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The COVID-19 severe treatment drug, Lianhua Qingwen, has been approved.
Release time:
2023-01-31
On January 18, the National Medical Products Administration approved the marketing of tocilizumab injection (trade name: Anwei Tai) submitted by Zhuhai Lizhu Biotech Co., Ltd. This drug is the second domestically approved biosimilar tocilizumab injection in China, indicated for rheumatoid arthritis. Currently, tocilizumab injection has been included in the "Diagnosis and Treatment Plan for Novel Coronavirus Infection (Trial Version 10)" and the "Diagnosis and Treatment Plan for Severe Cases of Novel Coronavirus Infection (Trial Version 4)."
Lizhu Biotech's tocilizumab injection (trade name: Anwei Tai) received SAS approval from the Indonesian Food and Drug Administration (BPOM) on July 26, 2021, during the overseas COVID-19 pandemic in 2021 when some Southeast Asian countries used tocilizumab for the treatment of severe COVID-19. It also received DEU approval from the Philippine Food and Drug Administration (FDA) on October 21, 2021.
Interleukin-6 (IL-6) is a pro-inflammatory cytokine and a key signaling molecule in the cytokine storm in the lungs caused by COVID-19 infection. Tocilizumab can specifically block the binding of IL-6 to its receptor, thereby inhibiting the inflammatory response caused by the IL-6 receptor, including the cytokine storm in the lungs caused by COVID-19 infection. During the prevention and treatment of the COVID-19 pandemic, multiple research teams worldwide have found that IL-6R monoclonal antibodies are effective in treating moderate to severe COVID-19 patients.
The World Health Organization strongly recommended the use of interleukin-6 receptor blockers (tocilizumab or sarilumab) for hospitalized patients with severe or critical COVID-19 in the updated dynamic guidelines on COVID-19 treatment on July 6, 2021. The European Medicines Agency and the U.S. FDA subsequently granted emergency use authorization for tocilizumab from Roche for hospitalized adults and children aged 2 years and older with COVID-19 infection. Multiple domestic and international clinical studies have shown that tocilizumab can significantly reduce the risk of death in hospitalized COVID-19 patients and shorten their hospital stay. The latest research (published in the prestigious medical journal JAMA) indicates that tocilizumab can significantly improve long-term survival benefits for severe COVID-19 patients, while traditional treatment drugs such as corticosteroids and hydroxychloroquine have not provided long-term benefits.
Since the outbreak of COVID-19, over 1 million people worldwide who were hospitalized due to COVID-19 have received tocilizumab treatment. Tocilizumab has been approved in more than 30 countries for patients hospitalized due to severe COVID-19. Studies have shown that the level of interleukin-6 is abnormally elevated in patients with novel coronavirus pneumonia, and administering tocilizumab to these patients can effectively reduce the occurrence of "white lung" or promote the improvement of COVID-19 pneumonia. The approval of Lizhu Biotech's tocilizumab injection will provide effective treatment drugs and plans for patients with severe novel coronavirus infection.
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