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Wen/Rainbow 3, according to the official website of the State Drug Administration, Xinda BioAdam single anti-biosynthic drug IBI-303 was approved, becoming the third domestic Adamu single anti-biological similar drug after Baiotai and Haizheng Pharmaceuticals.
IBI-303 was developed by AbbVie as an all-human anti-tumor necrotic cause ɑ (TNF-ɑ) monoclonal antibody Adamo monoantigen injection, i.e. the most famous Humira, TNF-α is secreted by macrophages, fat cells and activated TH cells, which increase the killing activity of phagocytotic cells by stimulating macrophages to produce cytotoxic metabolites.
TNF-α also stimulates the production of heat-producing proteins and promotes localization of inflammation.
has been shown that rheumatoid arthritis, psoriasis, Crohn's disease, orthopathy and other autoimmune diseases are closely related to TNF-α disease.
2002, Symele was approved by the FDA for the first time, becoming the world's first approved Adamo monoantigen injection.
Currently listed in more than 90 countries around the world, Shumeile has been approved for adaptations including rheumatoid arthritis, hyper-straightening spina bifidosis, psoriasis, early-onset arthritis, Crohn's disease, ulcerative colitis, purulent sweat adenitis, grape membraneitis, etc.
The only adaptations approved in China are rheumatoid arthritis, strong straightening spina bifidosis, psoriasis, multi-joint type of early idynetic arthritis, moderate and severe active Crohn's disease, and vineitis.
in 2012, Shumeile has been the world's highest-paid drug for seven consecutive years, creating a legend in the industry market.
last year, Therberle also generated nearly $20 billion in revenue for AbbVie.
not long ago, the U.S. government pointed out that in the 10 years from 2009 to 2019, AbbVie raised the price of the ride 18 times.
the U.S. House Oversight and Reform Committee (U.S.) has raised questions about the basis for high pricing. House Oversight and Reform Committee subpoenaed AbbVie for cooperating with the government's investigation and submitting documents related to the pricing strategy.
AbbVie's efforts to protect the patent rights to the "money-savvy" drug have also been moving in recent years.
U.S. market, AbbVie has reached agreements with Amjin, Samsung Bioepis, Mylan and other companies.
the terms of the agreement, adamo monobial-like drugs developed by these companies could reach the U.S. market as early as 2023.
2010, Shumeile was approved for listing in China, but has been flat, in addition to the current approval of less adaptive disorders, its high price is also an important reason.
these have led to the "drug king" Shumeile in China's patient use rate of less than 1%.
it was not until last year's health-care negotiations finalised that the unit price of The Mercer fell from 7,600 yuan to 1,290 yuan.
, which were approved late last year, are priced at 1,150 yuan per unit of Adamu monobial-like drugs, which undoubtedly poses a threat to Symele.
this time, Thyme Bio's IBI-303 was successfully approved, regardless of the final pricing, is another reshuffle of the Adamo single-resistance market.
, according to Minanet data show that at present, there are 38 manufacturers in Adamo single resistance with a declaration record.
In addition to the listed imported Shumeile and 3 domestic Adamo single anti-bio-similar drugs, CDE also hosted Zhengda Tianqing, Junshi Biological and Fuhong Hanyu's Adami single anti-injection application for new drugs.
from this point of view, the current domestic Adamo single resistance market still has a lot of run space.
the future domestic market pattern, still need to be considered.