On July 13, InnoCare Pharma and Biogen made joint announcement that they have entered into an agreement on the license and cooperation of the BTK inhibitor Orelabrutinib.
As per the agreement, Biogen will claim the exclusive global rights of Orelabrutinib in the field of multiple sclerosis, plus the exclusive rights of Orelabrutinib in certain autoimmune diseases in regions outside China (including Hong Kong, S.A.R., China, Macau, S.A.R., China and Taiwan, China). InnoCare Pharma retains the exclusive global rights of Orelabrutinib in the field of oncology and the exclusive rights of certain autoimmune diseases in China (including Hong Kong, S.A.R., China, Macau, S.A.R., China and Taiwan, China). InnoCare Pharma will garner a down payment of 125 million US dollars and be eligible to gain up to 812.5 million US dollars at potential clinical development milestones and commercial milestone payments when the those milestones and sales milestones are met.
Orelabrutinib is known to be a class 1 innovative drug independently developed by InnoCare Pharma. It features a new type of BTK inhibitor that has a high target selectivity in the treatment of lymphoma and autoimmune diseases. In December 2020, the drug was issued with a license from NMPA for the treatment of relapsed/refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), as well as two indications of R/R MCL.
BTK is recognized as a key kinase in the B cell receptor signaling pathway. It plays a vital role in the development and function of immune cells, such as B lymphocytes, macrophages and microglia, involved in the pathological process of MS. It is hopeful that BTK inhibitors will make available novel treatment options for the treatment of autoimmune diseases including MS.
It has been reported in studies that Orelabrutinib in the field of multiple sclerosis is identified to have high selectivity and blood-brain barrier permeability, which allows for a high target occupancy rate in the central nervous system. At present, Orelabrutinib is undergoing a global phase II clinical study for patients that experience relapsing-remitting multiple sclerosis (RRMS). Furthermore, Orelabrutinib has also been rolled out to Phase IIa clinical trials for systemic lupus erythematosus (SLE) in China.
With endorsed R&D strength of Chinese pharmaceutical businesses, a bunch of new drugs going universal
Since CHIPSCREEN's Chidamide was available overseas in 2007, sorts of new drugs have been granted with an overseas license. Incomplete statistics reveal that, so far, at least 17 overseas licenses have been released in 2021. The transaction products chiefly fall into tumor and autoimmune disease drugs, with 3 transactions topping 1 billion US dollars.
License-out Projects in 2021
Orelabrutinib is established as the second domestically authorized BTK inhibitor in China.
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