Blue Whale Finance Tu Jun
Autumn and winter are high incidence seasons for respiratory infectious diseases. In addition to mycoplasma and influenza, respiratory syncytial virus (RSV) is also the most common viral pathogen.
On January 2nd, AstraZeneca and Sanofi collaborated to develop and commercialize a long-acting monoclonal antibody called Nirsevimab, which has been officially approved for marketing by the National Medical Products Administration of China. It is used to prevent lower respiratory tract infections (LRTI) caused by respiratory syncytial virus (RSV) in newborns and infants. This medication is suitable for newborns and infants who are about to enter or are born during the first RSV infection season.
Nicetizumab is also the first and currently the only approved preventive measure in China to protect the vast infant population against RSV infection.
"At present, there is no specific therapeutic drug for respiratory syncytial virus disease in infants, and the impact of severe infection with syncytial virus during infancy may be long-term. Therefore, prevention has become the key to protecting infants." Professor Liu Hanmin, Dean of West China Second Hospital of Sichuan University and main researcher (PI) of the Phase III clinical trial of Nisetumab in China, said.
For a long time, the clinical treatment options for RSV infected individuals were very limited. Taking children as an example, RSV infection is limited to supportive care and adjuvant treatment, such as oxygen, nasal congestion relievers, nutritional and water supplements, and the use of bronchodilators. The main antiviral treatment methods include ribavirin and interferon, but due to toxic side effects, the use of these two antiviral drugs is more cautious.
The development of respiratory syncytial virus vaccines has also been quite bumpy, starting with the inactivated formalin RSV vaccine in the early 1960s. However, this study was unable to successfully develop a vaccine with protective effects. In the following years, several RSV vaccines that entered clinical trials also failed, such as Novavax's recombinant nanoparticle RSV vaccine, Jassen's adenovirus vector RSV vaccine, and so on. Prior to May last year, there were no effective RSV vaccines available globally.
However, the just passed year of 2023 can be considered a breakthrough year for respiratory syncytial virus vaccines. Last May, GSK's Arexvy RSV vaccine was approved by the US FDA for marketing to prevent lower respiratory tract disease (LRTD) caused by RSV in individuals aged 60 and above.
Subsequently, Pfizer's bivalent vaccine Abrysvo also received FDA approval for marketing at the end of May 2023, protecting the same elderly population. The vaccine was approved for extended indications in August last year, protecting newborns by vaccinating pregnant women. Therefore, 2023 is also known as the "first year of commercialization of RSV vaccines".
However, the two vaccines mentioned above have not yet been launched in China, and the development strategy of Nisetivir monoclonal antibody targets a different patient group, filling the gap in the prevention of respiratory syncytial virus in newborns and infants in China. This approval has made Nisevizumab the first and only approved preventive measure in China to protect the general infant population against RSV infection, covering healthy full-term infants, premature infants, and infants who are susceptible to severe RSV infection due to special health conditions.
As an innovative long-acting monoclonal antibody, Nisetivir monoclonal antibody has been approved in China mainly based on three key clinical trial results and Chinese clinical research and development projects. For all clinical trial endpoints, a single injection of niseverumab has shown consistent efficacy in treating lower respiratory tract diseases caused by respiratory syncytial virus, with a sustainable protection period of five months, which is a typical RSV infection season.
"The approval of niseverumab for marketing in China not only reduces the disease burden caused by syncytial virus infection in children and families, but also hopes to reduce the medical system burden caused by respiratory diseases in pediatrics," said Professor Liu Hanmin.
It is reported that Nisevirumab is expected to be launched in China during the RSV infection season from 2024 to 2025.
Previously, Nisevizumab was approved in the European Union in October 2022 to prevent lower respiratory tract diseases caused by RSV in newborns and infants during the first season of RSV infection. Subsequently, in July 2023, based on the unanimous recommendation of the Antibacterial Drugs Advisory Committee, Nisetumab was approved by the US Food and Drug Administration (FDA). At present, the listing applications submitted by Nisevizumab in Japan and multiple other markets are also under review.
It is worth mentioning that since mid October last year, there has been a surge in cases of respiratory syncytial virus infection in infants and young children in the United States. Since then, there has been a shortage of supply of niseverumab. According to a White House statement, relevant government officials have urged the expansion of niseverumab vaccine supply.
Industry insiders have pointed out that the domestic RSV prevention and treatment track is just beginning, which can be described as a blue ocean. In fact, many domestic enterprises have also laid out this track.
According to data from Zhuo Shi Consulting, the global market size of RSV drugs, including therapeutic and preventive drugs, is expected to increase from $1.9 billion in 2022 to $12.8 billion in 2032, with a compound annual growth rate of 20.8%.
Last October, Zhifei Biotechnology mentioned in the announcement on signing an exclusive distribution and joint promotion agreement with GSK that GlaxoSmithKline would prioritize becoming the exclusive partner of Zhifei Biotechnology in the joint development and commercialization of any respiratory syncytial virus (RSV) vaccines for the elderly in the cooperation area.
In terms of independent research and development, multiple companies including Adivixin, Tainuomabo, Zhifei Biotechnology, Aimei Vaccine, Shiyao Group, Baike Biotechnology, etc. are also laying out respiratory syncytial virus (RSV) vaccines. In addition to reaching an agency cooperation with GSK, Zhifei Biotechnology is also researching RSV vaccines.