Still working! The first domestic COVID-19 special drug maintains neutral activity on Omi kerong

On the evening of December 12, Temshengbo Announced that new in vitro chimeric virus experiments and data show that its combination ambavir/romizumab (previously known as BRII-196/BRII-198 combination therapy) maintains neutralizing activity against the novel coronavirus variant Omicron.

Temsenbo said the data added more evidence that the combination of amphavir monoclonal antibody/romizumab has remained neutral in activity against major strains of COVID-19 of concern to the World Health Organization (WHO), including Delta and Delta Plus.

Temcent Huachuang CEO Luo Yongqing said at the press conference on the 9th that the FDA is currently reviewing the application for the emergency use authorization (EUA) of Temsheng Bo Pharmaceuticals for the combination of ambavir monoclonal antibody/romidavir monoclonal antibody. This application is based on the final results of international Phase III clinical trials. The final results showed that the combination of amphavir monoclonal antibody/romizumab reduced the risk of hospitalization and death in COVID-19 outpatients at high risk of clinical progression by 80% compared with placebo, which was statistically significant. And as of the 28-day end point, there were zero deaths in the treatment group and 9 deaths in the placebo group, which was better clinically safe than the placebo group.

Ambavir maclizumab and romimab are non-competitive novel severe acute respiratory syndrome virus 2 (SARS-CoV-2) monoclonal neutralizing antibodies obtained by Tengsheng Bo Pharmaceutical in cooperation with Shenzhen Third People's Hospital and Tsinghua University from patients recovering from the new coronavirus pneumonia (COVID-19), and bioengineering technology is specially applied to reduce the risk of antibody-mediated dependence enhancement and extend the plasma half-life for more durable treatment effects.

On the evening of 8 December, the combination of ambavir monoclonal antibody/romizumab was approved by the China Drug Administration (NMPA) as the first domestically produced COVID-19 drug for the treatment of adults and adolescents (12-17 years, weighing ≥40 kg) with mild and ordinary types and high risk factors that progress to severe (including hospitalization or death). Among them, adolescents (12-17 years old, weight ≥40 kg) are conditionally approved.

In October 2021, Temsex Pharmaceuticals completed the submission of an Emergency Use Authorization (EUA) application to the U.S. Food and Drug Administration (FDA) for the combination of amphavir monoclonal antibody/romizumab.

In addition, Temson Bo Pharmaceuticals is actively promoting the registration of ampavirinumab/romimavir monoclonal antibody combination therapy in other mature and emerging markets around the world, first ensuring market access in countries where clinical trials have been conducted and where there are large gaps in access to highly effective treatments. Tengsheng Bo Pharmaceuticals will also conduct further research in China to evaluate the preventive immune enhancement effect of ampavirusumab/romizumab combination therapy in immunosuppressed populations.

For the price issue that has attracted public attention, Li Ankang, chief financial officer of Tengsheng Bo Pharmaceutical, said that the price per dose in the United States is $2100. In China, order volume and supply are still being discussed with the government, which will be related to pricing, so the government purchase price in China has not yet been determined.

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Heavy! The first domestic new crown special drug was born in Haidian!

On December 8, the State Drug Administration (NMPA) approved the registration application of Tengsheng Huachuang Pharmaceutical Technology (Beijing) Co., Ltd. (hereinafter referred to as "Tengsheng Huachuang") for the new coronavirus neutralization antibody combination treatment drugs ambarweisumab injection (BRII-196) and romizumab injection (BRII-198) of Haidian enterprise Tengsheng Huachuang Pharmaceutical Technology (Beijing) Co., Ltd. (hereinafter referred to as "Tengsheng Huachuang").

Specifically for the treatment of adults and adolescents (≥ 12 years of age, weighing ≥40 kg) who test positive for novel coronavirus with risk factors for progression to severe COVID-19.

In clinical trials, high-risk COVID-19 outpatients treated with the drug had an 80% lower risk of hospitalization and death compared to placebo. At the same time, antibodies can persist in the human body for 9 to 12 months, which also has a little effect on preventing infection.

The approval of the listing marks that China has the first fully independent research and development, and after strict random double-blind control standards, the research has proved to be effective anti-new crown virus special drugs.

Zhang Linqi, professor of Tsinghua University School of Medicine and director of the Center for Global Health and Infectious Diseases Research and COMPREHENSIVE RESEARCH Center of AIDS of Tsinghua University, said: "The approval of the combination therapy of ampaviumab/romimavir monoclonal antibody has brought the first special drug for the treatment of covid-19 for China. This therapy has demonstrated excellent safety and protection in international multicentre trials, and is the only antibody drug in the world to have evaluated the therapeutic efficacy of patients with mutant strains and obtained optimal data so far. ”

According to the reporter's understanding, the approved drug is based on the interim results and final results of the 3rd phase of ACTIV-2 supported by the National Institutes of Health.

In the 28-day clinical trial, of the 847 enrolled patients, there were zero deaths in the treatment group and 9 deaths in the placebo group, and the clinical safety was better than that in the placebo group, and the hospitalization and mortality reductions were significantly reduced, both in participants who began treatment early (within 5 days after symptoms appeared) or late in the treatment (within 6 to 10 days after symptoms appeared).

This provides a longer treatment window for COVID-19 patients.

In addition, as part of the study, the team also evaluated the clinical effectiveness of antibody drugs based on the category of the virus variant.

Current in vitro chimeric virus detection data show that the combination of amphavir monoclonal antibody/romizumab has maintained neutral activity against the current major variants, such as delta, alpha, beta, and gamma. Testing of the currently menacing Omiljunn variant is also underway.

It took less than 20 months to go to market

It is worth mentioning that the drug took less than 20 months from research and development to approval. In May 2020, Tengsheng Bo Pharmaceutical, Tsinghua University and the Third People's Hospital of Shenzhen jointly established Tengsheng Huachuang to develop "amphavir monoclonal antibody" and "romizumab" new crown antibody drugs.

During the initial isolation and neutralization of antibodies, the team specifically applied bioengineering techniques to reduce the risk of antibody-mediated dependence enhancement, as well as to extend plasma half-lifespans for more durable therapeutic effects.

In less than 20 months, the team went from initial neutralizing antibody isolation and screening to completing international Phase 3 clinical trials and finally obtaining domestic marketing approval.

Luo Yongqing, President and General Manager of Tengsheng Bo Pharmaceuticals in Greater China, said: "We are excited to achieve this important milestone and are working hard to promote the accessibility of this combination therapy for COVID-19 patients in China. This achievement is a testament to our unwavering commitment to accelerating global innovation in infectious diseases to fill unmet medical needs with efficient, scientific, rigorous and outstanding outcomes. ”

It is reported that since June 2021, Tengsheng Huachuang has provided nearly 3,000 copies of drugs free of charge, supported 22 hospitals in 21 cities to carry out patient treatment, and nearly 900 patients have received clinical treatment, including mild, ordinary, severe and critically ill patients.

Source Beijing Daily client, Beijing Haidian official release

Edited by Huang Pinchao

Process Editor Wu Yue