The National Medical Products Administration Approves Novel Drug Olverembatinib for the Treatment of Chronic Myeloid Leukemia of Innovent Biologics, Inc
November 25, 2021 at 06:46 pm EST
The board of directors of Innovent Biologics, Inc. announced that the novel drug olverembatinib (Innovent R&D code: IBI-348) has been approved by the China National Medical Products Administration ("NMPA") for the treatment of adult patients with tyrosine
kinase inhibitor (" TKI ")-resistant chronic phase chronic myeloid leukemia (" CML-CP ") or accelerated-phase chronic myeloid leukemia (" CML-AP ") harboring the T315I mutation as confirmed by a validated diagnostic test. Olverembatinib is the sixth approved product of the
Company and is also the second approved small-molecule drug.
Olverembatinib is a potentially best-in-class BCR-ABL TKI that is developed by Ascentage
Pharma Group International (" Ascentage Pharma ") and has been supported by the major
new drug project of the Ministry of Science and Technology. Innovent and Ascentage will be
mutually committed to the commercialization of olverembatinib in China market. As China's first
third-generation BCL-ABL TKI developed for the treatment of TKI-resistant CML, this approval
will address an important unmet treatment need in T315I-mutant CML, bringing benefits for more
patients and their families.
This approval for olverembatinib is based on the results from two pivotal Phase II studies - the
HQP1351CC201 study and the HQP1351CC202 study. These results showed that olverembatinib
is efficacious and well-tolerated in patients with CML-CP and CML-AP, and the probability and
deepness of clinical response is expected to increase with prolonged treatment period.
CML is a hematologic malignancy of the white blood cells. The introduction of BCR-ABL TKIs
have significantly improved the clinical management of CML. However, acquired resistance to
TKIs remains a major challenge in the treatment of CML. BCR-ABL tyrosine kinase mutations
represent a key mechanism of acquired drug resistance; T315I, which is the most common
drug-resistant mutation, occurs in about 25% of patients with drug-resistant CML. Patients with
T315I-mutant CML are resistant to both first- and second-generation BCR-ABL inhibitors, hence
presenting an urgent unmet medical need for an effective treatment. The Company is pleased about
the NDA approval of olverembatinib in China and looks forward to bringing out this novel drug
to solve the unmet medical needs from Chinese TKI-resistant T315I-mutated CML patients as early
as possible.