The nearly 10 billion US dollar drug market is attracting many pharmaceutical companies

【Pharmaceutical Network Enterprise News】Recently, Simcere Pharmaceutical ibrutinib capsules were approved for marketing by the State Food and Drug Administration, becoming the first imitation
of the product.
It is understood that on April 7, 2021, the marketing application for ibrutinib capsules submitted by Simcere Pharmaceutical has been accepted by the State Food and Drug Administration, and the drug was also the first generic ibrutinib
drug submitted for marketing in China at that time.
According to public information, ibrutinib is the world's first BTK inhibitor, and the original product Imbruvica is jointly developed
by Johnson & Johnson and Pharmacyclics.
It was approved by the FDA in November 2013 for the treatment of mantle cell lymphoma (MCL).

Up to now, ibrutinib has been approved by the FDA for a number of indications, including mantle cell lymphoma, graft-versus-host disease, marginal zone lymphoma, small lymphocytic lymphoma, Waldenstrom macroglobulinemia, chronic lymphocytic leukemia
.
In August 2017, the product entered the Chinese market and has been approved for the treatment of patients with mantle cell lymphoma, chronic lymphoblastic leukemia, small lymphocytic lymphoma and Waldenstrom macroglobulinemia
.
As a BTK inhibitor, ibrutinib has the characteristics of
long-lasting inhibitory effect, rebuilding immune function, excellent efficacy, safety and reliability in clinical treatment.
Since its approval in 2013, the global sales of ibrutinib have continued to grow, reaching more than US$9.
4 billion in 2020 and US$9.
683 billion
in 2021.
Among them, AbbVie ibrutinib sales in the U.
S.
market reached more than $5.
3 billion, and Johnson & Johnson sales in other regions reached more than
$4.
1 billion.
At present, the excellent performance of the ibrutinib market is also attracting many corporate layouts
.
It is understood that in addition to Simcere Pharmaceutical, domestic companies such as Central America East China, Hisun Pharmaceutical, and CP Tianqing are also developing generic ibrutinib
.
In fact, since its launch, the global sales of ibrutinib have been growing, and with the expansion of the range of indications, the market position of ibrutinib is further consolidating
.
However, with the arrival of the patent period, more and more domestic companies have begun to lay out the research of ibrutinib generic drugs, and the industry expects that the competition in the ibrutinib market will continue to intensify in the future, and with the acceleration of the research and development process of BTK inhibitors, the ibrutinib market is also facing competition
brought by other BTK inhibitors 。 In fact, as an important therapeutic drug for the treatment of B-cell lymphoma, inflammation and autoimmune diseases, 5 BTK inhibitors have been approved worldwide, including Johnson & Johnson/AbbVie's ibrutinib, AstraZeneca's acalabrutinib, Ono Pharmaceutin's tiralutinib, BeiGene's zebrutinib, and InnoCare's orelabrutinib, which are basically deployed in the field of
hematological tumors and autoimmune diseases 。 It is worth mentioning that BeiGene also recently announced that in the final analysis of the global Phase 3 head-to-head ALPINE trial, the independent review committee (IRC) and investigators evaluated the efficacy of BRUKINSA ® (zebrutinib) versus Ecol ® (ibrutinib) to achieve progression-free survival (PFS
).
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to anyone.