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The new drug application is based on a three-stage trial of randomized, double-blind, parallel control in China to assess the safety and efficacy of GB242 contrast grams (Invlisi monoantigen) and methotrexate combined at a dose of 3 mg/kg intravenously treated patients with rheumatoid arthritis. Class
has the most widely approved adaptations in China in targeted TNF-α drugs, including rheumatoid arthritis (RA), rheumatoid spina bifiditis (AS), psoriasis arthritis (PsA), Crohn's disease (CD) and ulcerative colitis (UC).
sales, including original and biosimilars, were $6.9 billion in 2019.
According to a consulting report, the market size of Invlisi Mono-Resistance in China will be RMB600 million in 2019 and is expected to grow to RMB3.2 billion by 2023 and RMB7.5 billion by 2030, with a compound annual growth rate of 25.6% from 2019 to 2030.
expect biospolitics to account for 64.2% of the market share in Inflissi by 2030.
According to the official website of the China Drug Administration, in addition to Johnson and Johnson's original research drug queer (Invlisi monoanti) at present, there is no Invlixi monobial similar drugs approved for listing in China.
According to the prospectos, three of the four companies in China that are conducting research related to Invlixi mono-drugs, including Jiahe Biopharmaceity, Zhejiang Haizheng Pharmaceuticals and Maybo Pharmaceuticals, have submitted applications for new drugs, while the remaining one (Celltrion) is conducting Phase III trials.
and bioGB242 Invlisi single anti-biosynthic drug applications are listed before industry competition.
about GB242 GB242 is a biosynthic drug candidate for Invlisi monoantigen, which is sold in China in commodity grams.
, similar to Invlisi monoantigen, GB242 is able to bind TNF-α at low doses, thereby inhibiting the body's natural response to TNF-α and improving inflammatory responses and autoimmune diseases.
570 patients in the third phase of the study, which focused on the equivalent efficacy of ACR20 at 30 weeks.
results, GB242 is comparable to glycogen efficacy and there is no clinical difference in immunogenicity.
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