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    Home > Active Ingredient News > Immunology News > The third domestic Adamo single anti-injection fluid was approved for listing.

    The third domestic Adamo single anti-injection fluid was approved for listing.

    • Last Update: 2020-09-24
    • Source: Internet
    • Author: User
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    Recently, according to the official website of the State Drug Administration information, Cynda bioAdamu single anti-injection was approved for the treatment of strong spina bifida, rheumatoid arthritis and psoriasis and other autoimmune diseases, which is also after Baiotai, Haizheng Pharmaceuticals, the third domestic Adamo single anti-approval enterprises.
    it is understood that the original study of Adamo monoantigen (commodity name: Shumeile) is the world's first approved listed all-human source anti-tumor necrotic cause monoclonal antibody, in December 2002 was first approved by the U.S. FDA for the treatment of moderate to severe classes Rheumatoid arthritis, approved by the European EMA in September 2003, has been approved for more than 10 adaptations, including rheumatoid arthritis, mandatory spina bifiditis and psoriasis, sold in more than 96 countries and regions. Known as the "King of Drugs", it has topped the list of the world's best-selling drugs for many years, with global sales of $19.73 billion in 2019, compared with 199.36 in 2018 The $100 million decline, but ultimately the world's best-selling drug Top1, made $9.54 billion in sales in the first half of 2020 and has accumulated more than $140 billion in sales since its launch.
    In terms of global competition, Adamo monoantigens have been approved for listing in the European Union, among them AMJEVITA of Amgen, Hyrimoz of Sandoz and Celtezo of Grigg Ingham have also been approved for listing in the United States as biosimics.
    in the Chinese market, in 2010, Shumeile was approved for listing in China, currently approved including rheumatoid arthritis, strong straight spina bifiditis, plaque psoriasis and other 7 adaptive disorders, in May 2019, Shumei Le was also included in the CDE "China's second batch of clinical urgent need for foreign new drugs list" for the treatment of staphylococcitis, the adaptive can be in accordance with the "clinical continued overseas new drug review and approval procedures" to submit relevant information, directly apply for listing, and will enjoy priority review and approval treatment.
    November 28, 2019, Shumeile entered the 2019 Medicare Category B list through negotiations, with a Medicare payment standard of 1,290 yuan per unit, after being approved for low numbers due to high prices. Shumeile's sales performance in the Chinese market has been poor, statistics show that in 2013-2017, Shumeile's domestic sales in the past five years less than 1% of the total global sales, is now included in the health care catalog, or will usher in a round of market volume.
    However, since the antibody sequence patent for Shumeile expired as early as 2017, the wave of imitations from domestic pharmaceutical companies should not be taken lightly, and according to Frost Sullivan, China's Adamo monobiotic similar drug market is expected to grow to 4.7 billion yuan by 2023 and reach 11.5 billion yuan by 2030.
    Up to now, there are 3 domestic enterprises Adamu single resistance approved, in addition to Xinda Bio, has been approved Baiotai and Haizheng Pharmaceuticals Adamo single resistance has been approved 5 indications and 3 indications, at the same time, according to the pharmaceutical Rubik's Cube database shows that Fuhong Hanxuan, Zhengda Tianqing and Junshi Bio also submitted Adamu single anti-bio-similar drug listing applications, among which, Fuhong Hanxuan declared products are significantly included in the review.
    name source: Medical Valley network !-- content display end -- !-- determine whether the login ends.
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