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【Pharmaceutical Network Market Analysis】Adalimumab is the world's first fully human anti-tumor necrosis factor ɑ (TNF-ɑ) monoclonal antibody, which can specifically bind to soluble human TNF-ɑ and block its interaction with TNF receptors p55 and p75 on the cell surface, thereby effectively blocking the inflammatory effect
of TNF-ɑ.
The drug is mainly used for the treatment of autoimmune diseases, has been approved for more than 17 different indications, because of the efficacy and safety is widely recognized, has been marketed
in more than 90 countries around the world.
The original research of the drug was developed by AbbVie, which was launched in the United States in 2003 (trade name: Humira), and entered the Chinese market
in 2010.
According to AbbVie's financial report released on February 2 this year, Humira (adalimumab injection) sales in 2021 were $20.
696 billion, an increase of 3.
5%
over 2020.
In China, as the drug has successively entered the medical insurance for serious diseases in many regions, actively reduced prices in many provinces, and was included in the medical insurance category B directory in 2019, it is also rapidly expanding, and the sales in the hospital in the first three quarters of 2021 have exceeded 500 million yuan, an increase of 382%
year-on-year.
The market space of tens of billions is attracting many enterprises to layout, and at present, the domestic adalimumab biosimilar market has been "full of gunsmoke"
.
Incomplete statistics show that there are more than 20 companies in China that have laid out adalimumab biosimilars
.
Among them, a number of companies have been approved for adalimumab injection, including Innovent Biologics, Chia Tai Tianqing, Henlius, Bio-Thera, Hisun Biologics, a wholly-owned subsidiary of Blank Biologics, and Suzhou United Biologics
.
Previously, China Cell reported the production of adalimumab injection in class 3.
3, intended to be used for the treatment of immune system diseases such as psoriasis, rheumatoid arthritis and ankylosing spondylitis, which was undertaken by CDE on December 16, 2021, and was the seventh company
in China to declare the biosimilar.
In addition, adalimumab biosimilars from Hualan Biologics, Shandong Danhong Pharmaceutical, Wuhan Biologics and other companies have entered the clinical phase III stage
.
On the whole, in addition to the commonly used TNF-α antagonist adalimumab, three imported IL-17(R) target monoclonal antibody injection drugs have been approved for marketing
in China.
Among them, Novartis' skuchilumab injection for ankylosing spondylitis and moderate to severe plaque psoriasis have been included in medical insurance
.
According to incomplete statistics, there are at least 10 anti-IL-17 monoclonal antibodies in clinical trials in China, including Hengrui Pharmaceutical SHR-1314, Junshi Biologics JS005, Akeso Biologics AK111, etc.
, all of which include the development of
ankylosing spondylitis.
Industry analysis believes that adalimumab has completed market education and is widely recognized, due to the wide range of indications, large patient base, and lack of better treatment drugs for various diseases, so the market opportunity for generic drugs is clear
.
In the future, although many competitors will lead to fierce market competition, the huge demand space will also bring more enterprises to expect performance
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice
to anyone.