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.