On Monday, December 8, 2025, Ascentage Pharma Group International presented the first dataset from its global Phase III POLARIS‑1 study of olverembatinib (HQP1351) in combination with low‑intensity chemotherapy for newly diagnosed Philadelphia‑chromosome‑positive acute lymphoblastic leukemia (Ph+ ALL) at the 67th American Society of Hematology (ASH) Annual Meeting in Orlando, Florida. The poster data showed a best minimal residual disease (MRD) negativity rate of 66.0 % and an MRD‑negative complete response (CR) rate of 64.2 % after three induction cycles, the highest rates reported to date for this patient population.
The 66 % MRD negativity and 64 % MRD‑negative CR rates represent a significant therapeutic advance. In Ph+ ALL, deep MRD responses are strongly correlated with long‑term survival and reduced relapse risk. Achieving these rates with a low‑intensity chemotherapy backbone suggests that olverembatinib can deliver durable remissions while limiting treatment‑related toxicity, potentially positioning it as a new standard of care for patients who are ineligible for intensive regimens.
Olverembatinib’s clinical promise is reinforced by recent regulatory milestones. The FDA and EMA have cleared the global Phase III POLARIS‑1 trial, enabling the company to pursue international approvals. In addition to Ph+ ALL, Ascentage is conducting two other Phase III registrational trials—one in chronic‑phase chronic myeloid leukemia (CML‑CP) and another in SDH‑deficient gastrointestinal stromal tumors (GIST)—which together broaden the drug’s potential market and strengthen its commercial pipeline.
The data are part of a broader partnership with Takeda that has already provided a $100 million option payment and a $75 million equity investment. In 2024, Ascentage reported a 342 % year‑over‑year revenue increase to $134.3 million, driven largely by the Takeda deal and a 52 % rise in olverembatinib sales in China to $33.0 million. The company also posted a net profit in the first half of 2024, underscoring the financial momentum behind its clinical program.
Chief Medical Officer Dr. Yifan Zhai highlighted the significance of the results, stating, “The POLARIS‑1 data demonstrate that olverembatinib can achieve deep, durable responses with a tolerable safety profile, supporting its potential to become a new standard of care outside China.” He added that the FDA and EMA clearances “validate the global development strategy and accelerate the drug’s path to market.”
These findings reinforce Ascentage’s strategy to expand olverembatinib beyond China, leveraging its partnership with Takeda and the momentum from its Phase III trials to capture a growing share of the global Ph+ ALL market while maintaining a strong financial foundation.
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