INNOVENT BIO (01801): Orelabatinib tablets have been officially approved for the treatment of CML-CP patients who are resistant or intolerant to first and second-generation TKIs.

INNOVENT BIO (01801) announced that Orelabatini tablets (brand name: Niletinib) have officially received approval from the National Medical Products Administration (NMPA) of China for the treatment of adult patients with chronic-phase chronic myeloid leukemia (CML-CP) who are resistant or intolerant to first- and second-generation tyrosine kinase inhibitors (TKIs). This approval marks another significant progress for the drug following its initial approval in 2021 and inclusion in the 2022 edition of the national medical insurance drug list, and it will further accelerate its availability to a wider range of CML patients in China. Niletinib has received full approval for the target indication based on the results of a pivotal open-label, nationwide, multicenter, randomized Phase 2 clinical study (HQP1351CC203). The study aimed to evaluate the efficacy and safety of Niletinib in CML-CP patients who are resistant or intolerant to first- and second-generation TKIs. Patients were randomly assigned to the Niletinib treatment group or the Best Available Treatment (BAT) control group. Clinical data showed statistically significant improvement in event-free survival (EFS) in the Niletinib treatment group compared to the BAT control group, meeting the primary endpoint of the study. CML is a malignant tumor associated with white blood cells. The advent of targeted BCR-ABL TKI drugs has revolutionized the treatment of CML. However, 20% to 40% of patients still experience treatment failure due to resistance or intolerance during TKI treatment, leading to disease progression or even death. TKI resistance has now become a global challenge in the treatment of CML, highlighting the urgent need for safe and effective new-generation drugs. As the first and only third-generation BCR-ABL inhibitor approved for marketing in China, Niletinib demonstrates outstanding efficacy against BCR-ABL and various BCR-ABL mutations, including the T315I mutation. It has shown good safety and significant effectiveness in patients resistant to first- and second-generation TKIs. In November 2021, Niletinib was approved for the treatment of adult patients with CML-CP or accelerated phase (CML-AP) who are resistant to any TKI and have the T315I mutation. In January 2023, Niletinib was officially included in the national medical insurance drug list, further enhancing its affordability and accessibility. The commercial promotion of this drug in China is jointly undertaken by INNOVENT BIO and Akeso, a company of Ascentage Pharma Group (06855).