"0" breakthrough: The first domestic new crown neutralizing antibody was approved for listing

In 2021, China's new crown neutralizing antibody drugs will achieve a breakthrough of zero. Beijing News Drafting/Xu Xiao

In 2021, the new crown epidemic is still continuing, especially the emergence of the Olmi kerong mutation, making the global anti-epidemic situation more severe. On December 8 this year, the State Food and Drug Administration (NMPA) urgently approved the listing of ambavir monoclonal antibody injection and romidavir monoclonal antibody injection of Tengsheng Bo Pharmaceutical Holdings subsidiary Tengsheng Bo Pharmaceutical. This is China's first independent intellectual property rights of the new crown virus neutralizing antibody combination treatment drug - China's new crown neutralizing antibody drug to achieve zero breakthrough. Data from multiple third-party independent laboratories show that the above drugs are fully effective in neutralizing Omexon.

The APPROVAL BYA is based on the final and interim results of a positive study of ACTIV-2, a Phase 3 clinical trial supported by the National Institutes of Health. The study, which involved 847 patients enrolled, showed that combined ambavirumab/romizumab had an 80% reduction in hospitalizations and deaths (78% in the medium term) in non-hospitalized COVID-19 patients whose clinical progression from high risk to serious disease compared with placebo, while fewer deaths within 28 days (0 in the treatment group and 9 in the placebo group) and a higher safety and statistically significant difference. Similar efficacy was observed in participants who started treatment early (0-5 days) and late (6-10 days) after symptom onset, providing much-needed clinical evidence for patients with COVID-19 who received treatment later.

Data from a number of third-party independent laboratories such as tsinghua university laboratories, columbia university laboratories, and independent laboratories of the U.S. Food and Drug Administration show that in the above-mentioned combination therapy of new crown neutralizing antibodies, the activity of ampaviumab on the Omilcroon mutant strain is reduced, but it still has a certain inhibitory effect, and in the case of high concentrations, more than 90% of the virus can be suppressed. The activity of romizumab against the Omikejong mutant strain did not change at all. This means that the domestic new crown "special drug" can be completely effective in neutralizing Omi kerong.

"Combined with clinical trials at home and abroad and emergency rescue experience in China, the earlier this antibody drug intervenes in patient treatment, the better the effect, because the virus will replicate and multiply in large quantities without inhibition." Tengsheng Huachuang CEO Luo Yongqing said.

Up to now, a total of 5 new crown neutralization antibodies or combination therapies have been approved/emergency use authorizations worldwide, in addition to the new crown neutralization antibody combination therapy of Tengsheng Bo Medicine, there are also bamlanivimab/etesevimab combination therapy of Eli Lilly and Junshi Bio, casirivimab/imdevimab combination therapy of regeneration yuan, GlaxoSmithKline and VIR's sotorovimab monoclonal antibody and Celltrion's regdanvimab monoclonal antibody. In addition to COVID-19 neutralizing antibodies for treatment, there are also COVID-19 neutralizing antibodies for prophylaxis: AstraZeneca's combination of long-acting antibodies (tixagevimab and cilgavimab) has been authorized for emergency use in the United States for USE in PRE-exposure prophylaxis (PREP) and is the first COVID-19 neutralizing antibody approved for PRE-exposure prophylaxis of COVID-19.

Up to now, the research and development of domestic new crown pneumonia treatment drugs is mainly centered on the three technical routes of "inhibiting virus replication", "blocking virus entry into cells" and "regulating the human immune system", including amphavir monoclonal antibody injection and romimavir monoclonal antibody injection neutralizing antibody combination therapy, azfedine, pkrutide and other key drugs. In addition to Tengsheng Bo Pharmaceutical and Junshi Biologics, there are also a number of domestic pharmaceutical companies in the layout of the research and development of new crown pneumonia drugs, including Shutaishen, Luye Pharmaceutical, BeiGene, Pioneering Pharmaceutical, Danxu Biologics, etc.

Beijing News reporter Wang Kara

Proofread by Zhao Lin