Novartic BTK inhibitor "Abtini tablets" have been officially approved for the market

On December 25th, orelabrutinib was approved by NMPA for treatment: 1) for adult sleeve lymphoma (MCL) patients who have received at least one treatment in the past.
2) Patients with chronic lymphoblastic leukemia (CLL)/small lymphocytic lymphoma (SLL) who have received at least one treatment in the past.
Auboutini became the third BTK inhibitor to be listed in the country after Ibdini and Zebtini.
The State Drug Administration requires the licensed holders of the varieties to continue to complete the relevant post-market research in accordance with the conditions and requirements attached.
is a new, powerful BTK inhibitor developed by Novarthren Jianhua.
clinical studies have shown a higher BTK selectivity and nearly 100% BTK occupancy.
BTK is a key signaling molecule of B-cell antigen (BCR) and cytokine-like pathogen pathogens, widely expressed in different types of malignant blood diseases, involving the proliferation, differentiation and apoptosis process of B-cells.
inhibits the proliferation and survival of malignant B cells in the body.
the 2020 ASH Conference, Novarma announced the latest results of a Phase II (NCT03493217) clinical study conducted in 80 patients with difficulty or recurrence in China, with a patient ORR of 91.3% after at least 12 cycles of treatment, of which 10% reached CR.
12-month DOR reached 77.1 per cent, the 12-month progress-free survival rate reached 81.1 per cent and the total survival rate reached 86.3 per cent.
showed significantly higher CR rates during the same treatment cycle than other BTK inhibitors.
addition, the adaptive stage of Aubdinib's treatment of cytolymphoma is also in the filing stage and was included in the CDE's priority review on 26 March.
according to the Pharmaceutical Rubik's Cube NextPharma database, Ebtini still has eight adaptations in development.
, developed jointly by Johnson and Johnson/AbbVie, is the world's first BTK inhibitor to go on the market.
was approved in China in August 2017 and negotiated into the 2017 National Health Insurance Category B list, with a winning bid of 189.00 yuan/140 mg/granules and an annual treatment cost of 207,000 yuan for CLL/SLL.
approved by NMPA on June 10 this year, the winning bid is 176.6 yuan / 80mg / grain, CLL / SLL adaptation treatment costs of 258,000 yuan.
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