Ascentage Pharma Group International announced that the U.S. Food and Drug Administration and the European Medicines Agency have granted clearance to launch the global Phase III POLARIS‑1 study of its third‑generation BCR‑ABL inhibitor olverembatinib in combination with low‑intensity chemotherapy for newly diagnosed Philadelphia‑chromosome‑positive acute lymphoblastic leukemia (Ph+ ALL). The clearance allows the company to enroll patients across multiple countries, accelerating the path to registration in the United States and Europe.
The approval marks a significant regulatory milestone for Ascentage. By opening a global registrational study, the company can demonstrate efficacy and safety in a broader patient population, positioning olverembatinib as a potential first‑line therapy in a high‑margin oncology market that currently relies on older TKIs and intensive chemotherapy regimens. The study builds on the drug’s success in China, where it has already been approved for chronic myeloid leukemia and is generating strong sales growth.
POLARIS‑1 will enroll adult patients newly diagnosed with Ph+ ALL and will evaluate olverembatinib in combination with a low‑intensity chemotherapy backbone. The primary endpoint is the rate of minimal residual disease (MRD) negativity after three treatment cycles, a surrogate for long‑term remission. The study is scheduled to release its first dataset at the 2025 American Society of Hematology Annual Meeting, where early data showed a 65% MRD‑negative complete response rate among treatment‑naïve patients.
The clearance expands olverembatinib’s commercial potential beyond its current indications in China. Ascentage’s recent U.S. IPO raised $132.5 million, and the company’s revenue from olverembatinib sales in China grew 93% year‑over‑year to $30.3 million in the first half of 2025. Despite a $82.5 million loss for the same period, the company has secured a $100 million IP income and a $75 million equity investment from Takeda, which holds an exclusive option to license global rights outside key Asian territories. The partnership is expected to provide the resources and expertise needed to accelerate global development and commercialization.
Investors responded positively to the announcement, reflecting confidence in the drug’s potential to transform the Ph+ ALL treatment landscape and to broaden Ascentage’s revenue base. The company’s strategic focus on next‑generation kinase inhibitors and its growing pipeline position it to transition from a clinical‑stage developer to a commercial biopharmaceutical entity.
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