Third-generation BCR-ABL inhibitor Assin Pharmaceutical Leukemia candidates were included in the priority review.

It's worth noting that, according to the press release, the inclusion of the drug in the priority review not only means that Arribatini is expected to become Chinese mainland's first third-generation BCR-ABL inhibitor, but also means that Asaan Pharma will welcome the first new drug to be approved for sale.
CML is a malignant tumor associated with white blood cells.
although the first generation of BCR-ABL inhibitors and several subsequent second-generation drugs have significant clinical benefits for the treatment of CML, access resistance has been a major challenge for CML treatment.
BCR-ABL kinase region mutation is one of the important mechanisms of obtainive resistance, of which T315I mutation is one of the common drug-resistant mutation types, the occurrence rate in drug-resistant CML is as high as about 25%.
CML patients with T315I mutations are resistant to the current first- and second-generation BCR-ABL inhibitors, there is a clinical need for an effective new generation of therapeutic drugs.
is an oral third-generation BCR-ABL inhibitor developed by Asaan Pharmaceuticals and is the core variety of Asaan Pharma.
this product has outstanding effects on BCR-ABL and a variety of BCR-ABL mutants, including T315I mutations, for the treatment of first- and second-generation TKI-resistant CML patients.
In June this year, as a result of two key Phase 2 clinical studies, Asahan Pharma submitted to NMPA an application for the listing of a new drug, which is worth mentioning, the first application for the listing of a new drug since the founding of Asaan Pharmaceuticals.
CDE's official website shows that oribathinib is included in the priority review for "qualified approved drugs" and that the indication applied is - intended for adult patients with chronic myeloid leukemia chronic or accelerated periods with T315I mutations after resistance to any tyrosine kinase inhibitor.
is expected to become the first follow-up third-generation BCR-ABL target drug in China to treat drug-resistant CML, according to a press release.
screenshot Source: CDE.com Acen Pharmaceuticals is currently developing Oribatinib worldwide.
July 2019, the species was approved by fda clinical trials in the United States to go directly to Phase 1b clinical studies.
May 2020, Oribatinib received FDA-granted orphan drug and fast-track eligibility to treat CML patients with specific gene mutations that failed to treat existing TKI treatments.
source: Medical Mission Hills.