial registry website, and 56 clinical trials retrieved on, using the keyword “COVID-19.” Most are investigator-initiated trials to develop both western medicine and traditional Chinese medicine. The NMPA and NHC are working with Gilead and other healthcare professionals to launch two phase 3 randomized, double-blind, placebo-controlled multicenter studies to evaluate the efficacy and safety of remdesivir in hospitalized adult patients with different severity levels (mild, moderate, or severe) of COVID-19 respiratory disease. These two trials were started in early February and are estimated to complete by early May.

The National Health Commission of the People’s Republic of China (hereafter referred to as NHC) monitoring the outbreak of COVID-19 has released several public guidelines to help protect citizens against the coronavirus infection. NHC has also been exploring the latest diagnosis and treatment methods and providing them to the public. The pamphlet Diagnosis and treatment of pneumonia caused by novel coronavirus infection was recently updated to the sixth edition as new information on epidemiological and clinical characterization of the COVID-19 outbreak emerged.

In China, biotechnology and pharmaceutical companies as well as research organizations are racing to develop effective vaccines, antibodies, and medicines. As of January 29, five strains of SARS-CoV-2 were isolated, two of which were suitable for vaccine development. The translational medical platform of Dongfang Hospital affiliated to Tongji University is collaborating with Siwei (Shanghai) Biotechnology Co., Ltd. to research and develop a new preventive coronavirus mRNA vaccine, which is now undergoing animal test. Inovio Pharmaceuticals, Inc. is working with Beijing Advaccine Biotechnology Co. to accelerate development of the INO-4800 vaccine against SARS-CoV-2. On February 25, WuXi Biologics and Vir Biotechnology jointly announced developing human monoclonal antibodies for treatment of COVID-19. Screening and developing new indications for previously approved drugs are believed to be the fastest way to deliver effective treatments to those infected with this disease.