Johnson & Johnson's Ibrutinib New Indication Receives Notification from NMPA
Johnson & Johnson
Medical Device R&D and Manufacturer
Pharmacyclics
Clinical-Stage Biopharmaceutical Company
BeOne
Developer of Molecular Targeted and Immune Anti-Tumor Drugs
InnoCare
Innovative Drug Developer
AstraZeneca
Pharmaceutical Technology Research and Development Provider
According to the NMPA official website,Johnson & JohnsonSubmittedIbrutinib CapsulesThe 2.4 category marketing application has received a notification.
Screenshot source: NMPA official website
Ibrutinib is the world's first marketed BTK inhibitor, developed byJohnson & JohnsonAndPharmacyclicsCo-development. In March 2015, AbbVie spent a whopping $21 billion to acquire Pharmacyclics, obtaining the development rights for the U.S. market of Ibrutinib, while Johnson & Johnson holds the development rights for Ibrutinib in other countries globally. In June last year, Johnson & Johnson submitted a new indication marketing application for Ibrutinib capsules.
Currently, six BTK inhibitors have been approved globally, four of which have been launched in China.RespectivelyAbbVieAndJohnson & JohnsonTheIbrutinib、BeOne MedicinesTheZanubrutinib, andInnoCareTheOrelabrutinibAndAstraZenecaTheAcalabrutinib, and all have been included in the medical insurance catalog. Among them, ibrutinib belongs to the first-generation BTK inhibitor and has been approved for use in China.Treatment of patients with mantle cell lymphoma, chronic lymphocytic leukemia, small lymphocytic lymphoma, and Waldenström's macroglobulinemia.
According to the PharmaCloud database, there are currentlySimcere Pharmaceutical, Beijing Haibu Pharmaceutical, Qilu PharmaceuticalDomestic pharmaceutical companies have submitted generic listing applications for Ibrutinib, including Simcere Pharmaceutical.BeOne Medicines' Ibrutinib capsules were approved last year, securing the first generic version.
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