Qilu won the first imitation!

Recently, the field of JAK inhibitors has been booming: Qilu won the first imitation of Tofacitinib Citrate Sustained-release Tablets, Pfizer Abraxitinib Tablets was approved in China, and Tofacitinib Citrate Tablets added new indications.
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At present, 9 JAK inhibitors have been approved for marketing in the world, of which 5 have been approved in China; the global sales of the 5 JAK inhibitors in 2021 will total US$6.
89 billion, while the domestic market is still in its infancy
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Among the domestic JAK inhibitors, only tofacitinib citrate tablets have been approved for generic drugs, and Hengrui, Kelun, Chia Tai Tianqing.
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17 Class 1 new drugs are under development
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Qilu won the first imitation of tofacitinib sustained-release tablet, Pfizer's second JAK inhibitor came after AbbVie's JAK inhibitor uppatinib sustained-release tablet was approved for marketing in China, and 2 new adaptations were added After the disease, another JAK inhibitor landed in the domestic market
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At the same time, the first imitation of Qilu Pharmaceutical's tofacitinib citrate sustained-release tablets followed
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On April 11, the State Food and Drug Administration announced that Pfizer's class 1 innovative drug JAK1 inhibitor abroxitinib (trade name: Cipco/CIBINQO) was approved for marketing for use in other systemic treatments (such as hormones or biological drugs).
preparations) in adult patients with refractory, moderate-to-severe atopic dermatitis who do not respond well or who are not suitable for the above treatments
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Abraxitinib is the second JAK inhibitor approved by Pfizer in China
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The first JAK inhibitor tofacitinib citrate tablets (trade name: Shangjie/Xeljanz) was approved for marketing in the United States in 2012 and approved for import in China in 2017.
It is the world's first small molecule for the treatment of rheumatoid arthritis Targeted JAK kinase inhibitors
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On April 18, Pfizer announced that the second indication of tofacitinib citrate was approved and the country's first prescription was issued for the treatment of ankylosing spondylitis
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In the domestic market, tofacitinib citrate tablets are falling into a fierce wave of imitation substitution.
Chia Tai Tianqing, Qilu Pharmaceutical, Kelun Pharmaceutical.
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15 companies have been approved to imitate tofacitinib citrate tablets, and The oral normal-release dosage form of fatinib has also been included in the third batch of centralized procurement to further accelerate the replacement of original research
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On April 21, the official website of the State Food and Drug Administration showed that Qilu Pharmaceutical's tofacitinib citrate sustained-release tablets were approved for marketing, becoming the first domestic imitation + first review
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Qilu Pharmaceutical's tofacitinib citrate tablets are the second in China, and the approval of the sustained-release dosage form will further enhance the company's competitiveness in the field of JAK inhibitors
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Nine JAK inhibitors have been approved worldwide, with five major products totaling US$6.
9 billion.
JAK belongs to the non-receptor protein tyrosine kinase family and consists of four subtypes, JAK1, JAK2, JAK3 and TYK2
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As one of the hot research and development targets in the industry, there are 9 JAK inhibitors approved globally, involving pharmaceutical giants such as Pfizer, Eli Lilly and Novartis
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Among the 9 JAK inhibitors, 5 are first-generation JAK inhibitors, including ruxolitinib from Novartis, tofacitinib from Pfizer, baricitinib from Eli Lilly, Stella's peficitinib, Japan's Tobacco's delgocitinib; 4 are second-generation JAK inhibitors, including Celgene's fedratinib, AbbVie's upadacitinib, Gilead's filgotinib, and Pfizer's abrucitinib (abrocitinib)
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According to data from Minet.
com, the global sales of five JAK inhibitors, including ruxolitinib, tofacitinib, baricitinib, upatinib, and Fedratinib, will total $6.
89 billion in 2021
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Pfizer's tofacitinib led the way with $2.
455 billion in sales, while AbbVie's upatinib surpassed Novartis' tofacitinib in sales three years after its launch
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Globally listed JAK inhibitors At present, five JAK inhibitors, including tofacitinib, ruxolitinib, baricitinib, upatinib, and abrucitinib, have been approved for marketing in China
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Due to the late launch time, the domestic JAK inhibitor market is still in its infancy
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According to the data of Minet.
com, the total terminal sales of tofacitinib, ruxolitinib and baricitinib in Chinese urban public hospitals, county-level public hospitals, urban community centers and township health centers (referred to as Chinese public medical institutions) in 2020 It is close to 400 million yuan, and the total sales in the first half of 2021 will exceed 300 million yuan
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17 Class 1 new drugs under development! Hengrui, Kelun.
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Make efforts Although the domestic JAK inhibitor market is still in its infancy, many local companies have already laid out the research and development of JAK target innovative drugs
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At present, 17 new class 1 drugs of JAK inhibitors are in the clinical research stage
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Among them, Hengrui Medicine's SHR0302 and Zejing Pharmaceutical's Jaketinib are in phase III clinical stage, and the research and development progress is the fastest; Kelun Pharmaceutical's KL130008 capsules, Chia Tai Tianqing's TQ05105 tablets, and Dizhe Medicine's TLL-018 tablets .
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6 new drugs are in Phase II clinical stage
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Research status of domestic JAK inhibitors Hengrui Medicine's SHR0302 takes JAK1 as the target, and has developed two dosage forms of tablet and ointment, and has laid out a number of indications
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At present, the indications of SHR0302 tablets for rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, atopic dermatitis, alopecia areata, and colitis are all in the phase III clinical stage, and the indications for atopic dermatitis have been Include breakthrough therapy
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Zejing Pharma's Jacktinib is a JAK inhibitor targeted small molecule, which has been developed in two dosage forms: tablet and cream
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At present, the indications for myelofibrosis and severe alopecia areata of Jacktinib Hydrochloride Tablets are in Phase III clinical stage; the indications for Jacktinib Hydrochloride Cream for mild to moderate alopecia areata and mild to moderate atopic dermatitis are all in Phase I clinical trials stage
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The KL130008 capsule of Sichuan Kelun Botai, a subsidiary of Kelun Pharmaceutical Holdings, is a selective inhibitor targeting JAK1 and JAK2 kinases.
The product is in the phase II clinical stage for the indications of rheumatoid arthritis, and the indications for severe alopecia areata are In March 2022, it was approved to carry out phase II clinical trials
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Chia Tai Tianqing's TQ05105 tablet is a JAK and ROCK inhibitor, and its indication for myelofibrosis is in the phase II clinical stage
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From the perspective of research and development progress, Hengrui Medicine's SHR0302 is expected to become the first domestic innovative JAK inhibitor
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Data source: Minet database, NMPA, etc.
Note: The statistics are as of April 21.
If there are any omissions, please correct me!