Johnson & Johnson Submits New Indication Application for BTK Inhibitor Ibrutinib in China

On May 31, the CDE website showed that Johnson & Johnson's Ibrutinib Capsules (Imbruvica, Yike) new indication marketing application was accepted, with specifics undisclosed.

Ibrutinib is the world's first marketed BTK inhibitor, jointly developed by Johnson & Johnson and Pharmacyclics. It received FDA approval for its initial market launch in November 2013 for the treatment of mantle cell lymphoma (MCL). In March 2015, AbbVie acquired Pharmacyclics for $21 billion, obtaining commercial rights to ibrutinib in the U.S. market, while Johnson & Johnson retained commercial rights in other global markets.

As of 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's macroglobulinemia, and 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 lymphocytic leukemia, small lymphocytic lymphoma, and Waldenström's macroglobulinemia.

Since its launch, ibrutinib has performed exceptionally well in the market. However, in 2021, due to competition from similar products, the growth rate of ibrutinib slowed down, with global sales reaching $9.78 billion. Nevertheless, after the patent expiration of lenalidomide, ibrutinib is expected to become the new leading small molecule "king" in the field of oncology.

Currently, there are five BTK inhibitors available on the global market. In 2021, both acalabrutinib and zanubrutinib showed strong growth, reaching $1.238 billion and $218 million, respectively. Zanubrutinib's sales in China amounted to $101.2 million, accounting for nearly half of its global sales. Velexbru from Ono Pharmaceutical and Gilead, as well as orelabrutinib from InnoCare Pharma, are only available in Japan and China, respectively.

From the perspective of the indication layout of marketed BTK inhibitors, Ibrutinib is in a globally leading position with six approved indications and three more in Phase III clinical trials. Zanubrutinib ranks second with five approved indications.

Source: PharmaCube NextPharma