The first domestically produced special medicine for COVID-19 is approved: seizing the 10-day golden treatment period!

On December 8, my country's first novel coronavirus neutralizing antibody combination therapy with independent intellectual property rights was approved. The combination drug was jointly developed by Tsinghua University, Shenzhen Third People's Hospital and Brii Biopharma.

The final results of the latest phase III clinical trial showed that the combined treatment reduced the risk of hospitalization and death of outpatients by 80%. Even more unique is that the combined drug treatment provides a golden treatment period of up to 10 days (other international clinical trials of new crown treatment drugs are mostly designed to treat within 5 days).

Grab the 10-day golden treatment period

On this year's AIDS Day, an article titled "After HIV infects you, you still have 72 hours of golden time to save yourself!" received widespread attention.

It can be seen that in the fight against infectious diseases, a longer treatment window is crucial and determines the entire outcome of the battle.

Although the new coronavirus is completely different from HIV, being able to save more time when treating infected people means a greatly increased success rate of treatment.

As the Delta strain becomes the widely prevalent mainstream strain, the short incubation period and rapid disease progression make clinical treatment more difficult, and targeted clinically effective drugs are urgently needed.

The approved combination of ambavir and romisvir (BRII-196/BRII-198) buys more time for treatment. Compared with other COVID-19 treatment drugs in the world, this combination provides a golden treatment period of up to 10 days. The final results of the Phase III clinical trial showed that whether the patient went to the outpatient clinic for treatment 1-5 days after the onset of symptoms (early stage) or started treatment 6-10 days (late stage), the hospitalization and mortality rates were significantly reduced. This provides a longer treatment window for COVID-19 patients.

"The development of neutralizing antibody drugs is to find antibodies from the infected person's immune system that can neutralize the virus and block it from entering cells." Zhang Linqi, head of the research and development team and professor at the School of Medicine of Tsinghua University, said in a previous interview that the team not only focuses on the antibodies themselves but also studies their "family tree." For example, what are the similarities and differences between two "sister" antibodies? Through microscopic level comparisons, they can determine the relationship between antibody structure and antiviral activity and find antibodies with good clinical efficacy.

Already "fighting" with the mutant virus

"Compared with the new coronavirus antibody drugs that have been approved for emergency use in Europe and the United States, we are the only one that has evaluated the treatment effects on patients infected with mutant strains and obtained data," said Zhang Linqi.

It is reported that the U.S. FDA has previously identified the activity of these two antibody combinations against major mutant virus strains. The results showed that the BRII-196/BRII-198 antibody combination is sensitive to all major international mutant strains: Alpha, Beta, Gamma, Ipsilon, Delta, Lambda, and Miu.

Zhang Linqi's laboratory has been closely tracking virus mutations and has previously studied the impact of variants on the effectiveness of neutralizing antibodies. The results of the study were published in the journal Immunity in July this year. The study showed that the combination of drugs still maintains neutralizing activity against alpha, beta, and gamma.

Next stop, prevention!

In order to prolong the efficacy of the drug, the research team also genetically modified it to extend the half-life of the drug, making it effective in the human body for several months. In addition, the application of bioengineering technology has greatly reduced the risk of antibody-mediated dependent enhancement.

"These unique characteristics mean that the combination drug is not only effective in treating people infected with the new coronavirus, but will also have a highly effective preventive effect on uninfected high-risk groups or people with immunodeficiency." Zhang Linqi said that prevention-related research and analysis are underway.

According to reports, Fosun Pharma is actively advancing the registration application for the combination therapy of Ambavir/Romivir in other mature and emerging markets around the world to obtain market access. Fosun Pharma will also conduct further studies in China to evaluate the preventive immune enhancement effect of the combination therapy of Ambavir/Romivir in immunosuppressed people.

More new drugs on the way

Since January 21, 2020, when the Ministry of Science and Technology deployed a special emergency research and development plan to carry out the task of developing drugs for the new coronavirus, the research and development of new coronavirus treatment drugs has been continuously promoted. On February 16, 2020, the Ministry of Science and Technology, the National Health Commission, the Ministry of Industry and Information Technology, the National Development and Reform Commission, the State Food and Drug Administration, the State Administration of Traditional Chinese Medicine and other departments formed a special drug research and development team to organize a national team of superior experts to continue to make full efforts to promote it.

One neutralizing antibody drug has been approved for emergency use abroad. JS016, developed by Yan Jinghua's team at the Institute of Microbiology, Chinese Academy of Sciences, combined with another antibody from Eli Lilly, a multinational pharmaceutical company, has been authorized for emergency use in 15 countries around the world, with orders for more than 1 million doses.

Chen Zhinan, an academician of the Chinese Academy of Engineering and a professor at the Air Force Medical University, also disclosed at a previous academic seminar that the mepozumab developed by his team obtained clinical trial approval from the U.S. FDA on November 13 last year, and launched an international multicenter Phase III clinical study, awaiting unblinding, and will be used to treat patients with COVID-19 in Shanghai, Shenzhen, Chengdu, Guangzhou and other places in my country.

In terms of small molecule drugs, Azvudine independently developed by Henan Normal University has shown good anti-new coronavirus activity against COVID-19. It is currently undergoing Phase III clinical trials in China, Brazil and Russia, and is expected to be approved for emergency use in Brazil in December.

FB2001, an anti-coronavirus drug candidate jointly developed by the Shanghai Institute of Materia Medica, Chinese Academy of Sciences, ShanghaiTech University, Wuhan Institute of Virology, Chinese Academy of Sciences, and other institutions, was approved by the U.S. FDA for clinical trials in August 2020, and officially launched Phase I clinical trials in the United States in March 2021.

The oral drug candidate VV116 was jointly developed by a number of domestic research institutions, including the Shanghai Institute of Materia Medica, Chinese Academy of Sciences, the Wuhan Institute of Virology, Chinese Academy of Sciences, and the Xinjiang Technical Institute of Physics and Chemistry, Chinese Academy of Sciences. It has now completed preclinical research and was first approved to conduct Phase I, Phase II, and Phase III clinical trials in Uzbekistan.

◎ Science and Technology Daily reporter Zhang Jiaxing

Source: Science and Technology Daily

Editor: Liu Yiyang

Review: Julie

Final review: Liu Haiying