Johnson & Johnson BTK Inhibitor Ibrutinib New Indication for Listing

On May 31, the CDE official website showed that Johnson & Johnson’s new indications for ibrutinib capsules (Imbruvica, Yike) have been accepted for marketing, but the details were not disclosed.

Ibrutinib is the world's first marketed BTK inhibitor, developed by Johnson & Johnson and Pharmacyclics. It was first approved by the FDA in November 2013 for the treatment of mantle cell lymphoma (MCL). In March 2015, AbbVie spent US$21 billion to acquire Pharmacyclics, obtaining the commercial rights of ibrutinib in the US market, while Johnson & Johnson has commercial rights in other countries around the world.

Up to now, ibrutinib has been approved by the FDA for multiple indications, including mantle cell lymphoma, graft-versus-host disease, marginal zone lymphoma, small lymphocytic lymphoma, Waldenström macroglobulinemia, chronic lymphocytic lymphoma leukemia. In August 2017, the product entered the Chinese market and has been approved for the treatment of patients with mantle cell lymphoma, chronic lymphocytic leukemia, small lymphocytic lymphoma and Waldenström macroglobulinemia.

Since its launch, ibrutinib has performed very well in the market. However, due to competition from similar competing products in the market in 2021, the growth rate of ibrutinib will slow down, and the global sales will be US$9.78 billion. However, after the lenalidomide patent expires, ibrutinib may become the new small molecule "king" in the field of oncology.

At present, there are 5 BTK inhibitors on the market worldwide. In 2021, both acalatinib and zanubrutinib will see strong growth, reaching $1.238 billion and $218 million, respectively. Among them, domestic sales of zanubrutinib were US$101.2 million, accounting for almost half of global sales. Ono Pharmaceuticals and Gilead's Velexbru and InnoCare's Orelabrutinib are only available in Japan and China, respectively.

From the perspective of the indications of BTK inhibitors that have been listed, ibrutinib is in a leading position in the world, with 6 indications approved and 3 indications in Phase III clinical stage. Zanubrutinib is in the second position and has been approved for 5 indications.