By Daniella Parra

Ascentage Pharma (NASDAQ: AAPG; HKEX) said that its drug Olverembatinib is the first China-approved third-generation BCR-ABL inhibitor, and has been approved for certain chronic myeloid leukemia (CML) indications and included in China’s National Reimbursement Drug List.

Olverembatinib, is first-line treatment of newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) in combination with low-intensity chemotherapy, Ascentage said.

Ph+ ALL, which accounts for 20%-30% of adult ALL cases, has poor treatment tolerance and prognosis, with existing first- and second-generation tyrosine kinase inhibitors (TKIs) facing limitations such as high relapse rates, they said.

 “We are much encouraged to have olverembatinib’s clinical value once again recognized by the regulatory authority in China,” Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma, said. “This BTD underscores the therapeutic potential and utility of olverembatinib in Ph+ ALL, a hematologic malignancy with dismal prognosis. Moving forward, we will strive to accelerate this clinical development program for olverembatinib and bring it to more patients as quickly as possible.”

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